Recent results with Megace.

HIV-related weight loss can be broken into four categories: 1) episodic weight loss accompanying acute infections or malignancies; 2) intermittent anorexia; 3) the late, accelerated weight loss phase associated with a 10 -20 percent loss of body weight; and 4) the terminal phase of HIV disease in which weight loss has resulted in cachexia and weakness. Several studies using megestrol acetate to treat advanced breast cancer, HIV-associated cachexia, and AIDS wasting, have demonstrated its association with weight gain. These led to the establishment of two multicenter, randomized, double- blind trials. In the first study patients received either 800 mg/day of Megace (a liquid suspension of megestrol acetate) or placebo; and in the second they received one of three daily doses of Megace (100 mg, 400 mg, or 800 mg) or placebo. Most patients were in the fourth phase of weight loss. Over 50 percent of the enrollees dropped out of the first study. Increased calorie consumption, fat mass and overall weight was observed in the remaining 65 enrollees in the treatment group. The second study, enrolling 271 patients, showed a dose-dependent, step-wise relationship between megestrol acetate administration and weight gain. Overall, megestrol acetate was well tolerated. Patients receiving treatment experienced greater caloric and protein intake, weight gain and subjective sense of well-being. Therefore, a starting dose of 400 mg/day is recommended, to be adjusted after four weeks of therapy. Drug treatment in the earlier stages of weight loss should be considered.