MDNews - Central New York

+++++++++++++++++ + + +++++++++++++++++ BARIATRICS +++ +++ Rx TWO NEW MEDICATIONS APPROVED FOR WEIGHT LOSS BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) GIVE PHYSICIANS MORE OPTIONS FOR TREATING OBESE PATIENTS BUT REINFORCE THE NEED FOR ONGOING PATIENT EDUCATION AND A TEAM APPROACH FOR LONG-TERM SUCCESS. O BESITY IS AN epidemic in the United States, affect- ing more than one-third of the adult population. Two new drugs, Belviq (lorcaserin hydrochloride) and Qsymia (phentermine and topiramate), were approved this past summer for chronic weight management when used as adjuvant therapy to a regimen that includes exercise and a reduced-calorie diet. The approvals marked the FDA's fi rst for anti-obesity medications in more than a decade. These new medications will join phentermine, recommended for short-term use, and orlistat — available over the counter as alli or in a prescription as Xenical — but they work differently. Belviq is a fi rst-in-class medication that binds to serotonin receptor 5HT2C to help patients feel full after consuming smaller portions of food. Qsymia, a combination of two already approved drugs — phentermine, an appetite suppressant, and topiramate, an anti-seizure medication — targets brain pathways to curb overeating. Defi nition of Effectiveness According to Quang Nguyen, D.O., FACP, FACE, endocri- nologist at Carson Tahoe Physician Clinics in Carson City, NV, medication is deemed an effective weight loss agent by the FDA if, after one year of treatment, either: + The difference in mean weight loss for subjects using the active product compared with those using the placebo is at least 5%. + The proportion of subjects who lose a minimum of 5% of baseline body weight in an active product group is at least 35% and is at least double the proportion in the placebo group. 20 | Central New York MD NEWS s MDNEWS.COM Measures of Success Three randomized, placebo-controlled trials were used to evaluate Belviq's effectiveness. Nearly 8,000 overweight and obese patients — some with and some without type 2 diabetes — were treated for one to two years with a regimen including exercise counseling and a reduced-calorie diet. Nearly half (47%) of patients without type 2 diabetes in the active group lost at least 5% of their body weight, compared with about 23% of those taking a placebo. Treatment with Belviq for up to one year resulted in an average weight loss of 3% to 3.7% of original body weight. Belviq can disrupt memory and attention and should not be used during pregnancy. Patients who have not lost at least 5% of their body weight after 12 weeks of treatment should discontinue use. Qsymia was evaluated during two one-year, placebo-controlled, randomized trials open to obese and overweight individuals without signifi cant weight-related conditions. Participants also fol- lowed a reduced-calorie diet and participated in regular exercise. In this group, weight loss at one year showed patients taking the recommended and the highest dose had an average weight loss of 6.7% and 8.9%, respectively. More than half of patients (62% and 69%) in the active group lost at least 5% of body weight, compared with 20% of those taking a placebo. s

• Cover