0221 GMT January 23, 2020
Researchers at Brigham and Women's Hospital conducted a clinical trial of overweight and obese patients to test the cardiovascular safety of Lorcaserin. They published their findings in the New England Journal of Medicine and presented them at the 2018 European Society of Cardiology meeting in Munich, Germany, UPI wrote.
The weight loss drug is sold under the brand name Belviq by Eisai Inc., the sponsor of the CAMELLIA-TIMI 61 trial.
"The study showed for the first time in a rigorous, randomized way that this weight loss drug helps people lose weight without causing an increase in adverse cardiovascular events in a population at higher risk for heart attacks and strokes," lead author Dr. Erin Bohula, a BWH cardiovascular medicine and critical care specialist, said in a press release.
The US Food and Drug Administration has conditionally approved weight loss agents like lorcaserin contingent on dedicated follow-up studies to assess the risk of adverse cardiovascular outcomes.
In the past, many weight loss drugs have had adverse cardiovascular effects, leading to dangerous conditions such as strokes, heart attacks, pulmonary hypertension and valvular heart disease — causing them to be withdrawn from the market.
In the new study, 12,000 overweight or obese patients with a median age of 64 were randomly assigned to receive lorcaserin or a placebo. They were followed for a median time of more than three years. Patients were recruited from January 2014 to November 2015.
The researchers found no statistical difference in the percentage of patients with a major adverse cardiovascular event, with group that received lorcaserin, at 6.1 percent, and the group receiving a placebo, at 6.2 percent.
Coupled with lifestyle changes, lorcaserin helped patients lower their weight by 9.3 pounds on average compared with a placebo at one year.
Specifically, more patients taking lorcaserin lost at least 5 percent of their body weight — 39 percent — compared with 17 percent who were in the placebo group.
The statistics were the same throughout the trial, which had a median follow up of more than three years.
Those taking the drug had better levels of triglycerides, blood glucose, heart rate and blood pressure — all factors associated with cardiovascular disease.
"For now, after rigorous testing, we can report that this is the first and only weight loss agent to show long-term cardiovascular safety in a high-risk population," Bohula said.