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4. Correlations between 4β-hydroxycholesterol and hepatic and intestinal CYP3A4: protein expression, microsomal ex vivo activity, and in vivo activity in patients with a wide body weight range

Author

Eide Kvitne, Kine, Hole, Kristine, Krogstad, Veronica, Wollmann, Birgit Malene, Wegler, Christine, Johnson, Line K., Hertel, Jens K., Artursson, Per, Karlsson, Cecilia, Andersson, Shalini, Andersson, Tommy B., Sandbu, Rune, Hjelmesæth, Jøran, Skovlund, Eva, Christensen, Hege, Jansson-Löfmark, Rasmus, Åsberg, Anders, Molden, Espen, and Robertsen, Ida

Published
2022
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5. Oral Drug Dosing After Gastric Bypass and Diet‐Induced Weight Loss: Simpler Than We Think? Lessons Learned From the COCKTAIL Study

Author

Kvitne, Kine Eide, primary, Hjelmesæth, Jøran, additional, Hovd, Markus, additional, Sandbu, Rune, additional, Johnson, Line Kristin, additional, Andersson, Shalini, additional, Karlsson, Cecilia, additional, Christensen, Hege, additional, Jansson‐Löfmark, Rasmus, additional, Åsberg, Anders, additional, and Robertsen, Ida, additional

Published
2024
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9. Digoxin Pharmacokinetics in Patients with Obesity Before and After a Gastric Bypass or a Strict Diet Compared with Normal Weight Individuals

Author

Kvitne, Kine Eide, primary, Hovd, Markus, additional, Johnson, Line Kristin, additional, Wegler, Christine, additional, Karlsson, Cecilia, additional, Artursson, Per, additional, Andersson, Shalini, additional, Sandbu, Rune, additional, Hjelmesæth, Jøran, additional, Skovlund, Eva, additional, Jansson-Löfmark, Rasmus, additional, Christensen, Hege, additional, Åsberg, Anders, additional, and Robertsen, Ida, additional

Published
2023
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15. Impact of type 2 diabetes on in vivo activities and protein expressions of cytochrome P450 in patients with obesity

Author

Kvitne, Kine Eide, primary, Åsberg, Anders, additional, Johnson, Line K., additional, Wegler, Christine, additional, Hertel, Jens K., additional, Artursson, Per, additional, Karlsson, Cecilia, additional, Andersson, Shalini, additional, Sandbu, Rune, additional, Skovlund, Eva, additional, Christensen, Hege, additional, Jansson‐Löfmark, Rasmus, additional, Hjelmesæth, Jøran, additional, and Robertsen, Ida, additional

Published
2022
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20. The Authors’ Reply

Author

Egeland, Erlend Johannessen, Størset, Elisabet, Robertsen, Ida, Hermann, Monica, Midtvedt, Karsten, Gustavsen, Marte Theie, Klaasen, Rolf, Bergan, Stein, Hartmann, Anders, and Åsberg, Anders

Published
2018
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22. Short‐ and long‐term effects of body weight, calorie restriction and gastric bypass on CYP1A2, CYP2C19 and CYP2C9 activity

Author

Kvitne, Kine Eide, primary, Krogstad, Veronica, additional, Wegler, Christine, additional, Johnson, Line Kristin, additional, Kringen, Marianne K., additional, Hovd, Markus Herberg, additional, Hertel, Jens K., additional, Heijer, Maria, additional, Sandbu, Rune, additional, Skovlund, Eva, additional, Artursson, Per, additional, Karlsson, Cecilia, additional, Andersson, Shalini, additional, Andersson, Tommy B., additional, Hjelmesæth, Jøran, additional, Åsberg, Anders, additional, Jansson‐Löfmark, Rasmus, additional, Christensen, Hege, additional, and Robertsen, Ida, additional

Published
2022
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24. Short‐ and long‐term effects of body weight loss following calorie restriction and gastric bypass on CYP3A‐activity – a non‐randomized three‐armed controlled trial

Author

Kvitne, Kine Eide, primary, Robertsen, Ida, additional, Skovlund, Eva, additional, Christensen, Hege, additional, Krogstad, Veronica, additional, Wegler, Christine, additional, Angeles, Philip Carlo, additional, Wollmann, Birgit Malene, additional, Hole, Kristine, additional, Johnson, Line Kristin, additional, Sandbu, Rune, additional, Artursson, Per, additional, Karlsson, Cecilia, additional, Andersson, Shalini, additional, Andersson, Tommy B., additional, Hjelmesæth, Jøran, additional, Jansson‐Löfmark, Rasmus, additional, and Åsberg, Anders, additional

Published
2021
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27. Short‐ and long‐term effects of body weight loss following calorie restriction and gastric bypass on CYP3A‐activity – a non‐randomized three‐armed controlled trial.

