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| |  Weight-Loss Drug Receives FDA Clearance MT. OLIVE, NJ - November 24, 1997 -- The United States Food and Drug Administration (FDA) has granted marketing clearance to Knoll Pharmaceutical Co.'s Meridia(R) (sibutramine hydrochloride monohydrate) capsules, pending U.S. Drug Enforcement Administration (DEA) scheduling. The drug will be indicated for the management of obesity, including weight loss and maintenance of weight loss, when used in conjunction with a reduced-calorie diet. Meridia works in a different manner than other prescription weight management medications. It is a neurotransmitter reuptake inhibitor that enhances the body's normal function. The drug works by affecting natural chemicals in the brain involved in regulating appetite – allowing them to act longer. The appetite control center in the brain is believed to regulate the amount of food eaten through feelings of hunger and fullness. Unlike other anti-obesity drugs, Meridia is not a releasing agent. It does not get inside the cells to boost the release of neurotransmitters, such as serotonin. Instead, as a reuptake inhibitor, the drug works outside the cells to stop neurotransmitters from being reabsorbed. Drugs that work by reuptake inhibition -- including such antidepressants as Prozac(R) -- have been used safely for many years. Meridia is the only reuptake inhibitor indicated for the management of obesity. Meridia is recommended for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg/m(2) or greater than or equal to 27 kg/m(2) in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia) and should be used as part of a comprehensive lifestyle management program. Clinical trials have shown the drug to be beneficial to patients with co-morbidities, including controlled hypertension. Dosage will be once a day without regard to meals. It will also be available in multiple doses (5, 10, and 15 mg), enabling physicians to individualize therapy for their patients. The recommended starting dose of the drug is one 10 mg capsule per day. Patients with inadequate weight loss should be titrated to a 15 mg dose. In clinical trials of 6,000 individuals, Meridia produced clinically and statistically significant weight loss as compared with placebo. On average, patients on the drug achieved a five to 10 percent reduction from baseline at various dosage levels. In two 12-month studies, maximal weight loss was achieved by six months and statistically significant weight loss was maintained over 12 months. Studies indicate that for overweight people, a weight loss of as little as five to 10 percent, followed by weight maintenance, can reduce health risk factors associated with obesity. Meridia was studied among men and women, ages 18 to 65, with a BMI range of 27 kg/m(2) to 40 kg/m(2). In one trial enrolling 485 patients, among those who stayed on the drug for 12 months, 56 percent achieved a five-percent weight reduction and 30 percent achieved a 10-percent weight reduction while taking the 10 mg dose. Of those patients taking the 15 mg dose, 65 percent achieved a five-percent weight reduction and 39 percent achieved a 10-percent weight reduction. In a separate study of 1,047 obese individuals, among those taking the 15 mg dose for six months, 67 percent achieved a five-percent weight loss and 35 percent achieved a 10-percent weight loss. Study participants followed healthy lifestyle guidelines, including modified diet and increased physical activity. Additionally, in clinical trials, the drug showed a positive effect on lipids that is consistent with weight reduction. Most side effects associated with Meridia are mild and transient in nature, including dry mouth, headache, constipation and insomnia. In some patients, the drug substantially increases blood pressure. Across the broad dose range studied, small mean increases in blood pressure (1-2 mm Hg) and small mean increases in heart rate (four beats per minute) were seen in patients who took 5-15 mg of the drug once daily. In clinical trials, the number of patients who discontinued Meridia use because of hypertension (0.4% for patients taking placebo and 0.4% for patients on Meridia) or tachycardia (0.1% for placebo and 0.4% for Meridia) was small for all dose ranges studied. Regular monitoring of blood pressure is required when prescribing the drug. Clinical studies showed that these blood pressure and heart rate increases generally occur early on in treatment and the prescribing physician may decide to decrease the dose of Meridia or discontinue the medication. These activities are consistent with the known pharmacological activity of the drug and Meridia can be used among patients with controlled hypertension. The drug should not be used in patients with a history of stroke, coronary artery disease, congestive heart failure, or uncontrolled hypertension. Certain centrally acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension (PPH) -- a rare but lethal disease -- and cardiac valve dysfunction. In pre-marketing clinical studies, no cases of PPH have been reported with Meridia. The possible occurrence of cardiac valve dysfunction was investigated in two studies. In summary, these studies showed that the incidence of valve dysfunction in patients given placebo and patients given the drug was similar. More information on: Meridia
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