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Issues for the Bariatric & Metabolic Professional
By Christina Frangou

After a series of national policy changes and drug approvals this summer, physicians now have new tools to help their patients who struggle with obesity.

In late June, the U.S. Preventive Services Task Force (USPSTF) recommended that all adults be screened for obesity during their checkups—a directive geared to primary care physicians but all physicians are asked to heed the recommendations. The USPSTF also called on clinicians to refer patients with a body mass index (BMI) of 30 kg/m2 or greater to intensive multicomponent behavioral interventions, or offer these patients interventions.

Several days later, the FDA approved Belviq (lorcaserin hydrochloride; Eisai Pharmaceuticals) as an addition to a reduced-calorie diet and exercise for chronic weight management. Belviq was the first anti-obesity drug to be approved in the past 13 years, and marked a significant shift in FDA policy. For the past decade, the agency has been reluctant to approve new diet drugs, largely because of a history with product withdrawals and serious side effects.

image Weeks after endorsing Belviq, the FDA also approved Qsymia (Vivus Pharmaceuticals), which combines the anti-seizure/migraine drug topiramate and the appetite-suppressant phentermine.

“Obesity threatens the overall well-being of patients and is a major public health concern,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

Neither of the new anti-obesity drugs is on the market yet, but both are expected by late 2012 or early 2013. Prior to Belviq and Qsymia, the only prescription drug currently approved for long-term treatment of obesity was orlistat, marketed as Xenical (Roche). Orlistat also is sold over the counter in a lower dose as Alli.

The FDA recommended that the U.S. Drug Enforcement Administration (DEA) classify Belviq as a scheduled drug. Once the DEA has provided the final scheduling designation, the company will announce when Belviq will be available to patients and physicians in the United States. Belviq is not recommended for pregnant women, and should be used with caution in patients with congestive heart failure. The approved labeling for Belviq recommends that the drug be discontinued in patients who fail to lose 5% of their body weight after 12 weeks of treatment, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

With Qsymia, too, the approval comes with restrictions. The drug must not be used during pregnancy, for patients with glaucoma or hyperthyroidism, and, because Qsymia can increase heart rate, usage in patients with unstable heart disease or stroke within the past six months is not recommended. Regular heart rate monitoring is recommended for all patients, especially when starting the drug or when increasing the dose.

The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a medication guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification.

In its recommendation, which came prior to the two new drug approvals, the USPSTF found that there is significant evidence that intensive, multicomponent behavioral interventions for obese adults leads to an average weight loss of 4 to 7 kg, and improves glucose tolerance and other physiologic risk factors for cardiovascular disease.

The approval of the new drugs along with the policy changes provide an opportunity for physicians to take a more proactive approach to managing obesity in their patients, said Amy Foxx-Orenstein, MD, associate professor of medicine at Mayo Clinic, Phoenix. “This is a chance not just to take care of a symptom that’s related to obesity but to encourage a full lifestyle change.”

Dr. Foxx-Orenstein said she expects to prescribe the new drugs when they come to market. She’s anticipating that her patients will be interested in these treatment options. Community gastroenterologists should also consider prescribing the new medications when their patients are committed to changing their weight, said Dr. Foxx-Orenstein.

Lisa Ganjhu, DO, gastroenterologist at St. Luke’s-Roosevelt Hospital Center, in New York City, said she expects primary care physicians or obesity specialists to take the lead in prescribing new obesity drugs. “I have not [prescribed Belviq], yet. I am not sure I will. I would like to see it being used by others and see what their outcomes are prior to considering it.”

She said she is watching to see if Belviq will play a role in the management of nonalcoholic steatohepatitis. “This may be the ideal population to use the drug in. I would just be concerned about the potential long-term adverse outcome.”

The new drugs do come with important restrictions. Both should be used in conjunction with a balanced diet and exercise, and both should be taken for life in patients who respond to and can tolerate the drugs.

“For many people, obesity is a lifelong condition, but we don’t always think of it—or treat it—as such,” said Amy Egan, MD, MPH, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, in a statement.

Overall, physicians and device manufacturers have been frustrated with the slow process of trying to get approval for devices and endoscopic procedures that could potentially facilitate weight loss and treat obesity, said Steven A. Edmundowicz, MD, professor of medicine and chief of endoscopy, Washington University School of Medicine, St. Louis. The hope is that the FDA follows the recent drug approvals with greater willingness to approve devices for obesity management.

To this end, the FDA has recently made steps toward speeding up that approval process. Earlier this year, the FDA held a panel meeting with physicians and device manufacturers and will generate a consensus statement based on those results. The statement is expected to outline the criteria the FDA will use for obesity devices in terms of the risk to the patient and the effectiveness, or how much weight loss, the devices are going to be able to generate in trials.

“What we’re hoping for in endoscopy and gastroenterology are new effective tools that we can use in addition to the medications that are currently available or going to be available,” said Dr. Edmundowicz.

The recent changes indicate that the government recognizes the obesity crisis and is starting to implement change, said Dr. Ganjhu. But patients have to be willing to change, as well, she said.

In New York City, where trans fats are banned in restaurant food, government officials are now debating a ban on super-sized sodas. Others, however, have fought back, saying the government is overreaching into people’s personal lives.

“I find the argument frustrating. Simple changes can make great results if only they are made,” said Dr. Ganjhu.