Author

Kvitne, Kine Eide, Robertsen, Ida, Skovlund, Eva, Christensen, Hege, Krogstad, Veronica, Wegler, Christine, Angeles, Philip Carlo, Wollmann, Birgit Malene, Hole, Kristine, Johnson, Line Kristin, Sandbu, Rune, Artursson, Per, Karlsson, Cecilia, Andersson, Shalini, Andersson, Tommy B., Hjelmesæth, Jøran, Jansson‐Löfmark, Rasmus, and Åsberg, Anders

Subjects
*WEIGHT loss, *GASTRIC bypass, *BODY weight, *MORBID obesity, *LOW-calorie diet, *MIDAZOLAM, *BIOAVAILABILITY
Abstract

It remains uncertain whether pharmacokinetic changes following Roux‐en‐Y gastric bypass (RYGB) can be attributed to surgery‐induced gastrointestinal alterations per se and/or the subsequent weight loss. The aim was to compare short‐ and long‐term effects of RYGB and calorie restriction on CYP3A‐activity, and cross‐sectionally compare CYP3A‐activity with normal weight to overweight controls using midazolam as probe drug. This three‐armed controlled trial included patients with severe obesity preparing for RYGB (n = 41) or diet‐induced (n = 41) weight‐loss, and controls (n = 18). Both weight‐loss groups underwent a 3‐week low‐energy‐diet (<1200 kcal/day) followed by a 6‐week very‐low‐energy‐diet or RYGB (both <800 kcal/day). Patients were followed for 2 years, with four pharmacokinetic investigations using semisimultaneous oral and intravenous dosing to determine changes in midazolam absolute bioavailability and clearance, within and between groups. The RYGB and diet groups showed similar weight‐loss at week 9 (13 ± 2.4% vs. 11 ± 3.6%), but differed substantially after 2 years (−30 ± 7.0% vs. −3.1 ± 6.3%). At baseline, mean absolute bioavailability and clearance of midazolam were similar in the RYGB and diet groups, but higher compared with controls. On average, absolute bioavailability was unaltered at week 9, but decreased by 40 ± 7.5% in the RYGB group and 32 ± 6.1% in the diet group at year 2 compared with baseline, with no between‐group difference. No difference in clearance was observed over time, nor between groups. In conclusion, neither RYGB per se nor weight loss impacted absolute bioavailability or clearance of midazolam short term. Long term, absolute bioavailability was similarly decreased in both groups despite different weight loss, suggesting that the recovered CYP3A‐activity is not only dependent on weight‐loss through RYGB. [ABSTRACT FROM AUTHOR]

Published
2022
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32. A Comparative Analysis of Cytochrome P450 Activities in Paired Liver and Small Intestinal Samples from Patients with Obesity

Author

Krogstad, Veronica, primary, Peric, Alexandra, additional, Robertsen, Ida, additional, Kringen, Marianne K., additional, Wegler, Christine, additional, Angeles, Philip Carlo, additional, Hjelmesæth, Jøran, additional, Karlsson, Cecilia, additional, Andersson, Shalini, additional, Artursson, Per, additional, Åsberg, Anders, additional, Andersson, Tommy B., additional, and Christensen, Hege, additional

Published
2019
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35. Proteomics‐Informed Prediction of Rosuvastatin Plasma Profiles in Patients With a Wide Range of Body Weight.

Author

Wegler, Christine, Prieto Garcia, Luna, Klinting, Signe, Robertsen, Ida, Wiśniewski, Jacek R., Hjelmesæth, Jøran, Åsberg, Anders, Jansson‐Löfmark, Rasmus, Andersson, Tommy B., and Artursson, Per

Subjects
BODY weight, ROSUVASTATIN, GASTRIC bypass, LIVER biopsy, PREDICTION models
Abstract

