OXYMETHOLONE PROMOTES WEIGHT-GAIN IN PATIENTS WITH ADVANCED HUMAN-IMMUNODEFICIENCY-VIRUS (HIV-1) INFECTION

The effect of the testosterone derivative oxymetholone alone or in com bination with the H-1-receptor antagonist ketotifen, which has recentl y been shown to block tumour necrosis factor alpha (TNF alpha), on wei ght gain and performance status in human immunodeficiency virus (HIV) patients with chronic cachexia was evaluated in a 30-week prospective pilot study, Thirty patients mere randomly assigned to either oxymetho lone monotherapy (n 14) or oxymetholone plus ketotifen (n 16), Patient s receiving treatment were compared with a group of thirty untreated m atched controls, who met the same inclusion criteria, Body weight and the Karnofsky index, which assesses the ability to perform activities of daily life, and several quality-of-life variables were measured to evaluate response to therapy, The average weight gain at peak was 8.2 (SD 6.2) kg (+ 14.5 % of body weight at study entry) in the oxymetholo ne group (P < 0.001), and 6.1 (SD 4.6) kg (+ 10.9 %) in the combinatio n group (P < 0.005), compared with an average weight loss of 1.8 (SD 0 .7) kg in the untreated controls, The mean time to peak weight was 19. 6 weeks in the monotherapy group and 20.8 weeks in the combination gro up, The Karnofsky index improved equally in both groups from 56% befor e to 67% after 20 weeks of treatment (P < 0.05), The quality of life v ariables (activities of daily life, and appetite/nutrition) improved i n 68 % (P < 0.05) and 91% (P < 0.01) of the treated patients respectiv ely, Oxymetholone was safe and promoted weight gain in cachectic patie nts with advanced HIV-1 infection, The addition of ketotifen did not f urther support weight gain, These results suggest the need for a rando mized, double-blind, placebo-controlled multicentre trial.