post em up
Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting.
ABSTRACT
Background: Despite highly active antiretroviral therapy (HAART), chronic involuntary weight loss of lean body mass (LBM) and body cell mass (BCM). still remains a serious problem in the care of HIV patients. Previous studies have been performed with androgen replacement therapy or treatment with recombinant growth hormone(rGH) showing partial restoration of LBM, but these treatments have largely not been assessed in eugonadal individuals.Study Design: Double-blind, randomized, placebo-controlled trial of 89 HIV-positive women and men with wasting assigned to the anabolic steroid oxymetholone (50 mg BID or TID) or placebo for 16 weeks followed by open-label treatment.Results: Oxymetholone led to a significant weight gain of 3.0 ±0.5 and 3.5 ±0.7 kg in the TID and BID groups, respectively (p<0.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0 ±0.7 kg. Body cell mass increased in the oxymetholone BID group (3.8 ±0.4 kg; p<0.0001) and in the oxymetholone TID group (2.1 ±0.6 kg; p<0.005), corresponding to 12.4% and 7.4% of baseline BCM, respectively. The most important adverse event was liver-associated toxicity. Overall, 35% of patients in the TID, 27% of patients in the BID oxymetholone group and no patients the placebo group had a greater than 5 times baseline increase for ALT during the double-blind phase of the study.
Conclusions: Oxymetholone can be considered an effective anabolic steroidin eugonadal male and female patients with AIDS-associated wasting. The BID (100 mg/day) regimen appeared to be equally effective to the TID (150 mg/day) regimenin terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity.