A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients

AbstractObjective:The most prevalent dyslipidemias in Mexico are low high-density lipoprotein (HDL) and high triglyceride (TG) levels. Hypertriglyceridemia (HTG) has been considered an independent risk factor for cardiovascular disease (CVD). The aim of this study was to evaluate the efficacy of rosuvastatin (RSV) in reducing TG levels in Mexican patients.Methods:A randomized, double-blind, double-dummy, parallel-group, placebo-controlled, multicenter, phase IV study was conducted. Patients were of both genders, ≥18 years old, with basal TG levels between 200 and 800 mg/dl, LDL levels ≤190 mg/dl. Patients were randomized to receive rosuvastatin 10 mg (Group 1), 20 mg (Group 2) or placebo (Group 3) once daily for 8 weeks. Primary efficacy was TG level; secondary efficacy was non-HDL; HDL, low-density lipoprotein (LDL), total cholesterol (TC), Apo (apolipoprotein) A1, and ApoB. Safety data were evaluated up to 30 days after the last dose of medication. The Mann–Whitney U-test was performed to contrast each ...