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Megestrol Acetate in Patients with AIDS-related Cachexia

Jamie H. Von Roenn, MD; Donald Armstrong, MD; Donald P. Kotler, MD; David L. Cohn, MD; Nancy G. Klimas, MD; N. S. Tchekmedyian, MD; Lawrence Cone, MD; Patrick J. Brennan, MD; and Sigmund A. Weitzman, MD
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Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1994;121(6):393-399. doi:10.7326/0003-4819-121-6-199409150-00001
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Objectives: To compare the effects of oral suspensions of megestrol acetate, 800 mg/d, and placebo on body weight in patients with acquired immunodeficiency syndrome (AIDS)-related weight loss.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Outpatient community and university patient care setting.

Patients: Consecutive patients with AIDS who had substantial weight loss and anorexia were enrolled. Of 271 patients, 270 and 195 were evaluable for safety and efficacy, respectively.

Interventions: Patients were randomly assigned to receive placebo or megestrol acetate (100 mg, 400 mg, or 800 mg) daily for 12 weeks.

Main Outcome Measures: The primary efficacy criterion was weight gain. Patients were evaluated at 4-week intervals for changes in weight and body composition, caloric intake, sense of well-being, toxic effects, and appetite.

Results: For evaluable patients receiving 800 mg of megestrol acetate per day, 64.2% gained 2.27 kg (5 pounds) or more compared with 21.4% of patients receiving placebo (P < 0.001). An intent-to-treat analysis showed significant differences (P = 0.002) between those receiving placebo and those receiving 800 mg of megestrol acetate for the number of patients who gained 2.27 kg (5 pounds) or more (8 of 32 [25%] compared with 38 of 61 [62.3%], respectively). Compared with patients receiving placebo at the time of maximum weight change, evaluable patients receiving megestrol acetate, 800 mg/d, reported improvement in overall well-being and had an increase in mean weight gain (−0.725 compared with 3.54 kg [ −1.6 compared with +7.8 pounds]; P < 0.001), lean body mass (−0.772 compared with +1.14 kg [ −1.7 compared with +2.5 pounds]; P < 0.001), appetite grade (P < 0.001), and caloric intake (−107 compared with +645.6 calories/d; P = 0.001).

Conclusions: In patients with AIDS-related weight loss, megestrol acetate can stimulate appetite, food intake, and statistically significant weight gain that is associated with a patient-reported improvement in an overall sense of well-being.


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Figure 1.
Weight gain of patients during the first 12 weeks of the study.P

A greater percentage (64.2%) of patients in the group receiving 800 mg of megestrol acetate than in the placebo group (21.4%) had a maximum weight gain of at least 2.27 kg (5 pounds) ( < 0.001). Mean values with 95% CIs (bars) are shown.

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Figure 2.
Well-being questionnaire responses.P

Patient responses to representative questions from the self-assessment questionnaire to evaluate the effect of therapy on perception of well-being are charted by group. For every question, significantly greater improvement in the patient's perception of well-being was reported by patients receiving 800 mg of megestrol acetate when compared with those receiving placebo. The degree of improvement reported by patients increased as the dose of megestrol acetate increased. There was a statistically significant quadratic trend ( < 0.001) in the mean patient well-being scores as the dose increased from 0 to 800 mg of megestrol acetate for each question presented. Mean values are presented with bars for 95% CIs.

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