The angina drug nifedipine is thought to be safe for long-term use, based on the results of a study published online by THE LANCET today.
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 (gastrointestinal therapeutic system) modifies 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 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.