RESUMO
This is a report of the results of a two years' randomized, double-blind placebo-controlled study of the efficacy, safety, and tolerability of policosanol administered at 5 mg twice-a-day in the treatment of type II hyperlipoproteinaemia. The study included 69 patients from both sexes, in whom total cholesterol and low-density-lipoprotein cholesterol (LDL-C) were not controlled sufficiently by diet. The treatment effect on total cholesterol and LDL-C was maintained during the 2-year follow up. Thus, percent reductions 24 months after therapy were 25% (LDL-C) and 18% (cholesterol). All comparisons with placebo were significant. Similarly, ratios of LDL-C to HDL-C and cholesterol to HDL-C were significantly reduced and such decreases were maintained during the study. Policosanol raised significantly the values of high-density lipoprotein cholesterol (HDL-C) during the study and maximal increases were reached 12 months after therapy (+21%). From this time the increases mildly declined to +14% and +11.2% respectively at 18 and 24 months after therapy. No significant changes in triglycerides were observed as compared with baseline or placebo. No patient withdrew from the study because of adverse effects. No drug-related clinical or biochemical adverse side-effects were observed. Any adverse experiences reported were mild and transient; moreover, no significant differences were obtained when compared with those reported by the placebo group. The results indicate that policosanol administered for two years to patients with type II hypercholesterolaemia shows a maintained efficacy as well as very good safety and tolerability.
Assuntos
Anticolesterolemiantes/uso terapêutico , Álcoois Graxos/uso terapêutico , Hiperlipoproteinemia Tipo II/tratamento farmacológico , Anticolesterolemiantes/efeitos adversos , LDL-Colesterol/sangue , Método Duplo-Cego , Álcoois Graxos/efeitos adversos , Feminino , Humanos , Hiperlipoproteinemia Tipo II/sangue , Masculino , Pessoa de Meia-IdadeRESUMO
In 12 patients with sinus rhythm (including 5 children and 6 young women), mitral valve replacement was performed with a microporous-surfaced valve similar to the Björk-Shiley Monostrut. After the first 3 months, permitting endothelialization of the suture ring to continue over the groove and adjacent metal valve ring, no long-term anticoagulant treatment was given. There was no thromboembolic complication in this group during follow-up for 6-8 years, during which four women gave birth to a total of seven children. In eight other cases, one mitral case with atrial fibrillation, anti-coagulant was not discontinued, and in the remaining aortic cases it was reinstituted. One of them (with atrial fibrillation) had hematuria during inadequate anticoagulant medication, but no thromboembolism. Of five patients with only aortic valve replacement, two had thromboembolic complications, one without residual symptoms and one with slight hand weakness. Another had a transient ischemic attack while on anticoagulant and acetylsalicylic acid was added. Two patients with aortic and mitral valve replacement died, one from heart tamponade and the other from venous thrombosis with pulmonary embolism.