Cyclosporine pharmacokinetics and blood pressure responses after conversion to once-daily dosing in maintenance liver transplant patients
: In this six‐month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant patients converting from twice‐daily to once‐daily cyclosporine dosing. A total of 60 patients were randomized as follows: group A (n = 14) ma...
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Published in | Clinical transplantation Vol. 22; no. 1; pp. 68 - 75 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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Oxford, UK
Blackwell Publishing Ltd
01.01.2008
Blackwell |
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Abstract | : In this six‐month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant patients converting from twice‐daily to once‐daily cyclosporine dosing. A total of 60 patients were randomized as follows: group A (n = 14) maintained twice‐daily dosing; group B (n = 24) converted to once‐daily dosing at the same total daily dose as pre‐conversion; and group C (n = 22) was treated the same as group B but with a 25% reduction in dose and C2 at two to three wk post‐conversion. After conversion to once‐daily dosing in groups B and C, trough blood levels (C0) did not change; whereas, C2 nearly doubled. The total daily area under the concentration–time curve AUC(0–24) increased by 29%. After the dose reduction in group C, the AUC(0–24) was similar to the pre‐conversion value. Hence, a 25–30% dose reduction can be considered after conversion to once‐daily dosing. In the study observation period in weeks 4–15, the median (25–75 percentile) C2 was 568 (469–750) ng/mL for group A; 1055 (840–1224) ng/mL for group B; and 764 (575–959) ng/mL for group C. Conversion to once‐daily dosing was associated with a decrease in nighttime mean arterial blood pressure. |
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AbstractList | : In this six‐month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant patients converting from twice‐daily to once‐daily cyclosporine dosing. A total of 60 patients were randomized as follows: group A (n = 14) maintained twice‐daily dosing; group B (n = 24) converted to once‐daily dosing at the same total daily dose as pre‐conversion; and group C (n = 22) was treated the same as group B but with a 25% reduction in dose and C2 at two to three wk post‐conversion. After conversion to once‐daily dosing in groups B and C, trough blood levels (C0) did not change; whereas, C2 nearly doubled. The total daily area under the concentration–time curve AUC(0–24) increased by 29%. After the dose reduction in group C, the AUC(0–24) was similar to the pre‐conversion value. Hence, a 25–30% dose reduction can be considered after conversion to once‐daily dosing. In the study observation period in weeks 4–15, the median (25–75 percentile) C2 was 568 (469–750) ng/mL for group A; 1055 (840–1224) ng/mL for group B; and 764 (575–959) ng/mL for group C. Conversion to once‐daily dosing was associated with a decrease in nighttime mean arterial blood pressure. In this six-month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant patients converting from twice-daily to once-daily cyclosporine dosing. A total of 60 patients were randomized as follows: group A (n = 14) maintained twice-daily dosing; group B (n = 24) converted to once-daily dosing at the same total daily dose as pre-conversion; and group C (n = 22) was treated the same as group B but with a 25% reduction in dose and C2 at two to three wk post-conversion. After conversion to once-daily dosing in groups B and C, trough blood levels (C0) did not change; whereas, C2 nearly doubled. The total daily area under the concentration-time curve AUC(0-24) increased by 29%. After the dose reduction in group C, the AUC(0-24) was similar to the pre-conversion value. Hence, a 25-30% dose reduction can be considered after conversion to once-daily dosing. In the study observation period in weeks 4-15, the median (25-75 percentile) C2 was 568 (469-750) ng/mL for group A; 1055 (840-1224) ng/mL for group B; and 764 (575-959) ng/mL for group C. Conversion to once-daily dosing was associated with a decrease in nighttime mean arterial blood pressure. |
Author | Nashan, Björn Levy, Gary Carlis, Luciano De Kovarik, John M Otero, Alejandra Cillo, Umberto Pollard, Steve Villamil, Federico Lynch, Stephen Fischer, Lutz |
