The effects of megestrol acetate suspension for elderly patients with reduced appetite after hospitalization: a phase II randomized clinical trial.

OBJECTIVES

To provide preliminary evidence on the effectiveness and optimal dosage of megestrol acetate for older persons with impaired appetite after hospitalization.

DESIGN

Randomized clinical trial.

SETTING

Acute care hospital.

PARTICIPANTS

Forty-seven older persons (mean age 83) who were recently discharged from an acute care hospital and had fair or poor appetite.

INTERVENTION

Participants were randomized to placebo or megestrol acetate suspension 200 mg, 400 mg, or 800 mg daily for 9 weeks.

MEASUREMENTS

Appetite, health-related quality of life, and adverse effects were measured at baseline and 20, 42, and 63 days. Serum nutritional markers were measured at baseline and 20 and 63 days.

RESULTS

During the course of the study, there were no significant differences between treatment groups on any of the appetite questions, although participants in the 400-mg and 800-mg groups demonstrated significant improvement from baseline on some questions. At 20 days, prealbumin increased in a dose-response relationship across the four groups (by 0.4, 5.1, 7.5, and 9.0 mg/dL, respectively). Participants in the 400-mg and 800-mg groups demonstrated greater improvement in prealbumin levels at 20 days than those receiving placebo (P=.009 and P=.004, respectively) and those in the 400-mg group also demonstrated improvement at 63 days (P=.02). At 20 days, no participant taking placebo had a morning serum cortisol level less than 8 ng/mL (the lower limit of normal). In contrast, 33%, 70%, and 78% of those taking 200 mg, 400 mg and 800 mg, respectively, had values below this level; by 63 days, these percentages were 11%, 30%, 56%, and 37%, respectively. No patient reported clinical symptoms of adrenal insufficiency. Diarrhea developed in three subjects, and thromboembolism occurred in two receiving active treatment.

CONCLUSION

Megestrol acetate at doses of 400 mg and 800 mg increases prealbumin in recently hospitalized older persons. Cortisol suppression is common at higher doses and may be persistent. In this small study, the drug did not confer benefit on other nutritional or clinical outcomes.