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 25th, 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 26th, 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.
WeightControl.com Interview with: Britt Burton–Freeman, Ph.D Director of the Center for Nutrition Research at IFSH Associate Professor, Food Science and Nutrition Illinois Institute of Technology
WeightControl.com: What is the
background for this study? What are the main findings?
Response: Red raspberries contain appreciable amounts of dietary fiber and a
variety of other nutrients, such as vitamin C, vitamin K, magnesium and
potassium. They also contain phytochemicals, such as polyphenols with
documented biological activity suggesting metabolic benefits. However, there is
limited data assessing the potential effects of red raspberries in humans,
particularly in those people who might benefit the most, ie., people at risk
for diabetes mellitus.
We investigated the health benefits of consuming 1-2
cups of red raspberries in a group of people who were overweight/obesity and had
prediabetes and insulin resistance.
The results showed that when a breakfast meal was
consumed with raspberries, less insulin was needed to manage blood sugar
compared with a meal with no raspberries. Moreover, when two cups of red
raspberries were included in the breakfast meal, blood sugar concentrations
were significantly lower compared to consuming breakfast without raspberries.
L. Kuk, PhD
School of Kinesiology and Health Science
Sherman Health Science Research Centre, Rm 2002
What is the background for this study? What are the main findings?
weight loss is prescribed at the rate of 1 to 2 pounds per week. However,
this is largely based on the observation that weight losses faster than 2
pounds per week put patients at an increased risk for gallstones. It is
unclear whether this is the optimal rate of weight loss for CVD or diabetes
outcomes. Furthermore, fast weight loss has historically thought to be
associated with poorer long term weight loss. However, this was largely
based on research using liquid diets. Recent evidence suggests that
faster weight loss may be similar to slower weight loss when more sensible
lifestyle interventions are used. Thus, if there are additional benefits
of faster weight loss for CVD or diabetes outcomes, then there may a rationale
for prescribing faster weight loss as the overall rate of gallstones is fairly
observed that those who lose weight faster than 2lb/wk tend to lose more weight
overall, but for the same overall weight loss, there is no difference in terms
of health benefits with fast or slow weight loss.
A study in BMC Public Health finds that although men’s magazine refer to scientific information, “the content, format and scientific basis of dietary content of MH leaves much to be desired. The dietary advice as provided may not be conducive to public health”.
“Incremental lifetime costs of a patient with obesity or overweight (vs. normal weight) increased with the patient’s age, peaked at age 50, and decreased with older ages. However, weight reduction even in older adults still yielded incremental cost savings.”
The Childhood Obesity Intervention Cost-Effectiveness Study (CHOICES),a collaboration between the Harvard School of Public Health, Columbia University and research partners at Deakin and Queensland University in Australia, is working to help reverse the US obesity epidemic by identifying the most cost-effective childhood obesity interventions.
“FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
All five reports indicate that patient deaths occurred within a month or less of balloon placement…..”
A study from the University of Texas San Antonio and published in the journal Cancer suggests that
“… women younger than age 60 diagnosed with breast cancer who have a genetic risk factor for obesity have a higher risk for gaining weight and therefore should begin a weight-loss program to increase their chance for survival.”