Sibutramine Reductil for Obesity Treatment
Sibutramine is one of two anti-obesity agents approved by the National Institute of Clinical Excellence. It inhibits the re-uptake of noradrenalin and serotonin in the brain. By enhancing the sensation of satiety after a meal and reducing the fall in basal metabolic rate which usually occurs during weight loss, Sibutramine is a useful aid to achieving weight loss and weight maintenance. Randomized controlled trials have shown that sibutramine 10 mg/day, in combination with diet and exercise, produces and maintains a dose-related weight loss of 5–10% in the majority of obese patients studied. This is accompanied by a range of important health benefits, including improvements in cholesterol and triglyceride levels.
Adverse publicity led to the European Commission's Committee for Proprietary Medicinal products recently carrying out an in-depth investigation into the use of sibutramine in over 12,000 patients across Europe. Its findings support the use of sibutramine in obesity management, with no causal link found between the use of the drug and mortality. No change has been made to the Summary Product of Characteristics regarding the cardiovascular safety of sibutramine and the drug has been re-instated for use in Italy. Prescribers should be aware of the cautions surrounding sibutramine use. While it is not advisable for those with a history of coronary heart disease or cardiac arrhythmias, published data reveal that most patients on sibutramine experience a drop in blood pressure and it may be used safely in patients with controlled hypertension. A small number of patients treated may show increases in blood pressure, particularly those who appear to be non-responders.
Regular blood pressure monitoring is therefore advised.
Reductil has been available for UK clinicians to prescribe since 2000. It is indicated as adjunctive therapy within a weight management programme for patients with obesity (body mass index [BMI] of 30 kg/m2 or higher, or for overweight patients with a BMI of 27 kg/m2 or higher with obesity-related co-morbidities such as type 2 diabetes or dyslipidaemia). As one of just two licensed weight management agents available on prescription, sibutramine has raised the profile of obesity within the medical profession. The availability of anti-obesity agents has encouraged many in primary care to set up weight management clinics to treat what has historically been considered more a lifestyle issue than a medical condition.
A consequence of Sibutramine mechanism of action is that it may increase the blood pressure (BP) of some individuals, indicating the need for care in selecting appropriate patients for treatment and for ongoing monitoring in those in whom treatment is started. Confidence in sibutramine was dented after the decision by the Italian Health Ministry in March 2002 to suspend the marketing authorization for the drug in Italy following the deaths of two patients who had been taking it.
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