Comparison of Efficacy of Bisoprolol and Metoprolol ZOK in Patients with Mild to Moderate Hypertension – Results of the CREATIVE Study
Suppression of increased activity in the sympathoadrenal system is currently one of the main goals of antihypertensive therapy. Beta-blockers play an important role in regulating the sympathetic nervous system. The CREATIVE study evaluated the efficacy of bisoprolol and metoprolol ZOK on blood pressure and heart rate in patients with mild to moderate primary arterial hypertension.
Introduction
The cause of primary or essential hypertension is an abnormality in regulatory mechanisms at various levels. One of these is increased activity in the sympathoadrenal system. Beta-blockers are thus ranked as the main class of antihypertensive drugs due to their regulation of the sympathoadrenal axis.
The results of many studies confirm their effectiveness not only in reducing blood pressure values but also in cardiovascular morbidity and mortality parameters. A crucial question remains the choice of the correct beta-blocker. A study by Chinese authors compared the efficacy of bisoprolol and metoprolol ZOK within a 12-week therapy period in patients with mild to moderate primary arterial hypertension.
Methodology and Course of the Study
The open-label study involved 186 patients who were evenly randomized to therapy with bisoprolol at 5 mg once daily or metoprolol ZOK at 47.5 mg once daily for 12 weeks. The primary aim of the study was to evaluate the average reduction in dynamic heart rate and dynamic diastolic blood pressure in the last 4 hours of the treatment period. Secondary aims of the study included evaluating ambulatory monitoring of blood pressure and heart rate, safety, and compliance with therapy.
Results
In the last 4 hours of the treatment period, a significant reduction in the average dynamic heart rate was observed in patients on bisoprolol compared to those on metoprolol (difference by the least squares method –3.79/min; 97.5% confidence interval [CI] –7.45 to –0.14; p = 0.0202). Regarding the average reduction in dynamic diastolic blood pressure, bisoprolol demonstrated non-inferiority compared to metoprolol (–1.00; 97.5% CI –4.79 to 2.78; p = 0.5495). Bisoprolol also showed a significant reduction in average pressure measured by 24-hour monitoring and in the average day and night heart rates.
The occurrence of adverse events was similar in patients on bisoprolol as in those on metoprolol. Non-compliance was observed in 3 patients on bisoprolol and 6 patients on metoprolol.
Conclusion
In the cited study, bisoprolol demonstrated superiority over metoprolol ZOK in terms of reducing dynamic heart rate and non-inferiority in reducing dynamic diastolic blood pressure values in the last 4 hours of the treatment period in patients with mild to moderate primary arterial hypertension. This effect is highly significant given the high incidence of cardiovascular events in the early hours of the morning.
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Source: Yang T., Jiang Y., Hao Y. et al. Comparison of bisoprolol to a metoprolol CR/ZOK tablet for control of heart rate and blood pressure in mild-to-moderate hypertensive patients: the CREATIVE study. Hypertens Res 2017; 40 (1): 79–86, doi: 10.1038/hr.2016.101.
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