AACE ePoster Library

EFFICACY AND SAFETY OF LIRAGLUTIDE 3.0 MG FOR WEIGHT MANAGEMENT ARE SIMILAR ACROSS RACE
AACE ePoster Library. Ard J. 05/15/15; 97745; 612
Jamy Ard
Jamy Ard
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Abstract
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Objective: Obesity is a significant public health challenge both in the Western world and in developing countries. Black/African-Americans (BAA) are disproportionately affected compared with white individuals. Further, BAA generally achieve lower weight loss using standard behavioral interventions. Thus it is important to evaluate emerging weight loss therapies in different racial subgroups for comparative efficacy and safety.
Methods: This was a post hoc analysis of pooled data from one 52-week Phase 2 trial and the 4 Phase 3 SCALE trials (three of 56 weeks’ duration, one 32 weeks). We compared the efficacy and safety of liraglutide 3.0 mg vs. placebo, as adjunct to diet and exercise, in different racial subgroups: white (n=4945), BAA (n=580), Asian (n=172) and other (n=116). The population of the randomized double-blinded trials was adults who were overweight or obese with (n=844; 14.5%) or without (n=4969; 85.5%) type 2 diabetes (T2D).
Results: Across the racial subgroups, most participants (~60-80%) were female. Mean age ranged between 40.8 and 47.5 years. Mean BMI and body weight were lowest in Asians (35.8 kg/m2 and 95.1 kg) and highest in BAA (39.5 kg/m2 and 109.9 kg). In each subgroup greater mean weight loss from baseline to end of treatment was achieved with liraglutide 3.0 mg vs. placebo: white, -7.74 vs. -2.35% (estimated treatment difference [ETD] 5.25% [95%CI -5.6; 4.9]; BAA, -6.29 vs. -1.36% (ETD -4.78% [-5.9; 3.7]); Asian, -6.29 vs. 2.52% (ETD -4.02% [-6.1; -2.0]); other, -7.31 vs. 0.49% (ETD 6.81% [ 9.3; -4.3]) (p<0.0001 for all, last observation carried forward). In each subgroup more individuals lost ≥5% of their baseline weight in the liraglutide 3.0 mg group (range 52 62%) vs. the placebo group (8.7 25%) and more lost >10% weight with liraglutide (range 22 33%) vs. placebo (0-8.9%) (p<0.02 for all). All mean and categorical weight loss effects were race independent (p>0.05).
Greater improvements in systolic and diastolic BP, lipids and A1C in individuals with and without T2D were generally seen with liraglutide 3.0 mg vs. placebo across racial subgroups; the treatment effects were independent of race (p>0.05).
The proportion of individuals reporting adverse events (AEs) and serious AEs was similar across racial subgroups. Gastrointestinal events were reported more frequently with liraglutide 3.0 mg (59.1-76.3% across racial subgroups) than placebo (31.4-40.1%) and were largely similar across the subgroups.
Conclusion: Effects of liraglutide 3.0 mg, as adjunct to diet and exercise, on weight loss, associated metabolic effects and clinical safety profile were generally consistent across racial subgroups, including black/African Americans, a group with higher rates of obesity.
Objective: Obesity is a significant public health challenge both in the Western world and in developing countries. Black/African-Americans (BAA) are disproportionately affected compared with white individuals. Further, BAA generally achieve lower weight loss using standard behavioral interventions. Thus it is important to evaluate emerging weight loss therapies in different racial subgroups for comparative efficacy and safety.
Methods: This was a post hoc analysis of pooled data from one 52-week Phase 2 trial and the 4 Phase 3 SCALE trials (three of 56 weeks’ duration, one 32 weeks). We compared the efficacy and safety of liraglutide 3.0 mg vs. placebo, as adjunct to diet and exercise, in different racial subgroups: white (n=4945), BAA (n=580), Asian (n=172) and other (n=116). The population of the randomized double-blinded trials was adults who were overweight or obese with (n=844; 14.5%) or without (n=4969; 85.5%) type 2 diabetes (T2D).
Results: Across the racial subgroups, most participants (~60-80%) were female. Mean age ranged between 40.8 and 47.5 years. Mean BMI and body weight were lowest in Asians (35.8 kg/m2 and 95.1 kg) and highest in BAA (39.5 kg/m2 and 109.9 kg). In each subgroup greater mean weight loss from baseline to end of treatment was achieved with liraglutide 3.0 mg vs. placebo: white, -7.74 vs. -2.35% (estimated treatment difference [ETD] 5.25% [95%CI -5.6; 4.9]; BAA, -6.29 vs. -1.36% (ETD -4.78% [-5.9; 3.7]); Asian, -6.29 vs. 2.52% (ETD -4.02% [-6.1; -2.0]); other, -7.31 vs. 0.49% (ETD 6.81% [ 9.3; -4.3]) (p<0.0001 for all, last observation carried forward). In each subgroup more individuals lost ≥5% of their baseline weight in the liraglutide 3.0 mg group (range 52 62%) vs. the placebo group (8.7 25%) and more lost >10% weight with liraglutide (range 22 33%) vs. placebo (0-8.9%) (p<0.02 for all). All mean and categorical weight loss effects were race independent (p>0.05).
Greater improvements in systolic and diastolic BP, lipids and A1C in individuals with and without T2D were generally seen with liraglutide 3.0 mg vs. placebo across racial subgroups; the treatment effects were independent of race (p>0.05).
The proportion of individuals reporting adverse events (AEs) and serious AEs was similar across racial subgroups. Gastrointestinal events were reported more frequently with liraglutide 3.0 mg (59.1-76.3% across racial subgroups) than placebo (31.4-40.1%) and were largely similar across the subgroups.
Conclusion: Effects of liraglutide 3.0 mg, as adjunct to diet and exercise, on weight loss, associated metabolic effects and clinical safety profile were generally consistent across racial subgroups, including black/African Americans, a group with higher rates of obesity.

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