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WOODCLIFF LAKE, N.J. July 17, 2018 / PRNewswire / – Eisai Inc. has reported positive results in the CAMELLIA-TIMI 61 clinical study on cardiovascular outcomes. This study of 12,000 patients of BELVIQ ® (lorcaserin HCl) CIV 10 mg twice daily was conducted on more than 400 sites in eight countries including in the United States in collaboration with thrombolysis of myocardial infarction. (TIMI) and is the largest test of cardiovascular (CV) results to date for a weight loss drug. The study was conducted as part of a post-marketing requirement by the United States Food and Drug Administration (FDA) aimed primarily at assessing long-term cardiovascular safety and assessing the risk of cardiovascular disease. Incidence of major adverse cardiovascular events in overweight and obese children. adults with cardiovascular disease or type 2 diabetes mellitus (T2DM) with cardiovascular risk factors.
CAMELLIA-TIMI 61 has achieved its primary safety goal, finding that a long-term treatment with BELVIQ does not increase the incidence of MACE, defined such as cardiovascular death or nonfatal myocardial infarction or nonfatal stroke, in overweight and obese patients with a high risk of CV events. With this result, BELVIQ is the first ever approved weight loss drug for chronic weight management to achieve this goal in a dedicated long-term cardiovascular outcome test.
Since the study reached the primary endpoint of safety for MACE, the study also assessed the primary efficacy endpoint, namely whether BELVIQ reduced the incidence of cardiovascular events compared to placebo for a broader composite parameter, MACE +, consisting of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization. Although superiority over placebo was not achieved, BELVIQ was not inferior to placebo on the MACE + composite, with similar event rates for BELVIQ and placebo.
CAMELLIA-TIMI 61 also evaluated the effects of BELVIQ on multiple cardiovascular risk factors. In addition to cardiovascular risk management, BELVIQ treatment resulted in significant improvement in several predefined secondary outcomes, including blood pressure, lipids, blood glucose, and renal function, as well as a reduction in blood pressure. conversion to T2DM in patients with diabetes initially.
In further subgroup analyzes, it was observed that BELVIQ improved long-term weight loss compared to placebo, including in subpopulations of patients with T2DM and T2DM. obstructive sleep apnea
. for BELVIQ in CAMELLIA-TIMI 61 was consistent with that of the approved label, with dizziness, urinary tract infection and fatigue being the most frequently reported adverse events in CAMELLIA-TIMI61.
"Obesity is a major problem said Lynn Kramer MD, Clinical Chief Executive Officer and Chief Medical Officer, Neurology Business Group, Eisai." The results of BELVIQ from This robust global study provides important information to health care professionals and patients, especially those with cardiovascular and obesity-related complications. "
" CAMELLIA-TIMI 61 was a rigorous evaluation of the disease. BELVIQ's safety and effectiveness as a metabolic intervention on cardiovascular health in a population of high-risk cardiovascular patients, " Marc Sabatine MD, MPH, chairman of the group, said. TIMI study, 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 the results of the CAMELLIA-TIMI 61 study at the meeting of the European Society of Cardiology (19459003) in Munich, Germany on August 26 and the European Association for the Study of Diabetes (EASD) meeting in Berlin, Germany Oct. 4.
With the results of this study, Eisai will have discussions with the US FDA, including the eventual review of the product's label to include significant and important information for prescribers. By continuing to provide additional clinical and scientific information regarding BELVIQ, Eisai continues to make other contributions to address unmet medical needs and increase benefits for patients and their families.
About BELVIQ ®
BELVIQ [19659002] ® / BELVIQ XR ® is indicated as an adjunct to a low-calorie diet and increase of l. physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg / m 2 or higher (obese), or 27 kg / m 2 or more (overweight) in the presence of at least one weight-related comorbid disorder (eg, hypertension, dyslipidemia, type 2 diabetes)
Limitations of Use:
- ] The safety and effectiveness of co-administration of BELVIQ / BELVIQ XR with other products intended for weight loss, including prescription drugs (eg phentermine) , over-the-counter medications, and herbal preparations, have not been established.
- The effect of BELVIQ / BELVIQ XR on cardiovascular morbidity and mortality has not been established.
About the study
The CAMELLIA ( C Ardiovascular To nd M Etabolic E ffects of L orcaserin I n Overweight A And Obese Patients) TIMI 61 study was the largest double-blind , placebo-controlled, parallel -Group Phase IIIB / IV study among weight loss drugs. The study involved more than 12,000 overweight and obese patients with established CV or CV risk factors.
The main safety objective was to assess that BELVIQ did not increase the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction or nonfatal stroke. If the primary safety goal was achieved, the goal of effectiveness 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 assessing the possibility of delaying or preventing conversion to T2DM in patients with prediabetes or any diabetes at baseline and improving glycemic control in patients with patients with T2D.
Important Safety Information
Contraindications
- Pregnancy: BELVIQ / BELVIQ XR should not be used during pregnancy or by women planning pregnancy.
