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Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial. Commentary

Identifieur interne : 001406 ( PascalFrancis/Curation ); précédent : 001405; suivant : 001407

Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial. Commentary

Auteurs : Philip A. Poole-Wilson [Royaume-Uni] ; Jacobus Lubsen [Pays-Bas, Suisse] ; Bridget-Anne Kirwan [Suisse] ; Fred J. Van Dalen [Suisse] ; Gilbert Wagener [Allemagne] ; Nicolas Danchin [France] ; Hanjörg Just [Allemagne] ; Keith A. A. Fox [Royaume-Uni] ; Stuart J. Pocock [Royaume-Uni] ; Tim C. Clayton [Royaume-Uni] ; Michael Motro [Israël] ; John D. Parker [Canada] ; Martial G. Bourassa [Canada] ; Anthony M. Dart [Australie] ; Per Hildebrandt [Danemark] ; Ake Hjalmarson [Suède] ; Johannes A. Kragten [Pays-Bas] ; G. Peter Molhoek [Pays-Bas] ; Jan-Erik Otterstad [Norvège] ; Ricardo Seabra-Gomes [Portugal] ; Jordi Soler-Soler [Espagne] ; Simon Weber [France] ; Bruce M. Psaty [États-Unis] ; Curt D. Furberg [États-Unis]

Source :

RBID : Pascal:04-0483358

Descripteurs français

English descriptors

Abstract

Background Calcium antagonists are widely prescribed for angina pectoris but their effect on clinical outcome is controversial. We aimed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris. Methods We randomly assigned 3825 patients with treated stable symptomatic coronary disease to double-blind addition of nifedipine GITS (gastrointestinal therapeutic system) 60 mg once daily and 3840 to placebo. The primary endpoint was the combination of death, acute myocardial infarction, refractory angina, new overt heart failure, debilitating stroke, and peripheral revascularisation. Mean follow-up was 4-9 years (SD 1.1). Analysis was by intention to treat. Findings 310 patients allocated nifedipine died (1.64 per 100 patient-years) compared with 291 people allocated placebo (1.53 per 100 patient-years; hazard ratio 1.07 [95% CI 0.91-1.25], p=0.41). Primary endpoint rates were 4.60 per 100 patient-years for nifedipine and 4.75 per 100 patient-years for placebo (0.97 [0.88-1.07), p=0.54). With nifedipine, rate of death and any cardiovascular event or procedure was 9.32 per 100 patient-years versus 10.50 per 100 patient-years for placebo (0.89 [0.83-0.95], p=0.0012). The difference was mainly attributable to a reduction in the need for coronary angiography and interventions in patients assigned nifedipine, despite an increase in peripheral revascularisation. Nifedipine had no effect on the rate of myocardial infarction. Interpretation Addition of nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival. Nifedipine GITS is safe and reduces the need for coronary angiography and interventions.
pA  
A01 01  1    @0 0140-6736
A02 01      @0 LANCAO
A03   1    @0 Lancet : (Br. ed.)
A05       @2 364
A06       @2 9437
A08 01  1  ENG  @1 Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial. Commentary
A11 01  1    @1 POOLE-WILSON (Philip A.)
A11 02  1    @1 LUBSEN (Jacobus)
A11 03  1    @1 KIRWAN (Bridget-Anne)
A11 04  1    @1 VAN DALEN (Fred J.)
A11 05  1    @1 WAGENER (Gilbert)
A11 06  1    @1 DANCHIN (Nicolas)
A11 07  1    @1 JUST (Hanjörg)
A11 08  1    @1 FOX (Keith A. A.)
A11 09  1    @1 POCOCK (Stuart J.)
A11 10  1    @1 CLAYTON (Tim C.)
A11 11  1    @1 MOTRO (Michael)
A11 12  1    @1 PARKER (John D.)
A11 13  1    @1 BOURASSA (Martial G.)
A11 14  1    @1 DART (Anthony M.)
A11 15  1    @1 HILDEBRANDT (Per)
A11 16  1    @1 HJALMARSON (Ake)
A11 17  1    @1 KRAGTEN (Johannes A.)
