MARINOL is indicated for anorexia associated with weight loss in adult patients with AIDS.
Appetite Stimulation in AIDS-Related Anorexia With Weight Loss:
Of the 112 patients who completed at least 2 visits in the trial, 99 patients had appetite data at 4 weeks (MARINOL n=50, placebo n=49) and 91 patients had appetite data at 6 weeks (MARINOL n=46, placebo n=45).
A statistically significant difference between MARINOL and placebo was seen in appetite as measured by the visual analog scale at Weeks 4 and 6 (see figure). Trends toward improved body weight and mood, and decreases in nausea were also seen.
Mean Appetite Change From Baseline
After completing the 6-week study, patients were allowed to continue treatment with MARINOL in an open-label study, in which there was a sustained improvement in appetite.
Side effects (feeling high, dizziness, confusion, somnolence) occurred in 13 of 72 patients (18%) at this dosage level and the dosage was reduced to 2.5 mg/day, administered as a single dose at dinner or bed time.