In the United Kingdom, an estimated 54% of men and 45% of women suffer from obesity. The incidence of obesity has increased substantially in the developed world over the past 20 years. The growing problem of obesity, with its link to serious health problems such as heart disease, respiratory ailments, and diabetes, necessitates the development of safe and efficient ways to help patients lose weight and keep it off.
One therapeutic option is a combination regimen of orlistat with a low-fat diet. Orlistat is a gastrointestinal lipase inhibitor that facilitates weight loss by lowering absorption of dietary fat, on average by 30% with a dose of 120 mg three times a day. A study published in Lancet focused on examining the efficacy and tolerability of orlistat in promoting weight loss and preventing regain;the effects on major cardiovascular factors were also assessed.
The study consisted of three parts: The first part was a four-week lead-in period, in which 743 men and women with body mass indexes between 28 and 47 kg/m2 from 15 European centers participated. Patients were placed on a hypocaloric diet (600 kcal/day deficit) and received placebo three times daily, under double-blind conditions, with meals. Six hundred eighty-eight patients continued on to the next phase of the study which lasted one year. Patients were assigned either 120 mg of orlistat or placebo under double-blind conditions, three times daily with meals, and they continued on their hypocaloric diets. In the third arm of the study, patients in each treatment group were reassigned either to continue on the same regimen or to switch to the alternative regimen for the second year of the study while blinding was maintained. This regimen was accompanied by a weight-maintenance diet. Body weight, glucose, insulin, total cholesterol, low-density-lipoprotein (LDL) cholesterol, high-density-lipoprotein (HDL) cholesterol, and triglycerides were measured and recorded at specific intervals. Five hundred forty-four patients from the initial 683 completed the treatment. The following table summarizes the results obtained after the first year of the study.
CHANGE IN BODY WEIGHT ORLISTAT GROUP (%) PLACEBO GROUP (%) lost more than 20% of body weight 9.3% 2.1% lost 10.1-20% of body weight 29.5% 15.6% lost 5.1-10% of body weight 29.7% 31.5% lost 0.1-5% of body weight 23.6% 32.7% body weight unchanged 7.9% 18.2% Year two focused on the ability of orlistat to aid in the maintenance of weight. Patients who switched from placebo to orlistat reduced body weight, and patients taking orlistat in the first year experienced smaller weight gain when kept on orlistat than when switched to placebo. Two of the cardiovascular factors, HDL cholesterol and triglycerides, showed a similar decrease in both orlistat- and placebo-treated patients. However, the orlistat group showed significantly larger decreases in fasting glucose and insulin at 2 years and in systolic and diastolic blood pressure at 1 year. Also, total cholesterol and LDL cholesterol remained stable in placebo patients, and these decreased substantially in the orlistat group. As for tolerability, most of the adverse events experienced were judged by investigators to be unrelated to treatment. The majority of the adverse events related to treatment were gastrointestinal in nature, occurred early in orlistat treatment, and lasted an average of 4 days.
Most physicians are wary of anorectic agents because the systemic mode of action of these drugs via the central nervous system elevates the risks for addiction, primary pulmonary hypertension, valvular heart disease, and systemic hypertension. Orlistat circumvents these problems because it is a member of a class of antiobesity drugs that acts directly at the site of fat breakdown: the lumen of the stomach and small intestine. Major adverse effects expected include gastrointestinal events and a decrease in ability to absorb fat-soluble vitamins, such as vitamins D and E and beta-carotene. This study verified that gastrointestinal problems are not experienced frequently and that vitamin concentrations remain at normal levels. Overall, the study showed that orlistat provides sustained improvements in weight loss, weight maintenance, and certain cardiovascular risk factors for up to 2 years.
References 1.Sjostrom L, Rissanen A, Andersen T, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. Lancet. 1998;352:167-172.
© 1998 VirSci Corporation. All rights reserved. As seen on PharmInfoNet (http://pharminfo.com)
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