For years, drug companies have been chasing the “holy grail” in the fight against obesity — an effective weight-loss pill without serious complications.
A new pharma-funded study released last month appears to be another step toward that goal, showing that the appetite suppressant lorcaserin did not increase the risk of serious heart problems.
But is the weight reduction large enough — and the risks small enough — that this drug should be prescribed more widely?
Lorcaserin is a twice-a-day pill that suppresses appetite by stimulating brain chemicals to create a feeling of fullness.
The Food and Drug Administration (FDA) approved the drug in 2012, but the agency restricted the drug’s use to overweight or obese people with an existing weight-related health condition.
The FDA also required drug company Arena Pharmaceuticals to do long-term studies of the drug’s safety.
The new study is one of those.
It included 12,000 overweight or obese people with atherosclerotic cardiovascular disease or multiple risk factors for heart disease.
During the study, people took either lorcaserin or an inactive placebo pill twice a day. Researchers tracked people on average for slightly more than three years.
People who took lorcaserin had similar rates of heart attack, stroke, and cardiovascular death as people taking the placebo — around 2 percent of people in both groups.
The study was published late last month in The New England Journal of Medicine.
In the past, several weight-loss drugs have run into trouble when they were found to increase the risk of cardiovascular problems.
This includes Meridia, which was withdrawn from the U.S. market in 2010.
Questions still remain
Lorcaserin performed well in this study, but some experts say questions about its safety still linger.
Dr. Cecilia Low Wang, an associate professor of medicine at the University of Colorado Anschutz Medical Campus School of Medicine, said the positive results of the study should “encourage broader use of lorcaserin, with the caveat that there were a few concerning signals.”
She pointed to the increased rates for people taking the drug of heart valve problems and high blood pressure in the arteries of the lungs and right side of the heart.
The authors of a related editorial in the New England Journal said that “for now, the drug may be best used on a cautious basis according to the needs of individual patients.”
Low Wang, who was not involved in the study, also said that “there was twice the rate of side effects such as headaches, fatigue, dizziness, nausea, and diarrhea on lorcaserin as on placebo.”
These side effects led to more people on lorcaserin to stop taking the pill, compared to those on the placebo.
Low Wang said longer-term follow-up studies are needed to better understand these risks.
Some weight loss was accomplished
As for weight loss, some people in the study did well on lorcaserin.
After one year, 38 percent of people taking the drug lost at least 5 percent of their body weight, compared to 17 percent of people taking the placebo.
In addition, almost 15 percent of people taking lorcaserin, and nearly 5 percent of people taking the placebo, lost at least 10 percent of their body weight.
After 40 months, people taking the drug lost an average of almost 9 pounds, compared to less than 5 pounds for the placebo group.
This means that more than 60 percent of people taking lorcaserin lost less than 5 percent of their body weight over the course of a year — at a cost of about $3,360.
Lorcaserin, sold in the U.S. under the brand name Belviq, costs about $280 per month, according to the website GoodRx.
Low Wang said the higher rates of weight loss compared to a placebo makes the drug promising, but “not enough to be a ‘holy grail.’”
Funding by pharma
This study was funded by pharmaceutical company Eisai Co., Ltd., which provided grants to lead author Dr. Erin Bohula and other researchers for work done during the study.
Several other researchers were paid personal fees and some of the authors were employees of the company.
Critics have raised concerns about studies funded by the same pharmaceutical companies that develop or market those drugs.
They argue that companies may be more interested in profit than accuracy. Companies could potentially design studies that emphasize benefits over risks, or publish only positive results.
Low Wang said that it would be “ideal” to have some drug studies done by public funding agencies, but the costs of large multicenter global trials makes that unlikely.
This doesn’t mean, though, that all studies done by a company making a drug should be discounted.
“Many of these types of studies, despite being pharma-funded, can be performed and analyzed to minimize potential bias and to give true results with which to base our clinical care decisions,” said Low Wang.
Advice on weight loss
If you’re searching for a weight-loss drug, talk to your doctor about your options, including the risks, benefits, and cost of each.
Also, other medications are available, some with more years of data about their safety.
“We have drugs right now that are approved for other indications that, when used in combination, could cause greater weight loss than any single medication used alone,” said Low Wang.
And keep in mind that a pill is just part of the equation.
The Diabetes Prevention Program, a lifestyle intervention for people at high risk for diabetes used by Medicare, leads to about 4 percent weight loss after a year.
“Behavioral modification and healthy lifestyle changes are fundamental to successful long-term maintenance of weight loss,” said Low Wang, “and all other weight-loss interventions including weight-loss medications are adjuncts.”