Pharmacoepidemiologic study of policosanol

Policosanol is a cholesterol-lowering drug that is purified from sugarcane wax and has concomitant antiplatelet effects. This pharmacoepidemiologic, open-label, cohort: study included 6611 patients (3602 policosanol-treated patients, 3009 controls) of both sexes (74.0% men, 26.0% women; mean age, 51 +/- 6 years) managed in a routine clinical practice from August 1991 to December 1996. Both groups showed similar characteristics at baseline, except for hypertension, ischemic cardiovascular disease, and vascular events, which were more frequent in the policosanol group than in the control group. Concomitant medications were similar in both groups. During the follow-up period, hospitalizations for any reason were reported more frequently in the control group than in the policosanol group (310 [10.3%] vs 271 [7.5%]; P < 0.0001), as were hospitalizations requiring special care (48 [1.6%] in the control group vs 35 [0.97%] in the policosanol group; P < 0.05). Five patients (0.08%) died during the study: 3 men in the control group died of myocardial infarction (1) or stroke (2); in the policosanol group, 1 woman died of intoxication and 1 man died of respiratory arrest. The previous history of serious vascular adverse events (AEs) was more frequent; in the policosanol group (34 events, 0.94%) than in the control group (14 events, 0.47%) (P < 0.05). However, during the present followup a lower rate of such events occurred in policosanol-treated patients (23 events, 0.64%) than in the control group (34 events, 1.13%) (P < 0.05). Twenty-six patients (0.72%) discontinued policosanol therapy because of AEs. The most frequently reported AEs (>0.3% of the study population) that did not result in discontinuation of therapy were weight loss (1.75%), polyuria (0.68%), headache (0.61%), dizziness (0.44%), and polyphagia (0.36%), with no significant between-group differences in frequency. Results of the present study corroborate the good tolerability of policosanol in routine clinical use and support its risk-to-benefit ratio in the study population.