A new first-line treatment containing new dosages of perindopril and amlodipine which were specially designed for treatment initiation in essential hypertension is available in Europe since mid-2015. The objective of this subanalysis was to assess the efficacy and safety of two strengths of this new first-line treatment in mild-to-moderate patients with hypertension versus another approved first-line treatment: ARB monotherapy with valsartan.Design and method:
A subanalysis of the first 2 months was performed of an international double-blind, parallel-group, randomized controlled trial whose endpoints were originally assessed at 3 months. The treatment regimens it compared were: perindopril/amlodipine 3.5/2.5 mg (uptitrated at 1 month to 7/5 mg in patients with uncontrolled hypertension, greater than or equal to 140/90 mmHg) and valsartan 80 mg (uptitrated at 1 month to 160 mg in patients with uncontrolled hypertension, over or equal to 140/90 mmHg).Results:
After 1 month, the rate of controlled hypertension was 33% with perindopril/amlodipine versus 27% with valsartan (estimate of difference, +6.1%, P = 0.005). At the end of the second month, the rate of controlled hypertension was 43% for perindopril/amlodipine and 34% for valsartan (estimate of difference, +9.0%, P < 0.001). The tolerability was similar in both groups: the incidence of emergent adverse events was 22% and 21% for the perindopril/amlodipine group and valsartan group (P = 0.643), respectively.Conclusions:
These results show that perindopril/amlodipine at adapted dosages for first-line treatment is as safe as valsartan monotherapy and more effective at controlling blood pressure after 2 months.