Abstract 17574: Effects of Ranolazine on Disease-Specific Health Status and Quality of Life Among Patients With Diabetes and Stable Angina: Results From the TERISA Randomized Trial
Background: Patients with CAD and type 2 diabetes mellitus (T2DM) represent a high-risk group, with extensive and diffuse CAD and a high burden of angina. The TERISA trial demonstrated that ranolazine reduced the frequency of angina episodes and use of sublingual nitroglycerin in patients with T2DM and chronic (stable) angina, as assessed by a daily diary. The effect of ranolazine on disease-specific health status and quality of life (HS/QOL) in this population has not been assessed in a randomized clinical trial.
Methods: TERISA was a multinational, randomized, double-blind trial of ranolazine vs. placebo in patients with T2DM, CAD, and stable angina despite treatment with 1 or 2 antianginal drugs. HS/QOL were evaluated at baseline and 8 weeks after study drug initiation using the Seattle Angina Questionnaire (SAQ), SF-36, and the Rose Dyspnea Scale. Analysis of covariance was used to compare changes in scores between groups.
Results: Overall, 927 patients were enrolled from 104 centers in 14 countries with mean age 64 years, 61% men, and mean HbA1c 7.3%. At baseline, mean HS/QOL scores demonstrated substantial symptom burden. All HS/QOL scores were similar between ranolazine and placebo groups at baseline and showed improvement at follow-up for both treatment groups for the majority of HS/QOL measurements, particularly disease-specific measures. Ranolazine resulted in significantly greater improvements in SAQ angina frequency, treatment satisfaction, and SF-36 physical component summary scales than placebo (Table). The therapeutic effectiveness of ranolazine on HS/QOL did not significantly differ across any of the pre-specified sub-groups (geographic region, number of baseline angina episodes, number of antianginal agents, sex, and age category; p>0.05 for all interactions).
Conclusion: Among patients with T2DM, CAD, and stable angina on 1 or 2 background antianginal drugs, ranolazine significantly improved several key measures of health status and QOL.
- © 2013 by American Heart Association, Inc.