Generic Lamotrigine, Levetiracetam Formulations Comparable to Brand Name AEDs
Bioequivalent generic formulations of 2 antiepileptic medications were comparable to brand name treatments for new-onset epilepsy.
|The following article is part of conference coverage from the American Epilepsy Society's Annual Meeting in New Orleans, LA. The Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AES 2018.|
NEW ORLEANS — The long-term efficacy and safety of bioequivalent generic formulations lamotrigine (LTG) and levetiracetam (LEV) were comparable to brand name antiepileptic medications in patients with new-onset epilepsy. This research was presented at the 72nd Annual Meeting of the American Epilepsy Society, held November 30-December 4, 2018.
Investigators sought to compare the long-term efficacy and tolerability of generic LTG and LEV formulations in managing newly-diagnosed epilepsy. The study sample included 442 consecutive patients with new onset focal epilepsy who were naive to antiepileptic drug use. Participants were initiated on either LTG (n=188) or LEV (n=254) between 2006 and 2012, and followed for 24 months; adjustments to antiepileptic drug dosing regimens were allowed in the first 6 months.
Efficacy (freedom from seizure) and tolerability measures were calculated at the end of the study using the chi-square formula and P value at <.05.
Of 188 participants in the LTG group, 66.5% remained seizure-free throughout the 24-month study period. In the LEV group, 72.4% of 25 participants remained seizure-free. In the LTG group, 23.9% experienced drug failure, and 9.6% dropped out due to adverse events; in the LEV group, 13% experienced drug failure, and 14.6% dropped out. The P value for seizure freedom was 0.18 and for tolerability 0.12; neither value was considered significant at P <.05. No hospitalizations or deaths due to adverse events were reported.
During the 24-month study period, LTG and LEV were found to have comparable seizure freedom rates and tolerability to brand name antiepileptic drugs in the treatment of newly diagnosed focal epilepsies, the researchers concluded.
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Chayasirisobhon S, Gurbani S, Gurbani A, Vaghasia U, Pietzsch E, Spurgeon B. Comparison of treatment outcomes at 24 months after monotherapy with single-source bioequivalent generic formulations of lamotrigine and levetiracetam in patients with newly diagnosed focal epilepsy. Presented at: 72nd Annual Meeting of the American Epilepsy Society; November 30-December 4, 2018; New Orleans, LA. Poster 2.147.