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Reply to Pratt et al

  • Bruce A. Cohen M.D., Davee Dept of Neurology, Feinberg School of Medicine, Northwestern University, 710 North Lake Shore Drive, Abbott Hall 1121, Chicago Illinois 60611bac106@northwestern.edu
  • Daniel D. Mikol, M.D. Ph.D
Submitted June 07, 2005

We appreciate the comments of Pratt et al regarding our comments on the need for more frequent monitoring of cardiac function when treating MS patients with mitoxantrone. [1]

The recent recommendations by Serono and the FDA now make our suggested intervals obsolete. Current data has indicated a low risk for both symptomatic heart failure and asymptomatic but significant reductions in cardiac ejection fraction. [2] Nonetheless, Avasarala et al described five patients with early significant decline in ejection fraction while undergoing mitoxantrone therapy for MS. [3] We concur with the decision by Serono and the FDA to amend the product labeling for mitoxantrone to incorporate earlier and more frequent cardiac monitoring. Prompt recognition of significant asymptomatic reduction in ejection fraction should further reduce the low incidence of symptomatic cardiac failure with this agent in doses used for MS.

References

1. Cohen BA, Mikol DD. Mitoxantrone treatment of multiple sclerosis:safety consideraions. Neurology 2004;63(suppl 6):S28-S32

2. Ghalie RG, Edan G, Laurent M, et al. Cardiac adverse effects associated with mitoxantrone (Novantrone)therapy in patients with MS. Neurology 2002;59:909-913.

3. Avasarala JR, Cross AH, Clifford DB, et al. Rapid onset mitoxantrone- induced cardiotoxicity in secondary progressive multiple sclerosis. Mult Scler 2003;9:59-62.

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Neurology | Print ISSN:0028-3878
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