Megestrol acetate in patients with AIDS-related cachexia.

Abstract

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.

• Authors: J H Von Roenn, D Armstrong, D P Kotler, D L Cohn, N G Klimas, N S Tchekmedyian, L Cone, P J Brennan, S A Weitzman
• Journal: Annals of internal medicine (Ann Intern Med) Vol. 121 Issue 6 Pg. 393-9 (Sep 15 1994) ISSN: 0003-4819 [Print] United States
• PMID: 7794302 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Megestrol
• Megestrol Acetate

Topics

• Acquired Immunodeficiency Syndrome (complications, psychology)
• Adult
• Aged
• Anthropometry
• Body Composition
• Cachexia (drug therapy, etiology)
• Double-Blind Method
• Electric Impedance
• Energy Intake (drug effects)
• Female
• Humans
• Male
• Megestrol (adverse effects, analogs & derivatives, therapeutic use)
• Megestrol Acetate
• Middle Aged
• Patient Satisfaction
• Pilot Projects
• Self Concept
• Time Factors
• Weight Gain (drug effects)