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IntroductionDRAXXIN is a highly effective, single-dose antimicrobial medication indicated for control of BRD in cattle at high risk of developing BRD caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, and for treatment of BRD caused by these three organisms and Mycoplasma bovis. When administered according to the label dose of 2.5 mg tulathromycin/kg body weight (BW), tulathromycin is rapidly absorbed, distributes widely and provides concentrations in bovine lung for an extended period.1 Clinical efficacy of
DRAXXIN for treatment of BRD, as well as for control of respiratory disease in cattle at high risk of developing BRD, has been well documented in multiple studies.2,3,4 This technical bulletin presents the results of a multilocation study designed to compare the efficacy of DRAXXIN or Baytril for treatment of naturally occurring BRD in feedlot calves. The same study protocol was used at all three sites. Results were analyzed separately by site, and results from two sites have been published in the peer-reviewed literature.5
DRX07033
8
August 2007
Efficacy of DRAXXIN or Baytril for treatment of naturally occurring bovine respiratory disease in calves at 3 feedlots
Key Points• Clinical success was significantly higher (P=0.009, P=0.031, P=0.031) for calves
treated with DRAXXIN® (tulathromycin) Injectable Solution (87.9%, 80.0%, 87.8%) than for those treated with Baytril® (enrofloxacin) Injectable Solution (70.2%, 62.5%, 74.7%).
• Fewer animals treated with DRAXXIN required second (n=44) and third (n=13) treatments than animals treated with Baytril (n=97 and n=27, respectively). Consequently, fewer total treatments were administered to cattle in the DRAXXIN groups than to cattle in the Baytril groups.
• DRAXXIN administered as a single subcutaneous (SC) injection was safe and effective for the initial treatment of bovine respiratory disease (BRD) in calves at 3 feedlots.
Materials and MethodsIn October and November 2005, calves were purchased at livestock markets in Mississippi and Texas and transported to the commercial feedlots in Colorado (n=806 mixed-breed steers), Texas site I (n=742 mixed-breed heifers) and Texas site II (n=802 mixed-breed heifers). Animals were processed on arrival using standard methods for commercial stocker/feeder operations, but were not vaccinated against Mannheimia or Pasteurella species. Calves with clinical signs of BRD were evaluated and enrolled if they had a clinical attitude score (CAS) of 1, 2 or 3 and pyrexia (rectal temperature ≥ 104ºF). According to the CAS system, 0=normal, bright, alert, responsive; 1=mild depression, signs of weakness usually not present; 2=moderate depression, some signs of weakness, may be reluctant to stand; 3=severe depression, difficulty standing, head lowered or extended; or 4=moribund. Calves that met the inclusion criteria were randomly assigned to treatment with either Baytril (5.7 mg enrofloxacin/lb; 12.5 mg/kg BW) or DRAXXIN (1.1 mg tulathromycin/lb; 2.5 mg tulathromycin/kg BW; Figure 1). Animals were blocked (2 animals per block, 1 from each group) by order of enrollment to avoid bias. One-hundred-twenty-five animals per treatment group were enrolled at each site and commingled in treatment pens to maintain masking of the treatment groups. Enrollment occurred during a 3-day period in Colorado, an 18-day period in Texas I and a 13-day period in Texas II.
Animals were assessed daily and CAS scores recorded for 28 days following enrollment; animals were observed for treatment response/nonresponse for 63 days in Colorado, 59 days in Texas I and 58 days in Texas II. Clinical assessors were masked to treatments. Animals were eligible for secondary treatments on day 3 after enrollment (day 0). On days 3 to the end of the study, animals with CAS scores of 1 or 2 and pyrexia (rectal temperature ≥ 104ºF) were considered nonresponders and received a second treatment with LIQUAMYCIN® LA-200® (9.0 mg oxytetracycline/lb; 20.0 mg oxytetracycline/kg). Animals that were a minimum of 2 days following treatment with LA-200 and met nonresponder criteria received a third treatment with Nuflor® (florfenicol) Injectable Solution (18.0 mg florfenicol/lb; 40.0 mg florfenicol/kg). Animals that met nonresponder criteria and were a
minimum of 2 days post-treatment with Nuflor were classified as chronics and received the standard feedlot treatment (SFLT).
According to the study protocol, animals were to be removed from the study before analysis for non-BRD reasons (concurrent disease or other physical conditions that might interfere with the progression of BRD or evaluation of response to therapy) or protocol deviations (allotment entry errors, errors in administration of medication, animals not evaluated/treated in a timely manner). Clinical success was defined as requiring no subsequent treatment. Mortality, CAS scores, body weights and weight gains were summarized for each treatment. Treatment differences were assessed at the 5% level of significance (P<0.05).
ResultsColorado
The clinical success for study days 0 to 59 was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%; Table 1). Figure 2a displays the cumulative treatment success by day. Animals with an in-pen CAS equal to 0 (normal) after the initial treatment are displayed in Figure 3a. Second treatments were administered to 37 animals in the Baytril group and 15 in the DRAXXIN group. Third treatments were administered to 9 animals in the Baytril group and 4 in the DRAXXIN group. Weight gains were numerically greater (P=0.0510) for animals treated with DRAXXIN (180.9 lb) than for those treated with Baytril (173.0 lb). One animal in the Baytril group was declared a chronic; no deaths due to BRD occurred in either group. DRAXXIN was significantly more efficacious than Baytril for treatment of naturally occurring BRD at this site.
