Biomaterial Database

Randomized trials of megestrol acetate for AIDS-associated anorexia and cachexia. 1994

J H Von Roenn

Department of Internal Medicine, Northwestern University, Chicago, IL 60611.

Involuntary weight loss is a frequent complication of acquired immune deficiency syndrome (AIDS) and ultimately affects the majority of patients. The deleterious effects of weight loss on immune function and the physical and psychological sequelae of severe weight loss are well recognized. Megestrol acetate induces appetite stimulation and nonfluid weight gain in patients with advanced hormone nonresponsive cancers. In a pilot study, megestrol acetate produced nonfluid weight gain in patients with AIDS. Two double-blind randomized placebo-controlled trials of megestrol acetate for the treatment of AIDS-related anorexia and cachexia have shown improvements in body weight with treatment. In a multicenter trial reported by Flynn et al. at the 7th International Conference on AIDS (1992), 65 patients with AIDS and weight loss of > 10% of ideal body weight were randomized to placebo or megestrol acetate 800 mg/day. Megestrol acetate-treated patients had a significantly greater mean maximum weight gain (p = 0.027) and appetite stimulation (p = 0.021) than did placebo-treated patients. In a second, larger randomized placebo-controlled trial, 271 patients with AIDS, anorexia and cachexia were randomized to receive placebo or multiple doses of megestrol acetate at 100, 400 or 800 mg/day for 12 weeks. A maximum weight gain of at least 5 lb (2.25 kg) was observed in 64.2% of patients in the 800-mg megestrol acetate group compared with 21.4% in the placebo group (p < 0.0001). Mean maximum weight change from baseline to last evaluation was +8.3 lb in the 800-mg group and -1.1 lb in the placebo group (p < 0.001). Mean change in lean body mass from baseline to last evaluation was +2.5 lb in the 800-mg group versus -1.7 lb in the placebo group (p < 0.001). A significant improvement in appetite was seen in patients receiving 800 mg megestrol acetate compared with patients receiving placebo. No significant toxicity was observed with megestrol acetate therapy. Megestrol acetate is an effective treatment for some patients with AIDS-related anorexia and cachexia.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008535	Megestrol	A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.	17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione,Pregna-4,6-diene-3,20-dione, 17-hydroxy-6-methyl-
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D011788	Quality of Life	A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.	HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D001835	Body Weight	The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.	Body Weights,Weight, Body,Weights, Body
D002100	Cachexia	General ill health, malnutrition, and weight loss, usually associated with chronic disease.
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000163	Acquired Immunodeficiency Syndrome	An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.	AIDS,Immunodeficiency Syndrome, Acquired,Immunologic Deficiency Syndrome, Acquired,Acquired Immune Deficiency Syndrome,Acquired Immuno-Deficiency Syndrome,Acquired Immuno Deficiency Syndrome,Acquired Immuno-Deficiency Syndromes,Acquired Immunodeficiency Syndromes,Immuno-Deficiency Syndrome, Acquired,Immuno-Deficiency Syndromes, Acquired,Immunodeficiency Syndromes, Acquired,Syndrome, Acquired Immuno-Deficiency,Syndrome, Acquired Immunodeficiency,Syndromes, Acquired Immuno-Deficiency,Syndromes, Acquired Immunodeficiency
D000328	Adult	A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available.	Adults