Author Affiliations: Division of Cardiovascular Medicine and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Despite an arsenal of medicines and revascularization options, millions of individuals experience acute and chronic anginal symptoms daily. Imperative upon physicians is a responsibility not only to extend life and prevent major life-threatening complications but also to improve the quality of life. To that end, clinical trials of new treatment modalities for ischemic heart disease and the adoption of new therapies into practice should weigh these twin goals.
Ranolazine represents a novel type of antianginal therapy thought to reduce symptoms by blocking intracellular sodium and calcium overload accompanying myocardial ischemia.1,2 Randomized trials demonstrated that ranolazine was effective in reducing angina symptoms and increasing exercise time to angina or ST-segment depression when compared with standard therapeutic agents, such as atenolol, diltiazem, and amlodipine without hemodynamic adverse effects.1,3,4 However, these trials were limited in size and duration, and were not powered to assess the effect of ranolazine on major clinical cardiovascular end points such as death or myocardial infarction (MI). In addition, safety concerns were raised that ranolazine administration prolongs the QT interval and may have caused rare cases of unexplained syncope.1 Although the US Food and Drug Administration ultimately approved ranolazine for US marketing in 2006, the agency also suggested further evaluation to address these lingering safety concerns.5
Newby LK, Peterson ED. Does Ranolazine Have a Place in the Treatment of Acute Coronary Syndromes?. JAMA. 2007;297(16):1823-1825. doi:10.1001/jama.297.16.1823