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0054 Knowledge, attitudes, and perceptions (KAP) regarding epilepsy among Zambian clerics
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Monday, November 7, 2005
the impact on concomitant medication costs should be included in the cost-benefit analysis of using such drugs. This would not be necessary with some newer AEDs which produce few or no drug interactions. 0051 Elti~efiveneSs, Tolerabilily and Sal~ty of LEV in the Treahnen! of Epilepsy Associated with Liver Diseases Di Bonaventur, C l, Egeo, G a, Marl, F a, Fattouch, J~, Vaudano, A ~, Prencipe, M ~, Manfredi, M L2, Giallonardo, A ~. 1Epilepsy Unit,
Poster Abstracts centered around 100% for CBZ, VPA, TPM and LTG and 90% confidence intervals were within 80-125%. Conclusion: LEV did not appear to modify plasnla concentrations of CBZ, VPA, TPM and LTG in children with epilepsy. Dosages of these AEDs do not require adjustnrent when LEV is added to, or removed from, therapeutic regimen. 0053 Levetiracetam Population Pharmaeokinetics in Children with Epilepsy
Department of Neurological Seiences, University of Rome "La Sapienza," Italy," 2Neuromed Institute of Pozzilli (IS), University of Rome 'Za Sapienza," Baly
Toublanc, N 1, Jacqmin, p 2 Stockis, A 1. ZUCB, Clinical Pharmacology,
Introduction: Levetiracetam (LEV) has a good pharmacological profile. It can be considered for patients with comorbidity of epilepsy with other medical disorders. Methods: We selected patients affected by partial or generalised epilepsy associated with liver diseases consisting of chrorfic or acute hepatopathies, in which treatment with old antiepileptic drugs (AEDs) led to complications, such as unfavorable metabolism or complex drug interactions causing a worsening of medical disease or a decrease in the plasmatic level of concomitant drugs. After an assessment of EEG-clinical and blood paranteters, we introduced LEV with a starting therapeutic dose and withdrew therapy of old AEDs. Results: 10 patients, 8 with partial epilepsy, 2 with generalised epilepsy; with seizures not fully controlled by their previous therapy in almost all the cases. Concomitant liver pathology consisted o f Hepatitis C Virus (HCV) chronic hepatopattffes in 7 cases and acute toxic hepatitis in 3 cases. Reasons for therapeutic change were liver failure or increased hepatic values in those patients treated with AEDs in which acute or chronic hepatotoxic effects were documented and/or interactions of specific drugs (i.e. interpheron) with enzyme inducer AEDs. LEV daily doses ranged from 1000-2000 mg. After a 6-12 month follow-up, seizure recurrence was not observed and an improvement in basal medical conditions was verified. Conclusions: LEV is a safe, effective and well tolerated new AED, which could be a first choice drug in the treatment of epilepsy associated with acute or chronic hepatopathies.
Purpose: To characterise the pharmacokinetic (PK) profile of levetiracetam (LEV) in children with epilepsy; identify demographic and/or physiological detetlmnalltS of LEV disposition; and define optimal dosing regimens. Methods: Data pooled from 5 studies were retrospectively analysed. Population P K analysis was performed using non-linear mixed effects modeling. Associations between P K parameters and age, gender, race, body weight (B'W), mass index, surface, LEV dose, creatinine clearance and conconfitant antiepileptic drugs (AEDs) were assessed. The final model sinlulated dosing regimens that achieve LEV concentrations similar to those reached in adults. Results: LEV concentration-time records with covariate information 0a -- 2319) were available from 228 children with epilepsy (age 0.0818 years; BW 6-101 kg). LEV clearance (CL/F) and distribution volunle (V/F) were mainly related to BW and euzyme-inducing AED use, described as follows: CL/F - Ind x 2.18 × (BW/30)o:z3; V/F 21.5 × (BW/30)°-~°l; where Ind - 1.21 for enzyme-inducing AEDs and 1 otherwise. Simulations showed that the following starting doses ensure plasma concentrations similar to those in adults receiving LEV 500 mg twice daily (bid): 10 mg/kg solution bid (BW < 50 kg); 500mg tablet bid (BW >50 kg). Alternatively: 10mg/kg solution bid (BW < 20 kg); 250 mg tablet bid (BW 20~40 kg); 500 mg tablet bid (BW > 40 kg). Conclusions; The primary predictor of LEV plasma concentration in this paediatric population is BW. The concentration-lowering effect of enzyme-inducing AEDs does not entail dose adjustment. The recommended starting dose to achieve plasma concentrations similar to those fi'om a 500 mg bid dose in adults is 10 mg/kg bid. Funded by UCB.