Texas I
The clinical success for study days 0 to 63 was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%; Table 1). This is also displayed in Figure 2b as cumulative treatment success by day. Animals displaying an in-pen CAS equal to 0 after the initial treatment are displayed in Figure 3b. Second treatments were administered to 44 animals in the Baytril group and 23 in the DRAXXIN group. Third treatments were administered to 17 animals in the Baytril group and 9 in the DRAXXIN group. Seventeen animals were classified as chronics, 7 in the DRAXXIN group and 8 in the Baytril group. One animal in each group died before SFLT. Weight gains were numerically greater (P=0.3589) for animals treated with DRAXXIN (78.1 lb) than for those treated with Baytril (71.6 lb). Mortality was similar for both groups: 6 animals in the DRAXXIN group and 5 in the Baytril group. DRAXXIN was significantly more efficacious than Baytril for treatment of naturally occurring BRD at this site.
Texas II
Two-hundred-fifty animals were enrolled in the study. Seventy-seven animals were excluded from the study analyses for non-
BRD reasons or protocol deviations defined before the study began. Additionally, for the 37 animals excluded for protocol deviations, 29 block mates were also excluded to avoid potential bias. (The numbers differ because in some instances both animals in a block were excluded for protocol deviations.) Data collected from 83 animals in the Baytril group and 90 animals in the DRAXXIN group were analyzed and are reported here. Because of the number of animals affected by protocol deviations, preliminary analysis of all cattle at this site was conducted and demonstrated no effect on statistical results.
Table 1 summarizes the response to treatment at this site. As depicted in Figure 2c, clinical success was significantly greater (P=0.031) for animals treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%). Second treatments were administered to 16 animals in the Baytril group and 6 in the DRAXXIN group. Third treatments were administered to 1 animal in the Baytril group and 0 in the DRAXXIN group. Animals displaying an in-pen CAS equal to 0 after the initial treatment are displayed in Figure 3c. A significant advantage (P=0.0035) in mean weight gains was observed for animals treated with DRAXXIN (202.7 lb) compared to those treated with Baytril (172.9 lb). Nine animals in the Baytril group and 5 in the DRAXXIN group died.
DiscussionAt all three sites, clinical success was significantly higher for calves treated with DRAXXIN (87.9%, 80% and 87.8%) than for those treated with Baytril (70.2%, 62.5%, 74.7%). The results of the primary study variable — first-treatment success — were similar at all sites. The treatment success for cattle treated with DRAXXIN was better at each individual site and collectively for all three sites. The numbers of cattle treated with DRAXXIN that required further treatment ranged from 6 to 15 per site compared to 16 to 44 per site for the cattle treated with Baytril. The first-treatment success and total number of treatments administered were more favorable at every site for the cattle treated with DRAXXIN. At all three sites, a total of 57 calves in the DRAXXIN groups and 124 calves in the Baytril groups required second and third treatments. Consequently, fewer antimicrobial treatments were administered to animals in the DRAXXIN groups than in the Baytril groups.
Taken together, evidence from the three sites demonstrates that DRAXXIN provides effective and consistent results in treating BRD in feedlot calves compared with Baytril. Enrollment times (3, 18 and 13 days) reflect realistic variances in groups of cattle and typical commercial-receiving conditions. The initial variable for enrollment was the CAS, which relies on clinical signs as evidence of BRD. Numerous factors could result in different CAS values among sites, including cattle source, disease exposure, transport conditions and local weather. The individuals responsible for evaluation and treatment of the cattle were blinded to the treatments administered and to the allocation and blocking of cattle in the treatment groups, so the
cattle were treated similarly within each site regardless of the time required for treatment allocation. In addition, the results were similar across sites in that there was a similar magnitude of difference in first-treatment successes between the treatment groups and no difference in mortality or chronics.
It is important to note that in this three-site study, comparing DRAXXIN to Baytril, cattle were eligible for retreatment three days following initial treatment. This interval was chosen in part to preserve masking of the treatments. However, the trend of successful treatment of BRD with DRAXXIN is supported by other studies with longer post-treatment intervals (PTIs).2,3,4 The PTI is a period of time after treatment with an antimicrobial when no further treatment is administered. DRAXXIN significantly reduced mortality and lung lesions in cattle if given as long as 9 days before experimental intratracheal inoculation of M. haemolytica.6 In a companion study, cattle with naturally occurring BRD were treated with DRAXXIN and no additional treatments were allowed for intervals of 7 days, 10 days or 14 days.6 There was no difference in first-treatment success, mortality or weight gain in the three groups. These two additional studies provide experimental and clinical evidence that DRAXXIN exerts a clinical effect against BRD in cattle for longer than the three-day PTI reported here for the three feedlot sites.
Clinical effect in response to bacterial pneumonias is, in part, a function of spectrum of activity, as most cases of bacterial pneumonias are the result of a mixed bacterial infection. Multiple factors, many of which are not clearly defined, make up the biological equation termed “response to treatment” or in this study CAS. From an anti-infective standpoint, spectrum of activity against the important target pathogens and length of effective treatment are important components. DRAXXIN is labeled for treatment of all four major bacterial pathogens causing BRD in cattle, including Mycoplasma bovis. Recent studies indicate that the two most common microbial agents associated with nonresponsive BRD are M. bovis and BVDV.7,8 The improved first-treatment success seen with DRAXXIN vs. Baytril in this three-site study parallels the results of studies comparing DRAXXIN with Micotil® 300 (tilmicosin injection) and Nuflor.3,4 The antimicrobial spectrum and pharmacokinetics of DRAXXIN in cattle provide measurable clinical advantages over these other antimicrobials used to treat BRD.
