In 2006, the Food and Drug Administration (FDA) approved Ranexa for the treatment of angina. (Angina is chest discomfort caused by coronary artery disease.) Ranexa (generic name ranolazine, from CV Therapeutics) is the first entirely new drug to be approved for for angina in many years. It has been shown to help relieve symptoms of angina that persist despite therapy with other medications.
However, until now the safety of Ranexa has been a concern. Specifically, doctors have worried because the drug can produce changes on the ECG (electrocardiogram) that have been associated with cardiac arrhythmias. (Ranexa can cause prolongation of what is called the "QT interval" on the ECG. You can read about heart rhythm disturbances related to lengthening of the QT interval here.) For this reason, when Ranexa was approved last year the FDA stipulated that it should be used only in patients whose angina was not adequately controlled with other medication.
The safety concern with Ranexa has now been addressed in a new clinical trial. The April 25 issue of the Journal of the American Medical Association reported on the MERLIN TIMI-36 trial, which randomized 6560 patients with coronary artery disease to receive either Ranexa or placebo. In this trial, not only did Ranexa not produce heart rhythm problems, but cardiac arrhythmias were actually significantly reduced in patients receiving this drug. Both the study investigators and the authors of a related editorial conclude that Ranexa appears to be safe, and should now be considered an attractive backup option to the more commonly used anti-angina drugs.
DrRich comments:
The safety of Ranexa is especially encouraging in light of the recent results of the COURAGE trial, which showed that patients with stable angina treated with drug therapy did just as well as those treated with stents. Patients (and doctors) wishing to avoid invasive procedures - or who simply wish to delay stenting at least until the controversy surrounding drug eluting stents is sorted out - now have an additional alternative.
Sources:
Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, et al. Effects of ranolazine on recurrent cardiovascular events in patients with non-ST-elevation acute coronary syndromes. The MERLIN-TIMI 36 randomized trial. JAMA 2007; 297:1775-1783.
Newby LK and Peterson ED. Does ranolazine have a place in the treatment of acute coronary syndromes? JAMA 2007; 297:1823-25.
