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

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. We randomly assigned 3825 patients with treated s...

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Veröffentlicht in:The Lancet (British edition) 2004-09, Vol.364 (9437), p.849-857
Hauptverfasser: Poole-Wilson, Philip A, Lubsen, Jacobus, Kirwan, Bridget-Anne, van Dalen, Fred J, Wagener, Gilbert, Danchin, Nicolas, Just, Hanjörg, Fox, Keith AA, Pocock, Stuart J, Clayton, Tim C, Motro, Michael, Parker, John D, Bourassa, Martial G, Dart, Anthony M, Hildebrandt, Per, Hjalmarson, Åke, Kragten, Johannes A, Molhoek, G Peter, Otterstad, Jan-Erik, Seabra-Gomes, Ricardo, Soler-Soler, Jordi, Weber, Simon
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container_end_page 857
container_issue 9437
container_start_page 849
container_title The Lancet (British edition)
container_volume 364
creator Poole-Wilson, Philip A
Lubsen, Jacobus
Kirwan, Bridget-Anne
van Dalen, Fred J
Wagener, Gilbert
Danchin, Nicolas
Just, Hanjörg
Fox, Keith AA
Pocock, Stuart J
Clayton, Tim C
Motro, Michael
Parker, John D
Bourassa, Martial G
Dart, Anthony M
Hildebrandt, Per
Hjalmarson, Åke
Kragten, Johannes A
Molhoek, G Peter
Otterstad, Jan-Erik
Seabra-Gomes, Ricardo
Soler-Soler, Jordi
Weber, Simon
description 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. 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. 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. 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. Published online August 31, 2004 http://image.thelancet.com/extras/04art6402web.pdf
doi_str_mv 10.1016/S0140-6736(04)16980-8
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We aimed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris. 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. 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. 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. 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We aimed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris. 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. 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. 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. 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Poole-Wilson, Philip A</au><au>Lubsen, Jacobus</au><au>Kirwan, Bridget-Anne</au><au>van Dalen, Fred J</au><au>Wagener, Gilbert</au><au>Danchin, Nicolas</au><au>Just, Hanjörg</au><au>Fox, Keith AA</au><au>Pocock, Stuart J</au><au>Clayton, Tim C</au><au>Motro, Michael</au><au>Parker, John D</au><au>Bourassa, Martial G</au><au>Dart, Anthony M</au><au>Hildebrandt, Per</au><au>Hjalmarson, Åke</au><au>Kragten, Johannes A</au><au>Molhoek, G Peter</au><au>Otterstad, Jan-Erik</au><au>Seabra-Gomes, Ricardo</au><au>Soler-Soler, Jordi</au><au>Weber, Simon</au><aucorp>on behalf of the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine gastrointestinal therapeutic system) investigators</aucorp><aucorp>Coronary disease Trial Investigating Outcome with Nifedipine gastrointestinal therapeutic system investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2004-09-04</date><risdate>2004</risdate><volume>364</volume><issue>9437</issue><spage>849</spage><epage>857</epage><pages>849-857</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>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. 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. 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. 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. Published online August 31, 2004 http://image.thelancet.com/extras/04art6402web.pdf</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>15351192</pmid><doi>10.1016/S0140-6736(04)16980-8</doi><tpages>9</tpages></addata></record>
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identifier ISSN: 0140-6736
ispartof The Lancet (British edition), 2004-09, Vol.364 (9437), p.849-857
issn 0140-6736
1474-547X
language eng
recordid cdi_proquest_miscellaneous_66848685
source MEDLINE; ScienceDirect Journals (5 years ago - present); Business Source Complete
subjects Angina pectoris
Angina Pectoris - drug therapy
Calcium
Calcium Channel Blockers - therapeutic use
Cardiovascular Diseases - mortality
Cardiovascular Diseases - prevention & control
Clinical trials
Double-Blind Method
Drugs
Endpoint Determination
Female
Humans
Male
Medical treatment
Middle Aged
Morbidity
Mortality
Myocardial infarction
Nifedipine - therapeutic use
Survival Analysis
title Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial
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