A CLINICAL-TRIAL OF IMMUNOSUPPRESSIVE THERAPY FOR MYOCARDITIS

Background. Myocarditis is a serious disorder, and treatment options a re limited, This trial was designed to determine whether immunosuppres sive therapy improves left ventricular function in patients with myoca rditis. Methods. We randomly assigned 111 patients with a histopatholo gical diagnosis of myocarditis and a left ventricular ejection fractio n 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 azathiopr ine, The primary outcome measure was a change in the left ventricular ejection fraction at 28 weeks. Results. In the group as a whole, the m ean (+/-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 s ignificantly between the group of patients who received immunosuppress ive 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 inte rval, 0.03 to 0.12), A higher left ventricular ejection fraction at ba se line, less intensive conventional drug therapy at base line, and a shorter duration df disease, but not the treatment assignment, were po sitive independent predictors of the left ventricular ejection fractio n 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 2 0 percent at 1 year and 56 percent at 4.3 years, features suggesting a n effective inflammatory response were associated with less severe ini tial disease. Conclusions. Our results do not support routine treatmen t of myocarditis with immunosuppressive drugs. Ventricular function im proved regardless of whether patients received immunosuppressive thera py, but long-term mortality was high.