Retention rate of Gabapentin in children with intractable epilepsies at 1 year.

Gabapentin (GAB) is a newer second-line antiepileptic drug (AED) used in children. This is a multi-centre retrospective observational study of the efficacy, tolerability and retention rate in 105 children, aged 0-17.5 years (mean 10.1) over a 14 year period. The median age of epilepsy onset was 2.5 years (range 0-14.6). 72% started GAB as at least the 3rd AED, with 43% having been withdrawn from at least 2 AEDs. 77% had focal and 52% symptomatic epilepsies. The maintenance doses for GAB ranged 6.0-87.3 mg/kg/day (mean 43.7). The study comprised 157 person-treatment years for GAB. GAB was well tolerated with 55% remaining on treatment beyond 1 year. No serious adverse events were reported whilst on GAB, but 39% reported possibly and probably related adverse events. Seizure improvement (<50% seizure frequency compared to baseline) at more than 12 months of treatment, was reported in 35% of patients starting GAB, including 6% who remained seizure free. The results demonstrated the efficacy and tolerability of GAB in children with difficult to treat epilepsies, and a good response to treatment beyond 12 months, in both focal and generalised epilepsies.

Retention rate of clobazam, topiramate and lamotrigine in children with intractable epilepsies at 1 year.

UNLABELLED: Clobazam (CLB), Topiramate (TOP) and Lamotrigine (LAM) are newer second-line antiepileptic drugs (AEDs) used in children. This is a single-centre retrospective observational study of the efficacy, tolerability and retention rate in 224 separate treatment episodes in 194 children, aged 0.1-16.7 years (median 9.4) over an 8 year period. The median age of epilepsy onset was 3.3 years (range 0-15.1). 79% started CLB, TOP or LAM as at least the 3rd AED, with 39% having been withdrawn from at least 2 AEDs. 53% had generalised and 37% idiopathic epilepsies. The maintenance doses for CLB ranged 0.12-3.50 mg/kg/day (mean 0.7); for TOP 0.45-32.0 mg/kg/day (mean 7.1) and for LAM 1.13-16.0 mg/kg/day (mean 5.6). The study comprised 75 person-treatment years for CLB, 56 for TOP, 124 for LAM. RESULTS: CLB, TOP and LAM were well tolerated with 51%, 37% and 69% remaining on treatment beyond 1 year respectfully. 1 serious adverse event for CLB (inducing seizures) and 2 for LAM (rashes) were reported, and 60%, 47% and 39% had possibly and probably related adverse events for CLB, TOP and LAM respectively. Beyond 12 months seizure improvement (< 50% seizure frequency compared to baseline) was reported in 43%, 35% and 44% on CLB, TOP and LAM, including 5% and 8% remaining seizure free on CLB and LAM respectively. CONCLUSION: Our results demonstrate the efficacy and tolerability of CLB, TOP and LAM in children with difficult to treat epilepsies and a good response in CLB and LAM, and a reasonable response in TOP beyond 12 months.

The critical phase inspection process: a benchmarking study in search of industries' best practices.

Benchmarking is the orderly process of measuring one's own products, services, and practices against those of companies recognized as leaders. Eli Lilly and Company's Quality Assurance Department formed the Critical Phase Inspection Team to benchmark the processes for selecting and conducting critical phase inspections and reporting inspection findings. The team developed a telephone survey that was conducted with 33 other quality assurance units across the country. Analysis of the phone survey responses resulted in the identification of 5 quality assurance units that we felt could provide valuable information to us on these activities. Site visits to these companies were arranged and information was shared. We present here the analysis and results of our benchmarking endeavor. Through the information sharing involved in the benchmarking process, namely, the telephone surveys and the site visits, fresh ideas emerged and new acquaintances were made. Comparisons and adaptations of our methods with others in the quality assurance business will lead us to breakthrough improvements that will allow us to improve our current processes.