Involuntary
weight loss is a frequent complication of
acquired immune deficiency syndrome (
AIDS) and ultimately affects the majority of patients. The deleterious effects of
weight loss on immune function and the physical and psychological sequelae of severe
weight loss are well recognized.
Megestrol acetate induces appetite stimulation and nonfluid
weight gain in patients with advanced
hormone nonresponsive
cancers. In a pilot study,
megestrol acetate produced nonfluid
weight gain in patients with
AIDS. Two double-blind randomized placebo-controlled trials of
megestrol acetate for the treatment of
AIDS-related
anorexia and
cachexia have shown improvements in
body weight with treatment. In a multicenter trial reported by Flynn et al. at the 7th International Conference on
AIDS (1992), 65 patients with
AIDS and
weight loss of > 10% of ideal body weight were randomized to placebo or
megestrol acetate 800 mg/day.
Megestrol acetate-treated patients had a significantly greater mean maximum
weight gain (p = 0.027) and appetite stimulation (p = 0.021) than did placebo-treated patients. In a second, larger randomized placebo-controlled trial, 271 patients with
AIDS,
anorexia and
cachexia were randomized to receive placebo or multiple doses of
megestrol acetate at 100, 400 or 800 mg/day for 12 weeks. A maximum
weight gain of at least 5 lb (2.25 kg) was observed in 64.2% of patients in the 800-mg
megestrol acetate group compared with 21.4% in the placebo group (p < 0.0001). Mean maximum weight change from baseline to last evaluation was +8.3 lb in the 800-mg group and -1.1 lb in the placebo group (p < 0.001). Mean change in lean body mass from baseline to last evaluation was +2.5 lb in the 800-mg group versus -1.7 lb in the placebo group (p < 0.001). A significant improvement in appetite was seen in patients receiving 800 mg
megestrol acetate compared with patients receiving placebo. No significant toxicity was observed with
megestrol acetate therapy.
Megestrol acetate is an effective treatment for some patients with
AIDS-related
anorexia and
cachexia.