A Prospective, Randomized, Controlled Trial of Prednisone for Dilated Cardiomyopathy

Abstract

Although prednisone has been used to treat patients with idiopathic dilated cardiomyopathy, its efficacy has not been rigorously studied. We therefore randomly assigned 102 patients to either treatment with prednisone (60 mg per day) or a control group. At three months, improvement, defined prospectively as an increase in the ejection fraction of greater than or equal to 5 percentage points, was observed in 53 percent of the patients receiving prednisone and 27 percent of the controls (P = 0.005). The mean (+/- SE) ejection fraction increased 4.3 +/- 1.5 percentage points (from 17.9 +/- 1.0 to 22.2 +/- 1.6 percent) in the prednisone group, as compared with 2.1 +/- 0.8 percentage points (from 17.1 +/- 1.1 to 19.3 +/- 1.4 percent) in the control group (P = 0.054). All patients were categorized prospectively in two separately randomized subgroups. "Reactive" patients (n = 60) were those who had fibroblastic (n = 36) or lymphocytic (n = 2) infiltration or immunoglobulin deposition (n = 16) on endomyocardial biopsy, a positive gallium scan (n = 7), or an elevated erythrocyte sedimentation rate (n = 18). "Nonreactive" patients (n = 42) had none of these features. At three months, 67 percent of the reactive patients who received prednisone had improvement, as compared with 28 percent of the reactive controls (P = 0.004). Nonreactive patients did not improve significantly with prednisone (P = 0.51). After three months, reactive patients who received prednisone daily were switched to alternate-day therapy (60 mg every other day), and after six months the improvement seen earlier was no longer present. These data suggest that patients with idiopathic dilated cardiomyopathy may have some improvement when given a high dose of prednisone daily. However, the increases in the ejection fraction that we observed during prednisone treatment were small, their duration was limited, and the side effects were important. Overall, prednisone was judged to have only marginal clinical benefit, and should not be administered as standard therapy for dilated cardiomyopathy.

Cell death, proliferation and repair in human myocarditis responding to immunosuppressive therapy

“…After controversial results from the systematic use of immunosuppression in the treatment of myocarditis, 13,14 recent reports seem to have identified biological markers recognizing specific subset of responders. In particular, patients with active lymphocytic myocarditis and myocyte expression of HLA molecules, 1 absence of myocardial viral genome at PCR and detectable cardiac autoantibodies in the serum 2 have been found highly susceptible to immunosuppressive therapy with significant or complete recovery of a severely depressed cardiac contractility in comparison with virus positive and cardiac autoantibodies negative patients.…”

I Diretriz Latino-Americana para avaliação e conduta na insuficiência cardíaca descompensada

“…Immune suppression has an important role in the treatment of patients with cardiac dysfunction due to autoimmune diseases, such as scleroderma, lupus erythematosus, polymyositis or sarcoidosis. Intravenous use of immunoglobulin, however, did not demonstrate a beneficial effect in immunosuppression [212][213][214] .…”

Myocarditis-A Quick Review

“…Future trials involving patients with acute myocarditis are probably not feasible since the disease affects so few patients, has a highly variable clinical prognosis, and is associated with substantial improvement in left ventricular function with usual care. 38 Unlike lymphocytic myocarditis, transplant-free survival in patients with giant-cell myocarditis may be prolonged with a combination of cyclosporine and corticosteroids. 39 There may be a broader role for immunosuppression in patients with chronic, moderate-to-severe cardiomyopathy, whose condition is unlikely to improve further after optimal care has been given for 6 to 12 months.…”