title: 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.
abstract: 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.
  
  
  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.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, MO 64111, USA.
authors.forename: Suzanne V
authors.initials: SV
authors.lastname: Arnold
authors.forename: David A
authors.initials: DA
authors.lastname: Morrow
authors.forename: Kaijun
authors.initials: K
authors.lastname: Wang
authors.forename: Yang
authors.initials: Y
authors.lastname: Lei
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Mahoney
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Scirica
authors.forename: Eugene
authors.initials: E
authors.lastname: Braunwald
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000083:Acetanilides / Q000008:administration & dosage* / Q000009:adverse effects; D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology*; D000368:Aged; D000789:Angina, Unstable / Q000517:prevention & control; D018450:Disease Progression; D004311:Double-Blind Method; D004417:Dyspnea; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D000069458:Ranolazine; D011795:Surveys and Questionnaires
chemical_list: D000083:Acetanilides; D004791:Enzyme Inhibitors; D010879:Piperazines; D000069458:Ranolazine