@article{TuetuencueOlmaKunzeetal.2022,
  author    = {T{\"u}t{\"u}nc{\"u}, Serdar and Olma, Manuel C. and Kunze, Claudia and Kr{\"a}mer, Michael and Dietzel, Joanna and Schurig, Johannes and Filser, Paula and Pfeilschifter, Waltraud and Hamann, Gerhard F. and B{\"u}ttner, Thomas and Heuschmann, Peter U. and Kirchhof, Paulus and Laufs, Ulrich and Nabavi, Darius G. and R{\"o}ther, Joachim and Thomalla, G{\"o}tz and Veltkamp, Roland and Eckardt, Kai-Uwe and Haeusler, Karl Georg and Endres, Matthias},
  title     = {Levels and dynamics of estimated glomerular filtration rate and recurrent vascular events and death in patients with minor stroke or transient ischemic attack},
  series = {European Journal of Neurology},
  volume    = {29},
  journal   = {European Journal of Neurology},
  number    = {9},
  doi       = {10.1111/ene.15431},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-287271},
  pages     = {2716 -- 2724},
  year      = {2022},
  abstract  = {Background and purpose Impaired kidney function is associated with an increased risk of vascular events in acute stroke patients, when assessed by single measurements of estimated glomerular filtration rate (eGFR). It is unknown whether repeated measurements provide additional information for risk prediction. Methods The MonDAFIS (Systematic Monitoring for Detection of Atrial Fibrillation in Patients with Acute Ischemic Stroke) study randomly assigned 3465 acute ischemic stroke patients to either standard procedures or an additive Holter electrocardiogram. Baseline eGFR (CKD-EPI formula) were dichotomized into values of < versus ≥60 ml/min/1.73 m\(^{2}\). eGFR dynamics were classified based on two in-hospital values as "stable normal" (≥60 ml/min/1.73 m\(^{2}\)), "increasing" (by at least 15\% from baseline, second value ≥ 60 ml/min/1.73 m\(^{2}\)), "decreasing" (by at least 15\% from baseline of ≥60 ml/min/1.73 m\(^{2}\)), and "stable decreased" (<60 ml/min/1.73 m\(^{2}\)). The composite endpoint (stroke, major bleeding, myocardial infarction, all-cause death) was assessed after 24 months. We estimated hazard ratios in confounder-adjusted models. Results Estimated glomerular filtration rate at baseline was available in 2947 and a second value in 1623 patients. After adjusting for age, stroke severity, cardiovascular risk factors, and randomization, eGFR < 60 ml/min/1.73 m\(^{2}\) at baseline (hazard ratio [HR] = 2.2, 95\% confidence interval [CI] = 1.40-3.54) as well as decreasing (HR = 1.79, 95\% CI = 1.07-2.99) and stable decreased eGFR (HR = 1.64, 95\% CI = 1.20-2.24) were independently associated with the composite endpoint. In addition, eGFR < 60 ml/min/1.732 at baseline (HR = 3.02, 95\% CI = 1.51-6.10) and decreasing eGFR were associated with all-cause death (HR = 3.12, 95\% CI = 1.63-5.98). Conclusions In addition to patients with low eGFR levels at baseline, also those with decreasing eGFR have increased risk for vascular events and death; hence, repeated estimates of eGFR might add relevant information to risk prediction.},
  language  = {en}
}
@phdthesis{Steigenberger2013,
  author    = {Steigenberger, Jana Su},
  title     = {Kosten der Nierentransplantation in Abh{\"a}ngigkeit von der Transplantatfunktion},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-116499},
  school      = {Universit{\"a}t W{\"u}rzburg},
  year      = {2013},
  abstract  = {Die Nierentransplantation ist neben den verschiedenen Formen der Dialyse die wichtigste Therapieform f{\"u}r Patienten mit terminaler Niereninsuffizienz. In dieser retrospektiven, monozentrischen Analyse wurden 204 Patienten erfasst, die von 2000 bis 2007 eine Nierentransplantation im Universit{\"a}tsklinikum W{\"u}rzburg erhalten hatten. Die Patienten wurden an Hand ihrer Nierenfunktion in vier Gruppen eingeteilt und miteinander verglichen. Ziel dieser Studie war es, Einflussfaktoren auf die Nierenfunktion, Komplikationen und Kosten im ersten Jahr nach Nierentransplantation zu untersuchen. Wir konnten zeigen, dass eine l{\"a}ngere Wartezeit auf ein Spenderorgan und ein hoher pr{\"a}operativer BMI mit einer schlechteren Nierenfunktion nach Transplantation assoziiert waren. Außerdem fiel auf, dass in den Gruppen mit besserer Nierenfunktion nach