Weight Control at WeightControl.com

UCI Irvine Study Finds Millions May Benefit from Reduced Cardiac Events With New Weight Control Drugs

While the drug is costly to obtain by some patients, the cost savings associated with fewer doctor and hospital visits due to obesity and obesity-related diseases, in particular cardiovascular diseases (especially heart attacks, strokes, and heart failure) could be substantial.

WeightControl.com Interview with:

Nathan D. Wong, PhD, FACC, FAHA
Professor and Director
Heart Disease Prevention Program
Division of Cardiology, UC Irvine and
and UC Irvine and Radiology and Public Health at UC Irvine

WeightControl.com: What is the background for this study?

Response: Wegovy (semaglutide 2.4 mg given as an injection once weekly) has been shown in the previously reported STEP 1 trial to result in on average a 15% body weight loss in patients with overweight or obesity. It also beneficially improves other cardiovascular risk factors including blood pressure and cholesterol levels. We applied the eligibility and findings of the STEP 1 trial to the US population-representative National Health and Nutrition Examination survey and estimated that 93 million US adults with overweight or obesity would be potentially eligible for the drug based on the STEP 1 eligibility criteria.

Five Anti-Obesity Medications Evaluated for Cost-Effectiveness

A primary consideration that this analysis could not investigate is the issue of long-term weight loss.

WeightControl.com Interview with:

Ainhoa Gomez-Lumbreras, MD, PhD
Post-Doctoral Fellow
Department of Pharmacotherapy
College of Pharmacy, University of Utah

Dan Malone, PhD
Professor
Department of Pharmacotherapy
College of Pharmacy, University of Utah
Salt Lake City, UT 84112

WeightControl.com: What is the background for this study?

Response: Obesity, defined as having a body mass index of 30 or more, is a multifactorial disease that has been associated with cardiovascular and respiratory diseases, diabetes, and others. By 2030 it is expected that half of the U.S. adult population will be obese. More pharmacologic products are being investigated for weight loss, including the new anti-diabetes medications liraglutide, semaglutide and tirzepatide.

BELVIQ® : FDA Accepts Eisai’s Supplemental New Drug Application to Update the Labeling For Anti-Obesity Agent

WeightControl.com Interview with:

Dr. Lynn Kramer, MD FAAN

Dr. Lynn Kramer, MD FAAN
VP and Chief Clinical Officer & Chief Medical Office
Eisai Co., Ltd

WeightControl.com: What is the background for this announcement?

Response: On February 25^th, Eisai announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application to potentially update the label for BELVIQ® (lorcaserin HCI) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCI) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).

CAMELLIA-TIMI 61 is the first completed large-scale cardiovascular outcomes clinical trial for a weight loss agent. As reported and published in the New England Journal of Medicine on August 26^th, the results showed that CAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ did not increase incidence of MACE in overweight and obese patients at high risk for a CV event (HR 0.99; 95% CI: 0.85 to 1.14; p<0.001). Since the study met the primary safety endpoint for non-inferiority for MACE, the study continued to assess for the primary efficacy endpoint assessing whether or not BELVIQ reduced the incidence of major CV events compared to placebo for a broader composite endpoint, MACE+ (consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization). Although superiority to placebo was not met, BELVIQ was non-inferior to placebo on the MACE+ composite, with similar event rates for BELVIQ and placebo.