POLICOSANOL - RESULTS OF A POSTMARKETING SURVEILLANCE STUDY OF 27,879PATIENTS

In this postmarketing surveillance study, the tolerability of policosa nol, a new cholesterol-lowering drug, was assessed. The study populati on 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 orall y, 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 patie nts (0.31%) reported adverse effects (AEs), the most frequent of which was weight loss (0.08%). Twenty-two patients (0.08%) discontinued tre atment 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 oth er randomized, double-masked clinical studies. The predictive value of premarketing studies was confirmed as well as the tolerability of lon g-term policosanol therapy, but only if the instructions in the packag e brochure were followed.