Twice Daily Fractionated Dose Administration of Prednisolone Compared to Standard Once Daily Administration to Patients with Glomerulonephritis or with Kidney Transplants*

Decker, Sebastian; Keller, Frieder; Mayer, Jens; Stracke, Sylvia

doi:10.1007/s00063-009-1091-x

Cited by 5 publications

(3 citation statements)

References 26 publications

(28 reference statements)

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“…There is currently no trial evidence to support the use of pharmacological therapy to delay or prevent the development of PTDM in kidney transplant recipients, although a small proofof-concept trial of 50 kidney transplant recipients without diabetes showed that the prescription of basal insulin in the immediate post-transplant period may reduce the incidence of PTDM, possibly by insulin-mediated protection of beta cells (127). Even though immunosuppressive agents have been shown to predispose to the development PTDM, it remains unclear whether the modification of immunosuppressive regimen (e.g., changing from tacrolimus to alternate agents; avoidance, minimization, or split dosing of corticosteroids) can reduce diabetogenic effect or consistently reverse the presence of established PTDM without resulting in a greater risk of other adverse allograft outcomes such as rejection and allograft loss (211)(212)(213)(214)(215)(216)(217). The benefit of lifestyle intervention (for weight reduction) or the use of "preventive" pharmacologic treatments including metformin, DPP4-inhibitor, and thiazolidinediones to reduce the risk of progression from a pre-diabetic state to type 2 diabetes in the general population has not been shown for kidney transplant recipients, but these approaches are currently being evaluated in this population group (218)(219)(220)(221)(222)(223).…”

Section: Management Of Kidney Transplant Recipients With Ptdmmentioning

confidence: 99%

Global Epidemiology, Health Outcomes, and Treatment Options for Patients With Type 2 Diabetes and Kidney Failure

Phillips¹,

Chen²,

Ooi³

et al. 2021

Front. Clin. Diabetes Healthc.

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The burden of type 2 diabetes and related complications has steadily increased over the last few decades and is one of the foremost global public health threats in the 21st century. Diabetes is one of the leading causes of chronic kidney disease and kidney failure and is an important contributor to the cardiovascular morbidity and mortality in this population. In addition, up to one in three patients who have received kidney transplants develop post-transplant diabetes, but the management of this common complication continues to pose a significant challenge for clinicians. In this review, we will describe the global prevalence and temporal trend of kidney failure attributed to diabetes mellitus in both developing and developed countries. We will examine the survival differences between treated kidney failure patients with and without type 2 diabetes, focusing on the survival differences in those on maintenance dialysis or have received kidney transplants. With the increased availability of novel hypoglycemic agents, we will address the potential impacts of these novel agents in patients with diabetes and kidney failure and in those who have developed post-transplant diabetes.

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Section: Management Of Kidney Transplant Recipients With Ptdmmentioning

confidence: 99%

Global Epidemiology, Health Outcomes, and Treatment Options for Patients With Type 2 Diabetes and Kidney Failure

Phillips¹,

Chen²,

Ooi³

et al. 2021

Front. Clin. Diabetes Healthc.

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“…An uncontrolled observational study of people with glomerulonephritis and ater kidney transplants appeared to support this notion because patients receiving twice daily fractionated doses of oral prednisolone had a decreased magnitude of proteinuria and a lesser requirement for additional immunosuppressive drugs compared with once daily dosing. 9 Conversely, more frequent administration of prednisolone results in greater adrenocortical suppression in dogs, 10 and may also increase the risk of typical adverse efects, including polyuria, polydipsia, polyphagia, excessive panting, muscle weakness and muscle wastage. 6 Previous studies have not focused on the impact these adverse efects could have on the quality of life (QoL) of the patient and their owner, even though these could have a substantial impact on the owner's decision to pursue treatment.…”

Section: Introductionmentioning

confidence: 99%

“…This relationship suggests that twice daily administration of prednisolone may increase its efficacy for management of autoimmune diseases by increasing its availability at the receptor site. An uncontrolled observational study of people with glomerulonephritis and after kidney transplants appeared to support this notion because patients receiving twice daily fractionated doses of oral prednisolone had a decreased magnitude of proteinuria and a lesser requirement for additional immunosuppressive drugs compared with once daily dosing 9 …”

Section: Introductionmentioning

confidence: 99%

Randomised controlled trial of fractionated and unfractionated prednisolone regimens for dogs with immune‐mediated haemolytic anaemia

