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Biomedical subjects

Y Sturm

Publications and source records attributed to Y Sturm.

8 recordsLinked to original sources
PubMed2006

Effects of oxcarbazepine on cognitive function in children and adolescents with partial seizures.

The authors investigated the effect of oxcarbazepine on cognitive function in children and adolescents (6 to younger than 17 years of age) with newly diagnosed partial seizures in an open-label comparison with standard antiepileptic drug therapy (carbamazepine and valproate). No differences in cognitive tests were observed between oxcarbazepine and carbamazepine/valproate over a 6-month treatment period.

Adolescent↗
PubMed2005

Oxcarbazepine adjunctive therapy in infants and young children with partial seizures.

OBJECTIVE: To evaluate the efficacy, safety, and pharmacokinetics of oxcarbazepine as adjunctive therapy in infants and young children (1 month to < 4 years). METHODS: Children 1 month to < 4 years of age with inadequately controlled partial seizures taking up to two concomitant antiepileptic drugs (AEDs) were enrolled in this rater-blind, randomized, parallel-group study. Patients received either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) oxcarbazepine as oral suspension. The primary efficacy variable was the absolute change in electrographic partial seizures with a behavioral correlate (type 1 seizure) frequency per 24 hours during the last 72 hours of continuous video-EEG monitoring in the treatment phase compared with baseline seizure frequency. RESULTS: Of 191 patients screened, 128 were randomized: 64 to both oxcarbazepine dose groups. The median absolute change in type 1 seizure frequency per 24 hours was more effective for the high-dose group (-2.00) compared with the low-dose group (-1.37; p = 0.043). The median percentage reduction in type 1 seizure frequency per 24 hours was also greater in the high-dose group (83.33%) than in the low-dose group (46.18%; p = 0.047). The most frequent adverse events (> or = 10%) were somnolence and pyrexia, and most were mild in severity. CONCLUSIONS: In this study, high-dose oxcarbazepine was significantly more effective than low-dose oxcarbazepine in controlling partial seizures in infants and very young children.

Administration, Oral↗
PubMed2000

Oxcarbazepine placebo-controlled, dose-ranging trial in refractory partial epilepsy.

PURPOSE: The goal of the study was to evaluate the safety and efficacy of a broad oxcarbazepine (OXC) dosage range (600, 1200, and 2400 mg/d) as adjunctive therapy for uncontrolled partial seizures and to determine the relationship between trough plasma 10-monohydroxy derivative concentrations and OXC safety and efficacy. METHODS: This multinational, multicenter, randomized, 28-week, double-blind, placebo-controlled, four-arm, parallel-group trial enrolled 694 patients aged 15-65 years with uncontrolled partial seizures with or without secondarily generalized seizures. The primary efficacy variable was percentage change in seizure frequency per 28 days relative to baseline. RESULTS: The median reduction in seizure frequency was 26%, 40%, 50%, or 8% for patients receiving 600, 1200, or 2400 mg/d OXC or placebo, respectively (all p < or = 0.0001). Of patients in the 600, 1200, or 2400 mg/d OXC groups, 27%, 42%, and 50% respectively, had more than 50% reduction in seizure frequency compared with 13% for placebo (all p < 0.001). Higher plasma 10-monohydroxy derivative concentrations were associated with larger decreases in seizure frequency (p = 0.0001). During the double-blind treatment phase, 84%, 90%, 98%, and 76% of patients receiving 600, 1200, or 2400 mg/d OXC or placebo, respectively, reported one or more adverse events. The most common adverse events were related to the nervous and digestive systems. CONCLUSIONS: OXC is safe and effective as adjunctive therapy in patients with uncontrolled partial seizures. OXC 600 mg/d was the minimum effective dosage; effectiveness of OXC increased with dose. The rapid and fixed titration to high doses was associated with an increased risk of adverse events, which could potentially be reduced by adjusting concomitant antiepileptic medication and by using a slower, flexible OXC titration schedule.

Administration, Oral↗
PubMed1999

Induction of ethinylestradiol and levonorgestrel metabolism by oxcarbazepine in healthy women.

