Health-related quality of life (HRQOL) of patients taking levetiracetam. (LEV) was evaluated in long-term follow-up. Short-term assessments compared LEV and placebo add-on therapy in an 18-week clinical trial, with long-term follow-up for a mean of 4.1 years. The QOLIE-31 was expanded to assess distress associated with each domain, change, and priority of importance of each domain. Significant improvements were observed at short-term in patients starting with LEV (N = 66), whereas patients initially randomized to placebo (N = 35) were unchanged. Improvement observed in LEV starters remained stable long-term. Placebo starters reached the same level of improvement in HRQOL at long-term. Correlations between the QOLIE-31-P distress items and domain items indicated that distress was significantly lower when HRQOL was better (P < 0.0001, all domains). At long-term, highest-priority QOLIE-31-P domains were Social Functioning, Cognitive Function, and Overall QOL. Thus, gains in HRQOL were maintained during long-term LEV treatment, whether LEV was initiated early or late. Patient distress and importance of domains are useful data in determining how treatments impact on HRQOL. (C) 2003 Elsevier Science (USA). All rights reserved.