The incidence and causes of mortality in patients with epilepsy enrolled in antiepileptic drug (AED) trials, and the risk factors for sudden unexplained death in epilespy (SUDEP) were examined in pooled data from New Drug Applications (NDA), at the Center for Drug Evaluation and Research, US FDA, Rockville, MD. Ages ranged from 1 to 72 years, with 10% between 1 and 14 years and 50% between 15 and 34 years. In children, the all-cause mortality rate (ALL) was 4.1 per 1000 person years; and the SUDEP rate was 2.4/1000 person years. Mortality rates increased with increasing age, reaching an ALL of 32 in 55-72 year olds. Sixty-five percent of all deaths were related to the underlying epilepsy. Of risk factors, only age was associated with the incidence of SUDEP, and disease severity is the probable determining factor. Length of epilepsy history, gender, and number of concomitant drugs did not influence the SUDEP rate. 
COMMENT. See Walczak TS et al  for SUDEP study.