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Cites_doi | 10.1002/lt.20609 10.1097/00007691-199312000-00006 10.1097/00007890-200205151-00002 10.2165/00003495-200161130-00006 10.1097/00007691-199406000-00002 10.2165/00003088-200241010-00005 10.1097/00007890-199305000-00006 10.1097/01.tp.0000167003.97452.a8 10.2165/00003088-200443100-00001 |
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Keywords | Human cyclosporine Digestive system Liver Patient Transplantation Maintenance Homotransplantation dosing Conversion Posology Medicine Response Drug conversion Treatment Surgery Graft Arterial pressure Ciclosporin Blood pressure Hemodynamics Immunosuppressive agent Daily dose Pharmacokinetics |
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References | Levy GA, Lilly LB, Grant DR et al. Once daily dosing with Neoral utilizing C2 monitoring in maintenance liver transplant patients. [Abstract] Am J Transplant 2003: 3(Suppl 5): 422. Covic A, Gusbeth-Tatomir P, Mardare N et al. Dynamics of the circadian blood pressure profiles after renal transplantation. Transplantation 2005: 80: 1168. Lindholm A, Welsh M, Rutzky L et al. The adverse impact of high cyclosporine clearance rates on the incidences of acute rejection and graft loss. Transplantation 1993: 55: 985. DeMattos AM, Olyaei AJ, Norman DJ et al. Systemic and Renal Hemodynamic Profiles of Neoral Once Versus Twice Daily Dosing: Results From OLN-453 Study. American Society of Transplantation Eighteenth Annual Meeting, Chicago, IL, 1999 (Abstract 789). Heifets M, Cooney GF, Shaw L et al. Diurnal variation of cyclosporine clearance in stable renal transplant recipients receiving continuous infusion. Transplantation 1995: 60: 1615. Dunn CJ, Wagstaff AJ, Perry CM et al. Cyclosporine: an updated review of the pharmacokinetic properties, clinical efficacy and tolerability of a microemulsion-based formulation (Neoral) in organ transplantation. Drugs 2001: 61: 1957. Schaedeli F, Maeti HP, Frey FJ et al. Population pharmacokinetic model to predict steady-state exposure to once-daily cyclosporine microemulsion in renal transplant recipients. Clin Pharmacokinet 2002: 41: 59. Kovarik JM, Mueller EA, Van Bree JB et al. Within-day consistency in cyclosporine pharmacokinetics form a microemulsion formulation in renal transplant patients. Ther Drug Monit 1994: 16: 232. Fukudo M, Yano I, Masuda S et al. Cyclosporine exposure and calcineurin phosphatase activity in living-donor liver transplant patients: twice daily vs. once daily dosing. Liver Transplant 2006: 12: 292. Lynch S, Cillo U, Villamil F et al. Conversion to once daily Neoral is feasible without risk of allograft rejection and may lead to improvement in renal function and blood pressure: results of the NEWROAD multicenter trial. [Abstract] Liver Transplant 2006: 12(Suppl 1): C111. Grevel J. Area-under-the-curve versus trough level monitoring of cyclosporine concentration: critical assessment of dosage adjustment practices and measurement of clinical outcome. Ther Drug Monit 1993: 15: 488. Saatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 2004: 43: 623. Nashan B, Cole E, Levy G et al. Clinical validation studies of Neoral C2 monitoring: a review. Transplantation 2002: 73: S3. 2004; 43 1993; 15 2003; 3 2001; 61 1995; 60 1994; 16 2005; 80 2002; 41 2006; 12 2002; 73 1993; 55 e_1_2_7_5_2 e_1_2_7_4_2 e_1_2_7_3_2 e_1_2_7_2_2 Levy GA (e_1_2_7_9_2) 2003; 3 e_1_2_7_7_2 e_1_2_7_6_2 e_1_2_7_14_2 e_1_2_7_13_2 Heifets M (e_1_2_7_12_2) 1995; 60 e_1_2_7_10_2 DeMattos AM (e_1_2_7_8_2) Lynch S (e_1_2_7_11_2) 2006; 12 |
References_xml | – volume: 61 start-page: 1957 year: 2001 article-title: Cyclosporine: an updated review of the pharmacokinetic properties, clinical efficacy and tolerability of a microemulsion‐based formulation (Neoral) in organ transplantation publication-title: Drugs – volume: 16 start-page: 232 year: 1994 article-title: Within‐day consistency in cyclosporine pharmacokinetics form a microemulsion formulation in renal transplant patients publication-title: Ther Drug Monit – volume: 41 start-page: 59 year: 2002 article-title: Population pharmacokinetic model to predict steady‐state exposure to once‐daily cyclosporine microemulsion in renal transplant recipients publication-title: Clin Pharmacokinet – volume: 80 start-page: 1168 year: 2005 article-title: Dynamics of the circadian blood pressure profiles after renal transplantation publication-title: Transplantation – volume: 43 start-page: 623 year: 2004 