Switching to a bisoprolol-amlodipine fixed-dose combination significantly reduced office systolic blood pressure by 13.9 mmHg and diastolic blood pressure by 11.2 mmHg at 12 weeks (P<0.0001).
Observational (n=78)
Yes
Does switching to bisoprolol-amlodipine fixed-dose combination improve blood pressure and heart rate control in Chinese patients with primary hypertension inadequately controlled by free combinations?
Switching to a bisoprolol-amlodipine fixed-dose combination significantly improves blood pressure and heart rate control in patients inadequately controlled on free combinations.
Mean Difference: -13.9
p-value: p=<0.0001
Objective: Hypertension is a leading chronic disease globally, with rising prevalence in China. A considerable number of primary mild-to-moderate hypertension patients struggle to achieve target blood pressure levels with monotherapy alone. The bisoprolol-amlodipine fixed-dose combination (FDC) shows promise for blood pressure control and adherence, whereas clinical evidence for Chinese patients is limited. This study evaluated efficacy and safety in patients inadequately controlled by free combinations of bisoprolol/metoprolol and amlodipine. Design and method: In a trial spanning 12 weeks across multiple centers, 78 patients were enrolled who failed 4-week free combinations (e.g., bisoprolol 2.5 mg/day or metoprolol formulations + amlodipine/levamlodipine). Inclusion required office systolic blood pressure (SBP) >140 mmHg and/or office diastolic blood pressure (DBP) >90 mmHg, with resting heart rate (RHR) >70 bpm. The assessments encompassed initial office blood pressure (OBP) at 4, 8, and 12 weeks, home blood pressure (HBP) at 0, 1, 5, and 9 weeks, dynamic blood pressure at 0 and 11 weeks, the duration within the time in target range (TTR) at 12 weeks. The average age of patients was 49 ± 12.4 years, with 73.1% being male. Results: After 9 weeks, there was a reduction in home SBP by 6.6 mmHg, home DBP by 4.2 mmHg, and RHR by 4 beats per minute (all P 70% increasing by 47.9% (P < 0.0001). At 11 weeks, dynamic SBP and heart rate (HR) fell substantially (P < 0.001), DBP similarly (P < 0.05). Adverse events were infrequent, and patient adherence was consistently high. Conclusions: The bisoprolol-amlodipine FDC provides a safe and effective treatment for Chinese patients with primary hypertension inadequately controlled by free combinations of bisoprolol/metoprolol and amlodipine.
Liu et al. (2026) conducted an observational in Primary mild-to-moderate hypertension (n=78). Bisoprolol-amlodipine fixed-dose combination (FDC) was evaluated on Change in office systolic blood pressure at 12 weeks (13.9 mmHg reduction, p=<0.0001). Switching to a bisoprolol-amlodipine fixed-dose combination significantly reduced office systolic blood pressure by 13.9 mmHg and diastolic blood pressure by 11.2 mmHg at 12 weeks (P<0.0001).