Study results presented at the European Society of Cardiology (ESC) congress showed that in a high-risk population of overweight or obese patients, Eisai's Belviq (lorcaserin) was associated with sustained weight loss without a higher rate of major cardiovascular events (MACE) compared to placebo. The company reported in July that the long-term cardiovascular outcome trial, dubbed CAMELLIA-TIMI 61, met its main safety goal.
The study involved 12 000 overweight or obese patients with established cardiovascular disease or diabetes and at least one weight-related health condition, such as hypertension or high cholesterol. Results, which were also published in the NEJM, showed that with a median follow-up of 3.3 years, Belviq did not increase the incidence of MACE, with a rate of 2 percent per year for Eisai's drug, versus 2.1 percent per year for placebo. Further, the rate of extended MACE was 4.1 percent per year and 4.2 percent per year, respectively.
Lead author Erin Bohula noted "this is the first approved chronic weight-management medication to demonstrate safety for MACE in a dedicated, long-term cardiovascular outcome trial." However, the study failed to reach its primary efficacy endpoint, which was the rate of the composite of MACE/hospitalisation for unstable angina/heart failure/coronary revascularisation, with results showing they were similar with Belviq and placebo, at 11.8 percent and 12.1 percent, respectively.
Results also showed that patients receiving Belviq lost on average 4.2 kg of weight in the first year, compared to a loss of 1.4 kg for placebo. Further, 38.7 percent of patients taking Eisai's drug lost at least 5 percent of their body weight, which was significantly more than 17.4 percent on placebo. "We also observed small, but significant improvements in multiple cardiovascular risk factors, including triglyceride levels, blood pressure and new onset diabetes," Bohula remarked.
In the study, side effects associated with Belviq included dizziness, fatigue, headache and nausea, while there was also a higher incidence of serious hypoglycaemia in patients receiving the drug. Results of an echocardiographic substudy also revealed a greater incidence of valvular disease at one year with Belviq, with rates of 1.8 percent versus 1.3 percent for placebo, although the difference was not significant.
In an accompanying editorial, Julie Ingelfinger and Clifford Rosen of Tufts University School of Medicine, remarked "for now, the drug may best be used on a cautious basis according to the needs of individual patients." They added "as in other reports on its use, the side effects of headache, fatigue, dizziness, diarrhoea and nausea led to twice the number of discontinuations in the [Belviq] group as in the placebo group, although the total rates of discontinuation were similar in the two groups."
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