Eisai Begins CAMELLIA-TIMI 61 Long-term Outcomes Study to Assess Cardiovascular and Metabolic Effects of Lorcaserin HCI CIV in Overweight/Obese Patients

WOODCLIFF LAKE, N.J., Feb. 24, 2014 /PRNewswire/ -- Eisai Inc. today announced that patient recruitment and enrollment are currently underway for CAMELLIA-TIMI 61, a randomized double-blind, placebo-controlled outcomes trial to evaluate the effect of long-term treatment with lorcaserin HCl on the incidence of major adverse cardiovascular events and new onset type 2 diabetes mellitus in obese (BMI > 30 kg/m²) and overweight (BMI > 27 kg/m²) patients with cardiovascular disease or cardiovascular risk factors.

The completion of this study will satisfy the postmarketing requirement from the U.S. Food and Drug Administration (FDA) to evaluate the long-term cardiovascular safety of lorcaserin HCl, marketed as BELVIQ^®. The five-year multicenter study, conducted in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, will include approximately 12,000 patients at 700 sites in 14 countries around the world.

"This robust global study underscores Eisai's commitment to improving human health care and will generate important data about the long-term safety and efficacy of lorcaserin HCl in overweight and obese patients, including the effects on comorbid risk factors associated with obesity," said Andrew Satlin, MD, Executive Vice President, Neuroscience and General Medicine PCU, Eisai Inc.

BELVIQ^® (lorcaserin HCl) CIV is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m² or greater (obese), or BMI of 27 kg/m² or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.

BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known.

"Obesity is a major problem globally with serious cardiovascular implications," said Marc Sabatine, MD, MPH, Chairman, TIMI Study Group, Brigham and Women's Hospital. "This study, led by Drs. Benjamin Scirica and Stephen Wiviott from the TIMI Study Group, represents a rigorous evaluation of the effects of lorcaserin HCl as a metabolic intervention on cardiovascular health."

About the Study

The CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study is the largest double-blind, placebo-controlled, parallel-group Phase IIIB/IV study underway to date among weight loss medications. The primary safety objective is to evaluate the incidence of major adverse cardiovascular events, specifically cardiovascular death, myocardial infarction or stroke.  If the primary safety objective is met, the co-primary efficacy objectives are to evaluate the impact of lorcaserin on the incidence of: (1) the composite of major adverse cardiovascular events, hospitalizations for unstable angina or heart failure, or any coronary revascularization, and (2) new-onset type 2 diabetes mellitus.

In addition, the study will evaluate the efficacy of lorcaserin HCl with respect to glycemic control in patients with type 2 diabetes mellitus.

To learn more about this clinical trial, please visit http://clinicaltrials.gov/ct2/show/NCT02019264?term=lorcaserin&rank=12.

Important Safety Information about BELVIQ^®

• Pregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and BELVIQ may harm your unborn baby.
• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
• Valvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ, tell your doctor if you have or have had heart problems.
• Changes in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you.
• Mental problems: Taking too much BELVIQ may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body.
• Depression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
• Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops.
• Painful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop taking BELVIQ and call your doctor or go to the nearest emergency room right away.
• Slow heartbeat: BELVIQ may cause your heart to beat slower.
• Decreases in blood cell count: BELVIQ may cause your red and white blood cell counts to decrease.
• Increase in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid, or if you are a male and your breasts increase in size.
• Most common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation.
• Most common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue.
• Nursing: BELVIQ should not be taken while breastfeeding.
• Drug interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines, or other medical conditions, such as: triptans; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC) common cold/cough medicine); OTC supplements such as tryptophan or St. John's Wort; or erectile dysfunction medicines.

BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence.

For more information about BELVIQ, click here for the full Product Information or visit www.BELVIQ.com.

BELVIQ^® is a registered trademark of Arena Pharmaceuticals GmbH.

About Obesity

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 one-third of American adults are classified as overweight and another one-third are affected by obesity. This dramatic rise in obesity has also had a major impact on other diseases.

About Eisai Inc.

At Eisai Inc., human health care 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 help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US. 

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

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.

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SOURCE Eisai Inc.