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Cited by 205Heart rate and cardiovascular healthDiabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and Lipoproteins

The DOI matches its Crossref record; 37 of the 37 references it cites were found in a registry or an index.

Evaluation of Ranolazine in Patients With Type 2 Diabetes Mellitus and Chronic Stable Angina

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Kosiborod, Mikhail, Arnold, Suzanne V., Spertus, John A., McGuire, Darren K., Li, Yan, Yue, Patrick, Ben-Yehuda, Ori, Katz, Amos, Jones, Philip G., Olmsted, Ann, Belardinelli, Luiz, Chaitman, Bernard R.·2013·Journal of the American College of Cardiology
DOI 10.1016/j.jacc.2013.02.011
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Abstract

Objectives This study sought to examine the efficacy of ranolazine versus placebo on weekly angina frequency and sublingual nitroglycerin use in subjects with type 2 diabetes mellitus, coronary artery disease (CAD), and chronic stable angina who remain symptomatic despite treatment with up to 2 antianginal agents.Background Patients with diabetes have more extensive CAD than those without diabetes, and a high burden of angina. Ranolazine is not only effective in treating angina but also may improve glycemic control, thus providing several potential benefits in this high-risk group. We conducted a randomized trial to test the antianginal benefit of ranolazine in patients with diabetes and stable angina.Methods TERISA (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina) was an international, randomized, double-blind trial of ranolazine versus placebo in patients with diabetes, CAD, and stable angina treated with 1 to 2 antianginals. After a single-blind, 4-week placebo run-in, patients were randomized to 8 weeks of double-blind ranolazine (target dose 1000 mg bid) or placebo. Anginal episodes and nitroglycerin use were recorded with daily entry into a novel electronic diary. Primary outcome was the average weekly number of anginal episodes over the last 6 weeks of the study.Results A total of 949 patients were randomized across 104 centers in 14 countries. Mean age was 64 years, 61% were men, mean diabetes duration was 7.5 years, and mean baseline HbA1c was 7.3%. Electronic diary data capture was 98% in both groups. Weekly angina frequency was significantly lower with ranolazine versus placebo (3.8 [95% confidence interval (CI): 3.6 to 4.1] episodes vs. 4.3 [95% CI: 4.0 to 4.5] episodes, p = 0.008), as was the weekly sublingual nitroglycerin use (1.7 [95% CI: 1.6 to 1.9] doses vs. 2.1 [95% CI: 1.9 to 2.3] doses, p = 0.003). There was no difference in the incidence of serious adverse events between groups.Conclusions Among patients with diabetes and chronic angina despite treatment with up to 2 agents, ranolazine reduced angina and sublingual nitroglycerin use and was well tolerated. (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina [TERISA]; NCT01425359).

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Authors
Kosiborod, M., Arnold, S. V., Spertus, J. A., McGuire, D. K., Li, Y., Yue, P., Ben-Yehuda, O., Katz, A., Jones, P. G., Olmsted, A., Belardinelli, L., & Chaitman, B. R.
Affiliations
  • Saint Luke's Health System (US)
  • University of Missouri–Kansas City (US)
  • The University of Texas Southwestern Medical Center (US)
  • Gilead Sciences (United States) (US)
  • Ben-Gurion University of the Negev (IL)
  • Saint Louis University (US)
Corresponding author
Kosiborod, Mikhail
ORCID
Venue
Journal of the American College of Cardiology
Publisher
Elsevier BV
Published
2013-05
Volume
61
Issue
20
Pages
2038-2045
ISSN
0735-1097 (ISSN-L)
DOI
10.1016/j.jacc.2013.02.011
OpenAlex
W126353551
Cited by
205
References
37
Citations by year
2026: 3 · 2025: 8 · 2024: 7 · 2023: 7 · 2022: 10 · 2021: 11 · 2020: 8 · 2019: 15 · 2018: 11 · 2017: 20 · 2016: 28 · 2015: 30 · 2014: 28 · 2013: 17
FWCI
23.35
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of the American College of Cardiology (publishedVersion)
  • PubMed (publishedVersion)
Funders
Gilead Sciences
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart rate and cardiovascular health
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
ranolazine, type 2 diabetes, stable angina, coronary artery disease, angina frequency, antianginal therapy, electronic diary, glycemic control, adverse events, serious adverse events, antiplatelet therapy, antianginal drugs, HbA1c
MeSH terms
Ranolazine, Acetanilides, Aged, Coronary Artery Disease, Diabetes Mellitus, Type 2, Double-Blind Method, Enzyme Inhibitors, Female, Nitroglycerin, Glycated Hemoglobin, Humans, Male, Middle Aged, Piperazines, Vasodilator Agents, Treatment Outcome, Sodium Channel Blockers, Angina, Stable

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