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
Journal of clinical hypertension (Greenwich, Conn.) | 15 Oct 2013
H Matsuoka, I Kuwajima, K Shimada, H Mitamura and T Saruta
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.
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