Open AccessComparison 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
Author(s) -
Matsuoka Hiroaki,
Kuwajima Iwao,
Shimada Kazuyuki,
Mitamura Hideo,
Saruta Takao
Publication year - 2013
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/jch.12208
Subject(s) - medicine , placebo , bisoprolol , transdermal patch , transdermal , blood pressure , clinical endpoint , essential hypertension , anesthesia , double blind , randomized controlled trial , pharmacology , alternative medicine , pathology
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.