article-title: Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation publication-title: Clin Pharmacokinet – volume: 73 start-page: S3 year: 2002 article-title: Clinical validation studies of Neoral C2 monitoring: a review publication-title: Transplantation – volume: 55 start-page: 985 year: 1993 article-title: The adverse impact of high cyclosporine clearance rates on the incidences of acute rejection and graft loss publication-title: Transplantation – volume: 12 start-page: 292 year: 2006 article-title: Cyclosporine exposure and calcineurin phosphatase activity in living‐donor liver transplant patients: twice daily vs. once daily dosing publication-title: Liver Transplant – volume: 60 start-page: 1615 year: 1995 article-title: Diurnal variation of cyclosporine clearance in stable renal transplant recipients receiving continuous infusion publication-title: Transplantation – volume: 3 start-page: 422 issue: Suppl 5 year: 2003 article-title: Once daily dosing with Neoral utilizing C2 monitoring in maintenance liver transplant patients publication-title: Am J Transplant – volume: 15 start-page: 488 year: 1993 article-title: Area‐under‐the‐curve versus trough level monitoring of cyclosporine concentration: critical assessment of dosage adjustment practices and measurement of clinical outcome publication-title: Ther Drug Monit – volume: 12 start-page: C111 issue: Suppl 1 year: 2006 article-title: Conversion to once daily Neoral is feasible without risk of allograft rejection and may lead to improvement in renal function and blood pressure: results of the NEWROAD multicenter trial publication-title: Liver Transplant – volume: 12 start-page: C111 issue: 1 year: 2006 ident: e_1_2_7_11_2 article-title: Conversion to once daily Neoral is feasible without risk of allograft rejection and may lead to improvement in renal function and blood pressure: results of the NEWROAD multicenter trial publication-title: Liver Transplant contributor: fullname: Lynch S – volume: 60 start-page: 1615 year: 1995 ident: e_1_2_7_12_2 article-title: Diurnal variation of cyclosporine clearance in stable renal transplant recipients receiving continuous infusion publication-title: Transplantation contributor: fullname: Heifets M – volume: 3 start-page: 422 issue: 5 year: 2003 ident: e_1_2_7_9_2 article-title: Once daily dosing with Neoral utilizing C2 monitoring in maintenance liver transplant patients publication-title: Am J Transplant contributor: fullname: Levy GA – ident: e_1_2_7_10_2 doi: 10.1002/lt.20609 – ident: e_1_2_7_5_2 doi: 10.1097/00007691-199312000-00006 – ident: e_1_2_7_4_2 doi: 10.1097/00007890-200205151-00002 – volume-title: Systemic and Renal Hemodynamic Profiles of Neoral Once Versus Twice Daily Dosing: Results From OLN‐453 Study ident: e_1_2_7_8_2 contributor: fullname: DeMattos AM – ident: e_1_2_7_2_2 doi: 10.2165/00003495-200161130-00006 – ident: e_1_2_7_13_2 doi: 10.1097/00007691-199406000-00002 – ident: e_1_2_7_7_2 doi: 10.2165/00003088-200241010-00005 – ident: e_1_2_7_6_2 doi: 10.1097/00007890-199305000-00006 – ident: e_1_2_7_14_2 doi: 10.1097/01.tp.0000167003.97452.a8 – ident: e_1_2_7_3_2 doi: 10.2165/00003088-200443100-00001 |
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Snippet | : In this six‐month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant... In this six-month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant... In this six‐month randomized multicenter trial, we characterized cyclosporine pharmacokinetics and blood pressure profiles in maintenance liver transplant... |
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SubjectTerms | Area Under Curve Biological and medical sciences blood pressure Blood Pressure - drug effects Blood Pressure Monitoring, Ambulatory Circadian Rhythm - physiology cyclosporine Cyclosporine - administration & dosage Cyclosporine - pharmacokinetics Dose-Response Relationship, Drug dosing Female Fundamental and applied biological sciences. Psychology Fundamental immunology Humans Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - pharmacokinetics Liver Transplantation - immunology Liver Transplantation - physiology Male Medical sciences Middle Aged pharmacokinetics Pilot Projects Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Tissue, organ and graft immunology |
Title | Cyclosporine pharmacokinetics and blood pressure responses after conversion to once-daily dosing in maintenance liver transplant patients |
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