ConclusionsUsing DRAXXIN for initial treatment of BRD in calves resulted in significantly greater first-treatment success and fewer second and third treatments than achieved with Baytril at three feedlots.
Do not use DRAXXIN in female dairy cattle 20 months of age or older. Do not use in calves to be processed for veal. DRAXXIN has a pre-slaughter time of 18 days.
Prepared from study reports 1133R-60-05-491, 1133R-60-05-492 and 1133R-60-05-493.
DRAXXIN and LIQUAMYCIN LA-200 are registered trademarks of Pfizer Inc. Baytril is a registered trademark of Bayer Aktiengesellschaft. Micotil is a registered trademark of Eli Lilly and Company. Nuflor is a registered trademark of Schering-Plough Veterinary Corp. ©2007 Pfizer Inc. All rights reserved.
Success
Removed
DRAXXIN
Chronics SFLT
Eligible for 2nd treatment
LA-200
Eligible for 3rd treatmentNuflor
3 days
2 days
2 days
Response/No response
CAS on days 1 to 28Observed on days 1 to 60 (+_ 3)SFLT=standard feedlot treatment
n=125
Abnormal CAS & T >_ 104ºF
1st treatment, day 0
Response/No response
3 feedlots: CO, TX I, TX II
Figure 1. Experimental Design
Baytriln=125
2 3
Materials and MethodsIn October and November 2005, calves were purchased at livestock markets in Mississippi and Texas and transported to the commercial feedlots in Colorado (n=806 mixed-breed steers), Texas site I (n=742 mixed-breed heifers) and Texas site II (n=802 mixed-breed heifers). Animals were processed on arrival using standard methods for commercial stocker/feeder operations, but were not vaccinated against Mannheimia or Pasteurella species. Calves with clinical signs of BRD were evaluated and enrolled if they had a clinical attitude score (CAS) of 1, 2 or 3 and pyrexia (rectal temperature ≥ 104ºF). According to the CAS system, 0=normal, bright, alert, responsive; 1=mild depression, signs of weakness usually not present; 2=moderate depression, some signs of weakness, may be reluctant to stand; 3=severe depression, difficulty standing, head lowered or extended; or 4=moribund. Calves that met the inclusion criteria were randomly assigned to treatment with either Baytril (5.7 mg enrofloxacin/lb; 12.5 mg/kg BW) or DRAXXIN (1.1 mg tulathromycin/lb; 2.5 mg tulathromycin/kg BW; Figure 1). Animals were blocked (2 animals per block, 1 from each group) by order of enrollment to avoid bias. One-hundred-twenty-five animals per treatment group were enrolled at each site and commingled in treatment pens to maintain masking of the treatment groups. Enrollment occurred during a 3-day period in Colorado, an 18-day period in Texas I and a 13-day period in Texas II.
Animals were assessed daily and CAS scores recorded for 28 days following enrollment; animals were observed for treatment response/nonresponse for 63 days in Colorado, 59 days in Texas I and 58 days in Texas II. Clinical assessors were masked to treatments. Animals were eligible for secondary treatments on day 3 after enrollment (day 0). On days 3 to the end of the study, animals with CAS scores of 1 or 2 and pyrexia (rectal temperature ≥ 104ºF) were considered nonresponders and received a second treatment with LIQUAMYCIN® LA-200® (9.0 mg oxytetracycline/lb; 20.0 mg oxytetracycline/kg). Animals that were a minimum of 2 days following treatment with LA-200 and met nonresponder criteria received a third treatment with Nuflor® (florfenicol) Injectable Solution (18.0 mg florfenicol/lb; 40.0 mg florfenicol/kg). Animals that met nonresponder criteria and were a
minimum of 2 days post-treatment with Nuflor were classified as chronics and received the standard feedlot treatment (SFLT).
According to the study protocol, animals were to be removed from the study before analysis for non-BRD reasons (concurrent disease or other physical conditions that might interfere with the progression of BRD or evaluation of response to therapy) or protocol deviations (allotment entry errors, errors in administration of medication, animals not evaluated/treated in a timely manner). Clinical success was defined as requiring no subsequent treatment. Mortality, CAS scores, body weights and weight gains were summarized for each treatment. Treatment differences were assessed at the 5% level of significance (P<0.05).
ResultsColorado
The clinical success for study days 0 to 59 was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%; Table 1). Figure 2a displays the cumulative treatment success by day. Animals with an in-pen CAS equal to 0 (normal) after the initial treatment are displayed in Figure 3a. Second treatments were administered to 37 animals in the Baytril group and 15 in the DRAXXIN group. Third treatments were administered to 9 animals in the Baytril group and 4 in the DRAXXIN group. Weight gains were numerically greater (P=0.0510) for animals treated with DRAXXIN (180.9 lb) than for those treated with Baytril (173.0 lb). One animal in the Baytril group was declared a chronic; no deaths due to BRD occurred in either group. DRAXXIN was significantly more efficacious than Baytril for treatment of naturally occurring BRD at this site.
Texas I
The clinical success for study days 0 to 63 was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%; Table 1). This is also displayed in Figure 2b as cumulative treatment success by day. Animals displaying an in-pen CAS equal to 0 after the initial treatment are displayed in Figure 3b. Second treatments were administered to 44 animals in the Baytril group and 23 in the DRAXXIN group. Third treatments were administered to 17 animals in the Baytril group and 9 in the DRAXXIN group. Seventeen animals were classified as chronics, 7 in the DRAXXIN group and 8 in the Baytril group. One animal in each group died before SFLT. Weight gains were numerically greater (P=0.3589) for animals treated with DRAXXIN (78.1 lb) than for those treated with Baytril (71.6 lb). Mortality was similar for both groups: 6 animals in the DRAXXIN group and 5 in the Baytril group. DRAXXIN was significantly more efficacious than Baytril for treatment of naturally occurring BRD at this site.
