Dietary advice with or without pravastatin for the management of hypercholesterolaemia associated with protease inhibitor therapy

Background: Therapy with a HIV protease inhibitor is associated with elevat ions in cholesterol and triglycerides. HMG-CoA reductase inhibitors ('stati ns') are the established therapy for persons with primary hypercholesterola emia. Because of drug interactions, pravastatin may represent the preferred choice in those taking HIV protease inhibitors. Design: A randomized, open-label comparative 24 week trial of dietary advic e alone or with pravastatin in 31 male patients established on protease inh ibitor-based regimens for greater than 12 weeks with viral load < 500 copie s/ml and cholesterol > 6.5 mmol/l. Results: There were no significant clinical or laboratory events and no pat ient discontinuation secondary to adverse effects. Viral rebound did not oc cur. Relative to baseline, total cholesterol at week 24 fell significantly in the pravastatin (1.2 mmol/l; 17.3%) (P < 0.05) but not in the dietary ad vice (0.3 mmol/l; 4%) group. The difference between the two groups approach ed significance at week 24 (P = 0.051). This fall was accounted for entirel y by a reduction in low density lipoprotein [calculated change 1.24 mmol/l (19%) and 0.07 mmol (5.5%) in pravastatin and dietary advice groups, respec tively] as high density lipoprotein rose non-significantly by 0.6 mmol/l in both groups. Weight, basal metabolic rate, fasting glucose and triglycerid es did not change significantly in either group. Conclusions: Dietary advice plus pravastatin significantly reduced total ch olesterol in HIV-positive individuals taking protease inhibitors, without s ignificant adverse effects. The inclusion of pravastatin substantially incr eases the magnitude of the change, which is comparable with changes achieve d in endogenous hyperlipidaemia.(C) 2001 Lippincott Williams & Wilkins.