Of the 3 orally active anabolic steroids, oxandrolone has been studied in HIV-infected patients more extensively than has oxymetholone. Stanozolol is used for the treatment of hereditary angioedema and has not been used for its anabolic effect in this patient population to any great extent.
One of the earlier studies of oxandrolone in HIV-infected patients was begun before the introduction of the PIs. Sixty-three HIV-infected men with a loss of body weight greater than 10% were randomized to receive placebo; oxandrolone, 5 mg/d; or oxandrolone, 15 mg/d. The patients who received 15 mg/d of oxandrolone gained weight throughout the 16-week period, whereas those who received 5 mg/d of oxandrolone maintained their weight. In contrast, the patients who received placebo continued to lose weight.
In a follow-up study, which has not yet been published, patients were randomized to placebo or to 1 of 3 dosages of oxandrolone -- 20 mg/d, 40 mg/d, or 80 mg/d (C. Grunfeld, unpublished data, 1998). The patients in the group who received 40 mg/d had the most statistically significant weight gain. However, both the patients in this group and those who received 80 mg/d showed significant increases in serum levels of liver transaminases.
A study sought to determine whether a regimen of supraphysiologic doses of androgen (testosterone) plus an anabolic steroid (oxandrolone) would improve the LBM and strength gains achieved with progressive resistance exercise in HIV-infected men who had experienced weight loss. A second objective of the study was to determine whether antiretroviral therapy with a PI prevented lean body anabolism.
All subjects in the study participated in supervised progressive resistance exercise for 8 weeks. At the same time, they received testosterone, 100 mg/wk, by intramuscular injection. Twenty-four eugonadal men were then randomized to either placebo or oxandrolone, 20 mg/d. Twenty-two patients completed the study. The results indicated that compared with patients who received placebo, those who received oxandrolone experienced improved nitrogen balance ( P = .05); increased LBM ( P = .005); and increased muscle strength, as judged by either maximum weight lifted ( P = .02 to .05) or dynamometry ( P = .01 to .05). The results were similar regardless of whether the patients were taking a PI. However, compared with placebo, oxandrolone was associated with a statistically significant decrease in blood levels of high-den-sity lipoprotein (HDL) cholesterol ( P < .001).
Because all patients in the study participated in progressive resistance training and received testosterone, only an additive effect of Oxandrolone versus placebo was being determined. Therefore, the study appears to be valid even though the number of patients enrolled was small. On the other hand, had the design of the study called for dividing the patients into multiple groups, so that not all patients received testosterone or participated in progressive resistance exercise, the number of patients required to reach statistical significance would have been much higher -- on the order of 350.
The conclusions that can be drawn from the study are that oxandrolone -- 20 mg/d, added to a program consisting of both progressive resistance exercise and physiologic doses of testosterone -- improved the anabolic and functional responses in patients who showed HIV-related weight loss.
Only one study of oxymetholone in HIV-infected patients has been reported. Patients were randomly assigned to receive either oxymetholone (14 patients) or oxymetholone plus ketotifen (16 patients). Ketotifen is an H 1-receptor antagonist (ie, antihista- mine) that has been shown to block tumor necrosis factor a. The patients receiving the medications under study were compared with 30 matched control patients who met the same inclusion criteria, such as advanced HIV infection and chronic cachexia.
At entry into the study, all patients had experienced significant weight loss (greater than 12 kg [26.4 lb]). The average weight gain by the patients who received oxymetholone was 8.2 kg (18 lb), a 14.5% increase over weight at entry ( P < .001). The average weight gain by the patients who received combination therapy was 6.1 kg (13.4 lb), a 10.9% increase over weight at entry ( P < .005). The untreated control patients lost an average of 1.8 kg (4 lb).
Both groups of treated patients showed improvement in the ability to perform activities of daily living (the Karnofsky Index) and in several quality-of-life variables.
Although this study was not a double-blind clinical trial, the investigators believed that the results suggested the need for a randomized, double-blind, placebo-controlled, multicenter trial.
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