OXANDROLONE IN AIDS-WASTING MYOPATHY

Objective: To evaluate oxandrolone, an oral anabolic steroid with pote nt anabolic activity and minimal androgenic effects, for the treatment of AIDS-associated myopathy and wasting. Methods: In a multicenter, d ouble-blind study, 63 HIV-seropositive men with >10% loss of body weig ht were randomized to receive either placebo, 5 mg/day oxandrolone, or 15 mg/day oxandrolone for 16 weeks. Body weight, neuromuscular evalua tion, and measures of well-being were repeatedly assessed. Results: Pa tients who received 15 mg/day oxandrolone showed weight gain throughou t the 16-week treatment period. Overall, the 5 mg/day oxandrolone grou p maintained their weight gain over the 16-week period, whereas the pl acebo group showed continual weight loss. At week 16, significantly mo re patients in the 15 mg/day dose group reported increases in appetite and activity than those receiving placebo. There were no consistent, dose-related, statistically significant differences from baseline in l aboratory values or adverse events. Conclusion: Oxandrolone, at a dose of either 5 mg/day or 15 mg/day, in contrast to placebo, had a positi ve impact on the weight and well-being of HIV-seropositive patients su ffering from wasting and weakness. Measurable improvement in muscle st rength was not noted at the doses employed in this study. Oxandrolone was well tolerated in all the patients who were enrolled in the study. Based on the results reported here, additional studies using higher d oses of oxandrolone seem warranted.