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Original Articles

Effects of Ranolazine on Disease-Specific Health Status and Quality of Life Among Patients With Acute Coronary Syndromes

Results from the MERLIN-TIMI 36 Randomized Trial

Suzanne V. Arnold, MD, MHA; David A. Morrow, MD, MPH; Kaijun Wang, PhD; Yang Lei, MS; Elizabeth M. Mahoney, ScD; Benjamin M. Scirica, MD, MPH; Eugene Braunwald, MD; David J. Cohen, MD, MSc on behalf of the MERLIN-TIMI 36 Investigators

From the Saint Luke’s Mid America Heart Institute (S.V.A., K.W., Y.L., E.M., D.J.C.), Kansas City, Mo; and TIMI Study Group (D.A.M., B.M.S., E.B.), Brigham and Women’s Hospital, Boston, Mass.

Correspondence to David J. Cohen, MD, MSc, Cardiovascular Division, Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd, Kansas City, MO 64111. E-mail dcohen{at}saint-lukes.org

Received April 7, 2008; accepted September 5, 2008.

Background— Ranolazine has been shown to reduce myocardial ischemia and symptom severity among selected patients with chronic angina. However, data regarding the effect of ranolazine on health status/quality of life (QOL) are limited.

Methods and Results— We performed a prospective QOL analysis alongside the Metabolic Efficiency with Ranolazine for Less Ischemia in Non–ST-elevation acute coronary syndromes (MERLIN)-TIMI 36 trial, a randomized, double-blind, placebo-controlled trial of ranolazine in 6560 patients with non–ST-elevation acute coronary syndromes. Health status/QOL was evaluated at baseline and 4, 8, and 12 months after index hospitalization using the Seattle Angina Questionnaire, Rose dyspnea scale, SF-12, and EuroQol-5D. Health status/QOL scores improved significantly at all follow-up time points for both treatment arms. In the overall population, randomization to ranolazine was associated with minimal 12-month improvements in angina frequency and Seattle Angina Questionnaire-QOL (P<0.05). In subsequent exploratory analyses, there was a significant interaction between the benefits of ranolazine and anginal status before the index event. Among patients with prior angina (n=3565), treatment with ranolazine was associated with modest benefits across the full range of QOL domains, with the greatest benefits observed in angina frequency (mean effect=3.4; P<0.001) and Seattle Angina Questionnaire-QOL (mean effect=2.7; P<0.001). There were no significant benefits among patients without prior angina, however.

Conclusion— Among a broad population of patients with unstable coronary disease, ranolazine had a minimal effect on disease-specific health status and QOL over 12 months of follow-up. Posthoc subgroup analysis, however, suggested a modest benefit among the subgroup of patients with angina before their acute coronary syndromes event.

Key Words: angina • quality of life • trials • ranolazine

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CLINICAL PERSPECTIVE

John S. Rumsfeld, MD, PhD, handled this manuscript.

Clinical Trial Registration Information: ClinicalTrials.gov, http://www.clinicaltrials.gov/; trial registration, NCT00099788.

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Effects of Ranolazine on Disease-Specific Health Status and Quality of Life Among Patients With Acute Coronary Syndromes: Results from the MERLIN-TIMI 36 Randomized Trial

Suzanne V. Arnold, David A. Morrow, Kaijun Wang, Yang Lei, Elizabeth M. Mahoney, Benjamin M. Scirica, Eugene Braunwald, David J. Cohen on behalf of the MERLIN-TIMI 36 Investigators
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