Abstract:
BACKGROUND:TY-0201 (TY) is a transdermal patch containing bisoprolol. The objectives of this study were to evaluate the noninferiority of TY to bisoprolol oral formulation (BO) in patients with persistent or permanent atrial fibrillation (AF). METHODS:In this multicenter, double-blind, comparative study, Japanese patients with persistent or permanent AF were randomized to TY 4-mg (n=55), TY 8-mg (n=55), BO 2.5-mg (n=55), or BO 5-mg (n=55) groups. All patients were administered TY 4mg or BO 2.5mg once a day for the first 2 weeks. Patients in the TY 8-mg or BO 5-mg group, in whom dose escalation was required, were administered TY 8mg or BO 5mg for a further 2 weeks, and the other patients continued to receive TY 4mg or BO 2.5mg. The primary endpoint was a change in 24-h mean heart rate (mHR) from baseline by Holter electrocardiogram, and the noninferiority of the TY 4-mg to the BO 2.5-mg groups and that of the TY 8-mg to the BO 5-mg groups were evaluated. RESULTS:Adjusted means of changes in 24-h mHR from baseline in the TY 4-mg, TY 8-mg, BO 2.5-mg, and BO 5-mg groups were -12.3, -13.8, -12.7, and -14.3bpm, respectively. Differences between values for the TY 4-mg and BO 2.5-mg groups and between values for the TY 8-mg and BO 5-mg groups were estimated to be 0.5 (95% CI: -1.9 to 2.9) and 0.5 (-1.9 to 2.9)bpm, respectively, which did not exceed the predefined noninferiority margins. The incidence of adverse events did not differ between the groups. CONCLUSIONS:In Japanese patients with persistent or permanent AF, TY 4mg and TY 8mg had heart rate-reducing effects similar to those of BO 2.5mg and BO 5mg, respectively.
journal_name
J Cardioljournal_title
Journal of cardiologyauthors
Yamashita T,Ikeda T,Akita Ydoi
10.1016/j.jjcc.2018.11.009subject
Has Abstractpub_date
2019-05-01 00:00:00pages
386-393issue
5eissn
0914-5087issn
1876-4738pii
S0914-5087(18)30336-8journal_volume
73pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVES:This study was designed to determine the prognostic importance of left ventricular (LV) myocardial stiffness, a hemodynamic index which is closely related to B-type natriuretic peptide (BNP) concentration in patients with congestive heart failure (CHF). BACKGROUND:While elevated BNP, an abnormality of cardi...
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journal_title:Journal of cardiology
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journal_title:Journal of cardiology
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journal_title:Journal of cardiology
pub_type: 杂志文章,评审
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pub_type: 杂志文章
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pub_type: 临床试验,杂志文章
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更新日期:1995-11-01 00:00:00
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journal_title:Journal of cardiology
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