Texas II
Two-hundred-fifty animals were enrolled in the study. Seventy-seven animals were excluded from the study analyses for non-
BRD reasons or protocol deviations defined before the study began. Additionally, for the 37 animals excluded for protocol deviations, 29 block mates were also excluded to avoid potential bias. (The numbers differ because in some instances both animals in a block were excluded for protocol deviations.) Data collected from 83 animals in the Baytril group and 90 animals in the DRAXXIN group were analyzed and are reported here. Because of the number of animals affected by protocol deviations, preliminary analysis of all cattle at this site was conducted and demonstrated no effect on statistical results.
Table 1 summarizes the response to treatment at this site. As depicted in Figure 2c, clinical success was significantly greater (P=0.031) for animals treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%). Second treatments were administered to 16 animals in the Baytril group and 6 in the DRAXXIN group. Third treatments were administered to 1 animal in the Baytril group and 0 in the DRAXXIN group. Animals displaying an in-pen CAS equal to 0 after the initial treatment are displayed in Figure 3c. A significant advantage (P=0.0035) in mean weight gains was observed for animals treated with DRAXXIN (202.7 lb) compared to those treated with Baytril (172.9 lb). Nine animals in the Baytril group and 5 in the DRAXXIN group died.
DiscussionAt all three sites, clinical success was significantly higher for calves treated with DRAXXIN (87.9%, 80% and 87.8%) than for those treated with Baytril (70.2%, 62.5%, 74.7%). The results of the primary study variable — first-treatment success — were similar at all sites. The treatment success for cattle treated with DRAXXIN was better at each individual site and collectively for all three sites. The numbers of cattle treated with DRAXXIN that required further treatment ranged from 6 to 15 per site compared to 16 to 44 per site for the cattle treated with Baytril. The first-treatment success and total number of treatments administered were more favorable at every site for the cattle treated with DRAXXIN. At all three sites, a total of 57 calves in the DRAXXIN groups and 124 calves in the Baytril groups required second and third treatments. Consequently, fewer antimicrobial treatments were administered to animals in the DRAXXIN groups than in the Baytril groups.
Taken together, evidence from the three sites demonstrates that DRAXXIN provides effective and consistent results in treating BRD in feedlot calves compared with Baytril. Enrollment times (3, 18 and 13 days) reflect realistic variances in groups of cattle and typical commercial-receiving conditions. The initial variable for enrollment was the CAS, which relies on clinical signs as evidence of BRD. Numerous factors could result in different CAS values among sites, including cattle source, disease exposure, transport conditions and local weather. The individuals responsible for evaluation and treatment of the cattle were blinded to the treatments administered and to the allocation and blocking of cattle in the treatment groups, so the
cattle were treated similarly within each site regardless of the time required for treatment allocation. In addition, the results were similar across sites in that there was a similar magnitude of difference in first-treatment successes between the treatment groups and no difference in mortality or chronics.
It is important to note that in this three-site study, comparing DRAXXIN to Baytril, cattle were eligible for retreatment three days following initial treatment. This interval was chosen in part to preserve masking of the treatments. However, the trend of successful treatment of BRD with DRAXXIN is supported by other studies with longer post-treatment intervals (PTIs).2,3,4 The PTI is a period of time after treatment with an antimicrobial when no further treatment is administered. DRAXXIN significantly reduced mortality and lung lesions in cattle if given as long as 9 days before experimental intratracheal inoculation of M. haemolytica.6 In a companion study, cattle with naturally occurring BRD were treated with DRAXXIN and no additional treatments were allowed for intervals of 7 days, 10 days or 14 days.6 There was no difference in first-treatment success, mortality or weight gain in the three groups. These two additional studies provide experimental and clinical evidence that DRAXXIN exerts a clinical effect against BRD in cattle for longer than the three-day PTI reported here for the three feedlot sites.
Clinical effect in response to bacterial pneumonias is, in part, a function of spectrum of activity, as most cases of bacterial pneumonias are the result of a mixed bacterial infection. Multiple factors, many of which are not clearly defined, make up the biological equation termed “response to treatment” or in this study CAS. From an anti-infective standpoint, spectrum of activity against the important target pathogens and length of effective treatment are important components. DRAXXIN is labeled for treatment of all four major bacterial pathogens causing BRD in cattle, including Mycoplasma bovis. Recent studies indicate that the two most common microbial agents associated with nonresponsive BRD are M. bovis and BVDV.7,8 The improved first-treatment success seen with DRAXXIN vs. Baytril in this three-site study parallels the results of studies comparing DRAXXIN with Micotil® 300 (tilmicosin injection) and Nuflor.3,4 The antimicrobial spectrum and pharmacokinetics of DRAXXIN in cattle provide measurable clinical advantages over these other antimicrobials used to treat BRD.
ConclusionsUsing DRAXXIN for initial treatment of BRD in calves resulted in significantly greater first-treatment success and fewer second and third treatments than achieved with Baytril at three feedlots.
Do not use DRAXXIN in female dairy cattle 20 months of age or older. Do not use in calves to be processed for veal. DRAXXIN has a pre-slaughter time of 18 days.
