Presentation Abstract

Session: General Poster Session 2
Abstract Number: 2117-P
Title: Lorcaserin HCl Phase 3 Trials in Obese and Overweight Patients: Week 52 Outcomes for Those Achieving at least 5% Weight Loss at Week 12 (Responders)-A Per Prescribing Information Analysis
Authors: STEVEN R. SMITH, MATILDE SANCHEZ, KYLE FRAHER, SCOTT STUBBE, CINDY TURNER, BRIAN RAETHER, DANA HALLIDAY, JACEK KROWLIKOWSKI, RANDI FAIN, WILLIAM R. SHANAHAN, Orlando, FL, San Diego, CA, Westcliff Lakes, NJ.
Abstract: Lorcaserin, a selective 5-HT2C agonist, was recently
approved for weight management in conjunction with lifestyle modification in
obese patients (BMI ≥30), and overweight patients (BMI ≥27) with at least one
co-morbidity. In patients without diabetes, proportions achieving ≥5% weight
loss and absolute weight loss at Week (W)52 for lorcaserin vs. placebo were 47
vs. 23% and 5.8 vs. 2.5kg, respectively (MITT-LOCF). In patients with type 2
diabetes mellitus (T2DM), results were 38 vs.16% and 4.7 vs.1.6kg,
respectively. To limit exposure and maximize benefit,
the predictive value for >5% W52 weight loss was assessed at W12. Patients
not losing at least 5% at W12 (non-responders) should be discontinued. Proportions of responders without diabetes,
lorcaserin vs. placebo, were 49.3 vs. 22.6%. W52 weight loss in lorcaserin
responders without diabetes was 10.6kg (23 lbs), with 86% and 50% achieving at
least 5% and 10% weight loss, respectively.
Proportions of responders with
T2DM, lorcaserin vs. placebo, were 35.9 vs. 11.5%. W52 weight loss in lorcaserin responders with
T2DM was 9.3kg (20 lbs), with 71% and 36% achieving 5% and 10% weight loss. W52
reductions in FPG and A1C in lorcaserin responders with T2DM were 29.3mg/dL and
1.2%, W52 reductions in systolic and diastolic BP and heart rate were 3.4mmHg, 2.5mmHg,
and 2.5BPM in lorcaserin responders without diabetes, and 2.6mmHg, 1.9mmHg, and
3.2BPM in lorcaserin responders with T2DM. Achievement of ≥5% weight loss by
W12 is a strong predictor of robust one-year lorcaserin responses in weight,
cardiovascular vital signs, and glycemia.





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