[Use of topiramate in clinical practice (part 2). Multicentric retrospective evaluation of its safety].

Randomized, controlled studies of new antiepileptic drugs are carried out following strict rules and do not always predict the drug's tolerability in clinical practice. The authors gathered 361 cases of focal epilepsies treated with topiramate (TPM) as an add-on to other antiepileptic drugs prior to marketing, in order to retrospectively analyze the incidence of adverse effects (AE). These patients had been treated by neurologists in a clinical setting, with free choice of associated drugs, titration and final daily dose. Compared with controlled studies, TPM was titrated slowly (mean rate: 43 mg/week, vs 100-200), and was given at a lower final dose (296 mg/d, vs 200 to 1000). This analysis shows that AE were less frequent and that TPM had an original tolerability profile, with CNS-related AE, often combined in the same patient (somnolence: 16. 1p.100, fatigue: 11.9p.100, mental slowing: 9.1p.100, slurred speech: 2,2p.100), and weight loss (14.7p.100 of patients, mean 4.5 kg or 6.6p.100 of body weight). Severe AE were uncommon (psychosis, 1; skin rash, 2; urinary lithiasis, 2). Withdrawal of TPM was caused by AE (13.6p.100), lack of efficacy (8.3p.100), aggravation of epilepsy (6.1p.100) or by a combination of these (5p.100). It is useful to use slow titration, in order to allow the greatest possible number of patients to benefit from its efficacy as an add-on drug in the treatment of resistant focal epilepsies.