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Anabolic Steroid Oxymetholone Reduces Wasting Among HIV Patients On HAART
A DGReview of :"Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting"
AIDS
03/27/2003
By Harvey McConnell
Oxymetholone, an anabolic steroid, appears to be effective in countering wasting among HIV positive patients taking highly active antiretroviral therapy (HAART).
This finding results from a double-blind, randomised, placebo-controlled trial at the University of Essen, and the University of Bonn, Germany. Eighty nine HIV-positive women and men participated.
Chronic involuntary weight loss is a serious problem among patients on HAART. The alterations in energy metabolism and endocrine regulation cause loss of lean body mass (LBM) and body cell mass (BCM).
There has been partial restoration of LBM in studies among HIV-positive men undergoing androgen replacement therapy, or treatment with recombinant growth hormone. However, these treatments have largely been ineffective among eugonadal individuals.
In the present study, the men and women with wasting were given oxymetholone 50 mg twice (BID), or three times daily (TID), or placebo for 16 weeks, followed by open-label treatment. Endpoints were body weight, bioimpedance measurements, and appetite.
The clinicians found that oxymetholone produced a significant weight gain of 3.0 ± 0.5 kg in the TID group, and 3.5 ± 0.7 kg in the BID group, while patients in the placebo group gained an average of 1.0 ± 0.7 kg. Body cell mass increased 3.8 ± 0.4 kg in the BID group and i2.1 ± 0.6 kg in the TID group. This corresponded to 12.4T and 7.4% of baseline BCM, respectively.
The patients taking oxymetholone reported a significant improvements in their appetite and food consumption, plus a reduction in feeling weak. 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 in the placebo group, had a greater than five times baseline increase for alanine aminotransferase during the double-blind phase of the study.
Clinicians concluded that "the BID (100 mg/day) regimen appeared to be equally effective as the TID (150 mg/day) regimen in terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity."
AIDS 2003 Mar 28;17:5:699-710.
"Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting"
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