Prepared from study reports 1133R-60-05-491, 1133R-60-05-492 and 1133R-60-05-493.
DRAXXIN and LIQUAMYCIN LA-200 are registered trademarks of Pfizer Inc. Baytril is a registered trademark of Bayer Aktiengesellschaft. Micotil is a registered trademark of Eli Lilly and Company. Nuflor is a registered trademark of Schering-Plough Veterinary Corp. ©2007 Pfizer Inc. All rights reserved.
Success
Removed
DRAXXIN
Chronics SFLT
Eligible for 2nd treatment
LA-200
Eligible for 3rd treatmentNuflor
3 days
2 days
2 days
Response/No response
CAS on days 1 to 28Observed on days 1 to 60 (+_ 3)SFLT=standard feedlot treatment
n=125
Abnormal CAS & T >_ 104ºF
1st treatment, day 0
Response/No response
3 feedlots: CO, TX I, TX II
Figure 1. Experimental Design
Baytriln=125
2 3
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
References1 Nowakowski MA, Inskeep P, Risk J, Skogerboe TL,
Benchaoui HA, Meinert TR. Sherington J, Sunderland SJ. Pharmacokinetics and lung tissue concentrations of tulathromycin, a new triamilide antibiotic, in cattle. Vet Ther 2004;5:60-74.
2 Nutsch RG, Skogerboe TL, Rooney KA, Weigel DJ, Gajewski K, Lechtenberg KF. Comparative efficacy of tulathromycin, tilmicosin and florfenicol in the treatment of bovine respiratory disease in stocker cattle. Vet Ther 2005;6(2):167-179.
3 Skogerboe TL, Rooney KA, Nutsch RG, Weigel DJ, Gajewski K, Kilgore WR. Comparative efficacy of tulathromycin versus florfenicol and tilmicosin against undifferentiated bovine respiratory disease in feedlot cattle. Vet Ther 2005;6(2):180-196.
4 Rooney KA, Nutsch RG, Skogerboe TL, Weigel DJ, Kimberly K, Kilgore WR. Efficacy of tulathromycin compared with tilmicosin and florfenicol for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease. Vet Ther 2005:6(2):154-166.
5 Robb EJ, Tucker CM, Corley L, et al. Efficacy of tulathromycin versus enrofloxacin for initial treatment of naturally occurring bovine respiratory disease in feeder calves. Vet Ther 2007;8(2):127-135.
6 Rooney KA, Meeuwse DM, Nutsch RG, et al. The efficacy and timing of tulathromycin (DRAXXIN Injectable solution) administration in calves challenged with Mannheimia haemolytica or managed in a feedlot. 2007; in press.
7 Shahriar FM, Clark EG, Janzen E, West K, Wobeser G. Coinfection with bovine viral diarrhea virus and Mycoplasma bovis in feedlot cattle with chronic pneumonia. Can Vet J 2002;43(11):863-868.
8 Haines DM, Martin KM, Clark EG, Jim GK, Janzen ED. The immunohistochemical detection of Mycoplasma bovis and bovine viral diarrhea virus in tissues of feedlot cattle with chronic, unresponsive respiratory disease and/or arthritis. Can Vet J 2001;42(11):857-860.
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
4 5
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
References1 Nowakowski MA, Inskeep P, Risk J, Skogerboe TL,
Benchaoui HA, Meinert TR. Sherington J, Sunderland SJ. Pharmacokinetics and lung tissue concentrations of tulathromycin, a new triamilide antibiotic, in cattle. Vet Ther 2004;5:60-74.
2 Nutsch RG, Skogerboe TL, Rooney KA, Weigel DJ, Gajewski K, Lechtenberg KF. Comparative efficacy of tulathromycin, tilmicosin and florfenicol in the treatment of bovine respiratory disease in stocker cattle. Vet Ther 2005;6(2):167-179.
3 Skogerboe TL, Rooney KA, Nutsch RG, Weigel DJ, Gajewski K, Kilgore WR. Comparative efficacy of tulathromycin versus florfenicol and tilmicosin against undifferentiated bovine respiratory disease in feedlot cattle. Vet Ther 2005;6(2):180-196.
4 Rooney KA, Nutsch RG, Skogerboe TL, Weigel DJ, Kimberly K, Kilgore WR. Efficacy of tulathromycin compared with tilmicosin and florfenicol for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease. Vet Ther 2005:6(2):154-166.
5 Robb EJ, Tucker CM, Corley L, et al. Efficacy of tulathromycin versus enrofloxacin for initial treatment of naturally occurring bovine respiratory disease in feeder calves. Vet Ther 2007;8(2):127-135.
6 Rooney KA, Meeuwse DM, Nutsch RG, et al. The efficacy and timing of tulathromycin (DRAXXIN Injectable solution) administration in calves challenged with Mannheimia haemolytica or managed in a feedlot. 2007; in press.
7 Shahriar FM, Clark EG, Janzen E, West K, Wobeser G. Coinfection with bovine viral diarrhea virus and Mycoplasma bovis in feedlot cattle with chronic pneumonia. Can Vet J 2002;43(11):863-868.
8 Haines DM, Martin KM, Clark EG, Jim GK, Janzen ED. The immunohistochemical detection of Mycoplasma bovis and bovine viral diarrhea virus in tissues of feedlot cattle with chronic, unresponsive respiratory disease and/or arthritis. Can Vet J 2001;42(11):857-860.
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
4 5
Tabl
e 1.
