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Clinical Trial
. 2019 May;28(5):573-582.
doi: 10.1089/jwh.2018.7019. Epub 2019 Mar 19.

Ranolazine Reduces Angina in Women with Ischemic Heart Disease: Results of an Open-Label, Multicenter Trial

Puja K Mehta  1 , Shilpa Sharma  2 , Margo Minissian  2 , Manya R Harsch  3 , Melissa Martinson  3 , John A Nyman  4 , Leslee J Shaw  5 , C Noel Bairey Merz  2 , Nanette K Wenger  1
Affiliations
Clinical Trial

Ranolazine Reduces Angina in Women with Ischemic Heart Disease: Results of an Open-Label, Multicenter Trial

Puja K Mehta et al. J Womens Health (Larchmt). 2019 May.

Abstract

Background: Persistent angina is prevalent in women, who more often present with atypical angina, and experience less relief from antianginal therapies. The impact of ranolazine on female-specific angina is unclear. A single-arm, open-label trial was conducted to quantify the impact of ranolazine on angina in women with ischemic heart disease (IHD). Materials and Methods: Women with IHD and ≥2 angina episodes/week were recruited from 30 U.S. sites. Angina and nitroglycerin (NTG) consumption were assessed using patient-reported diaries, Seattle Angina Questionnaire (SAQ), Duke Activity Score Index (DASI), and Women's Ischemia Symptom Questionnaire (WISQ) at baseline and at 4 weeks of treatment with ranolazine 500 mg twice/day. A modified intent-to-treat analysis and parametric or nonparametric methods were used as appropriate to analyze changes. Results: Of 171 women enrolled, mean age was 65 ± 12 years. Of the 159 women included in the analysis, at week 4 compared to baseline, median angina frequency decreased with ranolazine treatment from 5.0 to 1.5 attacks/week and median change from baseline was -3.3 (95% confidence interval [CI]: -4.0 to -2.5; p ≤ 0.0001). Median NTG consumption decreased from 2.0 to 0.0 per week over the 4 weeks and median change was -1.0 (95% CI: -2.0 to -0.5; p < 0.0001). All five SAQ subscales showed mean improvements: physical limitation 9.2 (standard error [SE] 1.5; p < 0.0001), angina stability 31.8 (SE 2.7; p < 0.0001), angina frequency 17.7 (SE 1.6; p < 0.0001), treatment satisfaction 9.3 (SE 1.6; p < 0.0001), and disease perception 2.9 (SE 0.8; p < 0.0001). DASI score also improved 2.9 (SE 0.8; p = 0.0014). WISQ subscales also showed significant improvements (all p < 0.0001). Thirty-one women reported drug-related adverse events (AEs), predominantly mild to moderate gastrointestinal symptoms. Conclusions: Women with IHD treated with ranolazine for 4 weeks experienced less angina measured by SAQ and WISQ. NTG use decreased, physical activity improved, and treatment satisfaction improved. AEs were consistent with prior reports.

Keywords: and heart disease; angina; ranolazine; women.

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Conflict of interest statement

P.K.M., research support: Gilead; M.M., contracted by Gilead; M.R.H., contracted by Gilead; M.M., research support: NINR, AHA, American Nurses Foundation and honorarium from North American Center for CME; J.A.N., none; L.J.S., none; C.N.B.M., consulting revenue paid to Cedars-Sinai from Gilead, Medscape, Research Triangle Institute, research money from Gilead, Erika Glazer, payments for lectures from Beaumont Hospital, European Horizon, Florida Hospital, INOVA, Korean Cardiology Society, Practice Point Communications, Pri-Med, University of Chicago, VBWG, University of Colorado, University of Utah, WomenHeart, Harold Buchwald Heart-Health, Tufts; N.K.W., consulting and research support: Gilead Sciences. ClinicalTrials.gov Identifier: NCT00644332.

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<b>FIG. 1.</b>
FIG. 1.
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