OBJECTIVE: The efficacy of a bisoprolol/amlodipine fixed-dose combination (FDC) in patients with essential hypertension who had not responded to bisoprolol or amlodipine monotherapy was investigated. RESEARCH DESIGN AND METHODS: In an 18 week, multicenter, randomized, comparative phase III study (ClinicalTrials.gov identifier: NCT01977794), patients with blood pressure uncontrolled bybisoprolol or amlodipine monotherapy (5 mg OD) began treatment withbisoprolol/amlodipine FDC 5/5 mg OD. Patients with controlled blood pressure (BP) at week 6/12 continued at current FDC strength, and patients with uncontrolled BP receivedFDC dose uptitration (maximum dose: 10/10 mg). The primary efficacy endpoint was change in systolic blood pressure (SBP) at week 18 versus baseline (corresponding to SBP under monotherapy), and secondary endpoints included change from baseline in SBP after week 6/12 and percentage of BP-controlled patients at week 6, 12 and 18. Safety was assessed by number/types of adverse events (AEs). RESULTS:Two hundred patients were randomized to treatment (100 with uncontrolled BP under bisoprolol and 100 underamlodipine monotherapy). Overall, 196 patients were eligible for analysis. The patient groups displayed similar mean SBP reductions from baseline by study end (bisoprolol monotherapy failure: 25.9 ± 12.82 mmHg reduction; amlodipine monotherapy failure: 24.7 ± 11.67 mmHg reduction; p < 0.001 for both). Overall mean SBP decreased by 25.3 ± 12.25 mmHg (p < 0.001). Mean heart rate reductions were also observed (bisoprolol monotherapy failure: 6.6 ± 9.67 bpm reduction; amlodipine monotherapy failure: 11.5 ± 8.65 bpm reduction; p < 0.001 for both). Most patients (83.2%) displayed BP control with bisoprolol/amlodipine 5/5 mg at 6 weeks. Treatment was well tolerated at all dose levels; treatment-related AEs (mostly of mild/moderate intensity) were reported by 52.5% of patients, with no severe or serious treatment-related AEs reported. As the study focused on hypertension, total cardiovascular risk was not assessed. CONCLUSIONS:Bisoprolol/amlodipine FDC therapy is associated with significant BP improvements in patients with essential hypertension following monotherapy failure.
RCT Entities:
OBJECTIVE: The efficacy of a bisoprolol/amlodipine fixed-dose combination (FDC) in patients with essential hypertension who had not responded to bisoprolol or amlodipine monotherapy was investigated. RESEARCH DESIGN AND METHODS: In an 18 week, multicenter, randomized, comparative phase III study (ClinicalTrials.gov identifier: NCT01977794), patients with blood pressure uncontrolled by bisoprolol or amlodipine monotherapy (5 mg OD) began treatment with bisoprolol/amlodipineFDC 5/5 mg OD. Patients with controlled blood pressure (BP) at week 6/12 continued at current FDC strength, and patients with uncontrolled BP received FDC dose uptitration (maximum dose: 10/10 mg). The primary efficacy endpoint was change in systolic blood pressure (SBP) at week 18 versus baseline (corresponding to SBP under monotherapy), and secondary endpoints included change from baseline in SBP after week 6/12 and percentage of BP-controlled patients at week 6, 12 and 18. Safety was assessed by number/types of adverse events (AEs). RESULTS: Two hundred patients were randomized to treatment (100 with uncontrolled BP under bisoprolol and 100 under amlodipine monotherapy). Overall, 196 patients were eligible for analysis. The patient groups displayed similar mean SBP reductions from baseline by study end (bisoprolol monotherapy failure: 25.9 ± 12.82 mmHg reduction; amlodipine monotherapy failure: 24.7 ± 11.67 mmHg reduction; p < 0.001 for both). Overall mean SBP decreased by 25.3 ± 12.25 mmHg (p < 0.001). Mean heart rate reductions were also observed (bisoprolol monotherapy failure: 6.6 ± 9.67 bpm reduction; amlodipine monotherapy failure: 11.5 ± 8.65 bpm reduction; p < 0.001 for both). Most patients (83.2%) displayed BP control with bisoprolol/amlodipine 5/5 mg at 6 weeks. Treatment was well tolerated at all dose levels; treatment-related AEs (mostly of mild/moderate intensity) were reported by 52.5% of patients, with no severe or serious treatment-related AEs reported. As the study focused on hypertension, total cardiovascular risk was not assessed. CONCLUSIONS:Bisoprolol/amlodipineFDC therapy is associated with significant BP improvements in patients with essential hypertension following monotherapy failure.