[PP.26.16] INDIVIDUAL DATA META-ANALYSIS IN 5507 SUBJECTS OF PERINDOPRIL 3.5 MG/AMLODIPINE 2.5 MG IN COMPARISON WITH RAS BLOCKER- MONOTHERAPIES

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Abstract

Objective:

To evaluate the blood pressure-lowering efficacy and tolerability of perindopril 3.5 mg/amlodipine 2.5 mg (P/A) once daily, a novel first-line treatment in comparison with renin–angiotensin system (RAS) blocker monotherapies after 1-month treatment.

Design and method:

A meta-analytic approach, based on individual data of 3 international randomized, double-blind studies (exhaustive data of the sponsor) was performed. The treatment effect (P/A vs RAS monotherapies: valsartan 80 mg, irbesartan 150 mg, or perindopril 5 mg) on office blood pressure (BP) change from baseline after 1 month was assessed in each individual study using analysis of covariance with treatment, baseline, and country as fixed effects. SAS (version 9.2) was used for all statistical analyses. In addition, a meta-analytic approach based on a similar model, taking into account the heterogeneity of treatment effects according to the different studies was performed on individual data.

Results:

A total of 5507 patients with mild-to-moderate hypertension (only 6.9% had grade 3 hypertension) were randomized. The baseline systolic BP/diastolic BP (SBP/DBP) was 163.5 ± 10.2/95.0 ± 8.6 mmHg and 163.1 ± 10.2/95.0 ± 8.6 mmHg for the P/A group (n = 2729) and the RAS blocker group (n = 2767), respectively. The decrease in SBP/DBP achieved with P/A was significantly superior to the decrease achieved with each RAS blocker monotherapy after 1 month of treatment. There was a difference of 2.4/1.3 mmHg (P = 0.002/0.005) in favor of P/A.

Results:

The tolerability was similar in all groups: the incidence of emergent adverse events was 28.4% for P/A vs 28.2% for the comparators (P = 0.929). Cough was more frequent in the P/A group (4.5%), while headache (3%) and diarrhea (0.8%) were more frequent in the RAS blocker group.

Conclusions:

The superior BP–lowering efficacy and favorable safety profile of perindopril 3.5 mg/amlodipine 2.5 mg, a new first-line treatment recently approved by the authorities, confirm that it is an interesting option for the medical community. This first-line treatment allows treating from mild hypertension with a dual mode of action instead of using monotherapy.

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