Antihypertensive Efficacy, Safety, and Adherence After Switching From a Free Combination of Bisoprolol/Metoprolol and Amlodipine to Bisoprolol/Amlodipine FDC Tablets (5/5 mg) in Chinese Patients With Hypertension

Hypertension is a leading chronic disease globally, with rising prevalence in China. A considerable number of hypertension patients struggle to achieve target blood pressure levels with monotherapy alone. The bisoprolol/amlodipine FDC shows promise for blood pressure control and adherence, whereas clinical evidence for Chinese patients is limited. This prospective study evaluated efficacy and safety in patients inadequately controlled by free combination of bisoprolol/metoprolol and amlodipine. In a prospective 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 beats per minute (bpm). Assessments included office BP (OBP) at 4th, 8th, 12th weeks; home BP (HBP) at 0, 1st, 5th, 9th weeks; ambulatory BP at 0, 11 weeks; and time in target range (TTR) at 12 weeks. Patients averaged 49±12.4 years, 73.1% male. After 1 week, home SBP decreased by 6.6 mmHg, DBP by 4.2 mmHg, RHR by 5.5 bpm (all p < 0.0001). OBP significantly reduced at 4 and 8 weeks. By 12 weeks, office SBP dropped by 13.9 mmHg, DBP by 11.2 mmHg, and RHR by 11.3 bpm (all p < 0.0001). The mean Clinic TTR significantly increased by 47.9 percentage points (from 31.3% to 79.2%, p < 0.0001), with the proportion of patients achieving Clinic TTR >70% rising from 19.2% to 66.7% (p < 0.0001). At 11 weeks, ambulatory SBP and HR fell substantially (p < 0.001), and Ambulatory TTR also significantly improved across 24-hour, daytime, and nighttime periods. Bisoprolol/amlodipine FDC is safe and effective for Chinese patients with hypertension not adequately controlled by free combinations of bisoprolol/metoprolol and amlodipine.