Cited by 1,274Viral Infections and Immunology ResearchStreptococcal Infections and TreatmentsKawasaki Disease and Coronary Complications

A Clinical Trial of Immunosuppressive Therapy for Myocarditis

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Mason, Jay W., O'Connell, John B., Herskowitz, Ahvie, Rose, Noel R., McManus, Bruce M., Billingham, Margaret E., Moon, Thomas E.·1995·New England Journal of Medicine

Abstract

Background Myocarditis is a serious disorder, and treatment options are limited. This trial was designed to determine whether immunosuppressive therapy improves left ventricular function in patients with myocarditis and to examine measures of the immune response as predictors of the severity and outcome of disease. Methods We randomly assigned 111 patients with a histopathological diagnosis of myocarditis and a left ventricular ejection fraction of less than 0.45 to receive conventional therapy alone or combined with a 24-week regimen of immunosuppressive therapy. Immunosuppressive therapy consisted of prednisone with either cyclosporine or azathioprine. The primary outcome measure was a change in the left ventricular ejection fraction at 28 weeks. Results In the group as a whole, the mean (+/- SE) left ventricular ejection fraction improved from 0.25 +/- 0.01 at base line to 0.34 +/- 0.02 at 28 weeks (P Conclusions Our results do not support routine treatment of myocarditis with immunosuppressive drugs. Ventricular function improved regardless of whether patients received immunosuppressive therapy, but long-term mortality was high. Patients with a vigorous inflammatory response had less severe disease.

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Crossref · 10.1056/nejm199508033330501

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  • Most attempts to alleviate acute myocarditis with anti-inflammatory drugs or immunosuppressants have failed because these agents have shown few positive effects and even side effects.

    “However, most attempts to alleviate acute myocarditis with anti-inflammatory drugs or immunosuppressants have failed because these agents have shown few positive effects and even side effects. 4”
  • In a 1995 clinical trial of 111 patients with myocarditis and reduced LVEF (<45%), there was no significant difference in mortality between conventional therapy and immunosuppressive therapy.

    “In a 1995 clinical trial, 111 patients with myocarditis and reduced L VEF (&lt;45%) were randomized into 3 groups-conventional therapy for heart failure, immunosuppressive therapy with either prednisone plus azathioprine or prednisone plus cyclosporine. 253 There was no significant difference in mortality between the groups.”

    From Autoimmune Myocarditis, Old Dogs and New Tricks. (2024) · cites this paper as [253]

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Authors
Mason, J. W., O'Connell, J. B., Herskowitz, A., Rose, N. R., McManus, B. M., Billingham, M. E., & Moon, T. E.
Affiliations
  • Johns Hopkins University (US)
  • University of British Columbia (CA)
  • Stanford University (US)
  • University of Arizona (US)
Venue
New England Journal of Medicine
Published
1995-08-03
Volume
333
Issue
5
Pages
269-275
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2313269561
Cited by
1,274
References
1
Citations by year
2026: 26 · 2025: 29 · 2024: 36 · 2023: 36 · 2022: 42 · 2021: 33 · 2020: 61 · 2019: 41 · 2018: 22 · 2017: 49 · 2016: 44 · 2015: 31 · 2014: 39 · 2013: 49 · 2012: 44
FWCI
25.71
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (5r01hl034744-04)
  • National Heart, Lung, and Blood Institute (R0-1-HL34744)
  • National Center for Research Resources (M01-RR 00064, M01RR000064)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Streptococcal Infections and Treatments
  • Health Sciences › Medicine › Surgery › Kawasaki Disease and Coronary Complications
Keywords
myocarditis, immunosuppressive therapy, prednisone, cyclosporine, azathioprine, left ventricular ejection fraction, left ventricular function, disease severity predictors, inflammation, mortality
MeSH terms
Adult, Autoantibodies, Azathioprine, Drug Therapy, Combination, Female, Heart Failure, Humans, Immunoglobulin G, Immunosuppression Therapy, Male, Myocarditis, Myocardium, Prednisone, Stroke Volume, Multivariate Analysis, Survival Analysis, Cyclosporine, Treatment Outcome

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