0052 Lack of interaction of levetixacetam with other antiepilepfic drugs (AEDs) in children with epilepsy Otoul C x, De Smedt H 1, Stockis A 2. 2Biostatisties and 2Clinical
Pharmacology, UCB Pharrna, Braine-l'Alleud, Belgium Propose: To assess the effect of levetiracetam (LEV) add-on treatment on plasma concentrations of other atttiepileptic drugs (AEDs) in a paediatric population with epilepsy. Methods: Retrospective analysis of plasma concentrations from a single placebo-controlled Phase IH trial and a pooled population (two Phase DH studies, one Phase IH and one long-term follow-up study). Most frequently used concomitant AEDs: carbamazepine (CBZ), valproate (VPA), topiramate (TPM), lamotrigine (LTG). Multiple AED plasma levels at baseline and during the evaluation period with concomitant LEV or placebo were evaluated by repeated measures covariance analysis, after logarithmic transformation and using 90% confidence interval o f the geometric mean ratio between evaluation and baseline periods. Results: Front the Phase Ill study, data were available from 187 children receiving any concomitant AED, alone or in combination. In the pooled analysis, data from 164 children receiving a single other AED were included. In the pooled population, geometric mean plasma concentrations (CV - coefficient of variation) varied from baseline to LEV period: CBZ: 7.8-8.1 pg/mL (CV -- 34%); VPA: 90-103 pg/mL (CV - 31'%); TPM: 11.3-12.8 pg/mL (CV -- 45%) and LTG: 8.08.7 pg/mL (CV -- 56%).In the Phase III study, the geometric mean ratio of concentration (LEV/placebo evaluation vs. baseline) was
Braine-l'Alleud, Belgium; 2E,~primo Consulting LLP, Colchester, Essex, UK
0054 Knowledge, attitudes, and perceptions (KAP) regarding epilepsT among Zambian clerics Atadzhanov, M, Chomba, E, Haworth, A, Mbewe, E, Bitbeck, G.
University of Zambia. Lusaka, ZAMBIA*Michigan State University, East Lansing, MI USA & Chikankata Health Services, Mazabuka, ZA Iv[BIA Objective: Epilepsy-associated stigma may be an important determinant o f social and medical morbidity. We conducted a K A P survey among clerics, art influential social group in Zambia. Methods: The ILAE K A P survey was adapted adding clergy-specific questions. Rural and urban regions were surveyed. Verbal interviews were provided where needed. Summary scores for knowledge and tolerance were developed. Linear regression models were developed to assess determinants of tolerance and knowledge. Results: 222 clerics fi'om various denominations returned surveys for a 93.4% response rate. The average age was 40.5 years (range 18-75), 77.9% were male, and most had completed secondary school. 97% had heard of epilepsy and 43.1% reported having a relative with the condition. Clerics attributed epilepsy to both biomedical (brain injury 61.6%; birth injury 25.9%) and supernatural (witchcraft 33.5%; spirit possession 23.3%) causes. Tiffs duality was matched by recommendations for epilepsy care 34.1% would recommend a traditional healer and 88.5% a physician. Contagion beliefs were common (42.5%).
Monday, November 7, 2005
the impact on concomitant medication costs should be included in the cost-benefit analysis of using such drugs. This would not be necessary with some newer AEDs which produce few or no drug interactions. 0051 Elti~efiveneSs, Tolerabilily and Sal~ty of LEV in the Treahnen! of Epilepsy Associated with Liver Diseases Di Bonaventur, C l, Egeo, G a, Marl, F a, Fattouch, J~, Vaudano, A ~, Prencipe, M ~, Manfredi, M L2, Giallonardo, A ~. 1Epilepsy Unit,
Poster Abstracts centered around 100% for CBZ, VPA, TPM and LTG and 90% confidence intervals were within 80-125%. Conclusion: LEV did not appear to modify plasnla concentrations of CBZ, VPA, TPM and LTG in children with epilepsy. Dosages of these AEDs do not require adjustnrent when LEV is added to, or removed from, therapeutic regimen. 0053 Levetiracetam Population Pharmaeokinetics in Children with Epilepsy
Department of Neurological Seiences, University of Rome "La Sapienza," Italy," 2Neuromed Institute of Pozzilli (IS), University of Rome 'Za Sapienza," Baly
Toublanc, N 1, Jacqmin, p 2 Stockis, A 1. ZUCB, Clinical Pharmacology,
Introduction: Levetiracetam (LEV) has a good pharmacological profile. It can be considered for patients with comorbidity of epilepsy with other medical disorders. Methods: We selected patients affected by partial or generalised epilepsy associated with liver diseases consisting of chrorfic or acute hepatopathies, in which treatment with old antiepileptic drugs (AEDs) led to complications, such as unfavorable metabolism or complex drug interactions causing a worsening of medical disease or a decrease in the plasmatic level of concomitant drugs. After an assessment of EEG-clinical and blood paranteters, we introduced LEV with a starting therapeutic dose and withdrew therapy of old AEDs. Results: 10 patients, 8 with partial epilepsy, 2 with generalised epilepsy; with seizures not fully controlled by their previous therapy in almost all the cases. Concomitant liver pathology consisted o f Hepatitis C Virus (HCV) chronic hepatopattffes in 7 cases and acute toxic hepatitis in 3 cases. Reasons for therapeutic change were liver failure or increased hepatic values in those patients treated with AEDs in which acute or chronic hepatotoxic effects were documented and/or interactions of specific drugs (i.e. interpheron) with enzyme inducer AEDs. LEV daily doses ranged from 1000-2000 mg. After a 6-12 month follow-up, seizure recurrence was not observed and an improvement in basal medical conditions was verified. Conclusions: LEV is a safe, effective and well tolerated new AED, which could be a first choice drug in the treatment of epilepsy associated with acute or chronic hepatopathies.
