Unleashing SPC power: the first data on efficacy, safety and adherence of bisoprolol amlodipine SPC in China

Background Single-pill combination (SPC) of bisoprolol and amlodipine has shown promising results in blood pressure (BP) and heart rate (HR) control. However, clinical studies of this combination in Chinese patients remain limited.

Methods This was a 12-week, interventional, multicenter clinical trial. Hypertensive patients who had failed to achieve BP control during a 4-week period with either “bisoprolol 2.5 mg/d” or “metoprolol tartrate 12.5 mg, bid” or “metoprolol sustained-release 23.75 mg/d” + “amlodipine 5 mg/d” or “levamlodipine 2.5 mg/d” free combinations were enrolled. The inclusion criteria were clinic systolic blood pressure (SBP) / diastolic blood pressure (DBP) ≥ 140/90 mmHg with resting HR≥ 70 beats per minute (bpm). Clinic BP was assessed at 4, 8, and 12 weeks, home BP was assessed at 0, 1, 5, and 9 weeks, dynamic BP was evaluated at 0 and 11 weeks. Time in therapeutic range (TTR) for BP control was measured at 12 weeks. Adverse events (AEs) and adherence were also recorded.

Results A total of 78 patients were included, with an average age of 49 ± 12.4 years, 73.1% were male. Baseline SBP and DBP were 141.7 ± 9.6 mmHg and 92.6 ± 8.4 mmHg. After 9 weeks of treatment, significant reductions were observed in home SBP (−3.9 mmHg), DBP (−5.6 mmHg), and HR (−7.0 bpm; all P < 0.01). Clinic BP showed a significant reduction from baseline at 4- and 8-weeks post-treatment. After 12 weeks, reductions were more pronounced, with changes of −13.9 mmHg in clinic SBP, −11.2 mmHg in DBP, and −11.3 bpm in HR (all P < 0.0001). After 11 weeks of treatment, 24-hour dynamic BP assessments showed significant reductions in SBP, DBP and HR (all P < 0.05). The percentage of patients with TTR >70% significantly increased from 19.2% at baseline to 66.7% at 12 weeks (P < 0.0001). A total of 6 AEs were reported in 6 patients (8%). No serious AEs occurred. After 12 weeks of treatment, 96% of patients demonstrated good to excellent adherence.

Conclusion The bisoprolol-amlodipine SPC is a safe and effective treatment with good adherence for Chinese hypertensive patients who have inadequate control with free combinations of bisoprolol/metoprolol and amlodipine.

Professor Wenli Cheng has rich experience in the diagnosis and treatment of hypertension and its related diseases. She once served as an invited visiting professor at the University of Helsinki in Finland, and currently serves as the Director of the Hypertension Center at Beijing Hospital. She also serves as a council member of the Hypertension Expert Committee of the Beijing Medical Doctor Association, the Chinese Hypertension League, the Beijing Hypertension Prevention and Treatment Association, the China Association for Healthcare Promotion, et. al.