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

Abstract

Objective: 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 RSV groups against placebo; p < 0.05 was considered significant. Trial registry number is NCT00473655.

Results: A total of 334 patients were randomized: Group 1 = 111, Group 2 = 112, and Group 3 = 111. Basal TG median value levels were 278 mg/dl, 266 mg/dl, 279 mg/dl with median reduction (MdR) at 8 weeks of 26.6%, 32.19% and 7.58%, respectively, (Group 1 vs. Group 3 p = 0.002, and Group 2 vs. Group 3 p < 0.0001). Basal non-HDL values were 179 mg/dl, 180 mg/dl and 179 mg/dl with a MdR of 27%, 32% and 8%, respectively (Group 1 vs. Group 3 p < 0.0001, and Group 2 vs. Group 3 p < 0.0001); basal LDL vales were 130 mg/dl, 130 mg/dl and 127 mg/dl with MdR 35%, 44% and -4% (Group 1 vs. Group 3 p < 0.0001, Group 2 vs. Group 3 p < 0.0001); basal ApoB values were 114 mg/dl, 115 mg/dl and 110.5 mg/dl with MdR 25%, 33% and -0.5% (Group 1 vs. Group 3 p < 0.0001, Group 2 vs. Group 3 p < 0.001).

Conclusion: Rosuvastatin 10 and 20 mg/day significantly reduced triglycerides and improved atherogenic lipid profile in HTG Mexican patients. The main limitation was the short follow-up time period.