Rosuvastatin is a frequently used probe to study transporter‐mediated hepatic uptake. Pharmacokinetic models have therefore been developed to predict transporter impact on rosuvastatin disposition in vivo. However, the interindividual differences in transporter concentrations were not considered in these models, and the predicted transporter impact was compared with historical in vivo data. In this study, we investigated the influence of interindividual transporter concentrations on the hepatic uptake clearance of rosuvastatin in 54 patients covering a wide range of body weight. The 54 patients were given an oral dose of rosuvastatin the day before undergoing gastric bypass or cholecystectomy, and pharmacokinetic (PK) parameters were established from each patient's individual time‐concentration profiles. Liver biopsies were sampled from each patient and their individual hepatic transporter concentrations were quantified. We combined the transporter concentrations with in vitro uptake kinetics determined in HEK293‐transfected cells, and developed a semimechanistic model with a bottom‐up approach to predict the plasma concentration profiles of the single dose of rosuvastatin in each patient. The predicted PK parameters were evaluated against the measured in vivo plasma PKs from the same 54 patients. The developed model predicted the rosuvastatin PKs within two‐fold error for rosuvastatin area under the plasma concentration versus time curve (AUC; 78% of the patients; average fold error (AFE): 0.96), peak plasma concentration (Cmax; 76%; AFE: 1.05), and terminal half‐life (t1/2; 98%; AFE: 0.89), and captured differences in the rosuvastatin PKs in patients with the OATP1B1 521T

Published
2021
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40. Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL)

Author

Hjelmesæth, Jøran, primary, Åsberg, Anders, additional, Andersson, Shalini, additional, Sandbu, Rune, additional, Robertsen, Ida, additional, Johnson, Line Kristin, additional, Angeles, Philip Carlo, additional, Hertel, Jens Kristoffer, additional, Skovlund, Eva, additional, Heijer, Maria, additional, Ek, Anna-Lena, additional, Krogstad, Veronica, additional, Karlsen, Tor-Ivar, additional, Christensen, Hege, additional, Andersson, Tommy B, additional, and Karlsson, Cecilia, additional

Published
2018
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43. High Tacrolimus Clearance Is a Risk Factor for Acute Rejection in the Early Phase After Renal Transplantation

Author

Egeland, Erlend Johannessen, primary, Robertsen, Ida, additional, Hermann, Monica, additional, Midtvedt, Karsten, additional, Størset, Elisabet, additional, Gustavsen, Marte Theie, additional, Reisæter, Anna Varberg, additional, Klaasen, Rolf, additional, Bergan, Stein, additional, Holdaas, Hallvard, additional, Hartmann, Anders, additional, and Åsberg, Anders, additional

Published
2017
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44. Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Posttransplant Diabetes Mellitus.

Author

Strøm Halden, Thea Anine, Kvitne, Kine Eide, Midtvedt, Karsten, Rajakumar, Laavanyaah, Robertsen, Ida, Brox, Jan, Bollerslev, Jens, Hartmann, Anders, Åsberg, Anders, Jenssen, Trond, and Halden, Thea Anine Strøm

Subjects
EMPAGLIFLOZIN, KIDNEY transplantation, DIABETES, KIDNEY transplant complications, PATIENT safety, TREATMENT effectiveness, TREATMENT of diabetes
Abstract

Objective: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have lately become the recommended treatment in patients with type 2 diabetes and high cardiovascular risk. Patients with posttransplant diabetes mellitus (PTDM) also have high cardiovascular risk. The aim of this study was to investigate the safety and efficacy of empagliflozin in renal transplant recipients with PTDM.Research Design and Methods: Forty-nine renal transplant recipients were included in an investigator-initiated, single-center, prospective, double-blind study and randomized to receive either 10 mg empagliflozin or placebo once daily for 24 weeks. Patients transplanted >1 year ago, diagnosed with PTDM, with stable renal function (estimated glomerular filtration rate [eGFR] >30 mL/min/1.73 m2), and with stable immunosuppressive therapy were studied.Results: Forty-four renal transplant recipients (22 empagliflozin/22 placebo, 34 males) completed the study. Median (interquartile range) change in glycated hemoglobin (HbA1c) was significantly reduced with empagliflozin compared with placebo: -0.2% (-0.6, -0.1) (-2.0 mmol/mol [-6.5, -1.0]) vs. 0.1% (-0.1, 0.4) (1.0 mmol/mol [-0.75, 3.8]) (P = 0.025). The magnitude of glucose reduction was dependent on GFR and baseline HbA1c. The treatment also resulted in a significant reduction in body weight of -2.5 kg (-4.0, -0.05) compared with an increase of 1.0 kg (0.0, 2.0) in the placebo group (P = 0.014). There were no significant differences between the groups in adverse events, immunosuppressive drug levels, or eGFR.Conclusions: Empagliflozin appeared safe and improved glycemic control in renal transplant recipients with PTDM compared with placebo. A concomitant reduction in body weight was seen. [ABSTRACT FROM AUTHOR]

Published
2019
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45. High tacrolimus clearance – a risk factor for development of interstitial fibrosis and tubular atrophy in the transplanted kidney: a retrospective single‐center cohort study.

