Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial.
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.
Poole-Wilson
Philip A
PA
Cardiac Medicine, Imperial College London, Dovehouse Street, London SW3 6LY, UK. p.poole-wilson@imperial.ac.uk
Lubsen
Jacobus
J
Kirwan
Bridget-Anne
BA
van Dalen
Fred J
FJ
Wagener
Gilbert
G
Danchin
Nicolas
N
Just
Hanjörg
H
Fox
Keith A A
KA
Pocock
Stuart J
SJ
Clayton
Tim C
TC
Motro
Michael
M
Parker
John D
JD
Bourassa
Martial G
MG
Dart
Anthony M
AM
Hildebrandt
Per
P
Hjalmarson
Ake
A
Kragten
Johannes A
JA
Molhoek
G Peter
GP
Otterstad
Jan-Erik
JE
Seabra-Gomes
Ricardo
R
Soler-Soler
Jordi
J
Weber
Simon
S
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
D002121:Calcium Channel Blockers; D009543:Nifedipine