A11 18  1    @1 MOLHOEK (G. Peter)
A11 19  1    @1 OTTERSTAD (Jan-Erik)
A11 20  1    @1 SEABRA-GOMES (Ricardo)
A11 21  1    @1 SOLER-SOLER (Jordi)
A11 22  1    @1 WEBER (Simon)
A11 23  1    @1 PSATY (Bruce M.) @9 comment.
A11 24  1    @1 FURBERG (Curt D.) @9 comment.
A14 01      @1 Cardiac Medicine, Imperial College London, Dovehouse Street @2 London SW3 6LY @3 GBR @Z 1 aut.
A14 02      @1 Department of Epidemiology and Biostatistics, Erasmus Medical Centre @2 Rotterdam @3 NLD @Z 2 aut.
A14 03      @1 SOCAR Research @2 Nyon @3 CHE @Z 2 aut. @Z 3 aut. @Z 4 aut.
A14 04      @1 Pharma Research Centre, Bayer Healthcare AG @2 Wuppertal @3 DEU @Z 5 aut.
A14 05      @1 Department of Cardiology, Georges Pompidou European Hospital @2 Paris @3 FRA @Z 6 aut.
A14 06      @1 University of Freiburg @2 Freiburg @3 DEU @Z 7 aut.
A14 07      @1 Centre for Cardiovascular Science, University of Edinburgh @2 Edinburgh @3 GBR @Z 8 aut.
A14 08      @1 Medical Statistics Unit, London School of Hygiene and Tropical Medicine @2 London @3 GBR @Z 9 aut. @Z 10 aut.
A14 09      @1 Ringer's Research Unit, Sheba Medical Centre, University of Tel Aviv @2 Tel Aviv @3 ISR @Z 11 aut.
A14 10      @1 Division of Cardiology, University Health Network and Mount Sinai Hospitals @2 Toronto, ON @3 CAN @Z 12 aut.
A14 11      @1 Department of Medicine, Montreal Heart Institute @2 Montreal, QC @3 CAN @Z 13 aut.
A14 12      @1 Cardiovascular Medicine, Alfred Hospital @2 Melbourne @3 AUS @Z 14 aut.
A14 13      @1 Department of Cardiology and Endocrinology, Frederiksberg University Hospital @2 Frederiksberg @3 DNK @Z 15 aut.
A14 14      @1 Cardiovascular Institute, Sahlgrenska University Hospital @2 Göteborg @3 SWE @Z 16 aut.
A14 15      @1 Atrium Medical Centre @2 Heerlen @3 NLD @Z 17 aut.
A14 16      @1 Medisch Spectrum Twente @2 Enschede @3 NLD @Z 18 aut.
A14 17      @1 Division of Cardiology, Vestfold Hospital @2 Toensberg @3 NOR @Z 19 aut.
A14 18      @1 Department of Cardiology, Hospital Santa Cruz @2 Lisbon @3 PRT @Z 20 aut.
A14 19      @1 Department of Cardiology, Vall d'Hebron University Hospital @2 Barcelona @3 ESP @Z 21 aut.
A14 20      @1 Department of Cardiology, René Descartes University @2 Paris @3 FRA @Z 22 aut.
A14 21      @1 Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology and Health Services, University of Washington @2 Seattle, WA 98101 @3 USA @Z 23 aut.
A14 22      @1 Department of Public Health Sciences, Wake Forest University School of Medicine @2 Winston-Salem, North Carolina @3 USA @Z 24 aut.
A17 01  1    @1 ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine gastrointestinal therapeutic system) investigators @3 INC
A20       @2 817-818,849-857 [11 p.]
A21       @1 2004
A23 01      @0 ENG
A43 01      @1 INIST @2 5004 @5 354000120255170140
A44       @0 0000 @1 © 2004 INIST-CNRS. All rights reserved.
A45       @0 36 ref.
