Safety and efficacy of clobazam versus phenytoin-sodium in the antiepileptic drug treatment of solitary cysticercus granulomas.
BACKGROUND
It is now agreed that the prognosis of seizure disorder due to solitary cysticercus granuloma (SCG) is generally good. However, the choice antiepileptic drugs (AEDs) remain empirical, with no comparative trials of different AEDs being available.


OBJECTIVE
To determine the safety and efficacy (measured by the incidence of 'treatment failure') of clobazam in comparison to standard treatment with phenytoin-sodium for prevention of seizures in persons with solitary cysticercus granulomas (SCGs).


METHODS
This pilot study was conducted in a neurology department of a medical college hospital in the form of a prospective, randomized, open-labeled trial.


METHODS
Forty-eight patients with seizures due to SCG were randomized in an open-labeled trial to either, clobazam (1 mg/kg oral loading followed by 0.5 mg/kg/d) (n=21) or phenytoin (15 mg/kg, oral loading in 3 divided doses over 24 h, followed by 5 mg/kg/d) (n=27). They were followed over 6 months with the primary outcome measure being treatment failure (either discontinuation or modification of AEDs) due to either adverse effects or breakthrough seizures.


RESULTS
Treatment failures were noted to be significantly less common (P =0.03) in the clobazam-treated group (n=1; 4.7%) than in phenytoin-treated group (n=9; 33.3%). These included one patient (4.7%) in the clobazam-group who had breakthrough seizures and 3 (11.1%) who had breakthrough seizures and 6 (22.2%) in the phenytoin-treated group who had adverse effects requiring treatment discontinuation.


CONCLUSIONS
Clobazam was well tolerated, safe and more effective than phenytoin in the AED treatment of patients with SCG.
Kaushal
Sandeep
S
Department of Neurology, Dayanand Medical College, Ludhiana, Punjab, India. gagandeep_si@yahoo.co.uk
Rani
Asha
A
Chopra
Sarvesh C
SC
Singh
Gagandeep
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects* / Q000627:therapeutic use*; D002675:Child, Preschool; D000078306:Clobazam; D004311:Double-Blind Method; D005260:Female; D006099:Granuloma / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D020019:Neurocysticercosis / Q000150:complications*; D010672:Phenytoin / Q000009:adverse effects* / Q000627:therapeutic use*; D011446:Prospective Studies; D012640:Seizures / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome
D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam; D010672:Phenytoin