title: Comparison of pharmacokinetics of the sirolimus-eluting stent in Japanese patients with those in American patients.
abstract: The aim of this study was to evaluate the pharmacokinetics of the sirolimus-eluting stent (SES) implanted in 20 Japanese patients with angina pectoris and compare it with that in US study. Bx VELOCITY stent loaded with a total sirolimus dose of 150 mug was used in this study. Ten patients were treated by single-SES (group 1) and 10 patients were treated by double-SES (group 2). Sirolimus levels in whole blood were serially measured in the 2 groups after the SES implantation and compared with the pharmacokinetics in US study. We also evaluated the side effect of sirolimus, major adverse clinical events, and binary angiographic restenosis at 8 months after the SES implantation. Peak concentrations were observed approximately 4 hours after the SES implantation, and sirolimus half-lives were approximately 120 hours in each group. Mean peak sirolimus levels were 0.86 and 2.00 ng/mL for the group 1 and group 2, respectively. The peak concentrations of sirolimus in this study were twice higher in Japanese than in Americans, but they were much lower than effective concentration of sirolimus when orally administrated as an immunosuppressive agent. There were no side effects of sirolimus and no binary angiographic restenosis in any patients. One patient had target vessel revascularization at 8 months after the SES implantation. Although blood concentrations of sirolimus in Japanese patients after SES implantation are somewhat higher than those in American patients, its level is extremely low compared with the systemic administration, indicating the same clinical benefits by the SES could be safely expected in Japanese patients.
authors.affiliation: Department of Cardiology, National Cardiovascular Center, Osaka, and Department of Cardiology, Toho University School of Medicine, Tokyo, Japan.
authors.forename: Yoritaka
authors.initials: Y
authors.lastname: Otsuka
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yasuda
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.forename: Hisao
authors.initials: H
authors.lastname: Hara
authors.forename: Isao
authors.initials: I
authors.lastname: Morii
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kawamura
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sase
authors.forename: Shunichi
authors.initials: S
authors.lastname: Miyazaki
mesh_terms: D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000188:drug therapy; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods; D017023:Coronary Angiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000493:pharmacokinetics*; D007564:Japan; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus