Study summary · research use only
Weight loss produced by tesofensine in patients with Parkinson's or Alzheimer's disease
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This meta-analysis pooled four randomized, double-blind human trials of tesofensine (TE), a norepinephrine, dopamine, and serotonin reuptake inhibitor, in Parkinson's or Alzheimer's disease, comparing TE (n = 740) with placebo (n = 228). Patients received oral TE or placebo once daily for 14 weeks without a weight-loss program. Obesity was present in 14% of the placebo group and 21% of the TE group. Weight change after 14 weeks was +0.5, -0.5, -0.9, -1.8, and -2.8% for placebo and the 0.125, 0.25, 0.5, and 1.0 mg TE groups (P = 0.015 for dose effect). In the obese subgroup, weight changes were -0.2, -1.7, -1.6, -1.5, and -3.7%, and 2.1, 8.2, 14.1, 20.9, and 32.1% achieved at least 5% weight loss. Heart rate changes were -0.4, 2.1, 4.2, 6.0, and 6.8 bpm.
Abstract
Tesofensine (TE) is a norepinephrine, dopamine, and serotonin reuptake inhibitor. We conducted a meta-analysis of TE's effect on body weight in trials investigating its potential for treatment of Parkinson's or Alzheimer's disease. Four randomized, double-blind, multicenter trials compared TE (n = 740) and placebo (n = 228), two in each disease. Patients received oral TE or placebo once daily for 14 weeks without any weight loss program. Results were adjusted for baseline values, age, and study. In the placebo group, 14% were obese and 21% were in the TE group. In the total cohort, weight change after 14 weeks was +0.5, -0.5, -0.9, -1.8, -2.8% in the placebo, 0.125, 0.25, 0.5 and 1.0 mg in the TE groups, respectively (P = 0.015 for dose effect). In the obese subgroup, weight changes were -0.2, -1.7, -1.6, -1.5, -3.7%, and 2.1, 8.2, 14.1, 20.9, 32.1% of the obese patients achieved > or = 5% weight loss (P < 0.001 for 0.25, 0.5, and 1.0 mg vs. placebo for both end points). Changes in heart rate were -0.4, 2.1, 4.2, 6.0, and 6.8 bpm after 14 weeks (TE vs. placebo: P < 0.001 from 0.25 mg), but no effect on blood pressure was observed. TE produced a placebo-subtracted weight loss of approximately 4% for >14 weeks without any diet and lifestyle therapy, which is similar to that of sibutramine, but with no effect on blood pressure. On the basis of these results, TE is now being developed for obesity management.
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