Author

Egeland, Erlend Johannessen, Reisæter, Anna Varberg, Robertsen, Ida, Midtvedt, Karsten, Strøm, Erik Heyerdahl, Holdaas, Hallvard, Hartmann, Anders, and Åsberg, Anders

Subjects
COHORT analysis, DISEASE risk factors, ATROPHY, FIBROSIS, KIDNEY transplantation, TACROLIMUS, METABOLIC clearance rate, BIOPSY
Abstract

Summary: Patients with high tacrolimus clearance are more likely to experience transient under‐immunosuppression in case of a missed or delayed dose. We wanted to investigate the association between estimated tacrolimus clearance and development of graft interstitial fibrosis and tubular atrophy (IFTA) in kidney transplant recipients. Associations between estimated tacrolimus clearance [daily tacrolimus dose (mg)/trough concentration (μg/l)] and changes in IFTA biopsy scores from week 7 to 1‐year post‐transplantation were investigated. Data from 504 patients transplanted between 2009 and 2013 with paired protocol biopsies (7 weeks + 1‐year post‐transplant) were included. There were no differences in baseline biopsy scores (7 weeks) in patients with different estimated tacrolimus clearance. Increasing tacrolimus clearance was significantly associated with increased ci + ct score of ≥2 at 1 year, odds ratio of 1.67 (95% CI; 1.11–2.51). In patients without fibrosis (ci + ct ≤ 1) at 7 weeks (n = 233), increasing tacrolimus clearance was associated with development of de novo IFTA (i + t ≤ 1 and ci + ct ≥ 2) at 1 year, odds ratio of 2.01 (95% CI; 1.18–3.50) after adjusting for confounders. High tacrolimus clearance was significantly associated with development of IFTA the first year following renal transplantation. [ABSTRACT FROM AUTHOR]

Published
2019
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46. Pharmacological treatments and monitoring strategies to improve outcome in solid organ transplants

Author

Robertsen, Ida

Abstract

Following solid organ transplantation individualizing the immunosuppressive therapy to obtain an optimal balance between therapeutic efficacy and the occurrence of adverse events is the ultimately goal. This is complicated by the high intra- and interindividual pharmacokinetic variability and the narrow therapeutic index of the immunosuppressive drugs. Small variations in drug exposure may result in suboptimal immunosuppression or drug toxicity, with potentially adverse effects on patient outcomes. Therapeutic drug monitoring (TDM) is therefore mandatory in order to individualize the therapy. More knowledge and further improvements of drug treatment strategies and monitoring techniques are still desirable to further improve TDM and hence potentially both short- and long term outcomes after transplantation. The primary objective of this thesis was to investigate some different pharmacological treatments and monitoring strategies to improve outcome in solid organ transplants. In this thesis results from three prospective clinical trials in solid organ transplants are presented. The lipid-lowering effect of rosuvastatin in comparison with fluvastatin, and the potential bilateral drug-drug interaction between rosuvastatin and everolimus (EVE) were assessed in renal transplant recipients at a stable phase following transplantation. Further, the relationship between both cyclosporine A (CsA) and EVE concentrations in different body compartments were evaluated as potential TDM tools in heart- and renal transplant recipients, respectively. Finally, the bioequivalence of an approved generic tacrolimus (TAC) was investigated with the original drug as reference in elderly stable renal transplant recipients. In renal transplant recipients receiving EVE based immunosuppression and treated with fluvastatin, a switch to rosuvastatin induced a significant additional lipid lowering effect. The combination of EVE and rosuvastatin appears to be safe as EVE pharmacokinetics were unaffected following the switch to rosuvastatin. The systemic exposure of rosuvastatin was less than 3-fold higher compared to non-transplants reported in the literature when combined with EVE, and this is comparable to what is previously shown for fluvastatin in combination with CsA, a combination considered to be safe in renal transplant recipients. Safely achieving reduction in lipids could be of great importance in reducing cardiovascular risk in this high risk population. No correlation between CsA concentrations in whole blood, T-lymphocytes or endomyocardial tissue was established in heart transplant recipients, potentially challenging traditional TDM based on whole blood CsA concentrations in these patients. In contrast, EVE concentrations in whole blood and PBMC correlated well and supports that TDM of EVE in whole blood is an appropriate choice. The generic TAC formulation was not found to be bioequivalent to the original drug in elderly renal transplant recipients. Use of generic TAC resulted in a significantly higher systemic drug exposure. In the long run this may put the patients at higher risk of calcineurin inhibitor-related toxicity and impaired long-term outcomes. Importantly, the lack of bioequivalence would not have been detected by the standard monitoring parameter, TAC trough concentrations, as these concentrations were similar for both formulations Generic TAC should be used with caution in elderly renal transplant recipients and it should be recognized that bioequivalence studies performed in healthy volunteers do not necessarily reflect the average transplant recipient.

