Megestrol acetate in patients with AIDS-related cachexia J. H. VON ROENN,D. ARMSTRONG,D. P. KOTLER,ET AL Ann Intern Med 121:393-399,1994

Abstract

Weight loss occurs in almost all patients with human immunodeficiency virus (HIV) infection, and its causes are multifactorial. One of the most common causes is anorexia, and there are presently two drugs available for these patients: megestrol acetate (Megace; Bristol-Myers Oncology Division, Princeton, NJ) and dronabinol (Marinol; Roxane Labs, Columbus, OH). A randomized, double-blind, placebo-controlled, multicenter study using megestrol acetate is reviewed here.¹ The purpose of this study was to compare the effects of different doses of the drug on weight gain and other parameters in acquired immunodeficiency syndrome (AIDS) patients who presented with weight loss. In an outpatient setting, 270 patients were evaluated for safety of the drug. Only 195 patients could be used for evaluation of both safety and efficacy. The megestrol acetate was administered at 100, 400, or 800 mg daily for 12 weeks. Patients had lost either 20% or their premorbid weight or were ≤90% of their ideal body weight. No one was included with impaired digestive or absorptive function or with severe diarrhea defined as five or more watery stools per day for ≥7 days. Weight gain was statistically better in those patients who received 800 mg of megestrol acetate compared with the placebo group. In the group receiving 800 mg of megestrol acetate, 64.2% gained ≥2.27 kg compared with the placebo group, of which 21.4% gained at least 5 pounds (p < .001). Patients receiving megestrol acetate had an increased weight gain in a dose-dependent manner (p < .001), ranging from an average of 1.9 ± 1.3, 4.2 ± 1.3, and 7.8 ± 1.3 pounds in 100, 400, and 800 mg of megestrol acetate, respectively. The placebo group lost an average of 1.6 ± 1.2 pounds. In addition to weight gain, the patients receiving the 800 mg of megestrol acetate reported improved overall feeling of well-being, appetite score, and consumed an average increase of 645.6 calories per day in contrast to a decrease of 107 calories per day in the placebo group. There were no major drug-related safety issues observed. Body composition was assessed by bioelectrical impedance and arm skinfold thicknesses. According to the skinfold thickness measurements, there was an increase in muscle mass of 1 kg in the group receiving 800 mg of the drug; all other groups lost muscle mass. All groups receiving the megestrol acetate showed increases in the triceps skinfold thicknesses in contrast to a decrease observed in the placebo group. Results of the bioelectrical impedance analyses were similar to the anthropometry measurements; the group receiving 800 mg of megestrol acetate had a mean increase of 1.14 kg lean body mass. There was no increase in total body water for any group receiving the drug therapy. The authors concluded that in patients with AIDS-related weight loss, megestrol acetate stimulates appetite and increases food intake that leads to statistically significant weight gain. These finding result in an improvement in quality of life.