Abstract 16016: The Effects of Lorcaserin on C-reactive Protein in Overweight and Obese Patients: Data From Two Phase 3 Trials
Background: Lorcaserin, a selective 5-HT2C agonist, 10 mg twice daily (bid) was approved in the US in 2012 for chronic weight management as an adjunct to reduced calorie diet and increased physical activity. This analysis evaluated the effect of weight loss on high-sensitivity C-reactive protein (hsCRP) in obese and overweight patients (pts) from the two phase 3 pivotal trials in which it was measured.
Methods: In BLOOM (3182 pts without diabetes with BMI 30-45 kg/m2 or 27-45 kg/m2 and ≥1 weight-related comorbid condition; NCT00395135) and BLOOM-DM (604 pts with BMI 27-45 kg/m2 and type 2 diabetes; NCT00603291), pts were randomized to placebo (pbo) or lorcaserin (lor) for 52 weeks. All pts received diet and exercise counseling. In this post hoc analysis, CRP levels at week (wk) 52 were assessed for the pbo and lor 10 mg bid groups of the modified intent-to-treat/last observation carried forward (MITT/LOCF) population of each study with a baseline hsCRP >3 mg/L (BLOOM 54% >3 mg/L, 46% 3 mg/L, 47% 3 mg/L.
Results: Baseline CRP levels were comparable except for the BLOOM-DM lor bid group, which was higher than for pbo. CRP levels for wk 52 non-responders (<5% weight loss at wk 52 LOCF) in both trials showed modest improvement compared with wk 52 responders, with lor-treated patients among the wk 52 non-responder cohort showing greater improvement relative to pbo.
Conclusions: Weight loss was associated with decreased hsCRP in patients with CRP levels >3 mg/L at baseline. Lorcaserin-treated wk 52 responders in the BLOOM trial had significantly greater improvements in hsCRP than wk 52 responders who received pbo. In this exploratory analysis, ≥5% weight loss at wk 52 on lorcaserin is associated with improved hsCRP levels compared with pbo in overweight and obese subjects without diabetes.
- © 2013 by American Heart Association, Inc.