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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 : 006E54 ( PascalFrancis/Curation ); précédent : 006E53; suivant : 006E55

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.
pA  
A01 01  1    @0 1064-1963
A03   1    @0 Clin. exp. hypertens. : (1993)
A05       @2 21
A06       @2 7
A08 01  1  ENG  @1 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
A11 01  1    @1 CASTAIGNE (A.)
A11 02  1    @1 CHALMERS (J.)
A11 03  1    @1 MORGAN (T.)
A11 04  1    @1 CHASTANG (C.)
A11 05  1    @1 FELDMANN (L.)
A11 06  1    @1 GUEZ (D.)
A14 01      @1 Hôpital Henri Mondor @2 Créteil @3 FRA @Z 1 aut.
A14 02      @1 Department of Medicine, Flinders Medical Center @2 Bedford Park @3 AUS @Z 2 aut.
A14 03      @1 Department of Physiology, University of Melbourne @2 Parkville, Victoria @3 AUS @Z 3 aut.
A14 04      @1 Department for Biostatistical and Medical Information, Hôpital Saint Louis @2 Paris @3 FRA @Z 4 aut.
A14 05      @1 Institut de Recherches Internationales Servier @2 Courbevoie @3 FRA @Z 5 aut. @Z 6 aut.
A20       @1 1097-1110
A21       @1 1999
A23 01      @0 ENG
A43 01      @1 INIST @2 18049A @5 354000088194510030
A44       @0 0000 @1 © 1999 INIST-CNRS. All rights reserved.
A45       @0 15 ref.
A47 01  1    @0 99-0516720
A60       @1 P
A61       @0 A
A64 01  1    @0 Clinical and experimental hypertension : (1993)
A66 01      @0 USA
C01 01    ENG  @0 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.
C02 01  X    @0 002B02F05
C03 01  X  FRE  @0 Hypertension artérielle @5 01
C03 01  X  ENG  @0 Hypertension @5 01
C03 01  X  SPA  @0 Hipertensión arterial @5 01
C03 02  X  FRE  @0 Voie orale @5 04
C03 02  X  ENG  @0 Oral administration @5 04
C03 02  X  SPA  @0 Vía oral @5 04
C03 03  X  FRE  @0 Antihypertenseur @5 07
C03 03  X  ENG  @0 Antihypertensive agent @5 07
C03 03  X  SPA  @0 Antihipertensivo @5 07
C03 04  X  FRE  @0 Périndopril @2 NK @2 FR @5 10
C03 04  X  ENG  @0 Perindopril @2 NK @2 FR @5 10
C03 04  X  SPA  @0 Perindopril @2 NK @2 FR @5 10
C03 05  X  FRE  @0 Inhibiteur angiotensin converting enzyme @5 11
C03 05  X  ENG  @0 ACE inhibitor @5 11
C03 05  X  SPA  @0 Inhibidor angiotensin converting enzyme @5 11
C03 06  X  FRE  @0 Indapamide @2 NK @2 FR @5 13
C03 06  X  ENG  @0 Indapamide @2 NK @2 FR @5 13
C03 06  X  SPA  @0 Indapamida @2 NK @2 FR @5 13
C03 07  X  FRE  @0 Diurétique @5 14
C03 07  X  ENG  @0 Diuretic @5 14
C03 07  X  SPA  @0 Diurético @5 14
C03 08  X  FRE  @0 Dose faible @5 16
C03 08  X  ENG  @0 Low dose @5 16
C03 08  X  SPA  @0 Dosis débil @5 16
C03 09  X  FRE  @0 Traitement @5 17
C03 09  X  ENG  @0 Treatment @5 17
C03 09  X  SPA  @0 Tratamiento @5 17
C03 10  X  FRE  @0 Chimiothérapie @5 18
C03 10  X  ENG  @0 Chemotherapy @5 18
C03 10  X  SPA  @0 Quimioterapia @5 18
C03 11  X  FRE  @0 Association médicamenteuse @5 19
C03 11  X  ENG  @0 Drug combination @5 19
C03 11  X  SPA  @0 Asociación medicamentosa @5 19
C03 12  X  FRE  @0 Homme @5 20
C03 12  X  ENG  @0 Human @5 20
C03 12  X  SPA  @0 Hombre @5 20
C07 01  X  FRE  @0 Appareil circulatoire pathologie @5 37
C07 01  X  ENG  @0 Cardiovascular disease @5 37
C07 01  X  SPA  @0 Aparato circulatorio patología @5 37
N21       @1 333

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Pascal:99-0516720

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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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<fC03 i1="05" i2="X" l="ENG">
<s0>ACE inhibitor</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Inhibidor angiotensin converting enzyme</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Indapamide</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>13</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Indapamide</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>13</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Indapamida</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Diurétique</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Diuretic</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Diurético</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Dose faible</s0>
<s5>16</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Low dose</s0>
<s5>16</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Dosis débil</s0>
<s5>16</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>17</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>17</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Chimiothérapie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Chemotherapy</s0>
<s5>18</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Quimioterapia</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Association médicamenteuse</s0>
<s5>19</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Drug combination</s0>
<s5>19</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Asociación medicamentosa</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Homme</s0>
<s5>20</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Human</s0>
<s5>20</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>20</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Appareil circulatoire pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Cardiovascular disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Aparato circulatorio patología</s0>
<s5>37</s5>
</fC07>
<fN21>
<s1>333</s1>
</fN21>
</pA>
</standard>
</inist>
</record>

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