title: 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).
  
  
  CONCLUSIONS
  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.
authors: Clinical Research Training Center, National Medical Center, XXI Century, Social Security Mexican Institute, F.D., Mexico.
authors: Juan-Osvaldo
authors: JO
authors: Talavera
authors: Gustavo
authors: G
authors: Martinez
authors: Jose-Luis
authors: JL
authors: Cervantes
authors: Javier-Aguila
authors: JA
authors: Marin
authors: Ignacio
authors: I
authors: Rodriguez-Briones
authors: Jose-Gerardo
authors: JG
authors: Gonzalez
authors: Rodolfo
authors: R
authors: Ocampo
authors: Hector
authors: H
authors: Sanchez-Mijangos
authors: Laura P
authors: LP
authors: Bernal-Rosales
authors: Ana
authors: A
authors: Polanco
mesh_terms: D016632:Apolipoprotein A-I / Q000097:blood; D001055:Apolipoproteins B / Q000097:blood; D002318:Cardiovascular Diseases / Q000097:blood* / Q000188:drug therapy*; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D015228:Hypertriglyceridemia / Q000097:blood / Q000188:drug therapy; D008075:Lipoproteins, HDL / Q000097:blood; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000188:drug therapy; D008800:Mexico; D008875:Middle Aged; D011743:Pyrimidines / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*; D014280:Triglycerides / Q000097:blood
chemical_list: D016632:Apolipoprotein A-I; D001055:Apolipoproteins B; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008075:Lipoproteins, HDL; D008077:Lipoproteins, LDL; D011743:Pyrimidines; D013449:Sulfonamides; D014280:Triglycerides; D000068718:Rosuvastatin Calcium; D002784:Cholesterol