ObjectivesTo evaluate the effectiveness and tolerability of clobazam as an adjunctive treatment for adults with drug-resistant epilepsy.MethodsWe performed a single-center, retrospective chart review of patients ≥18 years of age with drug-resistant epilepsy who started clobazam between 2010 and 2018. Included patients had outpatient visits both before and ≥1 month after clobazam initiation. Epilepsy classification, seizure frequency before and after clobazam, duration of clobazam treatment, and adverse effects were analyzed.ResultsA total of 417 patients met inclusion criteria. Mean age was 37.5 years, and 54% of patients were female. Patients were on a mean of 2.4 antiepileptic drugs at time of initiation of clobazam. Epilepsy types were focal (56.8%), Lennox-Gastaut syndrome (LGS) (21.1%), generalized (15.1%), and unclassified (7.0%). At the first follow-up visit ≥1 month after clobazam initiation, 50.3% of patients had >50% reduction in seizure frequency, and 20.5% were seizure-free. Of the initial cohort, 17.1% were followed >1 year and were seizure-free at last follow-up. Response rates did not differ between different epilepsy classifications. Fifty-one percent of patients experienced ≥1 side effect, most commonly lethargy/fatigue (30.7%) or mood changes (10.8%). A total of 178 (42.6%) patients discontinued clobazam, most commonly due to adverse effects (55%).ConclusionsClobazam is effective and safe as a long-term adjunctive therapy for adults with drug-resistant epilepsy; efficacy in off-label use is similar to that in LGS.Classification of evidenceThis study provides Class IV evidence that clobazam is an effective treatment for adults with drug-resistant epilepsy, independent of epilepsy classification.

1 This study was designed to evaluate the antihypertensive effects of oral nicardipine in patients treated for up to 2 years. Patients commenced the study on a fixed dose of 30 mg nicardipine three times a day with the dose then being varied in frequency and amount to suit each patient's requirements, in the range of 30-120 mg nicardipine day-'. Appropriate concomitant antihypertensive medication could be added to the nicardipine dosage regimen as required. 2 Adverse experiences generally were not severe. Withdrawal occurred in 14 patients (10%) due to adverse experiences, but these withdrawals occurred with greatest frequency during the early part of the study. Indeed no patient withdrew for adverse experiences during the second year of study. Eleven patients (8%) withdrew for intercurrent diseases and 18 (13%) patients withdrew for various other non-drug-related reasons. 3 A sustained antihypertensive effect was found over the 2 years of study. Supine systolic and diastolic blood pressures decreased from a mean of 170/105 mm Hg at baseline to a mean of 145/87 mm Hg at 2 years. Similar reductions were seen throughout the 2 years of study. An average clinical success rate of 60% was seen throughout the study for nicardipine as monotherapy and only 24 (17%) patients received a concomitant antihypertensive medication. 4 A significant age effect on antihypertensive response to nicardipine was seen for supine diastolic blood pressure but not for supine systolic blood pressure. The older the patient the greater the decrease in supine diastolic blood pressure. This was a consistent result across the 2 years of study. 5 No unexpected or unusual results were seen in the range of laboratory tests conducted or in the serial ECGs taken.

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