Abstract

To the Editor: I read with interest the recent article1 on the posthospitalization use of megestrol acetate suspension in older subjects with decreased appetite. Despite the use of megestrol in older subjects with weight loss, the data supporting its use in this population are limited. A previous study2 published in this Journal in 2000 showed no difference with the use of 800 mg/d megestrol suspension in a Department of Veterans Affairs nursing home at 12 weeks. At 3 months, there was an increase of 4 or more pounds in 61.9% of the patients treated with megestrol, compared with 21.7% for placebo. The increase was mostly in body fat and not in lean body mass. A small study,3 which lacked a placebo arm, showed a weight change of −3% to +11.3% 2 months after completion of a 28-day course of 480 mg megestrol acetate. A letter published in 1995 discussed four subjects and examined some inflammatory markers as well.4 A retrospective study examined deep vein thrombosis (DVT) incidence with megestrol use in a nursing home setting, but there was no control group.5 In a small retrospective study, there was an association with an increase in DVT risk with megestrol acetate as well.6 The exclusion of 99.3% of the subjects assessed at the start of the study limited the generalizability of the present study. Block randomization could have prevented the confounding effect of site of discharge. This trial had six primary (three for benefit and three for risk) and four secondary outcomes spread across four different groups. The only positive outcome was the higher prealbumin in the 400/mg/d group at Day 63 when compared with placebo. Was there a correction for the baseline difference in prealbumin (24.3 vs 18.3)? The development of two DVTs with one pulmonary embolism is troubling (Fischer exact test not significant), as is the decrease in serum cortisol level (statistically significant). Even though none of the subjects developed symptoms of adrenal insufficiency, addition of a stressor (e.g., infection) in this frail malnourished group may precipitate it. The consumer price of $4,750 per year (for the 800-mg suspension) is a barrier as well. An adequately powered study in older subjects, examining not only surrogate nutritional outcomes, but also the effect on mortality, health-related quality of life, and infections as primary outcomes would be helpful. Financial Disclosure: The author has no financial disclosure to report or any conflict of interest in regard to this manuscript. Author Contributions: Anupam Suneja was the sole author of this manuscript. Sponsor's Role: No sponsors.

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