Date: 2014-10-10
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in the October issue of Postgraduate Medicine
Company: Eisai (Japan) Arena Pharmaceuticals (USA - CA)
Product: Belviq® (lorcaserin hydrochloride)
Action
mechanism: Belviq® is a serotonin 2C receptor agonist approved in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes.
Disease: chronic weight management
Therapeutic area: Metabolic diseases
Country:
Trial
details: BLOOM and BLOSSOM were Phase 3, randomized, double-blind, placebo-controlled clinical trials designed to evaluate the efficacy and safety of overweight patients without diabetes and included a total of 6,136 patients in the modified-intent-to-treat population. Key inclusion criteria for both studies were age 18 to 65 years (inclusive) and a BMI of 30-45 kg/m2, or 27-29.9 kg/m2 with at least one coexisting condition (hypertension, dyslipidemia, cardiovascular disease, impaired glucose tolerance or sleep apnea). Key exclusion criteria included recent cardiovascular events, diabetes mellitus, use of serotonergic antidepressants and high blood pressure. In the two-year BLOOM trial, patients received either Belviq® 10 mg twice daily in combination with diet and exercise or placebo in combination with diet and exercise for the first year, and those in the Belviq® group were randomly reassigned to continue Belviq® or switch to placebo for the second year. In the one-year BLOSSOM trial, patients received either BELVIQ 10 mg once daily in combination with diet and exercise, or placebo. Pooled Phase 3 data indicate that 1,398 patients (43.7%) in the Belviq® group discontinued from the studies prior to Week 52, as compared to 1,640 (51.4%) in the placebo group. The most common reasons for discontinuation were withdrawal of consent (BELVIQ, 18.8%; placebo, 25.5%) and lost to follow-up (Belviq®, 12.2%; placebo, 14.4%).
Latest
news: * On October 10, 2014, Eisai and Arena Pharmaceuticals announced that a pooled analysis of the BLOOM and BLOSSOM pivotal, Phase 3 clinical trials of Belviq® (lorcaserin HCl) was published in the October issue of Postgraduate Medicine, a peer-reviewed medical journal for physicians. In the pooled analysis, Belviq® 10 mg twice daily, as compared to placebo and both in conjunction with diet and exercise, was associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters. The BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trials were conducted in overweight and obese adults without diabetes. The pooled, modified-intent-to-treat results show that a statistically significantly greater number of patients taking Belviq® lost greater than or equal to 5% and greater than or equal to 10% of body weight compared to placebo (47.1% vs. 22.6% and 22.4% vs. 8.7%, respectively) after one year of treatment. The mean percent weight loss for patients taking Belviq® was also statistically significantly greater than placebo (-5.8% vs. -2.5%). Mean percent weight loss for those completing one year of treatment was -8.0% for Belviq® and -3.7% for placebo, respectively. Echocardiograms were conducted on all patients as part of the primary safety endpoint of the trials. There was no apparent increased risk of cardiac valvulopathy associated with use in the combined dataset. The rates of FDA -defined valvulopathy were 2.3% and 2.2% for patients taking Belviq® or placebo, respectively. Additionally, the data showed that after one year, there were statistically significant improvements in lipid parameters, including total cholesterol, triglyceride levels and HDL cholesterol. Changes in glycemic indicators demonstrated a decrease of 0.11% in HbA1c for BELVIQ treated patients compared to a decrease of 0.05% for placebo treated patients. Mean decreases in both systolic and diastolic blood pressure were also seen and statistically significant for BELVIQ versus placebo.The most common adverse events in the pooled analysis included headache, upper respiratory tract infection and nasopharynigtis. Discontinuation rates for adverse events were 8.6% for patients taking BELVIQ and 6.8% for patients taking placebo, and the overall rates for serious adverse events were similar (2.7% and 2.3%, respectively).
