Randomized evaluation of a novel, fixed-dose combination of perindopril 3.5âmg/amlodipine 2.5âmg as a first-step treatment in hypertension.
J Hypertens
; 33(3): 653-61; discussion 662, 2015 Mar.
Article
en En
| MEDLINE
| ID: mdl-25479022
ABSTRACT
OBJECTIVE:
To evaluate perindopril 3.5âmg/amlodipine 2.5âmg once daily, a novel fixed-dose combination adapted for first-step treatment in patients with hypertension. This fixed dose had to be equivalent to amlodipine 5âmg in terms of blood pressure efficacy, but with an expected better tolerability profile. We selected two drugs with complementary modes of action, with doses chosen so that each drug would contribute similarly to the overall blood pressure-lowering effectMETHODS:
An international, randomized, double-blind, placebo-controlled study with six equal parallel treatment arms and an 8-week randomized treatment period, whose design, clinical significance and non-inferiority criteria were in accordance with European guidelines.RESULTS:
In all, 1581 patients with mild-to-moderate uncomplicated hypertension (mean age 51.7 years) were randomized and 94.7% completed the study. The combination was statistically and clinically superior to placebo (between-group differences SBP -7.22âmmHg, DBP -4.12âmmHg, Pâ<â0.001 for both). Rates of response and normalization of blood pressure were greater with the combination (Pâ<â0.001 for both) and numerical differences relative to placebo were apparent at 2 weeks. The combination was superior to either component given singly (Pâ<â0.001 for both drugs, for SBP and DBP), and was non-inferior to both component drugs given singly at their lowest clinically-approved doses. The components of the combination had similar effects on SBP (perindopril 3.5âmg -16.3âmmHg; amlodipine 2.5âmg -16.0âmmHg). Adverse events relating to peripheral oedema were less frequent with the combination than with amlodipine 5âmg.CONCLUSIONS:
The observed blood pressure-lowering efficacy, rapidity of onset of effect and favourable safety profile of the combination perindopril 3.5âmg/amlodipine 2.5âmg indicate its potential suitability for use as first-step treatment in hypertension.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Amlodipino
/
Perindopril
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Hipertensión
/
Antihipertensivos
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Hypertens
Año:
2015
Tipo del documento:
Article
País de afiliación:
Ucrania