AIMS: This multicenter, open-label, single-arm trial assessed the efficacy of the combination of amlodipine 10 mg and valsartan 160 mg to provide additional blood pressure reduction and tolerability in patients with moderate hypertension not adequately responding to the combination oframipril 5 mg and felodipine5 mg. RESULTS: Of 133 patients treated for 5 weeks withramipril 5 mg and felodipine5 mg, 105 failed to achieve mean sitting systolic blood pressure <140 mmHg. These non-responders were then treated for an additional 5 weeks with amlodipine 10 mg and valsartan 160 mg, which resulted in clinically and statistically significant additional reductions in mean sitting systolic blood pressure of 15.4 mmHg (p<0.0001) and mean sitting diastolic blood pressure of 7.0 mmHg (p<0.0001). Adverse event rates were low with both treatment regimens. CONCLUSIONS: In hypertensive patients not controlled at 5 weeks by ramipril 5 mg and felodipine5 mg, significant additional blood pressure reductions were observed after 5 weeks of treatment with amlodipine 10 mg and valsartan 160 mg. The combination of amlodipine 10 mg and valsartan 160 mg was well tolerated.
RCT Entities:
AIMS: This multicenter, open-label, single-arm trial assessed the efficacy of the combination of amlodipine 10 mg and valsartan 160 mg to provide additional blood pressure reduction and tolerability in patients with moderate hypertension not adequately responding to the combination of ramipril 5 mg and felodipine 5 mg. RESULTS: Of 133 patients treated for 5 weeks with ramipril 5 mg and felodipine 5 mg, 105 failed to achieve mean sitting systolic blood pressure <140 mmHg. These non-responders were then treated for an additional 5 weeks with amlodipine 10 mg and valsartan 160 mg, which resulted in clinically and statistically significant additional reductions in mean sitting systolic blood pressure of 15.4 mmHg (p<0.0001) and mean sitting diastolic blood pressure of 7.0 mmHg (p<0.0001). Adverse event rates were low with both treatment regimens. CONCLUSIONS: In hypertensivepatients not controlled at 5 weeks by ramipril 5 mg and felodipine 5 mg, significant additional blood pressure reductions were observed after 5 weeks of treatment with amlodipine 10 mg and valsartan 160 mg. The combination of amlodipine 10 mg and valsartan 160 mg was well tolerated.