Published
2014

47. Closer to the Site of Action

Author

Robertsen, Ida, primary, Vethe, Nils Tore, additional, Midtvedt, Karsten, additional, Falck, Pål, additional, Christensen, Hege, additional, and Åsberg, Anders, additional

Published
2015
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49. Rimonabants effekter på farmakokinetikken til ciklosporin A og takrolimus i nyretransplanterte pasienter

Author

Robertsen, Ida

Subjects
yretransplanterte cyklosporin
Abstract

Bakgrunn: De siste årene har overvekt og fedme blitt et økende problem hos nyretransplanterte pasienter, og bidrar til en økt risiko for kardiovaskulær sykdom. Kardiovaskulær sykdom er allerede den vanligste dødsårsaken hos nyretransplanterte, og det er derfor et stort behov for å minimere risikofaktorer for kardiovaskulær morbiditet og mortalitet hos denne pasientpopulasjonen. Nyretransplanterte blir behandlet med en livslang immunsuppresjonterapi, der kalsineurinhemmerene CsA og Tac, utgjør grunnsteinene. Begge legemidlene er karakterisert av et smalt terapeutisk vindu. Det er derfor svært viktig at alle nye legemidler vurderes som å ha et potensial til å påvirke CsA eller Tac konsentrasjoner inntil data eller erfaring tilsier det motsatte. Rimonabant er et nytt legemiddel, som i tillegg til sine vektreduserende egenskaper, også har vist gunstige effekter på andre risikofaktorer for kardiovaskulær sykdom av interesse for nyretransplanterte pasienter. En interaksjonsstudie mellom kalsineurinhemmerene og rimonabant har ikke tidligere blitt utført. Mål og metoder: I denne studien ble effektene av rimonabant på farmakokinetikken til CsA og Tac undersøkt i 18 pasienter med stabil nyrefunksjon. Pasientene brukte enten CsA (n = 10) eller Tac (n = 8), i tillegg til steroider og mykofenolat. 12-timers farmakokinetikk undersøkelser for å måle CsA og Tac konsentrasjoner ble utført før og etter en to måneders lang behandlingsperiode med 20 mg rimonabant daglig. Det ble i tillegg utført en oral glukosebelastning både før og etter rimonabantbehandlingen for å undersøke om pasientenes insulinsensitivitet ble forbedret av rimonabant. Det ble også observert om rimonabantbehandlingen førte til en reduksjon av kroppsvekten til pasientene. Resultater: En to måneders lang behandlingsperiode med rimonabant induserte en moderat 23 ± 56 %, men signifikant økning i CsA AUC0-12 (p = 0,043) etter at seks av pasientene var analysert. Farmakokinetikken til Tac endret seg ikke i noen relevant grad og nyrefunksjonen til pasientene holdt seg stabil under rimonabantbehandlingen. Det ble i tillegg vist en signifikant nedgang i vekt/BMI etter behandling med rimonabant. Insulinsensitiviteten viste derimot ingen forbedring etter den to måneders lange rimonabantbehandlingen. Konklusjon: En samtidig administrering av rimonabant i to måneder viste en moderat effekt på farmakokinetikken til CsA. Dette er av et omfang som det må ta hensyn til i klinikken, sett at analysene av de tre siste pasientene viser den samme tendensen. Farmakokinetikken til Tac ble ikke påvirket i noen relevant grad, og dette indikerer at det vil være trygt å administrere rimonabant samtidig med Tac i nyretransplanterte pasienter. Rimonabant induserte en svak nedgang i vekt/BMI, men hadde ingen effekt på insulinsensitiviteten etter den to måneders lange behandlingsperioden.

Published
2008

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