Long-term Effects of Plant Stanols on the Lipid Profile of Patients With Hypercholesterolemia. A Randomized Clinical Trial.

INTRODUCTION AND OBJECTIVES: Plant stanol consumption may improve long-term cholesterol control. The aim of the present study was to evaluate the effectiveness of 2g/day of plant stanols in reducing low-density lipoprotein cholesterol levels in patients with hypercholesterolemia. METHODS: This randomized, double-blind, and placebo-controlled study included 182 adults diagnosed with hypercholesterolemia. A yogurt drink containing 2g of plant stanols was administered to 91 participants in the intervention group; 91 participants in the control group received unsupplemented yogurt. The primary end point was the change in the lipid profile at 12 months. RESULTS: Low-density lipoprotein cholesterol levels at 12 months were significantly more reduced in the stanol intervention group than in the control group: 13.7 (95% confidence interval, 3.2-24.1) mg/dL (P=.011). A reduction of more than 10% in low-density lipoprotein cholesterol was achieved by a significantly higher proportion of participants in the intervention group (relative risk=1.7; 95% confidence interval, 1.1-2.7). In this group, the mean (standard deviation) level of low-density lipoprotein cholesterol decreased by 11.0% (23.9%). CONCLUSIONS: Our results confirm that administration of plant stanols at a dosage of 2 g/day for 12 months significantly reduces (by slightly more than 10%) the concentrations of low-density lipoprotein cholesterol in individuals with hypercholesterolemia. Trial registration (www.ClinicalTrials.gov): Current Controlled Trials NCT01406106.

[Therapeutic compliance in patients with cardiovascular diseases]. / Cumplimiento terapéutico en pacientes con enfermedades cardiovasculares.

BACKGROUND: Our purpose was to establish, by means of a survival analysis, the duration of therapeutic compliance and the probability of abandonment or prescription drugs in cardiovascular patients, as well as the prognostic factors that determine it. PATIENTS AND METHOD: Longitudinal observational study (1996-1998). By means of a consecutive sampling, 493 patients who initiated a cardiovascular treatment were selected. Through interviews, we obtained information on cardiovascular problems and treatment, concomitant diseases, consumption of other drugs and social and demographic variables. The consumption of prescribed drugs was established across 6 periodic observations. RESULTS: During the observational period, 39.4% of drugs prescribed by the general practitioner (GP) were abandoned, as compared to 22.4% of those prescribed by specialists (p < 0.05). The degree of abandonment was significantly higher among consumers of vasodilators and vasoprotective agents. Cardiac glycosydes and angiotensin converting enzyme inhibitors were among the therapeutic subgroups in which a longer survival time was observed (average: 19.8 and 16.5 months, respectively). By a Cox regression analysis, we noticed that the risk of abandonment was higher in patients who took two or more doses of the drug per day (OR = 2.8; 95% IC, 21-37), in consumers of medicines with a daily cost lower than ptas. 100 (OR = 1.4); 95% CI, 1.0-1.8) and in subjects younger than 65 years (OR = 1.3; 95% CI, 1.0-1.8). CONCLUSIONS: A higher degree of abandonment of cardiovascular medication occurs when it is administered in primary health-care (i.e., drugs prescribed by the GP), mainly in relation to a greater prescription of agents with a low therapeutic effectiveness. Abandonment is influenced by patients' social and demographic factors and also by the specific characteristics of the treatment.