- Hypersensitivity: Patients with hypersensitivity reactions prior to lorcaserine or any of the components of the product, do not take BELVIQ / BELVIQ XR. Hypersensitivity reactions have been reported.
Warnings and Precautions
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS): BELVIQ / BELVIQ XR is a serotoninergic drug. Serotonin syndrome or potentially fatal neuroleptic malignant syndrome (NMS) -related reactions have been reported with the use of serotonergic drugs, including, but not limited to, selective reuptake inhibitors. serotonin-norepinephrine and selective serotonin reuptake inhibitors, tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John's Wort and tryptophan, drugs that impair the metabolism of serotonin (including monoamine oxidase inhibitors ), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists. Patients should be monitored for symptoms of serotonin syndrome or NMS-like reactions, including agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea and stiffness. muscular. Treatment with BELVIQ / BELVIQ XR and any concomitant serotonergic or anti-dopaminergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
- Valvular heart disease: Patients should not combine BELVIQ / BELVIQ XR with potent 5-HT receptor agonists 2B that have been associated with regurgitant valvular heart disease (e.g. cabergoline). In clinical trials, 2.4% of BELVIQ patients and 2.0% of placebo patients experienced valve regurgitation: none of these patients was symptomatic. BELVIQ / BELVIQ XR should be used with caution in patients with congestive heart failure (CHF). Patients who develop signs and symptoms of valvular heart disease, including dyspnea, dependent edema, CHF, or new heart murmur, should be evaluated and discontinuation of BELVIQ / BELVIQ XR should be considered.
- Cognitive Impairment: Attention, memory, drowsiness, confusion and fatigue have been reported in patients taking BELVIQ. Patients should not drive a car or use heavy machinery until they know how BELVIQ / BELVIQ XR affects them.
- Psychiatric Disorders: The recommended daily dose should not be exceeded because higher doses can cause euphoria, hallucination and dissociation. . Monitor patients for the development or worsening of depression, suicidal thoughts or behaviors and / or any change in mood. Discontinue BELVIQ / BELVIQ XR in patients who develop suicidal thoughts or behaviors
- Hypoglycemia: Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with antidiabetic drugs . levels before and during treatment with BELVIQ / BELVIQ XR is recommended. Decreases in the doses of antidiabetic drugs or changes in the drug regimen should be considered.
- Priapism: Men who suffer from priapism should immediately stop taking BELVIQ / BELVIQ XR and consult an emergency doctor. BELVIQ / BELVIQ XR should be used with caution with drugs for erectile dysfunction. BELVIQ / BELVIQ XR should be used with caution in men with conditions that may predispose them to priapism (eg Sickle Cell Disease, Multiple Myeloma or Leukemia) or in men with anatomical deformity of the penis (eg angulation, cavernous fibrosis). ).
- Heart rate decreases: Since BELVIQ / BELVIQ XR may slow the heart rate, it should be used with caution in patients with a history of bradycardia or higher-grade heart block
- . ] Surveillance Considerations: Consider monitoring changes in blood count, signs, and symptoms of prolactin excess and pulmonary hypertension
Most Common Adverse Reactions in Non-diabetic Patients headache (17%), vertigo (9%), fatigue (7%), nausea (8%), dry mouth (5%) and constipation (6%).
The most common adverse reactions for BELV IQ XR
- Common adverse events in patients treated with BELVIQ XR were similar to those seen in patients receiving BELVIQ
Nursing Mothers
- BELVIQ / BELVIQ XR should not not be taken by breastfeeding women.
BELVIQ / BELVIQ XR is a federally controlled substance (CIV) because it can be abused or addictive
For more information on BELVIQ / BELVIQ XR, see Full Prescribing Information .
About Obesity
Obesity is a serious and growing public health problem. The prevalence of obesity in the United States has more than doubled in adults over the past 30 years. About 69 percent of US adults over the age of 20 are obese and overweight. This dramatic increase 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 intermediary risk factors, such as hypertension, dyslipidemia and diabetes.
About Eisai Inc.
At Eisai Inc., Human Health (hhc) is our goal. We give our first thoughts to patients and their families, and help increase the benefits of health care. As a US-based pharmaceutical subsidiary of Eisai Co., Ltd., based in Tokyo, we are passionately committed to patient care that drives our efforts to discover and develop innovative therapies to address unmet medical needs.
A fully integrated pharmaceutical company that operates in two global business groups: Oncology and Neurology (dementia – related diseases and neurodegenerative diseases). Each group operates as a global end-to-end company with discovery, development, manufacturing and marketing capabilities. Our US headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are located in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., visit www.eisai.com/US and follow us on Twitter and LinkedIn
About the TIMI Study Group
The TIMI Group Study is an academic research organization based at Brigham and Women's Hospital that runs cardiovascular clinical trials that have changed practice for 30 years. Brigham and Women's Hospital (BWH) is a non-profit educational association of 793 beds of the Harvard Medical School and founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birth center in New England and employs nearly 15,000 people. 19659077] Eisai Inc.
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