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Gay Men's Health Crisis
"Megace to Stimulate Appetite"
Gabriel Torres, M. D.
December 15, 1991
GMHC Treatment Issues 1991 Dec 15; 5(9): 11

Megace is the brand name of megestrol acetate, a synthetic substance derived from the female hormone, progesterone. The drug is marketed by Bristol-Myers Company for the treatment of breast cancer which has spread to other parts of the body. Another possible use of Megace is to stimulate appetite in order to produce weight gain. The actual way Megace works in appetite stimulation is unclear. Some experiments seem to indicate that the drug plays a role in fat synthesis in the body.[l] MEGACE HELPS IN WEIGHT GAIN AND IMPROVED APPETITE Several reports now indicate that Megace can be used successfully in the treatment of anorexia (poor appetite) and cachexia (wasting syndrome) associated with HIV infection. One of the initial studies was conducted at the Northwestern University Medical School in Chicago by Dr. Von Roenn and colleagues.[2] In an open study, 14 HIV-positive patients who had lost more than 10% of their body weight were treated with 80 mg of oral Megace four times daily. All patients received AZT previously, but five discontinued AZT when toxicity occurred.

All patients taking Megace gained weight at a rate of approximately 3.1 lbs. per week, with an average weight gain for the entire group of almost 14 lbs. Three patients returned to their original body weight. All patients reported a marked improvement in appetite, and seven had improved sense of well being. None of the common Megace-related side effects -- like swelling, low platelet counts, and impotence in men -- was noted. This study, however, was criticized for being uncontrolled, since many of the patients had recovered from opportunistic infections and thus were expected to gain weight. Additionally, others were on AZT, which may also account for some improvement in appetite.[3] UPDATED STUDY RESULTS At the VIIth International Conference on AIDS in Florence, Italy several placebo-controlled studies demonstrated that Megace is effective in producing weight gain in patients with advanced HIV disease.[4] The largest study was a multi-center trial sponsored by Bristol-Myers. Participating were 278 patients with more than 10% weight loss, anorexia, and absence of infections. Patients were randomized to receive either placebo or one of three doses of Megace (100 mg, 400 mg or 800 mg). Participants could not have initiated AZT within the 8 weeks prior to starting the study. Of the first 176 patients analyzed, 62.7% assigned to Megace at 800 mg/day gained more than 5 lbs. Only 16% of patients receiving placebo gained more than 5 lbs. The average weight gain for the group receiving Megace was 7.8 lbs. compared to an average loss of 1.5 lbs. for placebo recipients.

In another study reported in Florence similar weight gains were noted with Megace at doses of 400 mg/day and 800 mg/day, but not at 100 mg/day. Side effects included gastrointestinal upset and impotence in a few patients. Similar results were obtained in a study conducted by the New York Community Research Initiative (CRl),[5] which showed that doses of Megace above 100 mg produced an increase in fat-free mass and body fat, as well as improvement in perceived quality of life. No evidence of a favorable effect on the immune status (T4 cells) or effects which may prevent weight loss during disease complication was noted in this study.

Finally, a study about Megace, conducted at Brown University, was reported at the 31st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in October, 1991.[6] Megestrol acetate was administered as a single oral dose of 800 mg/day for 21 days to 9 HIV-infected patients. All of the participants had suffered weight loss of 10% of their total body fat. All patients reported an increase in appetite and eight patients gained weight at varying degrees (between 4 to 6 lbs.) after three weeks of therapy. However, unlike the special single dose used in the Brown University study, Megace is available in pill form only at 40 mg per tablet. Therefore, to duplicate the above noted studies, using 800 mg/day, a person must take 20 pills per day.

CONCLUSION Megace seems to be a reasonable therapy for persons with HIV-related weight loss, where the wasting is not the result of an infection, diarrhea, malabsorption, or cancer. The drug is expensive at $27 per day for an overall dose of 800 mg/day. The potential adverse effects (such as impotence) may make it unattractive to some men. The consumption of 20 pills a day may make it difficult for all patients. However, in most circumstances Megace is still considered a fairly viable option for increasing appetite.

REFERENCES 1. Tchekmedyian NS, Hickman M, Heber D. Treament of Anorexia and weight loss with Megestrol acetate in Patients with anorexia and AIDS. Seminars in Oncology, 1991; 18:35-42.

2. Von Roenn JH, Murphy R, Weber KM, Williams LM, Weitzmen SA. Megestrol Acetate for treatment of cachexia associated with HIV infection. Annals of Internal Medicine, 1988; 109:840-841.

3. Furth PA. Megestrol acetate and cachexia associated with HIV infection. (letter) Annals of Internal Medicine 1989; 110:667.

4. VIIth Int'l Confer on AIDS. Abstracts #W. B. 2392, #M. B. 2198, #M. B. 2233, Florence, Italy, June 1991.

5. CRI Representative, Personal Communication, October, 1991.

6. ICAAC, Abstract #550, Chicago, October, 1991.

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