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Abstract

Click to add/remove this article to your list of 'My Favorites' Changes in Glucose Tolerance and Cardiovascular Risk Factors after 52 Weeks of Treatment with Lorcaserin

Year: 2010

Abstract Number: 1855-P

Authors: MEREDITH C. FIDLER, MATILDE SANCHEZ, BRIAN L. RAETHER, CHRISTEN M. ANDERSON, WILLIAM R. SHANAHAN

Institutions: San Diego, CA

Results: Lorcaserin, a small molecule agonist of the serotonin 2C (5-HT2C) receptor, demonstrated effectiveness for weight management in two phase 3 studies (BLOOM and BLOSSOM). In these randomized trials, 6380 non-diabetic patients aged 18-66 years with a BMI 27-45 kg/m2 were treated for 52 weeks with lorcaserin 10 mg BID or placebo. Results from both trials were combined to evaluate the effect of lorcaserin treatment on fasting plasma glucose, LDL, HDL, total cholesterol (chol), and triglycerides (TG), analyzed by baseline (BL) value and responders vs. non-responders status. Responders were patients who achieved ≥5% weight loss after 52 weeks. Out of range (OOR) BL values were based on guidelines for assessing risk factors: TG ≥150 mg/dL, total chol ≥200 mg/dL, ≥LDL 130 mg/dL, HDL <40 mg/dL, and glucose ≥110 mg/dL.

After 52 weeks of treatment, changes in lipid and glucose values were more favorable in responders than non-responders, and there were twice as many responders to lorcaserin (47.1%) as placebo (22.6%) (Table 1, Intent to treat - last observation carried forward). Improvements were also greater in patients who had OOR BL values (Table 1). Overall, changes tended to be more favorable in patients treated with lorcaserin than placebo. The results indicate that weight loss is a good predictor for improvements in glucose and lipid values and the greatest benefits are seen in patients with baseline values beyond recommended limits.

Table 1: Summary of Mean ±SE Percent Change from Baseline at Week 52
  Responders Non-Responders 
  Lorcaserin Placebo Lorcaserin Placebo
Response: n/N (%) 1460/3098 (47.1) 687/3038 (22.6) 1638/3098 (52.9) 2351/3038 (77.4)
TG -14.5 ±0.8  -12.9 ±1.2  4.1 ±1.2 3.4 ±0.8
Total Chol -2.1 ±0.4 -1.1 ±0.5 0.5 ±0.3 0.8 ±0.3
LDL 0.6 ±0.6  2.0 ±0.9 2.7 ±0.5 3.3 ±0.5
HDL 4.0 ±0.4  4.3 ±0.6 -0.4 ±0.3 -0.7 ±0.3
Glucose -1.5 ±0.3 -2.3 ±0.4 1.1 ±0.3 1.4 ±0.2
  OOR Normal  
  Lorcaserin Placebo Lorcaserin Placebo
TG -20.6 ±1.1  -14.2 ±1.1 1.9 ±0.9 6.2 ±0.9
Total Chol -4.4 ±0.3 -3.1 ±0.3 1.8 ±0.3 3.0 ±0.3
LDL -5.9 ±0.6 -4.5 ±0.6 4.9 ±0.5 5.9 ±0.5
HDL 8.8 ±1.0  6.8 ±0.8 0.8 ±0.3 -0.4 ±0.3
Glucose -10.3 ±1.4  -10.7 ±1.4 0.4 ±0.2 1.1 ±0.2  

 

Category: Human