Journal of cardiology · 2018
Comparison of heart rate reduction effect and safety between bisoprolol transdermal patch and bisoprolol fumarate oral formulation in Japanese patients with persistent/permanent atrial fibrillation (BISONO-AF study).
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАEquivalence TrialНазвание и аннотация: Перевод в очереди
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Yamashita Takeshi, Ikeda Takanori, Akita Yasuhiko
Аннотация
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.
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.