Comment
The most difficult part in this debate is perhaps to question what the regulatory agencies should do. Giving future AEDs unlimited approval for monotherapy use based on adjunctive-therapy trials has its problems, as outlined above. How should the FDA resolve the current regulatory bind? If evidence is presented that denying patients valuable new AEDs in monotherapy is harmful, the regulatory authorities might be convinced about the need for change. Mintzer and colleagues are to be commended for having focused attention on this public-health problem, and their proposal should be carefully examined.
Dieter Schmidt Epilepsy Research Group, Berlin, Germany
[email protected] I declare no competing interests. 1 2 3
Mintzer S, French, JA, Perucca E, et al. Is a separate monotherapy indication warranted for antiepileptic drugs? Lancet Neurology 2015; 14: 1229–40. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000; 342: 314–19. Beyenburg S, Stavem K, Schmidt D. Placebo-corrected efficacy of modern antiepileptic drugs for refractory epilepsy: systematic review and metaanalysis. Epilepsia 2010; 51: 7–26.
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See Online for appendix
Elena Becker-Barroso The Lancet Neurology, London, EC2Y 5AS, UK
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Corrections Rohrer JD, Nicholas JM, Cash DM. Presymptomatic cognitive and neuroanatomical changes in genetic frontotemporal dementia in the Genetic Frontotemporal dementia Initiative (GENFI) study: a cross-sectional analysis. Lancet Neurol 2015; 14: 253–62—Giuliano Binetti (IRCCS Centro San Giovanni di Dio, Fatebenefratelli, Brescia, Italy) should have been listed as an author. This correction has been made to the online version as of Nov 9, 2015.
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