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Lorcaserin improved weight loss, cardiometabolic markers in adults
Lorcaserin 10 mg twice daily is safe and effective when combined with diet and exercise to treat adults with overweight or obesity but without type 2 diabetes, according to results published Postgraduate Medicine.
Lorcaserin hydrochloride (Belviq, Eisai Inc.) reduced weight, improved cardiometabolic markers and was well tolerated compared with placebo.
“This pooled phase 3 analysis of the BLOOM and BLOSSOM trials, the largest obesity trial dataset published to date within the US, shows lorcaserin 10 mg, twice daily, in combination with diet and exercise is associated with a statistically significant weight loss,” the researchers wrote. “Improvements in cardiometabolic parameters show that weight loss associated with lorcaserin use is clinically relevant.”
The randomized, double blind, placebo-controlled trials involved 6,136 patients aged 18 to 65 years with BMI between 30 kg/m2 and 45 kg/m2 with at least one coexisting condition.
In the 2-year BLOOM trial, patients received lorcaserin 10 mg twice daily or placebo combined with diet and exercise during the first year, then were randomly reassigned the second year to continued treatment or placebo. In the yearlong BLOSSOM trial, patients received lorcaserin 10 mg twice daily, lorcaserin 10 mg once daily or placebo combined with diet and exercise. Echocardiograms were conducted on all patients.
The pooled modified intent-to-treat analysis by Louis Aronne, MD, of Weill Cornell Medical College, and colleagues from other institutions focused on the dose and duration common to both.
Louis Aronne
When comparing lorcaserin with placebo, twice as many patients lost ≥5% (47.1% vs. 22.6%) and ≥10% (22.4% vs. 8.7%) of body weight after 1 year of treatment. The overall percentage of weight lost by patients with lorcaserin also was greater than with placebo (–5.8% vs. –2.5%). Lipid parameters, glycemic indicators, quality-of-life measures and vital signs all improved more with lorcaserin vs. placebo. All results were statistically significant.
In the combined dataset, no increased risk for cardiac valvulopathy was associated with treatment. Valvulopathy rates, as defined by the FDA, were 2.3% with lorcaserin and 2.2% with placebo.
Headache, upper respiratory tract infection and nasopharyngitis were the most comment adverse events associated with treatment.
Disclosure: The research was funded by Arena Pharmaceuticals, with editorial support funded by Eisai. Some of the researchers report being employed by Eisai or Arena Pharmaceuticals or consultants for the companies or other pharmaceutical companies.