title: Comparison of efficacy and safety between bisoprolol transdermal patch (TY-0201) and bisoprolol fumarate oral formulation in Japanese patients with grade I or II essential hypertension: randomized, double-blind, placebo-controlled study.
abstract: TY-0201 (TY) is a new drug absorbed by the transdermal delivery system developed for the treatment of hypertension, which contains the free base of bisoprolol fumarate that is widely used. An 8-week randomized, double-blind, placebo-controlled study was conducted in hypertensive patients to evaluate the superiority of TY 8 mg to placebo and the noninferiority of TY 8 mg to bisoprolol fumarate oral formulation (BO) 5 mg. Changes in diastolic blood pressure (BP) (primary endpoint) from baseline in the TY 8 mg group, the BO 5 mg group, and the placebo group were -12.2 mm Hg, -11.8 mm Hg, and -3.7 mm Hg, respectively, with TY 8 mg demonstrating superiority to placebo and noninferiority to BO 5 mg. Changes from baseline for systolic BP and pulse rate produced significant reductions compared with placebo. TY is expected to serve as a new treatment approach for hypertensive patients.
authors.affiliation: Utsunomiya Chuoh Hospital, Tochigi, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Matsuoka
authors.forename: Iwao
authors.initials: I
authors.lastname: Kuwajima
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.forename: Hideo
authors.initials: H
authors.lastname: Mitamura
authors.forename: Takao
authors.initials: T
authors.lastname: Saruta
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D017298:Bisoprolol / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D000075222:Essential Hypertension; D005260:Female; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D012720:Severity of Illness Index; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D017298:Bisoprolol