A double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy with health-related quality of life as an outcome measure

The aim of this study was to compare the effect of treatment with lamotrigi ne (LTG) or carbamazepine (CBZ) on health-related quality of life (HRQOL) a nd to demonstrate the use of the SEALS Inventory as a comparative tool in c linical trials. Two hundred and sixty patients with newly diagnosed epilepsy were randomize d to 48 weeks of treatment with LTG (n = 131) or CBZ (n = 129). HRQOL was m easured at baseline and weeks 4, 12, 24, and 48 using the modified Side Eff ect and Life Satisfaction (SEALS) Inventory-a 38-item questionnaire divided into five subscales: Worry, Temper, Cognition, Dysphoria, and Tiredness. Overall, SEALS scores in the LTG group decreased (improved) significantly f rom baseline (P = 0.001). The LTG group had improvement in all five subscal es over the 48 weeks of the study. CBZ patients had significantly worse SEA LS scores than LTG patients at week 4 (P < 0.038). There was no significant change (positive or negative) in subsequent SEALS assessments. Analysis of SEALS data by subscale showed that the the CBZ group experienced more cogn itive side-effects in general and more general changes in energy levels and affect during the first 4 weeks of treatment. These changes may help expla in the difference in study completion rate: LTG 65%, CBZ 51% (P = 0.018). LTG offers the patient with newly diagnosed epilepsy significant benefits o f greater tolerability and better health-related quality of life compared w ith CBZ. The SEALS Inventory is an effective tool for use in clinical trial s of AEDs; it was a better predictor of trial completion than seizure count s, and used as a covariate enabled better detection of treatment effects. I n general practice, the use of the SEALS Inventory to assess HRQOL has the potential to improve quality of care for people with epilepsy. (C) 2000 BEA Trading Ltd.