Safety and feasibility of switching from phenytoin to levetiracetam monotherapy for glioma-related seizure control following craniotomy: a randomized phase II pilot study.
Seizures are common in patients with gliomas, and phenytoin (PHT) is frequently used to control tumor-related seizures. PHT, however, has many undesirable side effects (SEs) and drug interactions with glioma chemotherapy. Levetiracetam (LEV) is a newer antiepileptic drug (AED) with fewer SEs and essentially no drug interactions. We performed a pilot study testing the safety and feasibility of switching patients from PHT to LEV monotherapy for postoperative control of glioma-related seizures. Over a 13-month period, 29 patients were randomized in a 2:1 ratio to initiate LEV therapy within 24 h of surgery or to continue PHT therapy. 6 month follow-up data were available for 15 patients taking LEV and for 8 patients taking PHT. In the LEV group, 13 patients (87%) were seizure-free. In the PHT group, 6 patients (75%) were seizure-free. Reported SEs at 6 months was as follows (%LEV/%PHT group): dizziness (0/14), difficulty with coordination (0/29), depression (7/14) lack of energy or strength (20/43), insomnia (40/43), mood instability (7/0). The pilot data presented here suggest that it is safe to switch patients from PHT to LEV monotherapy following craniotomy for supratentorial glioma. A large-scale, double-blinded, randomized control trial of LEV versus PHT is required to determine seizure control equivalence and better assess differences in SEs.
Lim
Daniel A
DA
Department of Neurological Surgery, University of California, San Francisco, 94143, USA. limd@neurosurg.ucsf.edu
Tarapore
Phiroz
P
Chang
Edward
E
Burt
Marlene
M
Chakalian
Lenna
L
Barbaro
Nicholas
N
Chang
Susan
S
Lamborn
Kathleen R
KR
McDermott
Michael W
MW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000150:complications* / Q000601:surgery; D003399:Craniotomy / Q000009:adverse effects; D005260:Female; D005910:Glioma / Q000150:complications* / Q000601:surgery; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010672:Phenytoin / Q000627:therapeutic use*; D010865:Pilot Projects; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012640:Seizures / Q000188:drug therapy* / Q000209:etiology
D000927:Anticonvulsants; D000077287:Levetiracetam; D010672:Phenytoin; D010889:Piracetam