title: Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cardiac Medicine, Imperial College London, Dovehouse Street, London SW3 6LY, UK. p.poole-wilson@imperial.ac.uk
authors.forename: Philip A
authors.initials: PA
authors.lastname: Poole-Wilson
authors.forename: Jacobus
authors.initials: J
authors.lastname: Lubsen
authors.forename: Bridget-Anne
authors.initials: BA
authors.lastname: Kirwan
authors.forename: Fred J
authors.initials: FJ
authors.lastname: van Dalen
authors.forename: Gilbert
authors.initials: G
authors.lastname: Wagener
authors.forename: Nicolas
authors.initials: N
authors.lastname: Danchin
authors.forename: Hanjörg
authors.initials: H
authors.lastname: Just
authors.forename: Keith A A
authors.initials: KA
authors.lastname: Fox
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.forename: Tim C
authors.initials: TC
authors.lastname: Clayton
authors.forename: Michael
authors.initials: M
authors.lastname: Motro
authors.forename: John D
authors.initials: JD
authors.lastname: Parker
authors.forename: Martial G
authors.initials: MG
authors.lastname: Bourassa
authors.forename: Anthony M
authors.initials: AM
authors.lastname: Dart
authors.forename: Per
authors.initials: P
authors.lastname: Hildebrandt
authors.forename: Ake
authors.initials: A
authors.lastname: Hjalmarson
authors.forename: Johannes A
authors.initials: JA
authors.lastname: Kragten
authors.forename: G Peter
authors.initials: GP
authors.lastname: Molhoek
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Otterstad
authors.forename: Ricardo
authors.initials: R
authors.lastname: Seabra-Gomes
authors.forename: Jordi
authors.initials: J
authors.lastname: Soler-Soler
authors.forename: Simon
authors.initials: S
authors.lastname: Weber
mesh_terms: D000787:Angina Pectoris / Q000188:drug therapy*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D002121:Calcium Channel Blockers; D009543:Nifedipine