PURPOSE: To evaluate the effect of oxcarbazepine (OCBZ) on the pharmacokinetic profile of steroid oral contraceptives. METHODS: Twenty-two healthy women aged 18-44 years were recruited, and 16 of them completed the study. By using a randomized double-blind crossover design, each woman was studied in two different menstrual cycles, during which placebo or OCBZ (maintenance dosage, 1,200 mg/day) was given in randomized sequence for 26 consecutive days with a washout of at least one cycle in between. A steroid oral contraceptive containing 50 microg ethinylestradiol (EE) and 250 microg levonorgestrel (LN) was taken for the first 21 days of each cycle. Plasma concentrations of EE and LN were measured by gas chromatography-mass spectrometry in samples collected at regular intervals on days 21-23 of each cycle. RESULTS: Compared with placebo, areas under the plasma concentration curves (AUC(0-24h, geometric means) decreased by 47% for both EE (from 1,677 to 886 pg.h/ml; p < 0.01) and LN (from 137 to 73 ng.h/ml; p < 0.01), during OCBZ treatment. Peak plasma EE concentrations decreased from 180 pg/ml during the placebo cycle to 117 pg/ml during the OCBZ cycle (p < 0.01), whereas peak plasma LN concentrations decreased from 10.2 to 7.7 ng/ml (p < 0.01). The half-lives of EE and LN also decreased from 13.6 to 7.9 h (p < 0.01) and from 28.8 to 15.8 h, respectively (p < 0.01). CONCLUSIONS: OCBZ reduces plasma concentrations of the estrogen and progestagen components of steroid oral contraceptives, presumably by stimulating their CYP3A-mediated metabolism in the liver or gastrointestinal tract or both. Because this may lead to a decreased efficacy of the contraceptive pill, women treated with OCBZ should receive preferentially a high-dosage contraceptive and should be monitored for signs of reduced hormonal cover.

Adolescent↗
PubMed1995

Effect of initial treatment with antidepressants as a predictor of outcome after 8 weeks.

Most findings of antidepressant treatment prediction have not been replicated, and this applies to biological predictors as well as sociodemographic and early course predictors. One exception might be early psychopathological improvement. To reevaluate this question, we examined the results of two large-scale controlled clinical trials comparing the selective and reversible inhibitor of monoamine oxidase type A (MAO-A) brofaromine with the standard tricyclic compound imipramine. One trial was carried out in a normal-aged patient group; the other, in elderly patients. Above all, we were interested in determining whether early treatment course would prove predictive of later outcome. The main finding was that the initial antidepressant effect (measured after 1 and 2 weeks) predicted longer term outcome. Although this association was not as strong in the elderly patient group, its predictive value did possess a certain clinical relevance.

Adult↗
PubMed1995

Antidepressant drugs and psychomotor performance. A review.

Nearly all antidepressants are tested psychometrically in order to detect side effects of these drugs. Based on a review of the relevant published data on critical flicker fusion frequency measurements, simple reaction time, complex reaction time, tracking, tapping, and car driving simulation measurements, the underlying principles of the different effects of these drugs in healthy volunteers are discussed. It seems that essentially the sedative properties of a compound are important rather than e.g. specific reuptake inhibiting properties or the chemical structure. This finding is discussed in the light of the usefulness of these test procedures for detecting side effects.

Animals↗
PubMed1992

Pharmacokinetics of the active metabolite of the prodrug repirinast in healthy Caucasian volunteers after a single oral dose.

The pharmacokinetics of BAY w 8199, the active metabolite of the prodrug repirinast (BAY u 2372), has been investigated after oral administration of 150, 300 and 450 mg repirinast to twelve healthy male Caucasians. Plasma BAY w 8199 concentrations were very variable between subjects. The mean peak level (geom.mean; 1s-range) was 0.14 (0.08-0.25), 0.19 (0.13-0.29) and 0.24 (0.14-0.42) mg/l after the 150, 300 and 450 mg doses, respectively. Peak levels were reached 0.5-2.5 h after drug intake. Terminal half-lives were calculated as 5.9 h (150 mg), 8.0 h (300 mg) and 9.8 h (450 mg). The dose proportionality of the plasma profiles of BAY w 8199 and of its excretion in urine was demonstrated by testing several parameters. About 7.4% of each dose (calculated as BAY w 8199) was excreted in urine over 36 h. The renal clearance of about 27 l/h suggests that BAY w8199 is excreted by tubular secretion in addition to glomerular filtration.

Administration, Oral↗