Methods:

TERISA was an international, multicenter, double-blind, placebo-controlled trial in which subjects with stable angina and type 2 diabetes mellitus were randomized to 1000 mg twice daily dose of ranolazine or matched placebo for 8 weeks. Through input into an electronic diary, patients were instructed to record the number of angina episodes and number of sublingual nitroglycerin taken in the preceding 24 hours. Disease-specific health status was assessed with the SAQ at randomization and at 8 weeks after study initiation; the SAQ AF scale is comprised of the following two questions: 1) “Over the past 4 weeks, on average, how many times have you had chest pain, chest tightness, or angina?” and 2) “Over the past 4 weeks, on average, how many times have you had to take nitros for your chest pain, chest tightness, or angina?” The authors performed cross-sectional and longitudinal analyses to validate the SAQ AF scale against daily records of angina frequency and sublingual nitroglycerin use.