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.
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"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: https://bit.ly/2BOd33J The New England Journal of Medicine,
online August 26, 2018.
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