(Reuters Health) – Eisa's weight loss drug lorcaserin does not increase the risk of cardiovascular events, according to a study of 12,000 overweight or obese patients.
Everyone in the study funded by Eisai had atherosclerotic cardiovascular disease or multiple risk factors for heart disease.
Half of the study participants observed for at least three years had no difference in the combined risk of heart attack, stroke, or any type of cardiovascular death between persons taking lorcaserin and those taking a dummy pill.
This result was observed in 2.0 percent of the subjects treated with lorcaserine per year compared to 2.1 percent of the placebo group.
When the researchers also looked at cases of heart failure, hospitalization for chest pain, and the need to reopen clogged arteries in the heart, rates were 4.1
At the one-year mark, 38.7 percent of the volunteers who received the drug and 17.4 percent who received the placebo lost at least 5 percent of their body weight.
Loss of 10 percent or more body weight occurred in 14.6 percent of the Lorcaserin recipients and in 4.8 percent of the placebo patients.
The study, known as CAMELLIA-TIMI 61, was published at the Annual Congress of the European Society of Cardiology in Munich and online in the New England Journal of Medicine.
"For the time being, the drug can best be used on a cautious basis according to the needs of individual patients," according to an editorial by journal editor Dr. Julie Ingelfinger and dr. Clifford Rosen of Tufts University School of Medicine in Boston.
"As in other reports of its use, admitting the side effects of headache, fatigue, dizziness, diarrhea and nausea to twice the number of discontinuities in the Lorcaserin group than in the placebo group, although the overall termination rates were similar in the both groups, "they remarked.
The drug, sold under the brand name Belviq, costs about $ 280 a month, according to the goodrx.com website.
About 40 percent of Americans are obese.
In the past, several promising weight loss drugs have been taken off the market for cardiovascular side effects.
Study patients were treated at 473 sites in eight countries. The drug approved by the US Food and Drug Administration in 2012 was given as a 10 mg dose twice daily.
SOURCE: bit.ly/BOd33J The New England Journal of Medicine, online August 26, 2018.