Reductions in need for coronary interventions and in development of heart failure with long-acting nifedipine suggest it is safe for long-term use, according to a study published online August 31st by the Lancet.

According to the article, calcium antagonists such as nifedipine are used to relieve symptoms of angina, but there have been doubts about their long-term safety. However, ACTION--A Coronary disease Trial Investigating Outcome with Nifedipine GITS--provided new information on the drug's long-term use. GITS (gastrointestinal therapeutic system) is the technology that modifies drug release to maintain stable long-term nifedipine concentrations.

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 myocardial infarction. Primary clinical outcomes included death from any cause, acute myocardial infarction, 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 the placebo group (3840 patients). After roughly 5 years follow-up, there were similar mortality rates for both groups; however, the incidence of heart failure and of coronary interventions were lower in the group receiving nifedipine. About one third of patients in each group withdrew from the study.

Lead investigator Dr. Philip Pool-Wilson concluded, "Nifedipine GITS can be used safely for the long-term treatment of patients with coronary disease and angina pectoris because, in addition to relieving symptoms of angina, it prolongs cardiovascular event and procedure free survival."

Bruce M Psaty wrote in an accompanying commentary, "ACTION provides support for the long-term treatment of the symptoms of angina in patients already on beta blockers and nitrates. However, long-acting nifedipine did not significantly reduce their risk of major cardiovascular events compared with placebo. In the past decade, many high-quality clinical trials have defined the proper role of various cardiovascular agents. Long-acting calcium-channel blockers are appropriate as second-line or third-line treatment of symptomatic angina not responsive to beta blockers or nitrates; and third-line or fourth-line treatment of hypertension not responsive to diuretics, beta blockers, ACE inhibitors, or angiotensin-receptor blockers."