EARLY ONLINE PUBLICATION: 31 August 2004
Newswise — 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 (Tuesday 31 August 2004).
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.
Lead investigator Philip Pool-Wilson (Imperial College London, UK) concludes: "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 (University of Washington, Seattle, USA) concludes in an accompanying commentary: "ACTION provides support for the long-term treatment of the symptoms of angina in patients already on b 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 b blockers or nitrates; and third-line or fourth-line treatment of high blood pressure not responsive to diuretics, b blockers, ACE inhibitors, or angiotensin-receptor blockers."
Please remember to cite The Lancet.