title: Clinical effects of rosuvastatin, a new HMG-CoA reductase inhibitor, in Japanese patients with primary hypercholesterolemia: an early phase II study.
abstract: The effects and tolerability of the new HMG-CoA reductase inhibitor rosuvastatin were assessed in 68 hypercholesterolemic Japanese patients (22 men and 46 postmenopausal women; age range 28-72 years) in a multicenter, double-blind, dose-ranging, early phase II study. Patients were randomized into three groups and received once-daily doses of 1, 2, or 4 mg rosuvastatin. Sixty evaluable patients (19 men and 41 women) with mean total cholesterol (TC) 294 mg/dl (7.60 mmol/l) and mean triglyceride (TG) 150 mg/dl (1.69 mmol/l) provided data in the efficacy analysis based on percentage changes in lipids at 4 and 8 weeks. All doses of rosuvastatin improved lipid parameters after both 4 and 8 weeks of therapy. On average, TC decreases were 22-29%, low-density lipoprotein cholesterol (LDL-C) decreases 32-42%, TG decreases 2% to 22%, and HDL-C increases 3-7%. There were no remarkable differences between efficacy at 4 and at 8 weeks, and dose-dependent reductions were noted for LDL-C, with 30, 39, and 42% decreases in the 1-, 2-, and 4-mg/ day dose groups, respectively, at 8 weeks. The drug was well tolerated over the 8 weeks of therapy. These preliminary results indicate that rosuvastatin is a potent cholesterol-lowering agent, capable of achieving marked reductions in LDL-C even at low doses.
authors.affiliation: National Cardiovascular Center Research Institute, Suita, Osaka, Japan. ymmt-a@juno.dti.ne.jp
authors.forename: Akira
authors.initials: A
authors.lastname: Yamamoto
authors.forename: Kikuo
authors.initials: K
authors.lastname: Arakawa
authors.forename: Jun
authors.initials: J
authors.lastname: Sasaki
authors.forename: Yuji
authors.initials: Y
authors.lastname: Matsuzawa
authors.forename: Kaoru
authors.initials: K
authors.lastname: Takemura
authors.forename: Motoo
authors.initials: M
authors.lastname: Tsushima
authors.forename: Takao
authors.initials: T
authors.lastname: Fujinami
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mabuchi
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Itakura
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Yamada
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Toyota
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oikawa
mesh_terms: D000328:Adult; D000368:Aged; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides; D016896:Treatment Outcome
chemical_list: D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D002784:Cholesterol