LONG-TERM EFFICACY AND SAFETY OF DRONABINOL FOR ACQUIRED IMMUNODEFICIENCY SYNDROME-ASSOCIATED ANOREXIA

We studied the effects of long-term (12 months) dronabinol in 94 late- stage acquired immunodeficiency syndrome (AIDS) patients (mean CD4 cou nt of 45/mm(3)) who previously participated in a 6-week study (placebo versus dronabinol). All patients received dronabinol orally-2.5 mg tw ice daily (90%) or 2.5 mg once daily (10%). Appetite was measured usin g a visual analogue scale for hunger (VASH). Dronabinol was associated with consistent improvement in mean appetite. Patients previously tre ated with dronabinol continued to show improvement in VASH (percent ch ange from baseline of 6-week trial: 48.6-76.1% at each month) whereas those previously treated with placebo exhibited substantial improvemen t in mean appetite, particularly during the initial 4 months of treatm ent (48.5-69.9%). Thereafter, dronabinol was associated with a VASH ch ange at least twice baseline. Patients tended toward stable body weigh t for at least 7 months. Adverse events were primarily related to know n central nervous system effects of dronabinol. These data support lon g-term, safe use of dronabinol for anorexia associated with weight los s in patients with AIDS. (C) U.S. Cancer Pain Relief Committee, 1997.