מתוך medicontext.co.il
By Megan Rauscher
WESTPORT, CT (Reuters Health) – Overweight or obese patients who lose weight in their first 3 months on orlistat (Xenical, Hoffmann-La Roche) have a good chance of dropping more weight and keeping it off by staying on the drug for 2 years, and will also improve their cardiovascular risk profile.
That's according to findings presented this week during the annual meeting of the North American Association for the Study of Obesity in Quיbec City, Canada. "This drug works effectively for around three-quarters of the people who take it," lead researcher Dr. Michael E. J. Lean of the University of Glasgow told Reuters Health. "Because the drug is not absorbed, side effects are negligible, provided patients stay on a low-fat diet," he added.
Dr. Lean and UK colleagues pooled data from two European multicenter, placebo-controlled trials that involved 295 overweight or obese patients with a body mass index of 28 to 43. Patients were randomized to orlistat, 120 mg before each meal, or placebo. During the first year, they reduced their daily caloric intake by 600 kcal and during the second year dietary adjustments were made to maintain their weight.
According to the team, 177 patients responded with weight loss of at least 5% during 6 months of orlistat therapy and gained less than 2 kg during months 4 to 6. These "6-month responders" benefited from continued therapy, with mean weight loss of 10.6% at 2 years (p = 0.0001). "A total of 54% of 6-month responders maintained 80% or more of their 6-month weight loss," the team notes in a meeting abstract.
By contrast, among the 118 patients who were non-responders at 6 months, mean weight loss at 2 years was just 2.4%, despite continued orlistat therapy. Dr. Lean said that "patients who do not lose weight in the first 3 months of orlistat probably won't, and should not, continue on it."
This calls for a fundamental change in the way anti-obesity trials are conducted, according to Dr. Lean. "In these clinical trials, non-responders carried on with the drug even though they didn't lose weight," he said. "The current design of anti-obesity drug trials is all wrong, because it's exposing people to a drug for 2 years even if it doesn't work."
Two years of orlistat was also associated with significant mean reductions in diastolic and systolic blood pressure, 4.6 mm Hg and 9.4% mm Hg, respectively, as well as a mean reduction in LDL cholesterol of 9.7% and a mean increase in HDL cholesterol of 9.2%. Triglycerides, fasting blood glucose and fasting insulin levels also improved significantly with orlistat treatment.
"These long-term results compare favorably with clinical benefits achieved by other treatments, supporting the choice of orlistat for long-term weight loss maintenance and risk factor reduction," Dr. Lean and colleagues conclude.
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