Sum
mar
y of
Res
pons
e to
Tre
atm
ent
Co
lora
do
Texa
s I
Texa
s II
An
imal
sTr
eatm
ents
, No
.A
nim
als
Trea
tmen
ts, N
o.
An
imal
sTr
eatm
ents
, No
.
Bay
tril
DR
AX
XIN
Bay
tril
DR
AX
XIN
Bay
tril
DR
AX
XIN
Bay
tril
DR
AX
XIN
Bay
tril
DR
AX
XIN
Bay
tril
DR
AX
XIN
Enr
olle
d, n
o.12
512
512
512
512
412
5
Rem
oved
fro
m A
ll A
naly
ses*
11
55
4135
Num
ber
that
Rec
ieve
d 1s
t Tre
atm
ent
124
124
124
124
120
120
120
120
8390
8390
1st T
reat
men
t S
ucce
ss, n
o.87
109
7596
6279
1st T
reat
men
t Fa
ilure
, no.
3715
4524
2111
1st T
reat
men
t S
ucce
ss, %
**70
.2a
87.9
b62
.5c
80.0
d74
.7e
87.8
f
Die
d be
fore
2nd
Trea
tmen
t, n
o.0
00
15
5
Rem
oved
Non
-BR
D-R
elat
ed o
r Pr
otoc
ol
Dev
iatio
ns a
fter
2nd
Trea
tmen
t, n
o.0
01
01
00
Num
ber
that
Rec
ieve
d 2n
d Tr
eatm
ent
3715
3715
4423
4423
166
166
2nd
Trea
tmen
t S
ucce
ss, n
o.27
1124
1211
6
2nd
Trea
tmen
t Fa
ilure
, no.
104
2011
50
2nd
Trea
tmen
t S
ucce
ss, %
73.0
73.3
54.5
52.2
68.8
100.
0
Die
d be
fore
3rd
Trea
tmen
t, n
o.0
02
14
0
Rem
oved
Non
-BR
D R
elat
ed o
r Pr
otoc
ol
Dev
iatio
ns, n
o.1
01
11
00
Num
ber
that
Rec
ieve
d 3r
d Tr
eatm
ent
94
94
179
179
10
10
3rd
Trea
tmen
t S
ucce
ss, n
o.8
48
11
N/A
3rd
Trea
tmen
t Fa
ilure
, no.
10
10
98
00
3rd
Trea
tmen
t S
ucce
ss, %
88.9
100
47.1
11.1
100.
00.
0
Die
d be
fore
SFL
T1
1
Rem
oved
Non
-BR
D R
elat
ed o
r Pr
otoc
ol
Dev
iatio
ns, n
o.1
00
SFL
T/C
hron
ics,
no.
19
48
78
70
01
Tota
l Tre
atm
ents
Adm
inis
tere
d, n
o.†
172
143
190
159
101
96
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
*P=0.009 *P=0.031
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
aB yt lirDRAXXIN
days daysdays
days daysdays
*
Figure 2a. Cumulative Treatment Success (Colorado)
0010203040506070809001
0 5 10 51 02 52 03 53 04 54 05
aB yt lirDRAXXIN*P=0.031
aB yt lirDRAXXIN
*
Figure 2b. Cumulative Treatment Success (Texas I)
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
% o
ftre
atm
ent g
roup
s
Figure 3a. Clinical Appearance After Treatment (Colorado): Animals with CAS of 0 through Day 28
0
02
04
06
08
001
021
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Figure 3b. Clinical Appearance After Treatment (Texas I): Animals with CAS of 0 through Day 28
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
% c
attle
rem
aini
ng fr
ee o
f BR
D
0010203040506070809001
0 5 01 51 20 52 03 53 04 54 05 55
Figure 2c. Cumulative Treatment Success (Texas II)
88
90
92
94
96
98
100
102
aD y 0 Day 3 D ya 6 D ya 9 D ya 21 Day 51 yaD 81 yaD 12 aD y 42 yaD 72
%of
trea
tmen
tgro
ups
Baytril DRAXXINBaytril DRAXXINBaytril DRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II): Animals with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for animals treated with DRAXXIN (87.9%) than for those treated with Baytril (70.2%).
Clinical success was significantly higher (P=0.031) for animals treated with DRAXXIN (80.0%) than for those treated with Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated with DRAXXIN (87.8%) than for those treated with Baytril (74.7%).
6 7
*
Thes
ean
imal
sw
ere
rem
oved
from
the
stud
yb
efor
ean
alys
esfo
rno
n-B
RD
reas
ons
orp
roto
cold
evia
tions
defi
ned
bef
ore
the
stud
yb
egan
.The
reas
ons
for
excl
usio
nat
Tex
asII
incl
uded
:1=
allo
tmen
tent
ry
e
rror
,3=
err
ors
ina
dmin
istr
atio
nof
med
icat
ions
,7=
CA
So
f2a
ndn
ote
valu
ated
furt
her
for
resp
ond
er/n
onre
spon
der
cla
ssifi
catio
n,3
7=
CA
So
f2a
ndw
ere
note
valu
ated
/tre
ated
ina
tim
ely
man
ner.
For
the
37
a
nim
als
excl
uded
for
prot
ocol
dev
iatio
ns,2
9b
lock
mat
esw
ere
also
exc
lud
edto
avo
idp
oten
tialb
ias.
The
num
ber
sd
iffer
bec
ause
ins
ome
inst
ance
sb
oth
anim
als
ina
blo
ckw
ere
excl
uded
for
prot
ocol
dev
iatio
ns.
