PP.LB01.01: SUPERIOR DYNAMIC HEART RATE CONTROL AND NON-INFERIOR BLOOD PRESSURE CONTROL WITH BISOPROLOL VS METOPROLOL SUSTAINED RELEASE TABLET IN MILD-TO-MODERATE HYPERTENSION. (June 2015)

• Record Type: Journal Article
• Authors: Yang, T.; Hao, Y.; Zhou, S.; Jiang, Y.; Xu, X.; Qu, B.; Lin, X.; Ma, T.; Luo, B.; Deng, H.; Liu, W.
• Is Part Of: Journal of hypertension. Volume 33(2015)Supplement 1
• Publication Date: 2015-06
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000468123.35853.e3
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: Both bisoprolol and metoprolol sustained release tablet (SR) are indicated in the management of hypertension. While long duration of effect in metoprolol SR was achieved through its sustained-release formulation, bisoprolol has intrinsic long duration of action. This study aimed to investigate long action of bisoprolol compared with metoprolol SR in controlling mean dynamic heart rate and diastolic blood pressure in the last 4 hours of a 12-week treatment period in patients with mild-to-moderate primary hypertension Design and method: 186 mild-to-moderate hypertensive patients from 7 centers in China were enrolled in this randomized, parallel, multicenter, open-label clinical study from Dec 2011 to Dec 2014. Patients were treated with either bispoprolol 5–10 mg or metoprolol SR 47.5–95 mg once daily for 12 weeks. Primary end points were mean dynamic heart rate control and mean dynamic diastolic blood pressure control in the last 4 hours of the treatment period. Secondary endpoints included ambulatory monitoring of the blood pressure and heart rate, safety, and compliance. Results: A total of 186 subjects were enrolled and analyzed, 93 subjects in each group respectively. In the last 4 hours of the treatment period, bisoprolol demonstrated significantly better control of mean dynamic heart rate compared with metoprolol SR (LSmeans difference: –3.79 bpm, 97.5% CI: –7.45, –0.14)). In the last 4 hours of the treatment period, the LSmeans difference of diastolic blood pressure was –1.00 (97.5% CI: –4.79, 2.78), with the upper limit less than 4, indicating that bisoprolol group was noninferior to metoprolol sustained release tablets group bisoprolol further provided significantly better control in 24 hour mean ambulatory, mean daytime, and nighttime heart rate. The overall adverse event (AE) rate was similar in bisoprolol group and metoprolol SR group (20.43% vs 17.20%). Noncompliance was reported in 3(3.53%) and 6(7.32%) subjects in bisoprolol and metoprolol sustained release tablets group respectively. Conclusions: Both bisoprolol and metoprolol SR could have long action. Bisoprolol provided superior dynamic heart rate control and non-inferior dynamic blood pressure control vs metoprolol SR in patients with mild-to-moderate hypertension. No new safety concern was found.