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Efficacy and safety of an oral fixed low-dose perindopril 2 mg/indapamide 0.625 mg combination : A randomized, double-blind, placebo-controlled study in elderly patients with mild to moderate hypertension

Identifieur interne : 00C761 ( Main/Exploration ); précédent : 00C760; suivant : 00C762

Efficacy and safety of an oral fixed low-dose perindopril 2 mg/indapamide 0.625 mg combination : A randomized, double-blind, placebo-controlled study in elderly patients with mild to moderate hypertension

Auteurs : A. Castaigne [France] ; J. Chalmers [Australie] ; T. Morgan [Australie] ; C. Chastang [France] ; L. Feldmann [France] ; D. Guez [France]

Source :

RBID : Pascal:99-0516720

Descripteurs français

English descriptors

Abstract

The efficacy and safety of 12 weeks treatment with an oral fixed low-dose perindopril 2 mg + indapamide 0.625 mg (Per/Ind) combination in elderly and very elderly patients (65-85 years) with mild to moderate systolic and diastolic hypertension (SDH) or isolated systolic hypertension (ISH) were investigated vs placebo. This trial was a multinational randomized double-blind study with doubling of active drug dosage in nonresponders. Intention to treat analysis was performed in 383 patients (age 72.4 years ; ISH 32%). 58.5% remained on their initial dosage. Per/Ind decreased supine diastolic and systolic blood pressure (sDBP/sSBP) by 13.2 ± 8.0 mm Hg and 22.5 ± 13.9 mm Hg (P <.0001) versus placebo - 7.3 ± 9.0 mm Hg and - 12.3 ± 15.2 mm Hg, respectively. In ISH (n = 123), Per/Ind decreased sSBP by 23.0 ± 11.8 mm Hg (P <.0001). Overall response and normotension rates was 81.3% with Per/Ind (P <.0001). Adverse event rates (including hypokalemia) were similarly low in both groups. Analysis in the over-75 year subgroup showed similar safety and efficacy results. Fixed low-dose Per/Ind is a safe and effective treatment of hypertension including isolated systolic hypertension in the elderly.


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Le document en format XML

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<div type="abstract" xml:lang="en">The efficacy and safety of 12 weeks treatment with an oral fixed low-dose perindopril 2 mg + indapamide 0.625 mg (Per/Ind) combination in elderly and very elderly patients (65-85 years) with mild to moderate systolic and diastolic hypertension (SDH) or isolated systolic hypertension (ISH) were investigated vs placebo. This trial was a multinational randomized double-blind study with doubling of active drug dosage in nonresponders. Intention to treat analysis was performed in 383 patients (age 72.4 years ; ISH 32%). 58.5% remained on their initial dosage. Per/Ind decreased supine diastolic and systolic blood pressure (sDBP/sSBP) by 13.2 ± 8.0 mm Hg and 22.5 ± 13.9 mm Hg (P <.0001) versus placebo - 7.3 ± 9.0 mm Hg and - 12.3 ± 15.2 mm Hg, respectively. In ISH (n = 123), Per/Ind decreased sSBP by 23.0 ± 11.8 mm Hg (P <.0001). Overall response and normotension rates was 81.3% with Per/Ind (P <.0001). Adverse event rates (including hypokalemia) were similarly low in both groups. Analysis in the over-75 year subgroup showed similar safety and efficacy results. Fixed low-dose Per/Ind is a safe and effective treatment of hypertension including isolated systolic hypertension in the elderly.</div>
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