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ACTION
A Coronary disease Trial Investigating Outcome with Nifedipine GITS
Author(s)
(a) Lubsen J, Poole-Wilson PA, Pocock SJ, van Dalen FJ, Baumann J, Kirwan BA, Parker AB
(b) Poole-Wilson PA, Lubsen J, Kirwan B-A, van Dalen FJ,Wagener G, Danchin N, Just H, Fox KAA, Pocock SJ, Clayton TC, Motro M, Parker JD, Bourassa MG, Dart AM, Otterstad J-E, Seabra-Gomes R, Soler-Soler J, Weber S
Title(s)
(a) Design and current status of ACTION: A Coronary disease Trial Investigating Outcome with Nifedipine GITS
(b) Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial
Reference(s)
(a) Eur Heart J 1998;19 Suppl I:I20–32
(b) Lancet 2004;364:849–57
Disease
Coronary artery disease and stable angina pectoris
Purpose
To assess the effect of nifedipine on clinical outcomes in patients with stable angina and without heart failure
Study design
Randomised, double-blind, placebo-controlled
Follow-up
Mean 4.9 years
Patients
7665 patients (3825 nifedipine, 3840 placebo), mean age 63.5 years, with stable angina, left ventricular ejection fraction ≥ 40%, and either a history of MI, angiographic coronary artery disease but no history of MI, or a positive exercise test or perfusion defect with no history of coronary angiography or MI
Treatment regimen
Nifedipine GITS, starting dose 30 mg once daily and increased to a maintenance dose of 60 mg once daily if tolerated, or placebo
Results
There was no significant difference between the groups in the combined incidence of all-cause mortality, AMI, refractory angina, new overt heart failure, debilitating stroke, or peripheral revascularisation (4.60 per 100 patient-years vs 4.75 per 100 patient-years in the nifedipine and placebo groups, respectively; p = 0.54)
Comments
This study has been the basis for a number of publications. A selection of references:

Coronary calcification
– Motro M et al, Cardiology 2007;107:165–71

Renal function
– Ruilope LM et al, J Hypertens 2007;25:1711–8

Safety
– Poole-Wilson PA et al, Cardiovasc Drugs Ther 2006;20:45–54
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