Megestrol acetate in patients with AIDS-related cachexia.
OBJECTIVE
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.


METHODS
Randomized, double-blind, placebo-controlled trial.


METHODS
Outpatient community and university patient care setting.


METHODS
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.


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


METHODS
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.
Von Roenn
J H
JH
Northwestern University, Chicago, IL 60611.
Armstrong
D
D
Kotler
D P
DP
Cohn
D L
DL
Klimas
N G
NG
Tchekmedyian
N S
NS
Cone
L
L
Brennan
P J
PJ
Weitzman
S A
SA
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications* / Q000523:psychology; D000328:Adult; D000368:Aged; D000886:Anthropometry; D001823:Body Composition; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D017097:Electric Impedance; D002149:Energy Intake / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008535:Megestrol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019290:Megestrol Acetate; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D012649:Self Concept; D013997:Time Factors; D015430:Weight Gain / Q000187:drug effects
D008535:Megestrol; D019290:Megestrol Acetate