Swann

Szladovits

Threlfall³

et al. 2019

Veterinary Record

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MethodsA randomised non-blinded non-inferiority trial was conducted to determine whether treatment with an unfractionated regimen of oral prednisolone was inferior to a fractionated regimen for dogs with primary immune-mediated haemolytic anaemia. Dogs received the same total daily dose of prednisolone as unfractionated (group 1, starting at 4 mg/kg orally once daily) or fractionated (group 2, starting at 2 mg/kg orally twice daily) doses. Questionnaires were administered to owners to assess adverse effects and quality of life (QoL). End points included survival to eight weeks, and changes in QoL and clinicopathological parameters over time.ResultsThirty-nine dogs were enrolled in the study, of which 5 were withdrawn and 17 were assigned to each group. The number of cases recruited was insufficient to determine whether unfractionated treatment was inferior to fractionated. Total serum bilirubin decreased more rapidly in dogs in group 2, whereas polydipsia improved more rapidly in group 1. Blood pressure and score for polyuria were higher in dogs in group 2 over time, whereas lymphocyte concentration was lower.ConclusionAdministration of the same total daily dose of prednisolone as an unfractionated dose resulted in fewer adverse effects but the effect on survival could not be assessed in this study.

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Clinical Pharmacokinetics and Pharmacodynamics of Prednisolone and Prednisone in Solid Organ Transplantation

et al. 2012

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Prednisolone and prednisone are integral components of induction and maintenance immunosuppressive regimens in solid organ transplantation. The pharmacokinetics of these agents are extremely complex. Prednisolone is the active drug moiety while prednisone is both a pro-drug and inactive metabolite of prednisolone. Within the dosage range used in transplantation, prednisolone and prednisone exhibit concentration-dependent non-linear pharmacokinetics when parameters are measured with reference to total drug concentration. Dose dependency disappears when free (unbound) prednisolone is measured. Altered organ function, changing biochemistry and use of a number of concomitant medicines in transplantation appear to lead to pharmacokinetic differences in transplant recipients compared with other patient groups. Greater than threefold variability in dose-adjusted exposure to total prednisolone in transplant recipients is evident. Time post-transplant, hepatic and renal dysfunction, patient age, sex, bodyweight, serum albumin concentration, concomitant medication exposure, various disease states and genetic polymorphisms in metabolic enzymes and drug transporters have sometimes been associated with prednisolone pharmacokinetic variability. The clinical impact of corticosteroid therapy on the disposition of ciclosporin, tacrolimus and sirolimus and the impact of different immunosuppressant therapy combinations on prednisolone exposure needs to be further elucidated. Patient response patterns to prednisolone are consistent with delayed and indirect mechanisms of corticosteroid action involving modification of nuclear transcription and protein synthesis. Many adverse effects have been linked with prednisolone and prednisone therapy, but not all of these have been investigated thoroughly in transplant populations. Dyslipidaemia, growth restriction, diabetogenesis, hypertension and cataracts are well studied toxicities. Evidence is less clear for prednisolone-induced osteonecrosis, obesity and hypertriglyceridaemia. There have been some reports of a relationship between prednisolone pharmacokinetics and incidence of acute rejection, Cushing's syndrome and adverse cardiovascular and metabolic events. Dosing of prednisolone and prednisone in transplantation is typically empirical and varies significantly across transplant centres. Currently, authoritative guidelines are conflicting in their opinions regarding corticosteroid avoidance and early discontinuation in adult kidney transplantation. Overall, data suggest the promise of corticosteroid-free immunosuppression in paediatric patients. Further investigation of the pharmacokinetics and pharmacodynamics of prednisolone and prednisone in transplant recipients based on new chromatography assay techniques and free drug measurement, population pharmacokinetic/pharmacodynamic modelling approaches, genetic testing and larger studies in patients on modern day immunosuppressant protocols may lead to better individualization of corticosteroid therapy in the future.

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Twice Daily Fractionated Dose Administration of Prednisolone Compared to Standard Once Daily Administration to Patients with Glomerulonephritis or with Kidney Transplants*

Abstract: Twice daily fractionated administration of prednisolone allows a lower daily dose (total 2.5 mg/day), and appears to be as efficient but less diabetogenic compared to the standard once daily dosing (4.0 mg/day).

Cited by 5 publications

References 26 publications

Global Epidemiology, Health Outcomes, and Treatment Options for Patients With Type 2 Diabetes and Kidney Failure

Global Epidemiology, Health Outcomes, and Treatment Options for Patients With Type 2 Diabetes and Kidney Failure

Randomised controlled trial of fractionated and unfractionated prednisolone regimens for dogs with immune‐mediated haemolytic anaemia

Clinical Pharmacokinetics and Pharmacodynamics of Prednisolone and Prednisone in Solid Organ Transplantation

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