After 2 months of treatment, perindopril 3.5 mg/amlodipine 2.5 mg was shown suitable for use as first-step treatment in uncomplicated hypertension. It has been also identified a rapid onset effect of this new first-line treatment on blood pressure compared with approved first-line monocomponent treatments. The objective is to analyse the efficacy and safety of perindopril 3.5 mg/amlodipine 2.5 mg once daily after 1 month of treatment.Design and method:
Sub-analysis of an international, randomised, double-blind, placebo-controlled study with parallel treatment arms at 4 weeks. It has been focused on first-line treatment approved for hypertension: perindopril 3.5 mg/amlodipine 2.5 mg, perindopril 5 mg, amlodipine 5 mg, and placebo.Results:
1006 patients (mean age 52 years) with mild-to-moderate uncomplicated hypertension were computed. Systolic and diastolic blood pressure decreases at 4 weeks were (mmHg) −20.3/−11.9, −17.0/−10.2, −19.4/−11.6 and −13.5/−8.7 for Per/Aml (perindopril 3.5 mg/amlodipine 2.5 mg), Per (perindopril 5 mg), Aml (amlodipine 5 mg) and placebo, respectively. Per/Aml was statistically superior in BP lowering at 1 month than Per (p = 0.009 and 0.018 for SBP/DBP, respectively) and placebo (p < 0.001 for both). 35%, 31%, 31% and 23% of patients were normalized (below 140/90 mmHg) on Per/Aml, Per, Aml and placebo, respectively. The tolerability was similar between groups.Conclusions:
Perindopril 3.5 mg/amlodipine 2.5 mg improved efficacy with the same safety as currently approved first-line monotherapy treatments in hypertension. This improvement occurred in mild-to-moderate hypertensive patients from the first treatment month.