Results of treatment with sibutramine in doses ranging from 1 to 30 mg per day for 24 weeks showed that weight loss depends on the dose. When receiving a placebo (dummy) was achieved weight loss of 0.9%, while taking sibutramine 30 mg per day - up 7.7% from baseline. At the moment, it is recommended to start treatment with a dose of 10 mg per day, then the dose can be increased or decreased to 5 mg based on tolerability or efficacy in any particular case.
Evaluating the effectiveness of sibutramine for weight loss and maintain it at an optimal level has been given in several prospective randomized controlled trials, one-year. According to these studies, patients taking 10 to 20 mg per day of sibutramine lost 5% and 10% by weight, respectively, in contrast to those who took placebo. Adjunctive therapy to maintain optimal weight was used to a minimum, so that those who took placebo, reduced their weight to a lesser degree than is commonly observed in other studies.
Other studies show that weight reduction using intermittent therapy with sibutramine (15 mg per day for 1-12 weeks, 19-30 weeks and 37-48 weeks, in the intervals assigned to placebo) is equivalent to the weight loss during continuous treatment with sibutramine 15 mg a day. Some studies have been devoted to studying the effectiveness of sibutramine for the maintenance of body weight at the level reached before.
One study involved 160 patients with obesity, which dropped 6 or more kg of body weight within 4 weeks of therapy with very low calorie diet, with further recommendations on diet. Over the next year they received either placebo or 10 mg of sibutramine per day, according to a random sample. A year after the start of the study, patients receiving sibutramine lost an average 5.2 kg more (total weight loss was 12.9 kg for the entire period), while patients taking placebo gained 0.5 kg again (total loss weight for the entire period was 6.9 kg). Among patients treated with sibutramine, 74% maintained their weight at the same level or lose weight even more, compared with 41% in patients treated with placebo.
In the other study involved 467 patients with obesity, reaching more than 5% weight loss within 6 months of treatment with sibutramine, 10 mg per day and a diet with a deficit of calories to 600 calories / day. In the following patients for 18 months in the continuation of diet administered sibutramine at a higher dose (15-20 mg daily) or placebo. Almost half the study participants dropped out before completing the 18-month period of treatment. Those patients who were treated with sibutramine, maintain your weight at the same level or even continued to decrease at 1 year, followed by a slight increase in weight. Those who took a placebo noted a progressive increase in body weight after withdrawal of sibutramine. Of those that completed the study, 43% of patients treated with sibutramine, and 16% of those taking placebo, maintained at 80 wt% or more of the previously achieved.
The most common side effects of sibutramine - dry mouth, headache, constipation and insomnia - usually mild and go over time. Sibutramine also causes a dose-dependent increase in blood pressure and heart rate, which usually appear in the first few weeks of treatment and continues throughout the period of treatment. A dose of 10-15 mg per day is an average increase in systolic and diastolic blood pressure (BP) by 2-4 mm Hg. of Art. and heart rate (HR) at 4-6 beats per minute. However, some patients reported significantly greater increase in blood pressure and heart rate, which require dose reduction or discontinuation. The risk of these side effects are not increased in patients with controlled hypertension. Sibutramine is contraindicated in the presence of poorly controlled hypertension.