title: Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study.
abstract: BACKGROUND
  Patients with ischemic cardiomyopathy (ICM) may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients.
  
  
  METHODS
  In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40%) were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker), and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ), or in dyspnea as assessed by the Rose Dyspnea Scale (RDS). Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test.
  
  
  RESULTS
  Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%); prior coronary bypass surgery (67.9%); prior coronary percutaneous intervention (85.7%); prior myocardial infarction (82.1%); diabetes (67.9%); and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20) (P≥0.05). There was however, an improvement in anginal frequency (8/10 patients) (P=0.058), quality of life (8/10 patients) (P=0.048), and mean score of all components of the SAQ questionnaire (n=10) (P=0.047) with ranolazine compared with placebo.
  
  
  CONCLUSIONS
  In optimally treated ICM patients with continued chest pain or dyspnea, ranolazine possibly had a positive impact on quality of life, a reduction in anginal frequency, and an overall improvement in the mean SAQ component score compared with baseline. Ranolazine did not change the dyspnea score compared with baseline.
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
authors.forename: Nicolas W
authors.initials: NW
authors.lastname: Shammas
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
authors.forename: Gail A
authors.initials: GA
authors.lastname: Shammas
authors.affiliation: Cardiovascular Medicine, Private Corporation, Davenport, IA, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Keyes
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
authors.forename: Shawna
authors.initials: S
authors.lastname: Duske
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Kelly
authors.affiliation: St Ambrose University, Davenport, IA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Jerin
keywords: angina; controlled study; ischemic heart disease; microvascular disease; reduced ejection fraction
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