By Wei Yu
Capital News Service
LANSING – Two new obesity drugs are awaiting approval from the Food and Drug Administration, but federal advisers say Qnexaand Lorcaserin should undergo clinical trials to ensure there are no heart-risks.
According to the Michigan Department of Community Health, the state has the 10th highest rate of obesity in the U.S. Thirty percent of adults were obese and about one in six children aged 2 to 5 were obese or overweight in 2010.
“It is necessary to initiate clinical trials of the new drugs,” said Tom Rifai, medical director of metabolic nutrition and weight management at St. Joseph Mercy Oakland in Pontiac, Mich.
“Large, placebo-controlled, prospective trials would be ideal for any type of drug like this,” Rifai said. “If these drugs are ever used, they should be combined with a comprehensive program of behavior modification classes so that they are more of a ‘kickstart’ for lifestyle change rather than a panacea, because they never will be.”
Rifai said an increased cardiovascular risk is likely with many, if not all, obesity drugs.
“While I cannot give you a cookie-cutter answer regarding obesity drugs, many are stimulant-like medications and may very well increase cardiovascular risk,” Rifai said.
However, Charles Burant, director of the Michigan Metabolomics and Obesity Center at the University of Michigan, said it is hard to tell whether weight-loss drugs pose a cardiovascular risk since each drug is a different chemical entity.
Burant said obesity drugs should be scrutinized for side effects.
“It’s likely these drugs will be used long-term in individuals. Thus, a small increase in signals of cardiovascular disease could result in harm to a large number of people,” he said.
“At the present time, there are few drug options for people with obesity,” Burant said. “I’m confident that researchers will come up with something, but a really effective intervention for obesity is still some time off.”
George Corcoran, chair of the Department of Pharmaceutical Sciences at Wayne State University, said there are no current obesity drugs — or other drugs — without side effects.
“While one of the goals of developing new drugs to treat obesity is to discover agents that will be more successful, it is critically important to minimize side effects,” Corcoran said. “It is unlikely that any future drug will have zero side effects, no matter how diligent the effort to eliminate them.”
Corcoran said it is important to understand the actions of obesity drugs through clinical trials that include bigger samples of people who may be at greatest risk of potentially deadly adverse effects.
For some people, drugs have an important place in the treatment and reversal of obesity, he said, but drugs are only one of an array of needed approaches.
“If a therapeutic plan to combat obesity is to succeed, it must begin with the individual agreeing to be decisive in taking responsibility for his or her own health,” Corcoran said.
“Elements of the plan should begin with health enhancement through diet modification and increased physical activity, and include supportive lifestyle changes, team support and counseling,” he said.
“Only if efforts in these areas are unsuccessful should drugs or surgery be initiated,” he said.