Safety of Overnight Switch from Brand-Name to Generic Levetiracetam.
OBJECTIVE
Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. The objective of this study was to evaluate the safety and tolerability of the brand-to-generic levetiracetam switch in patients with focal or generalized epilepsy.


METHODS
A prospective study in patients with primary, cryptogenic or symptomatic epilepsy, who were taking branded levetiracetam and were switched to generic levetiracetam. Patients were consecutively recruited from January 2013 to January 2015. We evaluated efficacy, tolerability and compliance before switching (T0) and after 6 months of therapy (T1). Evaluations were scheduled as follows: baseline, 7 and 15 days, 1, 3 and 6 months. At each visit clinical diary seizures, physical and neurological examination, laboratory parameters and electroencephalogram were evaluated.


RESULTS
Fifty-nine patients, equally mixed by sex, were included in the study. Mean age was 26.1 years. Forty-seven per cent of the patients enrolled received levetiracetam as monotherapy. One patient was lost during the follow-up: so at T1 we had 58 patients (28 monotherapy and 30 polytherapy). At T0 and at T1, there was no statistically significant difference in terms of seizure frequency and intensity, occurrence of adverse events, laboratory parameters and electroencephalographic features. Two patients stopped treatment with the generic (both at 3 months after the switch) and restarted therapy with brand levetiracetam because of seizure increase. At the end of the study, the switchback rate was 3.4%.


CONCLUSIONS
No increase of seizures and adverse effects were observed when branded levetiracetam was interchanged to a generic equivalent. More studies should be conducted with a larger series of patients to confirm these results.
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, "G. Gaslini" Institute, Genova, Italy.
Maria Stella
MS
Vari
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, "G. Gaslini" Institute, Genova, Italy.
Francesca
F
Pinto
Department of Paediatrics, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.
Elisabetta
E
Mencaroni
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, "G. Gaslini" Institute, Genova, Italy.
Giovanna
G
Giudizioso
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, "G. Gaslini" Institute, Genova, Italy.
Carlo
C
Minetti
Neurology Clinic, Ospedale Policlinico Universitario, Bari, Italy.
Angela
A
La Neve
Neurology Clinic, Ospedale Policlinico Universitario, Bari, Italy.
Tiziana
T
Francavilla
Neurophysiopathology Unit, San Filippo Neri Hospital, Roma, Italy.
Marta
M
Piccioli
Department of Neurosciences, Federico II University, Napoli, Italy.
Salvatore
S
Striano
Department of Neurosciences, Federico II University, Napoli, Italy.
Luigi
L
del Gaudio
Department of Paediatrics II, University of Turin, Regina Margherita Children Hospital, Torino, Italy.
Pierangelo
P
Tovo
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, "G. Gaslini" Institute, Genova, Italy.
Pasquale
P
Striano
Department of Paediatrics, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy. averrott@unich.it.
Alberto
A
Verrotti
D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000009:adverse effects; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011446:Prospective Studies; D055815:Young Adult
D000927:Anticonvulsants; D016568:Drugs, Generic; D000077287:Levetiracetam; D010889:Piracetam