Weight-loss drug Belviq seems safe for heart, study finds

For the first time, a drug has been shown to help people lose weight and keep it off for several years without raising their risk for heart problems — a safety milestone that may encourage wider use to help curb the obesity epidemic.

The drug, Belviq, has been sold in the United States since 2013 and is the first of several new weight-loss medicines to succeed in a long-term heart safety study now required by federal regulators to stay on the market.

“Patients and their doctors have been nervous about using drugs to treat obesity and for good reason. There’s a history of these drugs having serious complications,” said study leader Dr. Erin Bohula of Brigham and Women’s Hospital in Boston. With this study, Belviq has been convincingly shown safe for the heart, she said. Although Belviq did not raise heart risks, it didn’t lower them either, as many had hoped it would. The weight loss it produced was modest — after 40 months, Belviq users had shed 9 pounds (4 kilograms), twice as much as those on dummy pills.

Results were discussed Sunday at a European Society of Cardiology meeting in Munich and published by the New England Journal of Medicine. Belviq’s maker, Eisai Inc., sponsored the study and many of the researchers consult or work for the company.

Several popular diet medicines were previously withdrawn from sale after they were found to raise the risk for heart valve damage, suicidal thoughts or other problems, prompting the new requirement for heart safety studies.

Belviq is an appetite suppressant that works by stimulating brain chemicals to give a feeling of fullness. It costs roughly $220 to $290 a month in the United States.

Researchers tested it in a study of 12,000 people who were either obese or overweight with heart disease risk factors such as high blood pressure or cholesterol. They were given Belviq or dummy pills to take twice a day and offered lifestyle and diet advice.

At one year, 39 per cent on Belviq and 17 per cent on dummy pills had lost at least 5 per cent of their starting weight. Several previous studies also found the drug effective for weight loss.

After about three years, 6 per cent of each group had suffered a heart-related problem or death.

Fewer people on Belviq developed diabetes — 8.5 per cent versus 10.3 per cent on dummy pills.

Serious side-effects were similar, but more on Belviq stopped taking their pills because of them — 7 per cent versus 4 per cent. Common side-effects included dizziness, fatigue, headache and nausea.

Dangerously low blood sugar happened in 13 people on Belviq versus four in the other group; all but one case involved people also taking diabetes medicines, which lower blood sugar.

Tests for heart valve damage were done on 3,270 participants but no big differences in rates were seen. Suicidal thoughts or behaviour were reported in 21 people on Belviq versus 11 on dummy pills, but more on the drug had a history of depression and the difference was so small it could have been due to chance, Bohula said.