Transplantation h{\"a}ufiger Lebendspenden durchgef{\"u}hrt worden waren. Zu den h{\"a}ufigsten Komplikationen im ersten Jahr nach Nierentransplantation geh{\"o}rten An{\"a}mien, akute Abstoßungsreaktionen, die verz{\"o}gerte Funktionsaufnahme des Organs, Infektionen, arterielle Hypertonie und Verschlechterungen der Transplantatfunktion. Eine h{\"o}here Komplikationsrate war mit einer schlechteren Nierenfunktion und h{\"o}heren Kosten assoziiert. Der Kostenmehraufwand ergab sich aus der Zunahme an ambulanten Interventionen sowie verl{\"a}ngerten bzw. zus{\"a}tzlichen station{\"a}ren Aufenthalten. In unserer Studie hatte die Gruppe mit der schlechtesten Nierenfunktion die meisten Komplikationen und verursachte so die h{\"o}chsten Kosten. Wir errechneten einen Gesamtkostenbetrag von 43.000€ im ersten Jahr nach Nierentransplantation pro Patient. 48 \% der Gesamtkosten entfielen dabei auf die DRG-Pauschale der Transplantation selbst, 28\% auf die immunsuppressive Therapie sowie 10 \% auf die Therapie und Prophylaxe von Infektionen. Somit lagen unsere Kosten f{\"u}r eine Nierentransplantation im ersten Jahr verglichen mit den Kosten f{\"u}r die H{\"a}modialyse in anderen, aktuellen Studien gleich oder h{\"o}her. Im Vergleich zu den Kosten der Peritonealdialyse anderer Studien waren sie durchgehend h{\"o}her. Die Kosten f{\"u}r einen transplantierten Patienten reduzierten sich laut Studien jedoch deutlich ab dem zweiten Jahr auf durchschnittlich 12.000€. Die Kosten einer H{\"a}modialyse beliefen sich je nach Studie auf 28.000-43.000 € pro Jahr. Eine Peritonealdialyse kostete ca. 25.000€. Damit ist die Transplantation mittel- und langfristig die g{\"u}nstigste Therapieform. Aus finanzieller Sicht sollten mehr dialysepflichtige Patienten mittels Peritonealdialyse behandelt und die Transplantationszahlen m{\"o}glichst gesteigert werden. Da die Anzahl an Nierentransplantationen von Risikopatienten weiter steigen wird, ist mit einer Zunahme von behandlungsbed{\"u}rftigen Komplikationen und nachfolgend mit einer Kostensteigerung zu rechnen. Zuk{\"u}nftig sollte versucht werden, Wartezeiten zu reduzieren, die Anzahl der Lebendspenden zu steigern und m{\"o}glichst Normalgewicht vor Transplantation zu erreichen. Um dem Kostenanstieg entgegenzuwirken, sollten Kosteneinsparungen durch Optimierung der immunsuppressiven Schemata und verst{\"a}rkten Einsatz von Generika realisiert werden. Auch eine bessere Infektionsprophylaxe sowie ein fr{\"u}hzeitiges Erkennen und Behandeln von manifesten Infektionen k{\"o}nnten die Kosten weiter reduzieren und die Transplantation {\"o}konomisch noch attraktiver werden lassen.},
  subject      = {Nierentransplantation},
  language  = {de}
}
@article{LapaWernerBluemeletal.2014,
  author    = {Lapa, Constantin and Werner, Rudolf A. and Bluemel, Christina and Lueckerath, Katharina and Muegge, Dirk O. and Strate, Alexander and Haenscheid, Heribert and Schirbel, Andreas and Allen-Auerbach, Martin S. and Bundschuh, Ralph A. and Buck, Andreas K. and Herrmann, Ken},
  title     = {Prediction of clinically relevant hyperkalemia in patients treated with peptide receptor radionuclide therapy},
  series = {EJNMMI Research},
  volume    = {4},
  journal   = {EJNMMI Research},
  number    = {74},
  doi       = {10.1186/s13550-014-0074-y},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-124963},
  year      = {2014},
  abstract  = {Background Peptide receptor radionuclide therapy (PRRT) is applied in patients with advanced neuroendocrine tumors. Co-infused amino acids (AA) should prevent nephrotoxicity. The aims of this study were to correlate the incidence of AA-induced hyperkalemia (HK) (≥5.0 mmol/l) and to identify predictors of AA-induced severe HK (>6.0). Methods In 38 patients, standard activity of \(^{177}Lu\)-labelled somatostatin analogs was administered. Pre-therapeutic kidney function was assessed by renal scintigraphy and laboratory tests. For kidney protection, AA was co-infused. Biochemical parameters (potassium, glomerular filtration rate, creatinine, blood urea nitrogen (BUN), sodium, phosphate, chloride, and lactate dehydrogenase (LDH)) were obtained prior to 4 and 24 h after the AA infusion. Incidence of HK (≥5.0) was correlated with