A47 01  1    @0 04-0483358
A60       @1 P @3 AR @3 CT
A61       @0 A
A64 01  1    @0 Lancet : (British edition)
A66 01      @0 GBR
C01 01    ENG  @0 Background Calcium antagonists are widely prescribed for angina pectoris but their effect on clinical outcome is controversial. We aimed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris. Methods We randomly assigned 3825 patients with treated stable symptomatic coronary disease to double-blind addition of nifedipine GITS (gastrointestinal therapeutic system) 60 mg once daily and 3840 to placebo. The primary endpoint was the combination of death, acute myocardial infarction, refractory angina, new overt heart failure, debilitating stroke, and peripheral revascularisation. Mean follow-up was 4-9 years (SD 1.1). Analysis was by intention to treat. Findings 310 patients allocated nifedipine died (1.64 per 100 patient-years) compared with 291 people allocated placebo (1.53 per 100 patient-years; hazard ratio 1.07 [95% CI 0.91-1.25], p=0.41). Primary endpoint rates were 4.60 per 100 patient-years for nifedipine and 4.75 per 100 patient-years for placebo (0.97 [0.88-1.07), p=0.54). With nifedipine, rate of death and any cardiovascular event or procedure was 9.32 per 100 patient-years versus 10.50 per 100 patient-years for placebo (0.89 [0.83-0.95], p=0.0012). The difference was mainly attributable to a reduction in the need for coronary angiography and interventions in patients assigned nifedipine, despite an increase in peripheral revascularisation. Nifedipine had no effect on the rate of myocardial infarction. Interpretation Addition of nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival. Nifedipine GITS is safe and reduces the need for coronary angiography and interventions.
C02 01  X    @0 002B01
C02 02  X    @0 002B12A03
C03 01  X  FRE  @0 Angine poitrine @5 01
C03 01  X  ENG  @0 Angina pectoris @5 01
C03 01  X  SPA  @0 Angina pectoris @5 01
C03 02  X  FRE  @0 Nifédipine @2 NK @2 FR @5 02
C03 02  X  ENG  @0 Nifedipine @2 NK @2 FR @5 02
C03 02  X  SPA  @0 Nifedipino @2 NK @2 FR @5 02
C03 03  X  FRE  @0 Epidémiologie @5 03
C03 03  X  ENG  @0 Epidemiology @5 03
C03 03  X  SPA  @0 Epidemiología @5 03
C03 04  X  FRE  @0 Mortalité @5 05
C03 04  X  ENG  @0 Mortality @5 05
C03 04  X  SPA  @0 Mortalidad @5 05
C03 05  X  FRE  @0 Appareil circulatoire @5 06
C03 05  X  ENG  @0 Circulatory system @5 06
C03 05  X  SPA  @0 Aparato circulatorio @5 06
C03 06  X  FRE  @0 Morbidité @5 08
C03 06  X  ENG  @0 Morbidity @5 08
C03 06  X  SPA  @0 Morbilidad @5 08
C03 07  X  FRE  @0 Homme @5 09
C03 07  X  ENG  @0 Human @5 09
C03 07  X  SPA  @0 Hombre @5 09
C03 08  X  FRE  @0 Essai clinique @5 11
C03 08  X  ENG  @0 Clinical trial @5 11
C03 08  X  SPA  @0 Ensayo clínico @5 11
C03 09  X  FRE  @0 Action @5 12
C03 09  X  ENG  @0 Action @5 12
C03 09  X  SPA  @0 Acción @5 12
C03 10  X  FRE  @0 Médecine @5 14
C03 10  X  ENG  @0 Medicine @5 14
C03 10  X  SPA  @0 Medicina @5 14
C07 01  X  FRE  @0 Antagoniste calcium @5 37
C07 01  X  ENG  @0 Calcium antagonist @5 37
C07 01  X  SPA  @0 Antagonista calcio @5 37
C07 02  X  FRE  @0 Dihydropyridine dérivé @5 38
C07 02  X  ENG  @0 Dihydropyridine derivatives @5 38
C07 02  X  SPA  @0 Dihidropiridine derivado @5 38
C07 03  X  FRE  @0 Appareil circulatoire pathologie @5 39
C07 03  X  ENG  @0 Cardiovascular disease @5 39
C07 03  X  SPA  @0 Aparato circulatorio patología @5 39
C07 04  X  FRE  @0 Cardiopathie coronaire @5 40
C07 04  X  ENG  @0 Coronary heart disease @5 40
C07 04  X  SPA  @0 Cardiopatía coronaria @5 40
N21       @1 271
N44 01      @1 OTO
N82       @1 OTO

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<name sortKey="Danchin, Nicolas" sort="Danchin, Nicolas" uniqKey="Danchin N" first="Nicolas" last="Danchin">Nicolas Danchin</name>
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<name sortKey="Just, Hanjorg" sort="Just, Hanjorg" uniqKey="Just H" first="Hanjörg" last="Just">Hanjörg Just</name>
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<name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
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<name sortKey="Pocock, Stuart J" sort="Pocock, Stuart J" uniqKey="Pocock S" first="Stuart J." last="Pocock">Stuart J. Pocock</name>
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<name sortKey="Motro, Michael" sort="Motro, Michael" uniqKey="Motro M" first="Michael" last="Motro">Michael Motro</name>
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<author>
<name sortKey="Parker, John D" sort="Parker, John D" uniqKey="Parker J" first="John D." last="Parker">John D. Parker</name>
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<country>Canada</country>
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<name sortKey="Bourassa, Martial G" sort="Bourassa, Martial G" uniqKey="Bourassa M" first="Martial G." last="Bourassa">Martial G. Bourassa</name>
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<name sortKey="Dart, Anthony M" sort="Dart, Anthony M" uniqKey="Dart A" first="Anthony M." last="Dart">Anthony M. Dart</name>
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<name sortKey="Hildebrandt, Per" sort="Hildebrandt, Per" uniqKey="Hildebrandt P" first="Per" last="Hildebrandt">Per Hildebrandt</name>
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<name sortKey="Hjalmarson, Ake" sort="Hjalmarson, Ake" uniqKey="Hjalmarson A" first="Ake" last="Hjalmarson">Ake Hjalmarson</name>
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<s1>Cardiovascular Institute, Sahlgrenska University Hospital</s1>
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<country>Suède</country>
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<author>
<name sortKey="Kragten, Johannes A" sort="Kragten, Johannes A" uniqKey="Kragten J" first="Johannes A." last="Kragten">Johannes A. Kragten</name>
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<s1>Atrium Medical Centre</s1>
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<author>
<name sortKey="Molhoek, G Peter" sort="Molhoek, G Peter" uniqKey="Molhoek G" first="G. Peter" last="Molhoek">G. Peter Molhoek</name>
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<s1>Medisch Spectrum Twente</s1>
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<country>Pays-Bas</country>
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</author>
<author>
<name sortKey="Otterstad, Jan Erik" sort="Otterstad, Jan Erik" uniqKey="Otterstad J" first="Jan-Erik" last="Otterstad">Jan-Erik Otterstad</name>
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<country>Norvège</country>
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</author>
<author>
<name sortKey="Seabra Gomes, Ricardo" sort="Seabra Gomes, Ricardo" uniqKey="Seabra Gomes R" first="Ricardo" last="Seabra-Gomes">Ricardo Seabra-Gomes</name>
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<s1>Department of Cardiology, Hospital Santa Cruz</s1>
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<country>Portugal</country>
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<author>
<name sortKey="Soler Soler, Jordi" sort="Soler Soler, Jordi" uniqKey="Soler Soler J" first="Jordi" last="Soler-Soler">Jordi Soler-Soler</name>
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<s1>Department of Cardiology, Vall d'Hebron University Hospital</s1>
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<country>Espagne</country>
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<author>
<name sortKey="Weber, Simon" sort="Weber, Simon" uniqKey="Weber S" first="Simon" last="Weber">Simon Weber</name>
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<s1>Department of Cardiology, René Descartes University</s1>
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<country>France</country>
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<author>
<name sortKey="Psaty, Bruce M" sort="Psaty, Bruce M" uniqKey="Psaty B" first="Bruce M." last="Psaty">Bruce M. Psaty</name>
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<title xml:lang="en" level="a">Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial. Commentary</title>
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<name sortKey="Poole Wilson, Philip A" sort="Poole Wilson, Philip A" uniqKey="Poole Wilson P" first="Philip A." last="Poole-Wilson">Philip A. Poole-Wilson</name>
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<country>Royaume-Uni</country>
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<author>
<name sortKey="Lubsen, Jacobus" sort="Lubsen, Jacobus" uniqKey="Lubsen J" first="Jacobus" last="Lubsen">Jacobus Lubsen</name>
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<s3>NLD</s3>
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</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
<affiliation wicri:level="1">
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<s1>SOCAR Research</s1>
<s2>Nyon</s2>
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<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
</affiliation>
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<author>
<name sortKey="Kirwan, Bridget Anne" sort="Kirwan, Bridget Anne" uniqKey="Kirwan B" first="Bridget-Anne" last="Kirwan">Bridget-Anne Kirwan</name>
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<s1>SOCAR Research</s1>
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<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
</affiliation>
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<author>
<name sortKey="Van Dalen, Fred J" sort="Van Dalen, Fred J" uniqKey="Van Dalen F" first="Fred J." last="Van Dalen">Fred J. Van Dalen</name>
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<sZ>4 aut.</sZ>
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<country>Suisse</country>
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<author>
<name sortKey="Wagener, Gilbert" sort="Wagener, Gilbert" uniqKey="Wagener G" first="Gilbert" last="Wagener">Gilbert Wagener</name>
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<s3>DEU</s3>
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</inist:fA14>
<country>Allemagne</country>
</affiliation>
</author>
<author>
<name sortKey="Danchin, Nicolas" sort="Danchin, Nicolas" uniqKey="Danchin N" first="Nicolas" last="Danchin">Nicolas Danchin</name>
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<s1>Department of Cardiology, Georges Pompidou European Hospital</s1>
<s2>Paris</s2>
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<sZ>6 aut.</sZ>
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<country>France</country>
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<author>
<name sortKey="Just, Hanjorg" sort="Just, Hanjorg" uniqKey="Just H" first="Hanjörg" last="Just">Hanjörg Just</name>
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<inist:fA14 i1="06">
<s1>University of Freiburg</s1>
<s2>Freiburg</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
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<country>Allemagne</country>
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<author>
<name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
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<inist:fA14 i1="07">
<s1>Centre for Cardiovascular Science, University of Edinburgh</s1>
<s2>Edinburgh</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
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<author>
<name sortKey="Pocock, Stuart J" sort="Pocock, Stuart J" uniqKey="Pocock S" first="Stuart J." last="Pocock">Stuart J. Pocock</name>
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<inist:fA14 i1="08">
<s1>Medical Statistics Unit, London School of Hygiene and Tropical Medicine</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
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<author>
<name sortKey="Clayton, Tim C" sort="Clayton, Tim C" uniqKey="Clayton T" first="Tim C." last="Clayton">Tim C. Clayton</name>
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<inist:fA14 i1="08">
<s1>Medical Statistics Unit, London School of Hygiene and Tropical Medicine</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
</author>
<author>
<name sortKey="Motro, Michael" sort="Motro, Michael" uniqKey="Motro M" first="Michael" last="Motro">Michael Motro</name>
<affiliation wicri:level="1">
<inist:fA14 i1="09">
<s1>Ringer's Research Unit, Sheba Medical Centre, University of Tel Aviv</s1>
<s2>Tel Aviv</s2>
<s3>ISR</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Israël</country>
</affiliation>
</author>
<author>
<name sortKey="Parker, John D" sort="Parker, John D" uniqKey="Parker J" first="John D." last="Parker">John D. Parker</name>
<affiliation wicri:level="1">
<inist:fA14 i1="10">
<s1>Division of Cardiology, University Health Network and Mount Sinai Hospitals</s1>
<s2>Toronto, ON</s2>
<s3>CAN</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
</affiliation>
</author>
<author>
<name sortKey="Bourassa, Martial G" sort="Bourassa, Martial G" uniqKey="Bourassa M" first="Martial G." last="Bourassa">Martial G. Bourassa</name>
<affiliation wicri:level="1">
<inist:fA14 i1="11">
<s1>Department of Medicine, Montreal Heart Institute</s1>
<s2>Montreal, QC</s2>
<s3>CAN</s3>
<sZ>13 aut.</sZ>
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<country>Canada</country>
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</author>
<author>
<name sortKey="Dart, Anthony M" sort="Dart, Anthony M" uniqKey="Dart A" first="Anthony M." last="Dart">Anthony M. Dart</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>Cardiovascular Medicine, Alfred Hospital</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
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<author>
<name sortKey="Hildebrandt, Per" sort="Hildebrandt, Per" uniqKey="Hildebrandt P" first="Per" last="Hildebrandt">Per Hildebrandt</name>
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<inist:fA14 i1="13">
<s1>Department of Cardiology and Endocrinology, Frederiksberg University Hospital</s1>
<s2>Frederiksberg</s2>
<s3>DNK</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Danemark</country>
</affiliation>
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<author>
<name sortKey="Hjalmarson, Ake" sort="Hjalmarson, Ake" uniqKey="Hjalmarson A" first="Ake" last="Hjalmarson">Ake Hjalmarson</name>
<affiliation wicri:level="1">
<inist:fA14 i1="14">
<s1>Cardiovascular Institute, Sahlgrenska University Hospital</s1>
<s2>Göteborg</s2>
<s3>SWE</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Suède</country>
</affiliation>
</author>
<author>
<name sortKey="Kragten, Johannes A" sort="Kragten, Johannes A" uniqKey="Kragten J" first="Johannes A." last="Kragten">Johannes A. Kragten</name>
<affiliation wicri:level="1">
<inist:fA14 i1="15">
<s1>Atrium Medical Centre</s1>
<s2>Heerlen</s2>
<s3>NLD</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
</author>
<author>
<name sortKey="Molhoek, G Peter" sort="Molhoek, G Peter" uniqKey="Molhoek G" first="G. Peter" last="Molhoek">G. Peter Molhoek</name>
<affiliation wicri:level="1">
<inist:fA14 i1="16">
<s1>Medisch Spectrum Twente</s1>
<s2>Enschede</s2>
<s3>NLD</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
</author>
<author>
<name sortKey="Otterstad, Jan Erik" sort="Otterstad, Jan Erik" uniqKey="Otterstad J" first="Jan-Erik" last="Otterstad">Jan-Erik Otterstad</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>Division of Cardiology, Vestfold Hospital</s1>
<s2>Toensberg</s2>
<s3>NOR</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Norvège</country>
</affiliation>
</author>
<author>
<name sortKey="Seabra Gomes, Ricardo" sort="Seabra Gomes, Ricardo" uniqKey="Seabra Gomes R" first="Ricardo" last="Seabra-Gomes">Ricardo Seabra-Gomes</name>
<affiliation wicri:level="1">
<inist:fA14 i1="18">
<s1>Department of Cardiology, Hospital Santa Cruz</s1>
<s2>Lisbon</s2>
<s3>PRT</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Portugal</country>
</affiliation>
</author>
<author>
<name sortKey="Soler Soler, Jordi" sort="Soler Soler, Jordi" uniqKey="Soler Soler J" first="Jordi" last="Soler-Soler">Jordi Soler-Soler</name>
<affiliation wicri:level="1">
<inist:fA14 i1="19">
<s1>Department of Cardiology, Vall d'Hebron University Hospital</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
</affiliation>
</author>
<author>
<name sortKey="Weber, Simon" sort="Weber, Simon" uniqKey="Weber S" first="Simon" last="Weber">Simon Weber</name>
<affiliation wicri:level="1">
<inist:fA14 i1="20">
<s1>Department of Cardiology, René Descartes University</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author>
<name sortKey="Psaty, Bruce M" sort="Psaty, Bruce M" uniqKey="Psaty B" first="Bruce M." last="Psaty">Bruce M. Psaty</name>
<affiliation wicri:level="1">
<inist:fA14 i1="21">
<s1>Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology and Health Services, University of Washington</s1>
<s2>Seattle, WA 98101</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author>
<name sortKey="Furberg, Curt D" sort="Furberg, Curt D" uniqKey="Furberg C" first="Curt D." last="Furberg">Curt D. Furberg</name>
<affiliation wicri:level="1">
<inist:fA14 i1="22">
<s1>Department of Public Health Sciences, Wake Forest University School of Medicine</s1>
<s2>Winston-Salem, North Carolina</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
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</analytic>
<series>
<title level="j" type="main">Lancet : (British edition)</title>
<title level="j" type="abbreviated">Lancet : (Br. ed.)</title>
<idno type="ISSN">0140-6736</idno>
<imprint>
<date when="2004">2004</date>
</imprint>
</series>
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<title level="j" type="main">Lancet : (British edition)</title>
<title level="j" type="abbreviated">Lancet : (Br. ed.)</title>
<idno type="ISSN">0140-6736</idno>
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<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Action</term>
<term>Angina pectoris</term>
<term>Circulatory system</term>
<term>Clinical trial</term>
<term>Epidemiology</term>
<term>Human</term>
<term>Medicine</term>
<term>Morbidity</term>
<term>Mortality</term>
<term>Nifedipine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Angine poitrine</term>
<term>Nifédipine</term>
<term>Epidémiologie</term>
<term>Mortalité</term>
<term>Appareil circulatoire</term>
<term>Morbidité</term>
<term>Homme</term>
<term>Essai clinique</term>
<term>Action</term>
<term>Médecine</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Mortalité</term>
<term>Homme</term>
<term>Médecine</term>
</keywords>
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<front>
<div type="abstract" xml:lang="en">Background Calcium antagonists are widely prescribed for angina pectoris but their effect on clinical outcome is controversial. We aimed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris. Methods We randomly assigned 3825 patients with treated stable symptomatic coronary disease to double-blind addition of nifedipine GITS (gastrointestinal therapeutic system) 60 mg once daily and 3840 to placebo. The primary endpoint was the combination of death, acute myocardial infarction, refractory angina, new overt heart failure, debilitating stroke, and peripheral revascularisation. Mean follow-up was 4-9 years (SD 1.1). Analysis was by intention to treat. Findings 310 patients allocated nifedipine died (1.64 per 100 patient-years) compared with 291 people allocated placebo (1.53 per 100 patient-years; hazard ratio 1.07 [95% CI 0.91-1.25], p=0.41). Primary endpoint rates were 4.60 per 100 patient-years for nifedipine and 4.75 per 100 patient-years for placebo (0.97 [0.88-1.07), p=0.54). With nifedipine, rate of death and any cardiovascular event or procedure was 9.32 per 100 patient-years versus 10.50 per 100 patient-years for placebo (0.89 [0.83-0.95], p=0.0012). The difference was mainly attributable to a reduction in the need for coronary angiography and interventions in patients assigned nifedipine, despite an increase in peripheral revascularisation. Nifedipine had no effect on the rate of myocardial infarction. Interpretation Addition of nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival. Nifedipine GITS is safe and reduces the need for coronary angiography and interventions.</div>
</front>
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<fA14 i1="02">
<s1>Department of Epidemiology and Biostatistics, Erasmus Medical Centre</s1>
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<s3>NLD</s3>
<sZ>2 aut.</sZ>
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<sZ>4 aut.</sZ>
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<fA14 i1="04">
<s1>Pharma Research Centre, Bayer Healthcare AG</s1>
<s2>Wuppertal</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
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<fA14 i1="05">
<s1>Department of Cardiology, Georges Pompidou European Hospital</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
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<fA14 i1="06">
<s1>University of Freiburg</s1>
<s2>Freiburg</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
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<fA14 i1="07">
<s1>Centre for Cardiovascular Science, University of Edinburgh</s1>
<s2>Edinburgh</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
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<fA14 i1="08">
<s1>Medical Statistics Unit, London School of Hygiene and Tropical Medicine</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="09">
<s1>Ringer's Research Unit, Sheba Medical Centre, University of Tel Aviv</s1>
<s2>Tel Aviv</s2>
<s3>ISR</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="10">
<s1>Division of Cardiology, University Health Network and Mount Sinai Hospitals</s1>
<s2>Toronto, ON</s2>
<s3>CAN</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="11">
<s1>Department of Medicine, Montreal Heart Institute</s1>
<s2>Montreal, QC</s2>
<s3>CAN</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="12">
<s1>Cardiovascular Medicine, Alfred Hospital</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="13">
<s1>Department of Cardiology and Endocrinology, Frederiksberg University Hospital</s1>
<s2>Frederiksberg</s2>
<s3>DNK</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="14">
<s1>Cardiovascular Institute, Sahlgrenska University Hospital</s1>
<s2>Göteborg</s2>
<s3>SWE</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="15">
<s1>Atrium Medical Centre</s1>
<s2>Heerlen</s2>
<s3>NLD</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA14 i1="16">
<s1>Medisch Spectrum Twente</s1>
<s2>Enschede</s2>
<s3>NLD</s3>
<sZ>18 aut.</sZ>
</fA14>
<fA14 i1="17">
<s1>Division of Cardiology, Vestfold Hospital</s1>
<s2>Toensberg</s2>
<s3>NOR</s3>
<sZ>19 aut.</sZ>
</fA14>
<fA14 i1="18">
<s1>Department of Cardiology, Hospital Santa Cruz</s1>
<s2>Lisbon</s2>
<s3>PRT</s3>
<sZ>20 aut.</sZ>
</fA14>
<fA14 i1="19">
<s1>Department of Cardiology, Vall d'Hebron University Hospital</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>21 aut.</sZ>
</fA14>
<fA14 i1="20">
<s1>Department of Cardiology, René Descartes University</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>22 aut.</sZ>
</fA14>
<fA14 i1="21">
<s1>Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology and Health Services, University of Washington</s1>
<s2>Seattle, WA 98101</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
</fA14>
<fA14 i1="22">
<s1>Department of Public Health Sciences, Wake Forest University School of Medicine</s1>
<s2>Winston-Salem, North Carolina</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1">
<s1>ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine gastrointestinal therapeutic system) investigators</s1>
<s3>INC</s3>
</fA17>
<fA20>
<s2>817-818,849-857 [11 p.]</s2>
</fA20>
<fA21>
<s1>2004</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>5004</s2>
<s5>354000120255170140</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2004 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>36 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>04-0483358</s0>
</fA47>
<fA60>
<s1>P</s1>
<s3>AR</s3>
<s3>CT</s3>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Lancet : (British edition)</s0>
</fA64>
<fA66 i1="01">
<s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>Background Calcium antagonists are widely prescribed for angina pectoris but their effect on clinical outcome is controversial. We aimed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris. Methods We randomly assigned 3825 patients with treated stable symptomatic coronary disease to double-blind addition of nifedipine GITS (gastrointestinal therapeutic system) 60 mg once daily and 3840 to placebo. The primary endpoint was the combination of death, acute myocardial infarction, refractory angina, new overt heart failure, debilitating stroke, and peripheral revascularisation. Mean follow-up was 4-9 years (SD 1.1). Analysis was by intention to treat. Findings 310 patients allocated nifedipine died (1.64 per 100 patient-years) compared with 291 people allocated placebo (1.53 per 100 patient-years; hazard ratio 1.07 [95% CI 0.91-1.25], p=0.41). Primary endpoint rates were 4.60 per 100 patient-years for nifedipine and 4.75 per 100 patient-years for placebo (0.97 [0.88-1.07), p=0.54). With nifedipine, rate of death and any cardiovascular event or procedure was 9.32 per 100 patient-years versus 10.50 per 100 patient-years for placebo (0.89 [0.83-0.95], p=0.0012). The difference was mainly attributable to a reduction in the need for coronary angiography and interventions in patients assigned nifedipine, despite an increase in peripheral revascularisation. Nifedipine had no effect on the rate of myocardial infarction. Interpretation Addition of nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival. Nifedipine GITS is safe and reduces the need for coronary angiography and interventions.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B01</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B12A03</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Angine poitrine</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Angina pectoris</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Angina pectoris</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Nifédipine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Nifedipine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Nifedipino</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Epidémiologie</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Epidemiology</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Epidemiología</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Mortalité</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Mortality</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Mortalidad</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Appareil circulatoire</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Circulatory system</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Aparato circulatorio</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Morbidité</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Morbidity</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Morbilidad</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Homme</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Human</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Ensayo clínico</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Action</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Action</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Acción</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Médecine</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Medicine</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Medicina</s0>
<s5>14</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Antagoniste calcium</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Calcium antagonist</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Antagonista calcio</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Dihydropyridine dérivé</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Dihydropyridine derivatives</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Dihidropiridine derivado</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Appareil circulatoire pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Cardiovascular disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Aparato circulatorio patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Cardiopathie coronaire</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Coronary heart disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Cardiopatía coronaria</s0>
<s5>40</s5>
</fC07>
<fN21>
<s1>271</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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