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. Healthstatus/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 AnginaQuestionnaire-QOL (mean effect=2.7; P<0.001). There were no significant benefits among patients without prior angina, however. CONCLUSIONS: Among 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.
RCT Entities:
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. CONCLUSIONS: Among 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.
Authors: Mohammed Qintar; J Aaron Grantham; James Sapontis; Kensey L Gosch; William Lombardi; Dimitri Karmpaliotis; Jeffery Moses; Adam C Salisbury; David J Cohen; John A Spertus; Suzanne V Arnold Journal: Circ Cardiovasc Qual Outcomes Date: 2017-12
Authors: Paolo Izzo; Andrea Macchi; Luisa De Gennaro; Antonio Gaglione; Matteo Di Biase; Natale Daniele Brunetti Journal: Eur Heart J Acute Cardiovasc Care Date: 2012-06