Oxandrolone in the Treatment of HIV-Associated Weight Loss in Men: A Randomized, Double-Blind, Placebo-Controlled Study
"Serum albumin, total protein, bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH), and gamma-glutamyl transferase (GGT) levels were not significantly changed (see Table 3). However, there were dose-dependent increases in AST and ALT appearing by the first 4 to 8 weeks of therapy. The increase in AST was significant at the 80-mg dose compared with baseline, whereas the increase in ALT was significant at the 40-mg and 80-mg doses. Furthermore, there was a dose-related increase in the incidence of WHO grade III and IV liver toxicity for ALT and AST with increasing dose of oxandrolone (Table 4). For AST, WHO grade III and IV toxicity occurred in 2 of 61 subjects on placebo, 2 of 60 on 20 mg of oxandrolone, 6 of 61 on 40 mg of oxandrolone, and 9 of 61 on 80 mg of oxandrolone. For ALT, WHO grade III and IV toxicity occurred in 1 of 61 subjects on placebo, 3 of 60 on 20 mg of oxandrolone, 7 of 61 on 40 mg of oxandrolone, and 9 of 61 on 80 mg of oxandrolone (for trend, P = 0.0047). Three subjects receiving the 40-mg dose and 4 subjects receiving the 80-mg dose were discontinued from the drug because of laboratory abnormalities."