• Circ Cardiovasc Qual · Nov 2008

    Randomized Controlled Trial

    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, and MERLIN-TIMI 36 Investigators.
    • Saint Luke's Mid America Heart Institute, Kansas City, MO 64111, USA.
    • Circ Cardiovasc Qual. 2008 Nov 1;1(2):107-15.

    BackgroundRanolazine 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 ResultsWe 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.ConclusionsAmong a broad population of patients with unstable coronary disease, ranolazine had a minimal effect on disease-specific health status and QOL over approximately 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.

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