**
Bac
k-tr
ansf
orm
ed le
ast
squa
res
mea
n(L
SM
).a,
bD
iffer
ent
sup
ersc
ripts
ind
icat
esi
gnifi
cant
lyd
iffer
ent
valu
es(P
=0.
009)
.c,
d D
iffer
ent
sup
ersc
ripts
ind
icat
esi
gnifi
cant
lyd
iffer
ent
valu
es(P
=0.
031)
.e
,fD
iffer
ent
sup
ersc
ripts
ind
icat
esi
gnifi
cant
lyd
iffer
ent
valu
es(P
=0.
031)
.
†D
ead
sex
clud
ed.
Table 1. Summary of Response to Treatment
Colorado Texas I Texas II
Animals Treatments, No. Animals Treatments, No. Animals Treatments, No.
Baytril DRAXXIN Baytril DRAXXIN Baytril DRAXXIN Baytril DRAXXIN Baytril DRAXXIN Baytril DRAXXIN
Enrolled, no. 125 125 125 125 124 125
Removed from All Analyses* 1 1 5 5 41 35
Number that Recieved 1st Treatment 124 124 124 124 120 120 120 120 83 90 83 90
1st Treatment Success, no. 87 109 75 96 62 79
1st Treatment Failure, no. 37 15 45 24 21 11
1st Treatment Success, %** 70.2a 87.9b 62.5c 80.0d 74.7e 87.8f
Died before 2nd Treatment, no. 0 0 0 1 5 5
Removed Non-BRD-Related or Protocol Deviations after 2nd Treatment, no. 0 0 1 0 1 0 0
Number that Recieved 2nd Treatment 37 15 37 15 44 23 44 23 16 6 16 6
2nd Treatment Success, no. 27 11 24 12 11 6
2nd Treatment Failure, no. 10 4 20 11 5 0
2nd Treatment Success, % 73.0 73.3 54.5 52.2 68.8 100.0
Died before 3rd Treatment, no. 0 0 2 1 4 0
Removed Non-BRD Related or Protocol Deviations, no. 1 0 1 1 1 0 0
Number that Recieved 3rd Treatment 9 4 9 4 17 9 17 9 1 0 1 0
3rd Treatment Success, no. 8 4 8 1 1 N/A
3rd Treatment Failure, no. 1 0 1 0 9 8 0 0
3rd Treatment Success, % 88.9 100 47.1 11.1 100.0 0.0
Died before SFLT 1 1
Removed Non-BRD Related or Protocol Deviations, no. 1 0 0
SFLT/Chronics, no. 1 9 4 8 7 8 7 0 0 1
Total Treatments Administered, no.† 172 143 190 159 101 96
*P=
0.009*P
=0.031
0 01 02 03 04 05 06 07 08 09 001
05
0151
2052
0353
0454
0555
aB
ytlir
DR
AXXIN
daysdays
days
daysdays
days
*
Figure 2a. Cumulative Treatm
ent Success (Colorado)
0 01 02 03 04 05 06 07 08 09 001
05
1051
0252
0353
0454
05
aB
ytlir
DR
AXXIN
*P=
0.031a
Byt
lirD
RA
XXIN
*
Figure 2b. Cumulative Treatm
ent Success (Texas I)
0 02 04 06 08 001
021
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
Figure 3a. Clinical Appearance After Treatment (Colorado):
Anim
als with CAS of 0 through Day 28
0 02 04 06 08 001
021
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
Figure 3b. Clinical Appearance After Treatment (Texas I):
Anim
als with CAS of 0 through Day 28
% cattle remaining free of BRD
% cattle remaining free of BRD
% cattle remaining free of BRD
0 01 02 03 04 05 06 07 08 09 001
05
0151
2052
0353
0454
0555
Figure 2c.Cumulative Treatm
ent Success (Texas II)
88 90 92 94 96 98
100
102
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
BaytrilDRAXXIN
BaytrilDRAXXIN
BaytrilDRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II):
Anim
als with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for anim
als treated with
DRAXXIN (87.9%
) than for those treated with Baytril (70.2%
).Clinical success w
as significantly higher (P=0.031) for animals treated w
ith DRAXXIN
(80.0%) than for those treated w
ith Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated w
ith DRAXXIN
(87.8%) than for those treated w
ith Baytril (74.7%).
*P=
0.009*P
=0.031
0 01 02 03 04 05 06 07 08 09 001
05
0151
2052
0353
0454
0555
aB
ytlir
DR
AXXIN
daysdays
days
daysdays
days
*
Figure 2a. Cumulative Treatm
ent Success (Colorado)
0 01 02 03 04 05 06 07 08 09 001
05
1051
0252
0353
0454
05
aB
ytlir
DR
AXXIN
*P=
0.031a
Byt
lirD
RA
XXIN
*
Figure 2b. Cumulative Treatm
ent Success (Texas I)
0 02 04 06 08 001
021
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
Figure 3a. Clinical Appearance After Treatment (Colorado):
Anim
als with CAS of 0 through Day 28
0 02 04 06 08 001
021
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
Figure 3b. Clinical Appearance After Treatment (Texas I):
Anim
als with CAS of 0 through Day 28
% cattle remaining free of BRD
% cattle remaining free of BRD
% cattle remaining free of BRD
0 01 02 03 04 05 06 07 08 09 001
05
0151
2052
0353
0454
0555
Figure 2c.Cumulative Treatm
ent Success (Texas II)
88 90 92 94 96 98
100
102
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
BaytrilDRAXXIN
BaytrilDRAXXIN
BaytrilDRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II):
Anim
als with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for anim
als treated with
DRAXXIN (87.9%
) than for those treated with Baytril (70.2%
).Clinical success w
as significantly higher (P=0.031) for animals treated w
ith DRAXXIN
(80.0%) than for those treated w
ith Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated w
ith DRAXXIN
(87.8%) than for those treated w
ith Baytril (74.7%).
