The U.S. Food and Drug Administration has approved Belviq (lorcaserin hydrochloride) as an addition to a reduced-calorie diet and exercise for chronic weight management.
The drug, the first weight-loss drug to gain FDA approval in 13 years, is for use in adults with a body mass index of 30 or greater, or adults with a BMI of 27 or greater who have at least one weight-related condition such as hypertension, type 2 diabetes or dyslipidemia.
According to the Centers for Disease Control and Prevention, more than a third of adults in the United States are classified as obese because their BMI is 30 or higher.
Obesity "is a major public health concern," Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."
Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food, according to the FDA.
The safety and efficacy of Belviq were evaluated in three randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, who were treated for one to two years. All participants received lifestyle modification that consisted of a reduced-calorie diet and exercise counseling.
Compared with placebo, treatment with Belviq for up to a year was associated with average weight loss ranging from 3% to 3.7%.
About 47% of patients without type 2 diabetes lost at least 5% of their body weight, compared with about 23% of patients treated with placebo. In people with type 2 diabetes, about 38% of patients treated with Belviq and 16% treated with placebo lost at least 5% of their body weight. Belviq treatment was associated with favorable changes in glycemic control in those with type 2 diabetes.
Warnings
According to the approved labeling for Belviq, the drug should be discontinued in patients who fail to lose 5% of their body weight after 12 weeks of treatment. These patients are unlikely to achieve clinically meaningful weight loss with continued treatment.
Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.
In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor, according to the FDA.
Heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program. There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients. Because preliminary data suggest the number of serotonin 2B receptors may be increased in patients with heart failure, Belviq should be used with caution in patients with that condition. Belviq has not been studied in patients with serious valvular heart disease.
The drug’s manufacturer will be required to conduct six postmarketing studies, including a long-term trial to assess the effect of Belviq on the risk for major adverse cardiac events such as myocardial infarction and stroke.
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation, and in diabetic patients are hypoglycemia, headache, back pain, cough and fatigue.
Belviq is manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland, and distributed by Eisai Inc. of Woodcliff Lake, N.J.
The drug, the first weight-loss drug to gain FDA approval in 13 years, is for use in adults with a body mass index of 30 or greater, or adults with a BMI of 27 or greater who have at least one weight-related condition such as hypertension, type 2 diabetes or dyslipidemia.
According to the Centers for Disease Control and Prevention, more than a third of adults in the United States are classified as obese because their BMI is 30 or higher.
Obesity "is a major public health concern," Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."
Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food, according to the FDA.
The safety and efficacy of Belviq were evaluated in three randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, who were treated for one to two years. All participants received lifestyle modification that consisted of a reduced-calorie diet and exercise counseling.
Compared with placebo, treatment with Belviq for up to a year was associated with average weight loss ranging from 3% to 3.7%.
About 47% of patients without type 2 diabetes lost at least 5% of their body weight, compared with about 23% of patients treated with placebo. In people with type 2 diabetes, about 38% of patients treated with Belviq and 16% treated with placebo lost at least 5% of their body weight. Belviq treatment was associated with favorable changes in glycemic control in those with type 2 diabetes.
Warnings
According to the approved labeling for Belviq, the drug should be discontinued in patients who fail to lose 5% of their body weight after 12 weeks of treatment. These patients are unlikely to achieve clinically meaningful weight loss with continued treatment.
Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.
In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor, according to the FDA.
Heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program. There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients. Because preliminary data suggest the number of serotonin 2B receptors may be increased in patients with heart failure, Belviq should be used with caution in patients with that condition. Belviq has not been studied in patients with serious valvular heart disease.
The drug’s manufacturer will be required to conduct six postmarketing studies, including a long-term trial to assess the effect of Belviq on the risk for major adverse cardiac events such as myocardial infarction and stroke.
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation, and in diabetic patients are hypoglycemia, headache, back pain, cough and fatigue.
Belviq is manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland, and distributed by Eisai Inc. of Woodcliff Lake, N.J.
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