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Meta-Analyses of Phase 3 Trials Show Obese and Overweight Patients Taking Arena Pharmaceuticals' Lorcaserin Achieved Statistically Significant Weight Loss
Date:5/26/2011

disease that typically makes weight loss more difficult to achieve.

Changes in secondary endpoints of cardiovascular and metabolic risk were assessed in the Phase 3 program. Body Mass Index (BMI), waist circumference, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, systolic blood pressure, diastolic blood pressure, heart rate and quality of life were measured in all three trials in the Phase 3 program, and the integrated Year 1 results showed favorable statistically significant effects with lorcaserin 10 mg BID treatment compared to placebo. Lorcaserin did not increase heart rate or blood pressure; changes from baseline for patients who took lorcaserin 10 mg BID, lorcaserin 10 mg QD or placebo, respectively, were as follows: systolic blood pressure (mmHg), (-0.9, -0.2, -0.2); diastolic blood pressure (mmHg), (-1.4, -0.5, -0.8); and heart rate (bpm), (-1.0, -0.5, -0.2).

The most frequent lorcaserin-associated adverse events included headache, nausea, dizziness, fatigue and dry mouth. Headache was the only adverse event with an incidence that exceeded the placebo group by greater than 5%. In each trial, echocardiograms were performed at baseline and every six months to measure heart valve regurgitation. In the meta-analysis of the three trials, the proportion of patients who developed FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency) at Week 52 were as follows: lorcaserin 10 mg BID (2.37%), lorcaserin 10 mg QD (1.57%) and placebo (2.04%).

"There is a significant unmet need for effective treatment options that can help patients reduce their weight and improve their health in a well-tolerated manner," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "A diverse group of patients received lorcaserin in our Phase 3 program and achieved clinically meaningful weight loss and improvements in important cardiovascular and metabolic para
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SOURCE Arena Pharmaceuticals, Inc.
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