Improvement of Subjective Well-Being by Ranolazine in Patients with Chronic Angina and Known Myocardial Ischemia IMWELL StudyReport as inadecuate




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Cardiology and Therapy

, Volume 6, Issue 1, pp 81–88

First Online: 02 January 2017Received: 18 November 2016DOI: 10.1007-s40119-016-0081-3

Cite this article as: Bavry, A.A., Park, K.E., Choi, C.Y. et al. Cardiol Ther 2017 6: 81. doi:10.1007-s40119-016-0081-3

Abstract

IntroductionWe aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia.

MethodsEligible subjects had chronic stable angina and at least one coronary stenosis with fractional flow reserve FFR ≤0.80 or at least one chronic total occlusion CTO without attempted revascularization. Subjects were randomized to oral ranolazine 500 mg twice daily for 1 week, then ranolazine 1000 mg twice daily for 15 weeks versus matching placebo. The primary end point was change in angina at 16 weeks as assessed by the Seattle Angina Questionnaire SAQ.

ResultsBetween September 2014 and January 2016, 25 subjects were randomized to ranolazine versus 25 to placebo. The most common reason for eligibility was CTO 72%, while the remainder had myocardial ischemia documented by low FFR. The mean FFR was 0.57 ± 0.12. Sixty-eight percent of subjects were on two or more anti-angina medications at baseline. Study medication was discontinued in 32% eight of 25 of the ranolazine group versus 36% nine of 25 of the placebo group. By intention-to-treat, 46 subjects had baseline and follow-up SAQ data completed. Ranolazine was not associated with an improvement in angina compared with placebo at 16 weeks. The results were similar among 33 subjects that completed study medication. The incidence of ischemia-driven hospitalization or catheterization was 12% three of 25 of the ranolazine group versus 20% five of 25 in the placebo group p > 0.05.

ConclusionsIn subjects with chronic stable angina and documented myocardial ischemia, ranolazine did not improve angina symptoms at 16 weeks.

FundingGilead.

Clinical trial registrationThe study was registered at ClinicalTrials.gov NCT02265796.

KeywordsAngina Coronary artery disease Ranolazine Randomized controlled trial Revascularization Stable Enhanced contentTo view enhanced content for this article go to www.medengine.com-Redeem-3F47F06008C8FE80.

An erratum to this article is available at http:-dx.doi.org-10.1007-s40119-017-0083-9.





Author: Anthony A. Bavry - Ki E. Park - Calvin Y. Choi - Ahmed N. Mahmoud - Xuerong Wen - Islam Y. Elgendy

Source: https://link.springer.com/







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