(Reuters Health) - Eisai’s weight loss drug lorcaserin does not increase people’s risk of major cardiovascular events, according to data from a study of 12,000 overweight or obese patients.
Everyone in the study, which was funded by Eisai, had atherosclerotic cardiovascular disease or multiple risk factors for heart disease.
With half the study participants tracked for at least three years, there was no difference in the combined risk of heart attack, stroke or any type of cardiovascular death between people taking lorcaserin and people taking a dummy pill.
That outcome was seen in 2.0 percent of lorcaserin-treated subjects per year versus 2.1 percent of the placebo group.
When researchers also considered cases of heart failure, hospitalization for chest pain and the need to reopen clogged arteries in the heart, rates were 4.1 percent per year with lorcaserin and 4.2 percent with placebo.
At the one-year mark, 38.7 percent of volunteers getting the drug and 17.4 percent getting placebo had lost at least 5 percent of their body weight.
A loss of 10 percent or more of body weight occurred in 14.6 percent of lorcaserin recipients and 4.8 percent of placebo patients.
The study, known as CAMELLIA-TIMI 61, was reported at the European Society of Cardiology’s Annual Congress in Munich and online in The New England Journal of Medicine.
“For now, the drug may 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 on its use, the side effects of headache, fatigue, dizziness, diarrhea and nausea let to twice the number of discontinuations in the lorcaserin group as in the placebo group, although the total rates of discontinuation were similar in the two groups,” they noted.
The drug, sold under the brand name Belviq, costs about $280 per month according to the website goodrx.com.
About 40 percent of Americans are obese.
In the past, several promising weight loss medications have been pulled from the market because of cardiovascular side effects.
Study patients were treated at 473 sites in eight countries. The drug, approved by the U.S. Food and Drug Administration in 2012, was given as a 10-mg dose twice daily.
SOURCE: bit.ly/2BOd33J The New England Journal of Medicine, online August 26, 2018.