Purpose: To characterise the pharmacokinetic (PK) profile of levetiracetam (LEV) in children with epilepsy; identify demographic and/or physiological detetlmnalltS of LEV disposition; and define optimal dosing regimens. Methods: Data pooled from 5 studies were retrospectively analysed. Population P K analysis was performed using non-linear mixed effects modeling. Associations between P K parameters and age, gender, race, body weight (B'W), mass index, surface, LEV dose, creatinine clearance and conconfitant antiepileptic drugs (AEDs) were assessed. The final model sinlulated dosing regimens that achieve LEV concentrations similar to those reached in adults. Results: LEV concentration-time records with covariate information 0a -- 2319) were available from 228 children with epilepsy (age 0.0818 years; BW 6-101 kg). LEV clearance (CL/F) and distribution volunle (V/F) were mainly related to BW and euzyme-inducing AED use, described as follows: CL/F - Ind x 2.18 × (BW/30)o:z3; V/F 21.5 × (BW/30)°-~°l; where Ind - 1.21 for enzyme-inducing AEDs and 1 otherwise. Simulations showed that the following starting doses ensure plasma concentrations similar to those in adults receiving LEV 500 mg twice daily (bid): 10 mg/kg solution bid (BW < 50 kg); 500mg tablet bid (BW >50 kg). Alternatively: 10mg/kg solution bid (BW < 20 kg); 250 mg tablet bid (BW 20~40 kg); 500 mg tablet bid (BW > 40 kg). Conclusions; The primary predictor of LEV plasma concentration in this paediatric population is BW. The concentration-lowering effect of enzyme-inducing AEDs does not entail dose adjustment. The recommended starting dose to achieve plasma concentrations similar to those fi'om a 500 mg bid dose in adults is 10 mg/kg bid. Funded by UCB.
0052 Lack of interaction of levetixacetam with other antiepilepfic drugs (AEDs) in children with epilepsy Otoul C x, De Smedt H 1, Stockis A 2. 2Biostatisties and 2Clinical
Pharmacology, UCB Pharrna, Braine-l'Alleud, Belgium Propose: To assess the effect of levetiracetam (LEV) add-on treatment on plasma concentrations of other atttiepileptic drugs (AEDs) in a paediatric population with epilepsy. Methods: Retrospective analysis of plasma concentrations from a single placebo-controlled Phase IH trial and a pooled population (two Phase DH studies, one Phase IH and one long-term follow-up study). Most frequently used concomitant AEDs: carbamazepine (CBZ), valproate (VPA), topiramate (TPM), lamotrigine (LTG). Multiple AED plasma levels at baseline and during the evaluation period with concomitant LEV or placebo were evaluated by repeated measures covariance analysis, after logarithmic transformation and using 90% confidence interval o f the geometric mean ratio between evaluation and baseline periods. Results: Front the Phase Ill study, data were available from 187 children receiving any concomitant AED, alone or in combination. In the pooled analysis, data from 164 children receiving a single other AED were included. In the pooled population, geometric mean plasma concentrations (CV - coefficient of variation) varied from baseline to LEV period: CBZ: 7.8-8.1 pg/mL (CV -- 34%); VPA: 90-103 pg/mL (CV - 31'%); TPM: 11.3-12.8 pg/mL (CV -- 45%) and LTG: 8.08.7 pg/mL (CV -- 56%).In the Phase III study, the geometric mean ratio of concentration (LEV/placebo evaluation vs. baseline) was
Braine-l'Alleud, Belgium; 2E,~primo Consulting LLP, Colchester, Essex, UK
0054 Knowledge, attitudes, and perceptions (KAP) regarding epilepsT among Zambian clerics Atadzhanov, M, Chomba, E, Haworth, A, Mbewe, E, Bitbeck, G.
University of Zambia. Lusaka, ZAMBIA*Michigan State University, East Lansing, MI USA & Chikankata Health Services, Mazabuka, ZA Iv[BIA Objective: Epilepsy-associated stigma may be an important determinant o f social and medical morbidity. We conducted a K A P survey among clerics, art influential social group in Zambia. Methods: The ILAE K A P survey was adapted adding clergy-specific questions. Rural and urban regions were surveyed. Verbal interviews were provided where needed. Summary scores for knowledge and tolerance were developed. Linear regression models were developed to assess determinants of tolerance and knowledge. Results: 222 clerics fi'om various denominations returned surveys for a 93.4% response rate. The average age was 40.5 years (range 18-75), 77.9% were male, and most had completed secondary school. 97% had heard of epilepsy and 43.1% reported having a relative with the condition. Clerics attributed epilepsy to both biomedical (brain injury 61.6%; birth injury 25.9%) and supernatural (witchcraft 33.5%; spirit possession 23.3%) causes. Tiffs duality was matched by recommendations for epilepsy care 34.1% would recommend a traditional healer and 88.5% a physician. Contagion beliefs were common (42.5%).