Jul 17, 2018
WOODCLIFF LAKE, N.J., July 17, 2018 /PRNewswire/ -- Eisai Inc. announced positive topline results from the CAMELLIA-TIMI 61 cardiovascular outcome trial. This 12,000 patient study of BELVIQ® (lorcaserin HCl) CIV 10 mg twice-daily was conducted at over 400 sites in eight countries including the United States in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is the largest cardiovascular (CV) outcome trial to date for a weight loss medication. The study was conducted as part of a post-marketing requirement by the U.S. Food and Drug Administration (FDA) with the primary objective to evaluate long-term cardiovascular safety and assessed for the incidence of major adverse cardiovascular events (MACE) in overweight and obese adults with existing cardiovascular disease or type 2 diabetes mellitus (T2DM) with cardiovascular risk factors.
CAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ does not increase incidence of MACE, defined as cardiovascular death or non-fatal myocardial infarction or non-fatal stroke, in overweight and obese patients at high risk for CV events. With this result, BELVIQ is the first- ever weight loss medication approved for chronic weight management to achieve this objective in a dedicated long-term cardiovascular outcome trial.
Since the study met the primary safety endpoint for MACE, the study also assessed for the primary efficacy endpoint of whether or not BELVIQ reduced the incidence of cardiovascular 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.
CAMELLIA-TIMI 61 also assessed for effects of BELVIQ on multiple cardiovascular risk factors. On top of standard of care for CV risk management, treatment with BELVIQ resulted in significant improvements in a number of predefined secondary endpoints, including blood pressure, lipids, blood sugar and renal function, as well as a reduction in conversion to T2DM in patients without diabetes at baseline.
In additional subgroup analyses, on a background of lifestyle modification, it was observed that BELVIQ improved long-term weight loss, compared to placebo, including in subpopulations of patients with T2DM and obstructive sleep apnea.
The overall safety profile for BELVIQ in CAMELLIA-TIMI 61 was consistent with that of the approved label, with dizziness, urinary tract infection, and fatigue being the most commonly reported adverse events in CAMELLIA-TIMI61.
"Obesity is a major problem globally and associated with increased risk for heart disease and other serious health conditions such as hypertension, type 2 diabetes and obstructive sleep apnea," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The results for BELVIQ from this robust global study provide important information to health care providers and patients, particularly those with cardiovascular and obesity-related complications."
"CAMELLIA-TIMI 61 was a rigorous evaluation of the safety and efficacy of BELVIQ as a metabolic intervention on cardiovascular health in a high cardiovascular risk patient population," said Marc Sabatine, MD, MPH, Chairman, TIMI Study Group, Brigham and Women's Hospital. "We look forward to sharing the full results with the scientific community."
Eisai and the TIMI Study Group will present results of the CAMELLIA-TIMI 61 study at the European Society for Cardiology (ESC) Meeting in Munich, Germany on August 26 and the European Association for Study of Diabetes (EASD) Meeting in Berlin, Germany on October 4.
With the results of this study, Eisai will have discussions with the U.S. FDA, including potential revision of the product label to include meaningful and important information for prescribers. By continuing to provide additional clinical and scientific information regarding BELVIQ, Eisai continues to make further contributions to address unmet medical needs and increase the benefits for patients and their families.
BELVIQ®/BELVIQ XR® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
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About the Study
The CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study was the largest double-blind, placebo-controlled, parallel-group Phase IIIB/IV study among weight loss medications. The study consisted of over 12,000 overweight and obese patients with established CV disease or CV risk factors.
The primary safety objective was to evaluate that BELVIQ did not increase the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. If the primary safety objective was met, the efficacy objective was to evaluate the impact of BELVIQ on reducing the incidence of MACE+, defined as MACE or hospitalization due to unstable angina or heart failure, or any coronary revascularization. Secondary objectives included evaluation for the potential to delay or prevent conversion to T2DM in patients with pre-diabetes or no diabetes at baseline and improvement of glycemic control in patients with T2DM.
Important Safety Information
Warnings and Precautions
Most Common Adverse Reactions for BELVIQ
Most Common Adverse Reactions for BELVIQ XR
BELVIQ/BELVIQ XR is a federally controlled substance (CIV) because it may be abused or lead to dependence.
For more information about BELVIQ/BELVIQ XR, see full Prescribing Information.
Obesity is a serious and growing public health issue. The prevalence of obesity in the U.S. has more than doubled among adults in the past 30 years. Approximately 69 percent of American adults over the age of 20 are affected by obesity and overweight. This dramatic rise in obesity has also had a major impact on other diseases. Indeed, obesity is an important risk factor for heart disease and stroke, directly or indirectly through intervening risk factors, such as hypertension, dyslipidemia, and diabetes.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, manufacturing and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
About the TIMI Study Group
The TIMI Study Group is an Academic Research Organization based at Brigham and Women's Hospital that has been leading practice-changing cardiovascular clinical trials for 30 years. Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people.
SOURCE Eisai Inc.