Managed Care - August 2012 - (Page 45)
insurers Find small Gains in weight Control with Belviq
Clinical trial data from the lorcaserin submission suggest modest weight loss over a short period
Thomas Morrow, MD
t is obvious to anyone walking in any public area of the United States that we have a major problem with obesity. Data from the National Health and Nutrition Examination Survey (NHANES) show that 36 percent of adults and 17 percent of children — over 90 million Americans — were obese in 2010. Adults are obese if they have a body mass index of greater than 30. Obesity in children is a BMI greater than or equal to the age- and sex-specific 95th percentiles of the 2000 CDC growth charts. Obesity causes or is associated with a myriad of diseases. This has led to both medical and nonmedical approaches to this growing problem, including Mayor Michael Bloomberg’s recent proposal to legislate the size of sugary beverages in New York City. Arena Pharmaceuticals gained FDA approval for a new drug, lorcaserin (brand name Belviq), a selective serotonin agonist believed to decrease food consumption and promote satiety by selectively activating the 5-HT2C receptors in the hypothalamus. As a matter of record, there are also 2A and 2B receptors that have been targets of drug studies. The FDA denied approval in October 2010 because the federal advisory committee was concerned about the safety of the drug. Tumors had been found in rats. But further studies were submitted that led to its approval last June. The FDA has granted a rather complex indication that reads: Belviq is “… indicated as an adjunct to a reducedcalorie diet and increased physical activity for chronic weight management in adults with an
Thomas Morrow, MD, is the immediate past president of the National Association of Managed Care Physicians. He has 24 years of managed care experience at the payer or health plan level. Contact him at TMorrow@ManagedCareMag.com
initial body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).” For example, a five-foot-six person who weighs 167 pounds has a BMI of 27. He has a BMI of 30 if he weighs 186 pounds. The FDA goes on to list “limitations of use” stating “the safety and efficacy of co-administration with other products for weight loss have not been established” and “the effect of Belviq on cardiovascular morbidity and mortality has not been established.” The dose of lorcaserin is 10 mg twice daily, with or without food. The FDA says that the drug should be discontinued if 5 percent of the person’s weight has not been lost by week 12.
Clinical trials Lorcaserin was studied in three double-blind placebo-controlled clinical trials of at least one year duration in 6,888 patients (3,437 additional patients on placebo) in patients ages 18–66. One trial included patients with type 2 diabetes. The primary efficacy endpoint was weight loss at one year and specifically included patients achieving greater than 5 percent and greater than 10 percent reductions in body weight and mean weight change. All patients received counseling on reducing calories and on exercise. Results were statistically superior for lorcaserin for all endpoints. Studies 1 and 2 combined had a mean reduction of 5.8 kg in the lorcaserin group and 2.5 kg in the placebo group for a mean change of 3.3 kg — about seven pounds. Of patients in the active group, 47.1 percent were able to achieve a weight drop of 5 percent or more, compared with 22.6 percent in the placebo group. Of active group members, 24.4 percent achieved a 10 percent drop in weight, versus 8.7 percent in the placebo group.
AUGUST 2012 / MANAGED CARE
Table of Contents for the Digital Edition of Managed Care - August 2012
Managed Care - August 2012
Legislation & Regulation
News & Commentary
Private Exchanges: Practice Makes Perfect
Hospitals and Providers Ganging Up on Plans?
Q&A: Kaiser Permanente’s Sharon Levine, MD
God Save the Health Care System!
Future Points to Greater PBM/Plan Cooperation
Managed Care - August 2012