BACKGROUND:Policosanol is a drug derived from sugar cane wax that has cholesterol-lowering and antiplatelet properties. Randomized, controlled studies are the gold standard for demonstrating drug efficacy, safety, and tolerability, but postmarketing surveillance studies are encouraged for corroborating drug effects. A valid proof of the safety of a drug is a well-documented, good tolerability profile in older individuals, since this population is more prone to drug-related adverse events (AEs).OBJECTIVE:This study investigated the tolerability of policosanol in the elderly population by monitoring the incidence and nature of AEs occurring in older Cuban patients treated with policosanol in routine clinical practice.METHODS:All patients aged > or =60 years treated with policosanol at 7 major medical centers from January 2000 to May 2003 were included. Policosanol (5, 10, or 20 mg/d) was prescribed to patients eligible to receive cholesterol-lowering and/or antiplatelet drugs, with the dosage recommended according to their individual atherosclerotic risk. Patients had follow-up visits approximately every 6 months. Data on AEs and other relevant information, including changes in policosanol treatment, concomitant medications, and discontinuations, were recorded on individual case-report forms.RESULTS:This study included 2252 patients (1306 women, 946 men): 647 (28.7%), 244 (10.8%), and 173 (7.7%) patients had coronary, cerebrovascular, and peripheral artery disease, respectively. A total of 1485 patients had hypercholesterolemia (65.9%), 1322 (58.7%) had hypertension, and 323 (14.3%) had diabetes mellitus. Of the enrolled patients, 1123 (49.9%), 644 (28.6%), and 485 (21.5%) received policosanol 5, 10, and 20 mg/d, respectively. Treatment duration varied: 2169 (96.3%), 1861 (82.6%), 1116 (49.6%), and 412 (18.3%) patients were treated for 6, 12, 24, and 36 months, respectively. Thirty-one patients (1.4%) experienced serious AEs, 18 of them fatal. Death was most often due to vascular events: myocardial infarction (4 patients), sudden cardiac arrest (1), ventricular arrhythmia (2), ischemic stroke (1), lung thromboembolism (1), cancer (5), pneumonia (1), peritonitis (1), lung edema (1), and dehydration (1). Another 13 patients (0.6%) were hospitalized, and 61 (2.7%) reported moderate or mild AEs. Overall, 21 patients (0.9%) discontinued prematurely from the study, 18 of them due to a fatal serious AE.CONCLUSIONS:Long-term tolerability of policosanol in elderly patients at high vascular risk was very good, as assessed under conditions of routine clinical practice. These results are consistent with those obtained in randomized, double-blind clinical studies of older patients treated with 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 [1.696] 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.