ArticleBMJ open2013
Renal function estimations and dose recommendations for dabigatran, gabapentin and valaciclovir: a data simulation study focused on the elderly.
Article in BMJ open, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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Who cites it
18 citing papers in PubMed, 43 citations in OpenAlex.
- Discrepancy Between Equations Estimating Kidney Function in Geriatric Care: A Study of Implications for Drug Prescription.Drugs & aging · 2019Article
- Choice of Renal Function Estimator Influences Adverse Outcomes with Dabigatran Etexilate in Patients with Atrial Fibrillation.TH open : companion journal to thrombosis and haemostasis · 2018Article
- Creatinine-Based Renal Function Estimates and Dosage of Postoperative Pain Management for Elderly Acute Hip Fracture Patients.Pharmaceuticals (Basel, Switzerland) · 2018Article
- Drug-Induced Kidney Injury in the Elderly.Drugs & aging · 2017Review
- Discrepancies between the Cockcroft-Gault and Chronic Kidney Disease Epidemiology (CKD-EPI) Equations: Implications for Refining Drug Dosage Adjustment Strategies.Clinical pharmacokinetics · 2017Article
- Direct oral anticoagulants in patients with chronic kidney disease: patient selection and special considerations.International journal of nephrology and renovascular disease · 2017Review
- Drug therapy management in patients with renal impairment: how to use creatinine-based formulas in clinical practice.European journal of clinical pharmacology · 2016Article
- Evaluation of the chromogenic anti-factor IIa assay to assess dabigatran exposure in geriatric patients with atrial fibrillation in an outpatient setting.Thrombosis journal · 2016Article
- Fluctuation of the renal function after discharge from hospital and its effects on drug dosing in elderly patients--study protocol.BMC nephrology · 2015Observational
- Development of a computerised decisions support system for renal risk drugs targeting primary healthcare.BMJ open · 2015Article
- Global Thrombosis Test - a possible monitoring system for the effects and safety of dabigatran.Thrombosis journal · 2015Article
- Influence of renal function estimation on pharmacokinetic modeling of vancomycin in elderly patients.Antimicrobial agents and chemotherapy · 2015Article
- Correlation between trough plasma dabigatran concentrations and estimates of glomerular filtration rate based on creatinine and cystatin C.Drugs in R&D · 2014Observational
- Measurement of non-VKA oral anticoagulants versus classic ones: the appropriate use of hemostasis assays.Thrombosis journal · 2014Review
- Management of non-vitamin K antagonist oral anticoagulants in the perioperative setting.BioMed research international · 2014Review
- Preventive strategies against bleeding due to nonvitamin K antagonist oral anticoagulants.BioMed research international · 2014Article
- Article
- In reply.Deutsches Arzteblatt international · 2013Article
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe thrombin inhibitor dabigatran is mainly excreted by the kidneys. We investigated whether the recommended method for estimation of renal function used in the clinical trials, the Cockcroft-Gault (CGold) equation and the estimated glomerular filtration rate (eGFR) modification of diet in renal disease equation 4 (MDRD4), differ in elderly participants, resulting in erroneously higher dose recommendations of dabigatran, which might explain the serious, even fatal, bleeding reported. The renally excreted drugs gabapentin and valaciclovir were also included for comparison.
designA retrospective data simulation study.
participantsParticipants 65 years and older included in six different studies.
main outcome measureEstimated renal function by CG based on uncompensated ('old Jaffe' method) creatinine (CGold) or by MDRD4 based on standardised compensated P-creatinine traceable to isotope-dilution mass spectrometry, and the resulting doses.
results790 participants (432 females), mean age (±SD) 77.6±5.7 years. Mean estimated creatinine clearance (eCrCl) by the CGold equation was 44.2±14.8 ml/min, versus eGFR 59.6±20.7 ml/min/1.73 m(2) with MDRD4 (p<0.001), absolute median difference 13.5, 95% CI 12.9 to 14.2. MDRD4 gave a significantly higher mean dose (valaciclovir +21%, dabigatran +25% and gabapentin +37%) of all drugs (p<0.001). With MDRD4 58% of the women would be recommended a full dose of dabigatran compared with 18% if CGold is used.
conclusionsMDRD4 would result in higher recommended doses of the three studied drugs to elderly participants compared with CG, particularly in women, and thus increased the risk of dose and concentration-dependent adverse reactions. It is important to know which method of estimation of renal function the Summary of Products Characteristics was based on, and use only that one when prescribing renally excreted drugs with narrow safety window. Doses based on recently developed methods for estimation of renal function may be associated with considerable risk of overtreatment in the elderly.
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Registered trials
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