Ketoconazole in the prevention of acute respiratory distress syndrome.

We conducted a critical review of the literature on ketoconazole in preventing acute respiratory distress syndrome (ARDS), a serious disorder associated with high mortality. Two double-blind, prospective, placebo-controlled, randomized trials compared ketoconazole with placebo for prophylaxis of ARDS. In one trial, compared with placebo, ketoconazole resulted in a reduced frequency of ARDS (6% vs 31%, p<0.01), lower plasma thromboxane B2 levels (33 vs 75 pg/ml, p<0.05), and shorter intensive care unit stay (7 vs 15.5 days, p<0.05). In the second trial the drug reduced the frequency of ARDS (15% vs 64%, p=0.002), lowered thromboxane B2 levels (83 vs 143 pg/ml), and reduced mortality (15% vs 39%, p=0.05) compared with placebo. Larger multicenter studies are warranted to validate the findings of these two trials.