Topiramate in clinical practice (part 2). Multicentric, retrospective evaluation of its tolerability.

Randomized, controlled studies of new antiepileptic drugs are carried out f ollowing strict rules and do not always predict the drug's tolerability in clinical practice. The authors gathered 361 cases of focal epilepsies treat ed with topiramate (TPM) as an add-on to other antiepileptic drugs prior to marketing, in order to retrospectively analyze the incidence of adverse ef fects (AE). These patients had been treated by neurologists in a clinical s etting, with free choice of associated drugs, titration and final daily dos e. Compared with controlled studies. TPM was titrated slowly (mean rate: 43 mg/week, vs 100-200), and was given at a lower final dose (296mg/d, vs 200 to 1000). This analysis shows that AE were less frequent and that TPM had a n 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 pati ents, mean 4.5kg or 6.6p. 100 of body weight). Severe AE were uncommon (psy chosis, I; skin rash, 2; urinary lithiasis, 2). Withdrawal of TPM was cause d 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 slo w 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 f ocal epilepsies.