Key result
Fixed-dose combination therapy of perindopril and amlodipine resulted in a significantly greater reduction in diastolic blood pressure (14.22% vs 4.92%, p<0.05) compared to free-dose combination therapy.
Why the study?
Does a fixed-dose combination of perindopril and amlodipine improve blood pressure reduction compared to a free-dose combination in patients with newly diagnosed arterial hypertension?
RCT (n=39)
2:1 randomization design based on a power analysis
No
Does a fixed-dose combination of perindopril and amlodipine improve blood pressure reduction compared to a free-dose combination in patients with newly diagnosed arterial hypertension?
Absolute Event Rate: 14.22% vs 4.92%
p-value: p=<0.05
A fixed-dose single-pill combination of an ACE inhibitor and a calcium channel blocker provides significantly greater diastolic blood pressure reduction than the same drugs administered separately, likely due to improved patient adherence.
Supports fixed-dose perindopril-amlodipine preference in hypertension; confirms RCT advantages of single-pill over free-dose regimens.
The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased patients compliance and adherence to therapy. At the moment, however, there are no data suggesting the better control of once-daily fixed (Fixed) over free doses in separate administrations combination therapy in hypertensives. In a population of 39 consecutive outpatient patients referred to the departmental Hypertension clinic of the University Hospital of Salerno Medical School with the first diagnosis of arterial hypertension, we tested the hypothesis that the Fixed achieve a better control of blood pressure than the Free combination. Patients were randomized to either strategy and after 3 months patients underwent a clinical assessment to evaluate the antihypertensive effect. The two groups, matched for anthropometric and clinical parameters, received Amlodipine (5-10 mg/daily) and Perindopril (5-10 mg/daily). Perindopril and Amlodipine doses did not significantly differ between the two groups. After 3 months BP control was improved in both groups and BP targets were similarly reached in both groups (SBP; Fixed: 61.54%; Free 69.23%; n.s. DPB; Fixed: 80.77%; Free 84.62%; n.s.). The reduction in systolic blood pressure was similar in both groups (Fixed:7.64±2.49%; Free: 7.81±4.00%, n.s.), while the reduction of diastolic blood pressure was greater in the Fixed group (Fixed: 14.22±2.03%; Free: 4.92±5.00%, p<0.05). Although both strategies are effective in reducing BP, the use of Fixed dose has an advantage in the reduction of BP. The present study does not allow to identify the mechanisms of this difference, which can be assumed to be due to the pharmacokinetics of the drugs administered in once-daily fixed combination.
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Visco et al. (2017) conducted an RCT in Essential hypertension (n=39). Fixed-dose combination of Perindopril and Amlodipine vs. Free-dose combination of Perindopril and Amlodipine in separate tablets was evaluated on Reduction in diastolic blood pressure (p=<0.05). Fixed-dose combination therapy of perindopril and amlodipine resulted in a significantly greater reduction in diastolic blood pressure (14.22% vs 4.92%, p<0.05) compared to free-dose combination therapy.
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