ACTION trial : addition of Nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival
Calcium antagonists such as Nifedipine are used to relieve the symptoms of angina, but there have been doubts about their long-term safety. However, ACTION ( A Coronary disease Trial Investigating Outcome with Nifedipine GITS ) provides new information on the drug's long-term use.
GITS is a gastrointestinal therapeutic system, modifing the release of the drug to provide stable long-term concentrations of Nifedipine in blood.
ACTION was designed to investigate the effects of long-acting Nifedipine GITS on the clinical outcomes in patients with stable symptomatic coronary disease, half of whom had a previous heart attack.
Primary clinical outcomes included death from any cause, acute heart attack, and debilitating stroke. The occurrence of secondary outcomes, such as any cardiovascular event, any death and any vascular event or procedure, were also assessed.
Angina patients from 19 countries were randomly assigned to the Nifedipine GITS group ( 3825 patients ) or to the placebo group ( 3840 patients ).
After around 5 years follow-up there were similar mortality rates among both groups; however, the incidence of heart failure and of coronary interventions were lower in the group receiving Nifedipine. About a third of patients in each group withdrew from the study.
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 PA et al, Lancet. 2004; 364 :849-857
XagenaMedicine2005