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Volume 333:269-275 August 3, 1995 Number 5 Next

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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.

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<0.001). The mean change in the left ventricular ejection fraction at 28 weeks did not differ significantly between the group of patients who received immunosuppressive therapy (a gain of 0.10; 95 percent confidence interval, 0.07 to 0.12) and the control group (a gain of 0.07; 95 percent confidence interval, 0.03 to 0.12). A higher left ventricular ejection fraction at base line, less intensive conventional drug therapy at base line, and a shorter duration of disease, but not the treatment assignment, were positive independent predictors of the left ventricular ejection fraction at week 28. There was no significant difference in survival between the two groups (P = 0.96). The mortality rate for the entire group was 20 percent at 1 year and 56 percent at 4.3 years. Features suggesting an effective inflammatory response were associated with less severe initial disease.

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.

Source Information

From the Division of Cardiology, University of Utah, Salt Lake City (J.W.M.); the Department of Medicine, University of Mississippi, Jackson (J.B.O.); the Division of Cardiology (A.H.) and the Department of Molecular Microbiology and Immunology (N.R.R.), Johns Hopkins University, Baltimore; the Department of Pathology, University of British Columbia, Vancouver (B.M.M.); the Department of Pathology, Stanford University, Stanford, Calif. (M.E.B.); and the Department of Family and Community Medicine, University of Arizona, Tucson (T.E.M.).

Address reprint requests to Dr. Mason at the Cardiology Division, University of Utah Medical Center, 50 N. Medical Dr., Salt Lake City, UT 84132.

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