Key result
A single-pill combination of amlodipine/valsartan 5/80 mg achieved greater BP control (70.5% vs 44.1-58.6%) and significantly greater BP reductions than valsartan monotherapies (p<0.0001).
Why the study?
Does a single-pill combination of amlodipine/valsartan improve blood pressure reduction in Asian hypertensive patients not responding to valsartan 80 mg?
RCT
Double-blind
Does a single-pill combination of amlodipine/valsartan improve blood pressure reduction in Asian hypertensive patients not responding to valsartan 80 mg?
p-value: p=<0.0001
A single-pill combination of amlodipine/valsartan 5/80 mg provides superior blood pressure reduction and control compared to valsartan monotherapy in Asian patients inadequately controlled on valsartan 80 mg.
Supports amlodipine/valsartan SPC in Asian patients uncontrolled on valsartan 80 mg; extends RCT evidence for combination therapy in non-responders.
This randomized, double-blind study evaluated efficacy of a single-pill combination of amlodipine/valsartan (Aml/Val) in Asian patients with hypertension not responding to Val 80 mg. Patients with mean sitting diastolic blood pressure (DBP) ≥90-≤110 mmHg were randomized to Aml/Val 5/80, Val 80, or Val 160 mg for 8 weeks. At week-8 endpoint, significantly greater reductions in BP were seen with Aml/Val 5/80 mg than valsartan monotherapies (p < 0.0001). The BP control was greater with Aml/Val 5/80 (70.5%) than Val (44.1-58.6%) monotherapies. The combination was well tolerated. In conclusion, single-pill combination with Aml/Val provided significant additional BP reduction and control in hypertensive patients not responding to Val 80 mg.
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Huang et al. (2011) conducted an RCT in Hypertension. Amlodipine/Valsartan single-pill combination vs. Valsartan 80 mg or 160 mg was evaluated on Blood pressure reduction and control (p=<0.0001). A single-pill combination of amlodipine/valsartan 5/80 mg achieved greater BP control (70.5% vs 44.1-58.6%) and significantly greater BP reductions than valsartan monotherapies (p<0.0001).
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