Anti-TNF inhibitors must be used with great caution or avoided altogether in patients with a history of congestive cardiac failure. Although there have been theoretical arguments to support the potential benefits of TNF inhibition in this condition, clinical studies with both etanercept and infliximab failed to demonstrate any benefit. Furthermore, in two clinical trials of etaner-cept in 2,000 patients with moderate to severe cardiac failure (New York Heart Classification functional class 2-4), the findings suggested the possibility of increased mortality in patients receiving etanercept, in particular at a dose regime of three times weekly. Infli-ximab has also been studied in a small group of patients with New York Heart Classification functional class 3 and 4 over a period of 1 year. In this study, there was an increased rate of hospitalization and mortality in patients receiving infliximab at a dose of 10 mg per kilogram at baseline, week 2, and week 6 (Keystone 2003).
In a post-drug approval surveillance study, 47 patients treated with either etanercept or infliximab were identified as having congestive cardiac failure. Of these, 38 had new-onset disease and nine had exacerbations of prior disease (Kwon et al. 2003). There were no identifiable risk factors in half the patients with new onset heart failure, 29 of whom were treated with etanercept and 18 treated with infliximab. The onset of congestive cardiac failure ranged from 2 h after treatment administration to 2 years, with a median time of
3% months. Ten patients under the age of 50 developed new-onset congestive cardiac failure and three of these had pre-existing risk factors. The condition improved or resolved in nine of these ten patients after discontinuation of the TNF inhibitor and institution of therapy for congestive cardiac failure.
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