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Evaluation of Ranolazine in Patients With Type 2 Diabetes Mellitus and Chronic Stable Angina
Open accessAbstract
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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“Ranolazine reduces myocardial ischemia at the cellular level and is the only antianginal medication to be tested and found effective specifically in patients with T2DM.”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [257]
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Metadata
- 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)
- 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
- bronze
- doi.org
- 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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