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.
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.