Bruce A.Cohen M.D., Davee Dept of Neurology, Feinberg School of Medicine, Northwestern University
Daniel D. Mikol, M.D. Ph.D
Published 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.
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.
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.