←Appetite Stimulation

Study register · detail Open-Label Extension (12 Monate) · Appetite Stimulation · 1997

Long-term efficacy and safety of dronabinol for acquired immunodeficiency syndrome-associated anorexia

Beal et al. ·Journal of Pain and Symptom Management Impact 0.8

Clear benefit GRADE Moderate 205 citations

Samplen = 94 Pat.

Duration12 months

EndpointVASH

Blindingoffen

DesignOpen-Label Extension (12 Monate)

Cannabinoidthc

Max. dose5.0 mg

Routeoral

Key finding

Dronabinol showed consistent improvement in appetite over 12 months, with appetite improvements of 48,6-76,1% in previously dronabinol-treated patients and 48,5-69,9% in previously placebo-treated patients, as well as stable body weight over at least 7 months.

Summary

Open-label long-term extension over 12 months with n=94 AIDS patients (mean CD4 count 45/mm³), dronabinol 2×2,5 mg/day (90%) or 1×2,5 mg/day (10%). Consistent appetite improvement: VASH increase of 48,6–76,1% (in patients with prior dronabinol therapy) and 48,5–69,9% (in patients with prior placebo, especially months 1–4). Weight stability for ≥7 months. Adverse effects primarily CNS-related.

PopulationAdults with advanced AIDS (mean CD4 count 45/mm³, anorexia/weight loss), n=94

InterventionDronabinol oral 2,5 mg twice daily (90%) or once daily (10%) over 12 months

OutcomeConsistent appetite increase (VASH): increase of 48,6–76,1% versus baseline in previously dronabinol-treated patients; 48,5–69,9% in previously placebo-treated patients; stable body weight over at least 7 months

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Open-label

Effect size Clear benefit

Citations / year ★★★★★

Authors

Beal J E, Olson R, Lefkowitz L et al.

DOI 10.1016/s0885-3924(97)00038-9↗

Design: Open-Label Extension (12 Monate)

Abstract

We studied the effects of long-term (12 months) dronabinol in 94 late-stage acquired immunodeficiency syndrome (AIDS) patients (mean CD4 count of 45/mm3) who previously participated in a 6-week study (placebo versus dronabinol). All patients received dronabinol orally-2.5 mg twice daily (90%) or 2.5 mg once daily (10%). Appetite was measured using a visual analogue scale for hunger (VASH). Dronabinol was associated with consistent improvement in mean appetite. Patients previously treated with dronabinol continued to show improvement in VASH (percent change from baseline of 6-week trial: 48.6-76.1% at each month), whereas those previously treated with placebo exhibited substantial improvement in mean appetite, particularly during the initial 4 months of treatment (48.5-69.9%). Thereafter, dronabinol was associated with a VASH change at least twice baseline. Patients tended toward stable body weight for at least 7 months. Adverse events were primarily related to known central nervous system effects of dronabinol. These data support long-term, safe use of dronabinol for anorexia associated with weight loss in patients with AIDS.

The impediment to action advances action. — Marcus Aurelius