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Initial anticoagulation therapy in patients with venous thromboembolism and impaired renal function: results of an observational study

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Abstract

Aim

Patients undergoing initial therapeutic anticoagulation after a venous thromboembolic event (VTE) with severely impaired renal function (RI-VTE-patients) are at high risk of accumulating the anticoagulants resulting in an increased risk of bleeding events. Current guidelines/approved summary of product characteristics (SPC) recommend usage of specific anticoagulants only, monitoring of aXa-activity, and/or dose adjustment (in the case of enoxaparin) for initial therapeutic anticoagulation of RI-VTE patients. This study investigates the treatment of German RI-VTE-patients and evaluates whether guideline/SPC recommendations are implemented in the practice of real life care.

Subjects and methods

We conducted a chart review in five German acute hospitals. All VTE patients treated in these hospitals from 01/01/2007–31/12/2011 were included. Renal insufficiency (RI) was defined as CrCl < 30 ml/min. Treatment did not conform to the recommendations in guidelines/SPCs, if (1) a drug was used that is contraindicated according to the SPC or no initial anticoagulation treatment was implemented at all; (2) the recorded daily dose of enoxaparin was higher than the recommended weight-adjusted dose.

Results

Of 5,263 VTE patients identified, 709 (13.5 %) cases could not be documented due to missing charts (601) or no documented creatinine serum levels (108). Of the remaining 4,554 patients (mean age ±SD 67.4 years ±15.7; 53.0 % female; weight 80.2 kg ±20.0; 54.5 % deep VT), 337 (7.4 %) had a mean estimated GFR < 30 ml/min. In 19 (5.6 %) of these cases, patients were treated with a drug not recommended for use, 21 (6.2 %) did not receive any initial anticoagulation treatment and 91 (27.0 %) received a higher than recommended dosage of enoxaparin. Additionally, for 22 patients (6.5 %) receiving enoxaparin, no weight information was recorded and it is therefore unlikely that the dosage was adjusted correctly.

Conclusion

VTE treatment in RI-VTE-patients differs remarkably from labelled recommendations; over-dosage of enoxaparin is common. It seems fair to assume that these patients face a higher risk of adverse reactions, in particular bleeding events.

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Conflict of interest

This study was financially supported by LEO Pharma GmbH, Germany. Martin Wehling: The author was employed by AstraZeneca R&D, Molndal, as director of discovery medicine (= translational medicine) from 2003–2006, while on sabbatical leave from his professorship at the University of Heidelberg. Since returning to this position in January 2007, he has received lecturing and consulting fees from Sanofi-Aventis, Novartis, Takeda, Roche, Pfizer, Bristol-Myers, Daichii-Sankyo, Lilly, Novo-Nordisk, Shire and LEO Pharma. Rupert Bauersachs: The author has received consulting fees from Boehringer Ingelheim Pharma, Bayer, Bristol Myers Squibb and Leo Pharma. Steffen Amann: The author has received consulting fees from Boehringer Ingelheim Pharma, B. Braun, Bristol Myers Squibb, MSD International, Novartis Pharma, Pfizer Pharma and Leo Pharma. Thomas Wilke: The author has received consulting fees from Boehringer Ingelheim Pharma, Bayer, Bristol Myers Squibb, Roche, Astra Zeneca, Janssen Cilag and Leo Pharma.

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Authors and Affiliations

  1. Institute for Pharmacoeconomics and Medication Logistics, Philipp-Müller-Str. 12, 23966, Wismar, Germany

    Bjoern Boettger & Thomas Wilke

  2. Clinical Pharmacology, Mannheim/Center for Gerontopharmacology, Medical Faculty Mannheim, University of Heidelberg, Maybachstr. 14, 68169, Mannheim, Germany

    Martin Wehling

  3. Medical Department IV-Vascular Medicine, Max Ratschow Klinik, Klinikum Darmstadt GmbH, Grafenstr. 9, 64283, Darmstadt, Germany

    Rupert M. Bauersachs

  4. Staedtisches Klinikum Muenchen GmbH, Krankenhausapotheke Schwabing, Koelner Platz 1, 80804, Muenchen, Deutschland, Germany

    Steffen Amann

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  1. Bjoern Boettger
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Correspondence to Bjoern Boettger.

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Boettger, B., Wehling, M., Bauersachs, R.M. et al. Initial anticoagulation therapy in patients with venous thromboembolism and impaired renal function: results of an observational study. J Public Health 22, 89–99 (2014). https://doi.org/10.1007/s10389-013-0598-z

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