Medical debate continues locally and nationally over two prescription drugs whose weight-loss potential is being weighed against potential side effects.
Qsymia, produced by Vivus Inc., and Belviq, manufactured by Arena Pharmaceuticals, have been available for more than a year, although they generally aren't covered by health-insurance plans.
The issue is benefits vs. risks.
Vicki March, an internist at Magee-Womens Hospital of UPMC, said the drugs actually cause more weight loss than advertised, with Belviq reducing body weight on average by 7 percent. That means the drug could help a 300-pound person shed 21 pounds. Dr. March is medical director of the Lifestyle Program in UPMC's Minimally Invasive Bariatric and General Surgery Division and co-director of BodyChangers, a lifestyle change and support program.
Studies have shown that the higher dose of Qsymia dropped body weight on average by 9 percent, or 27 pounds for a 300-pound person.
The totals might not sound dramatic, but Dr. March said it's enough to reduce blood pressure, blood-glucose levels, cholesterol, arthritis and the risk of fatty liver disease, with added improvements in mobility.
She's prescribed it to only a few patients and has yet to gather sufficient data to evaluate its effectiveness. Even if the person does not lose a lot of weight, she said, there are advantages to preventing further weight gain.
People with obesity already face significant health risks from diabetes, sleep apnea, hypertension and cardiovascular disease, and many have tried and failed to change their lifestyle to lose weight.
"Most people have failed with diets and exercise, so medicine is added," Dr. March said, adding that the medications not only led to weight loss but also helped keep it off. "The benefits are tremendous, and the risk is tiny."
Andrew C. Adams, an internist with West Penn Medical Associates, said he's awaiting data on the drugs' effectiveness.
"I'm not prescribing any of them at present," he said. "These are the first new diet pills in a long time, but it's not something I'm anxious to start prescribing. It has limited impact, and when prescribing these drugs you have look at the risk-benefit ratio, and the benefits are too low.
"There are no easy answers to this problem at this point," he said of obesity. "I haven't written it off. I'm hopeful that one or both drugs pan out and prove to be effective agents. It's wait-and-see, but I'm not terribly optimistic."
Another concern for Dr. Adams and others is the fact that European Medicines Agency procedures forced Arena Pharmaceuticals Inc. to withdraw its application for Belviq last May when the company could not address agency concerns under the given deadline.
Vivus faced a similar fate. The EMA rejected Qsymia last February because the company could not complete a cardiovascular-outcomes trial in time to show long-term safety of the drug.
In June 2012, the FDA approved Qsymia, which is a combination of phentermine and topiramate, with approval for Belviq (lorcaserin hydrochloride) in July 2012, both with limits. Prescriptions are limited to those with a BMI of 30 or higher, or a BMI of 27 or higher if the person has such weight-related health problems as type 2 diabetes, high blood pressure or heart disease.
One standing concern with Belviq are study findings that participants, on average, lost only 3.7 percent of their body weight.
The FDA recommends against using Qsymia in patients with glaucoma or hyperthyroidism. The drug also can increase one's heart rate, although its impact on people at high risk for heart attack or stroke isn't known. For that reason, Qsymia is not recommended for patients with recent or unstable heart disease or stroke. Patients on the drug also must have their heart rate monitored.
Pregnant women, or ones likely soon to be pregnant, should avoid Qsymia because it can cause birth defects, the FDA said.
The FDA also ordered Vivus Inc. to conduct a long-term cardiovascular-outcomes trial to assess the risk of Qsymia for major adverse cardiac events such as heart attack and stroke. Most commonly, patients experience tingling of hands and feet, dizziness, altered hand sensations, insomnia, constipation and dry mouth.health
David Templeton: firstname.lastname@example.org or 412-263-1578.