pre-therapeutic kidney function and serum parameters. Formulas for the prediction of severe hyperkalemia (>6.0) were computed and prospectively validated. Results At 4 h, HK (≥5.0) was present in 94.7\% with severe HK (>6.0) in 36.1\%. Values normalized after 24 h in 84.2\%. Pre-therapeutic kidney function did not correlate with the incidence of severe HK. Increases in K+ were significantly correlated with decreases in phosphate (r = -0.444, p < 0.005) and increases in BUN (r = 0.313, p = 0.056). A baseline BUN of >28 mg/dl had a sensitivity of 84.6\% and a specificity of 60.0\% (AUC = 0.75) in predicting severe HK of >6.0 (phosphate, AUC = 0.37). Computing of five standard serum parameters (potassium, BUN, sodium, phosphate, LDH) resulted in a sensitivity of 88.9\% and a specificity of 79.3\% for the prediction of severe HK >6.0 (accuracy = 81.6\%). Conclusions A combination of serum parameters predicted prospectively the occurrence of relevant HK with an accuracy of 81.6\% underlining its potential utility for identifying 'high-risk' patients prone to PRRT.},
  language  = {en}
}
@article{KremerKivitzSimonCamposetal.2015,
  author    = {Kremer, Joel M and Kivitz, Alan J and Simon-Campos, Jesus A and Nasonov, Evgeny L and Tony, Hans-Peter and Lee, Soo-Kon and Vlahos, Bonnie and Hammond, Constance and Bukowski, Jack and Li, Huihua and Schulman, Seth L and Raber, Susan and Zuckerman, Andrea and Isaacs, John D},
  title     = {Evaluation of the effect of tofacitinib on measured glomerular filtration rate in patients with active rheumatoid arthritis: results from a randomised controlled trial},
  series = {Arthritis Research \& Therapy},
  volume    = {17},
  journal   = {Arthritis Research \& Therapy},
  number    = {95},
  doi       = {10.1186/s13075-015-0612-7},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-143409},
  year      = {2015},
  abstract  = {Introduction: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). During the clinical development programme, increases in mean serum creatinine (SCr) of approximately 0.07 mg/dL and 0.08 mg/dL were observed which plateaued early. This study assessed changes in measured glomerular filtration rate (mGFR) with tofacitinib relative to placebo in patients with active RA. Methods: This was a randomised, placebo-controlled, Phase 1 study (NCT01484561). Patients were aged \(\geq\)18 years with active RA. Patients were randomised 2: 1 to oral tofacitinib 10 mg twice daily (BID) in Period 1 then placebo BID in Period 2 (tofacitinib -> placebo); or oral placebo BID in both Periods (placebo. placebo). Change in mGFR was evaluated by iohexol serum clearance at four time points (run-in, pre-dose in Period 1, Period 1 end, and Period 2 end). The primary endpoint was the change in mGFR from baseline to Period 1 end. Secondary endpoints included: change in mGFR at other time points; change in estimated GFR (eGFR; Cockcroft-Gault equation) and SCr; efficacy; and safety. Results: 148 patients were randomised to tofacitinib -> placebo (N = 97) or placebo -> placebo (N = 51). Baseline characteristics were similar between groups. A reduction of 8\% (90\% confidence interval [CI]: 2\%, 14\%) from baseline in adjusted geometric mean mGFR was observed during tofacitinib treatment in Period 1 vs placebo. During Period 2, mean mGFR returned towards baseline during placebo treatment, and there was no difference between the two treatment groups at the end of the study - ratio (tofacitinib -> placebo/placebo -> placebo) of adjusted geometric mean fold change of mGFR was 1.04 (90\% CI: 0.97, 1.11). Post-hoc analyses, focussed on mGFR variability in placebo -> placebo patients, were consistent with this conclusion. At study end, similar results were observed for eGFR and SCr. Clinical efficacy and safety were consistent with prior studies. Conclusion: Increases in mean SCr and decreases in eGFR in tofacitinib-treated patients with RA may occur in parallel with decreases in mean mGFR; mGFR returned towards baseline after tofacitinib discontinuation, with no significant difference vs placebo, even after post-hoc analyses. Safety monitoring will continue in ongoing and future clinical studies and routine pharmacovigilance.},
  language  = {en}
}