Policosanol: Results of a postmarketing surveillance study of 27,879 patients

In this postmarketing surveillance study, the tolerability of policosanol, a new cholesterol-lowering drug, was assessed. The study population consisted of 27,879 patients from six major Cuban medical centers: 17,225 patients (61.8%) were followed up for 2 years and 10,654 (38.2%) for 4 years. Most patients (95.2%) received policosanol 5 mg/d orally, and the remainder (4.8%) received 10 to 15 mg/d orally. All of the patients were treated for at least 1 month. During the study, 86 patients (0.31%) reported adverse effects (AEs), the most frequent of which was weight loss (0.08%). Twenty-two patients (0.08%) discontinued treatment because of AEs. The incidence of AEs did not show any apparent relationship to drug dosage. In terms of the type and profile of AEs, the results of the present study were similar to those reported in other randomized, double-masked clinical studies. The predictive value of premarketing studies was confirmed as well as the tolerability of long-term policosanol therapy, but only if the instructions in the package brochure were followed.