Clinical outcome in hypertensive patients treated with amlodipine plus bisoprolol or plus valsartan

Abstract

Objective

Several guidelines do not recommend beta-blocker as the first-line treatment for hypertension because of its inferior efficacy in stroke prevention. Combination therapy with beta-blocker is commonly used for blood pressure control. We compared the clinical outcomes in patients treated with amlodipine plus bisoprolol (A + B), a ß1-selective beta-blocker and amlodipine plus valsartan (A + V).

Methods

A population-based cohort study was performed using data from the Taiwan National Health Insurance Research Database. From 2012 to 2019, newly diagnosed adult hypertensive patients who received initial amlodipine monotherapy and then switched to A + V or A + B were included. The efficacy outcomes included all-cause death, atherosclerotic cardiovascular disease (ASCVD) event (cardiovascular death, myocardial infarction, ischemic stroke, and coronary revascularization), hemorrhagic stroke, and heart failure. Multivariable Cox proportional hazards model was used to evaluate the relationship between outcomes and different treatments.

Results

Overall, 4311 patients in A + B group and 10980 patients in A + V group were included. After a mean follow-up of 4.34 ± 1.79 years, the efficacy outcomes were similar between the A + V and A + B groups regarding all-cause death (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI] 0.83–1.18), ASCVD event (aHR 0.97, 95% CI 0.84–1.12), and heart failure (aHR 1.06, 95% CI 0.87–1.30). The risk of hemorrhagic stroke was lower in A + B group (aHR 0.70, 95% CI 0.52–0.94). The result was similar when taking death into consideration in competing risk analysis. The safety outcomes were similar between the 2 groups.

Conclusions

There was no difference of all-cause death, ASCVD event, and heart failure in A + B vs. A + V users. But A + B users had a lower risk of hemorrhagic stroke.

Keywords:

• Beta-blocker
• blood pressure control
• stroke

Transparency

Declaration of funding

This study was sponsored by Cheng-Hsing Medical Foundation, Tainan, Taiwan and IQVIA Solutions Taiwan Ltd. Taipei, Taiwan. The funders had no role in study design, data collection, manuscript preparation or decision to publish.

Declaration of financial/other relationships

Dr. Ulrike Gottwald-Hostalek is employed by Merck Healthcare KGaA, Darmstadt, Germany. Hung-Wei Lin is employed by IQVIA Solutions Taiwan Ltd., Taipei, Taiwan. The other authors declare no conflict of interest. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Yi-Heng Li, Ulrike Gottwald-Hostalek, Hung-Wei Lin and Sheng-Hsiang Lin were responsible for the study concept and design. Yi-Heng Li, Hui-Wen Lin and Sheng-Hsiang Lin were responsible for data acquisition, analysis and interpretation. Yi-Heng Li was responsible for manuscript writing. Ulrike Gottwald-Hostalek, Hung-Wei Lin and Sheng-Hsiang Lin were responsible for manuscript revision. All authors approved the final manuscript.

B. The crude and adjusted subdistribution hazard ratios of A + V and A + B users

Acknowledgements

Authors are grateful to the Health Data Science Center, National Cheng Kung University Hospital for providing administrative and technical support. The authors also thank Kuan-Lin Lin for providing supports on study coordination.