ce was statistically significant. There were no statistically significant differences between treatment groups in mean caloric change or in daily caloric intake at time to maximum weight change. In the same 9 question survey referenced in the first trial, patients’ assessments of weight change, appetite, appearance, and overall perception of well-being showed increases in mean scores in MA-treated patients as compared to the placebo group.
In both trials, patients tolerated the drug well and no statistically significant differences were seen between the treatment groups with regard to laboratory abnormalities, new opportunistic infections, lymphocyte counts, T4 counts, T8 counts, or skin reactivity tests (see ADVERSEREACTIONS section).
Megestrol Acetate Oral Suspension Clinical Efficacy Trials
Trial 1 Trial 2
Study Accrual Dates Study Accrual Dates
11/88 to 12/90 5/89 to 4/91
Megestrol Acetate, mg/day 0 100 400 800 0 800
Entered Patients 38 82 75 75 48 52
eva luable Patients 28 61 53 53 29 36
Mean Change in Weight (lb.)
Baseline to 12 Weeks 0.0 2.9 9.3 10.7 -2.1 11.2
% Patients ≥ 5 Pound Gain
At Last eva luation in 12 weeks 21 44 57 64 28 47
Mean Changes in Body Composition:
Fat Body Mass (lb.) 0.0 2.2 2.9 5.5 1.5 5.7
Lean Body Mass (lb.) -1.7 -0.3 1.5 2.5 -1.6 -0.6
Water (liters) -1.3 -0.3 0.0 0.0 -0.1 -0.1
% Patients With Improved Appetite:
At Time of Maximum Weight Change 50 72 72 93 48 69
At Last eva luation in 12 Weeks 50 72 68 89 38 67
Mean Change in Daily Caloric Intake:
Baseline to Time of Maximum Weight Change -107 326 308 646 30 464
*Based on bioelectrical impedance analysis determinations at last eva luation in 12 weeks
Presented below are the results of mean weight changes for patients eva luable for efficacy in trials 1 and 2.
INDICATIONS & USAGE
INDICATIONS AND USAGE
Megace &r |
