Letter: Renal risk stratification with the new oral anticoagulants (JULY 2013)

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"...Originally, the US Food and Drug Administration approved dabigatran (Pradaxa) at a dose of 150 mg orally twice daily in patients with a creatinine clearance of 15 to 30 mL/min/1.73 m². This dosing corresponded to the estimated glomerular filtration rate (eGFR) in patients with stage 4 chronic kidney disease, but this dosing is contraindicated in other guidelines worldwide (Canada, Europe, the United Kingdom, Japan, Australia, and New Zealand).² Not unexpectedly, 3,781 serious adverse effects were noted in the 2011 US postmarketing experience with dabigatran. These included death (542 cases), hemorrhage (2,367 cases), acute renal failure (291 cases), stroke (644 cases), and suspected liver failure (15 cases).³ Thirteen months after dabigatran’s approval in the United States, Boehringer Ingelheim changed the dosage and product guidelines.^2–4 The new dosage⁴ is 75 mg twice daily for patients with a creatinine clearance of 15 to 30 mL/min/1.73 m².

Therefore, I suggest a nephrologic “way out”⁵ when using the new oral anticoagulants to avoid the problems with dabigatran noted above......