A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients
Por:
Talavera J.-O., Martinez G., Cervantes J.-L., Marin J.-A., Rodriguez-Briones I., Gonzalez J.-G., Ocampo R., Sanchez-Mijangos H., Bernal-Rosales L.P., Polanco A.
Publicada:
1 ene 2013
Categoría:
Medicine (miscellaneous)
Resumen:
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 800mg/dl, LDL levels 190mg/dl. Patients were randomized to receive rosuvastatin 10mg (Group 1), 20mg (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 278mg/dl, 266mg/dl, 279mg/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 179mg/dl, 180mg/dl and 179mg/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 130mg/dl, 130mg/dl and 127mg/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 114mg/dl, 115mg/dl and 110.5mg/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 20mg/day significantly reduced triglycerides and improved atherogenic lipid profile in HTG Mexican patients. The main limitation was the short follow-up time period. © 2013 Informa UK Ltd All rights reserved.
Filiaciones:
Talavera J.-O.:
Clinical Research Training Center, National Medical Center, XXI Century, Social Security Mexican Institute, Mexico State, Mexico
Clinical Research Training Center, National Medical Center, XXI Century, Social Security Mexican Institute, Mexico
Martinez G.:
AstraZeneca, Mexico, F.D., Mexico
Cervantes J.-L.:
Angeles Del Pedregal Hospital, Mexico
Marin J.-A.:
Toluca Medical Center, Toluca, Mexico State, Mexico
Rodriguez-Briones I.:
Private Cardiovascular Office, San Luis Potosi, San-Luis-Potosi State, Mexico
Gonzalez J.-G.:
University Hospital, Monterrey, N.L., Mexico
Ocampo R.:
Santa Elena Hospital, Mexico
Sanchez-Mijangos H.:
Omega Clinic, Mexico
Bernal-Rosales L.P.:
Clinical Research Training Center, National Medical Center, XXI Century, Social Security Mexican Institute, Mexico
Polanco A.:
AstraZeneca Mexico, Mexico
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