PMID- 16515857 OWN - NLM STAT- MEDLINE DCOM- 20060711 LR - 20181201 IS - 0920-1211 (Print) IS - 0920-1211 (Linking) VI - 69 IP - 2 DP - 2006 May TI - Relationship between serum mono-hydroxy-carbazepine concentrations and adverse effects in patients with epilepsy on high-dose oxcarbazepine therapy. PG - 170-6 AB - PURPOSE: To investigate the relationship between the serum concentration of the mono-hydroxy-derivative (MHD) of oxcarbazepine (OXC) and adverse effects (AEs) in epileptic patients on high-dose OXC therapy. PATIENTS AND METHODS: Forty-four consecutive patients, aged 18-65 years, with refractory epilepsy receiving OXC dosages > or = 1500 mg/day (range 1500-3300 mg/day) were assessed at an outpatient clinic. Serum MHD concentrations were determined by a specific HPLC assay in samples collected before the morning dose and 2 h after drug intake. An independent observer assessed AEs at each sampling time. RESULTS: AEs were reported in five patients at the first sampling time, and in 26 patients at the second sampling time. Nystagmus, sedation, blurred vision, and dizziness were the most frequent AEs. MHD concentrations (means +/- S.D.) associated with AEs were 29.6 +/- 5.58 compared with 21.7 +/- 5.0 mg/L when no AEs were detected (p = 0.0001). AEs were minimized in most patients by reducing OXC dose, increasing the number of daily administrations, or both. CONCLUSION: Patients with serum MHD concentrations > or = 30 mg/L are at greater risk of developing AEs. In many patients, AEs occur intermittently in relation to fluctuations in serum MHD. Monitoring MHD concentrations could help in the management of patients on high-dose OXC therapy. FAU - Striano, Salvatore AU - Striano S AD - Epilepsy Center, Department of Neurological Sciences, Federico II University, Naples, Italy. sstriano@libero.it FAU - Striano, Pasquale AU - Striano P FAU - Di Nocera, Pierpaolo AU - Di Nocera P FAU - Italiano, Domenico AU - Italiano D FAU - Fasiello, Cecilia AU - Fasiello C FAU - Ruosi, Patrizia AU - Ruosi P FAU - Bilo, Leonilda AU - Bilo L FAU - Pisani, Francesco AU - Pisani F LA - eng PT - Journal Article DEP - 20060303 PL - Netherlands TA - Epilepsy Res JT - Epilepsy research JID - 8703089 RN - 0 (10,11-dihydro-10-hydroxycarbamazepine) RN - 0 (Anticonvulsants) RN - 33CM23913M (Carbamazepine) RN - VZI5B1W380 (Oxcarbazepine) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anticonvulsants/administration & dosage/*adverse effects/metabolism MH - Carbamazepine/administration & dosage/adverse effects/*analogs & derivatives/blood/metabolism MH - Dose-Response Relationship, Drug MH - Epilepsy/blood/*drug therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - Oxcarbazepine EDAT- 2006/03/07 09:00 MHDA- 2006/07/13 09:00 CRDT- 2006/03/07 09:00 PHST- 2005/10/05 00:00 [received] PHST- 2006/01/17 00:00 [revised] PHST- 2006/01/25 00:00 [accepted] PHST- 2006/03/07 09:00 [pubmed] PHST- 2006/07/13 09:00 [medline] PHST- 2006/03/07 09:00 [entrez] AID - S0920-1211(06)00058-1 [pii] AID - 10.1016/j.eplepsyres.2006.01.011 [doi] PST - ppublish SO - Epilepsy Res. 2006 May;69(2):170-6. doi: 10.1016/j.eplepsyres.2006.01.011. Epub 2006 Mar 3.