*P=
0.009*P
=0.031
0 01 02 03 04 05 06 07 08 09 001
05
0151
2052
0353
0454
0555
aB
ytlir
DR
AXXIN
daysdays
days
daysdays
days
*
Figure 2a. Cumulative Treatm
ent Success (Colorado)
0 01 02 03 04 05 06 07 08 09 001
05
1051
0252
0353
0454
05
aB
ytlir
DR
AXXIN
*P=
0.031a
Byt
lirD
RA
XXIN
*
Figure 2b. Cumulative Treatm
ent Success (Texas I)
0 02 04 06 08 001
021
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
Figure 3a. Clinical Appearance After Treatment (Colorado):
Anim
als with CAS of 0 through Day 28
0 02 04 06 08 001
021
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
Figure 3b. Clinical Appearance After Treatment (Texas I):
Anim
als with CAS of 0 through Day 28
% cattle remaining free of BRD
% cattle remaining free of BRD
% cattle remaining free of BRD
0 01 02 03 04 05 06 07 08 09 001
05
0151
2052
0353
0454
0555
Figure 2c.Cumulative Treatm
ent Success (Texas II)
88 90 92 94 96 98
100
102
aD
y0
Day
3D
ya6
Dya
9D
ya21
Day
51ya
D81
yaD
12a
Dy
42ya
D72
% of treatment groups
BaytrilDRAXXIN
BaytrilDRAXXIN
BaytrilDRAXXIN
Figure 3c. Clinical Appearance After Treatment (Texas II):
Anim
als with CAS of 0 through Day 28
*
Clinical success was significantly higher (P=0.009) for anim
als treated with
DRAXXIN (87.9%
) than for those treated with Baytril (70.2%
).Clinical success w
as significantly higher (P=0.031) for animals treated w
ith DRAXXIN
(80.0%) than for those treated w
ith Baytril (62.5%).
Clinical success was significantly higher (P=0.031) for calves treated w
ith DRAXXIN
(87.8%) than for those treated w
ith Baytril (74.7%).
67
*Theseanimalswereremovedfromthestudybeforeanalysesfornon-BRDreasonsorprotocoldeviationsdefinedbeforethestudybegan.ThereasonsforexclusionatTexasIIincluded:1=allotmententry error,3=errorsinadministrationofmedications,7=CASof2andnotevaluatedfurtherforresponder/nonresponderclassification,37=CASof2andwerenotevaluated/treatedinatimelymanner.Forthe37 animalsexcludedforprotocoldeviations,29blockmateswerealsoexcludedtoavoidpotentialbias.Thenumbersdifferbecauseinsomeinstancesbothanimalsinablockwereexcludedforprotocoldeviations. **Back-transformedleastsquaresmean(LSM).a,bDifferentsuperscriptsindicatesignificantlydifferentvalues(P=0.009).c,dDifferentsuperscriptsindicatesignificantlydifferentvalues(P=0.031).e , fDifferentsuperscriptsindicatesignificantlydifferentvalues(P=0.031). †Deadsexcluded.
H
H C3
H C3
H C3
H C3
H C3
H C3
H C3
H C3
H C3
HO
OCH
N
HN
NOH HO
OH
OH
NH
OH
OH
O
OO
O
O
O
O
O
O
OO
O
OH
OH
OH
CH3
2
3
3
3
3 3
3
3
3
3
3
3 2
3
3
3
3
3
CH
CH CH
CH
(CH )
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IntroductionDRAXXIN is a highly effective, single-dose antimicrobial medication indicated for control of BRD in cattle at high risk of developing BRD caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, and for treatment of BRD caused by these three organisms and Mycoplasma bovis. When administered according to the label dose of 2.5 mg tulathromycin/kg body weight (BW), tulathromycin is rapidly absorbed, distributes widely and provides concentrations in bovine lung for an extended period.1 Clinical efficacy of
DRAXXIN for treatment of BRD, as well as for control of respiratory disease in cattle at high risk of developing BRD, has been well documented in multiple studies.2,3,4 This technical bulletin presents the results of a multilocation study designed to compare the efficacy of DRAXXIN or Baytril for treatment of naturally occurring BRD in feedlot calves. The same study protocol was used at all three sites. Results were analyzed separately by site, and results from two sites have been published in the peer-reviewed literature.5
DRX07033
8
August 2007
Efficacy of DRAXXIN or Baytril for treatment of naturally occurring bovine respiratory disease in calves at 3 feedlots
Key Points• Clinical success was significantly higher (P=0.009, P=0.031, P=0.031) for calves
treated with DRAXXIN® (tulathromycin) Injectable Solution (87.9%, 80.0%, 87.8%) than for those treated with Baytril® (enrofloxacin) Injectable Solution (70.2%, 62.5%, 74.7%).
• Fewer animals treated with DRAXXIN required second (n=44) and third (n=13) treatments than animals treated with Baytril (n=97 and n=27, respectively). Consequently, fewer total treatments were administered to cattle in the DRAXXIN groups than to cattle in the Baytril groups.
• DRAXXIN administered as a single subcutaneous (SC) injection was safe and effective for the initial treatment of bovine respiratory disease (BRD) in calves at 3 feedlots.