23
We should use a polypill at 55 Dr. Carlos Brotons
We should use a polypill at 55
Dr Carlos Brotons
Polypill
BMJ VOLUME 326 28 JUNE 2003 bmjcom
The Polypill strategy based on a single daily pill containing six components would prevent 88 of heart attacks and 80 of strokes in healthy individuals aged 55 and older
Polypill
BMJ VOLUME 326 28 JUNE 2003 bmjcom
Fixed-dose combination strategies
for cardiovascular prevention
Sanz G amp Fuster V (2013) Polypills for cardiovascular prevention a step forward
Nat Rev Cardiol doi101038nrcardio2013157
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Polypill
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Polypill
BMJ VOLUME 326 28 JUNE 2003 bmjcom
The Polypill strategy based on a single daily pill containing six components would prevent 88 of heart attacks and 80 of strokes in healthy individuals aged 55 and older
Polypill
BMJ VOLUME 326 28 JUNE 2003 bmjcom
Fixed-dose combination strategies
for cardiovascular prevention
Sanz G amp Fuster V (2013) Polypills for cardiovascular prevention a step forward
Nat Rev Cardiol doi101038nrcardio2013157
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Polypill
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
The Polypill strategy based on a single daily pill containing six components would prevent 88 of heart attacks and 80 of strokes in healthy individuals aged 55 and older
Polypill
BMJ VOLUME 326 28 JUNE 2003 bmjcom
Fixed-dose combination strategies
for cardiovascular prevention
Sanz G amp Fuster V (2013) Polypills for cardiovascular prevention a step forward
Nat Rev Cardiol doi101038nrcardio2013157
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Polypill
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Fixed-dose combination strategies
for cardiovascular prevention
Sanz G amp Fuster V (2013) Polypills for cardiovascular prevention a step forward
Nat Rev Cardiol doi101038nrcardio2013157
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Polypill
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Polypill
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Polypill
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Polypill
9 randomised controlled trials with a total of 7047
participants
7 of the nine trials evaluated the effects of fixed-
dose combination therapy on primary CVD
prevention
The trial length ranged from six weeks to 15 months
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Compare with placebo single drug active component or usual care the effects of fixed-dose combination therapy on all-cause mortality or CVD events are uncertain
Adverse events were common in both the intervention (30) and comparator (24) groups with participants randomised to fixed-dose combination therapy being 20 (95 CI 9 to 30) more likely to report an adverse event
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Mean differences in systolic and diastolic blood
pressure between the intervention and control arms
were -705 mmHg (95 CI -1018 to -387) and -365
mmHg (95 CI -544 to -185) respectively
Mean differences in total and LDL cholesterol between
the intervention and control arms were - 075 mmolL
(95 CI -105 to -046) and -081 mmolL (95 CI -109
to -053) respectively
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Fixed-dose combination therapy improved adherence to
a multi-drug strategy by 33 (26 to 41) compared
with usual care (ONLY ONE STUDY)
Polypill
Cochrane Database Syst Rev 2014 Apr 164CD009868 doi 10100214651858CD009868pub2
Fixed-dose combination therapy for the prevention of cardiovascular disease
de Cates AN1 et al
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Polypill
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
695 CHD patients were randomized to test the effect of a FDC polypill
containing aspirin 100 mg simvastatin 40mg and ramipril 25 5 or 10
mg or the three drugs separately
Primary end-point was adherence to treatment measured by the self-
report Morisky-Green questionnaire (MAQ) and pill count
The FDC group showed improved adherence compared to the group
receiving separate medications after 9 months follow up
63 vs 52 (p=0006) when using MAQ plus pill count to assess
adherence
Polypill
Castellano et al J Am Coll Cardiol 2014() doi101016jjacc201408021
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Arguments For and Against the Polypill Concept
For
Better patient adherence to treatment
bull Reduction in treatment complexity for patients with multiple medications
bull Improved ease of prescription
Lower cost
bull Lower medication cost compared with generics in certain countries
particularly developing countries
bull Reduced health care cost due to the reduction in cardiovascular events
with improved adherence and prevention
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Arguments For and Against the Polypill Concept
Against
In the lsquolsquopreventive strategyrsquorsquo
Risks of systematic administration to an entire population without previous
assessment
bull Medicalization of a lsquolsquohealthyrsquorsquo population
bull Adverse psychological effects
bull Negative effect on healthy lifestyles
bull Fear of adverse reactions
Author Sanz G et al Policomprimido iquestquimera o realidad Rev Esp Cardiol 2014
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
Arguments For and Against the Polypill
Concept
Against
In primary prevention
Absence of studies that prove efficacy and acceptance by patients
and professionals
Difficulty of selecting drugs and doses
Difficulty of identifying suitable patients (indications) and the level of
risk required for beginning therapy
In secondary prevention
Difficulty of individualizing doses and achieving guideline
recommendations
Author Sanz G et al
Policomprimido
iquestquimera o realidad Rev
Esp Cardiol 2014
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
New trials
Ongoing trials on primary
prevention with major
cardiovascular diseases as
endpoints
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
New trials TIPS-3
Estimated Enrollment 5500
Study Start Date June 2012
Estimated Study Completion Date January 2019
Estimated Primary Completion Date June 2018 (Final data collection date
for primary outcome measure)
Arms Assigned Interventions
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
New trials HOPE-3
Enrollment 12705
Study Start Date May 2007
Estimated Study Completion Date March 2016
Estimated Primary Completion Date October 2015 (Final data collection
date for primary outcome measure)
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
New trials Poly-Iran
Estimated Enrollment 7000
Study Start Date February 2011
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018 (Final data collection date
for primary outcome measure)
Arms
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
The polypill could potentially be widely used
in secondary prevention and in selected
high-risk individuals without CVD (eg those
with severe hypertension or diabetes
mellitus with additional risk factors)
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
By contrast in individuals without CVD and
not at high risk large trials are needed to
quantify the benefits potential risks and
cost-effectiveness of the polypill
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
However the polypill should not be
considered in isolation but as an integral
part of a comprehensive CVD prevention
strategy that includes efforts to reduce
tobacco use increase physical activity and
increase consumption of heart-healthy diets
The Polypill as Part of a Global Strategy
to Substantially Reduce the CVD Burden
