In this article published online by Pharmacy Times in August 2016, “Is Apixaban Safe and Effective for Patients on Hemodialysis?”, Brandon Dyson, PharmD, BCPS, who is a clinical pharmacist at an academic medical center, puts some scrutiny on Eliquis, an increasingly popular blood-thinner drug:
[Eliquis (apixaban)] is the only [novel oral anticoagulants (NOAC)] approved for use with creatinine clearance <15 mL/min. In fact, according to its package insert, there isn’t even a dose adjustment…. [T]he clinical trials for [Eliquis (apixaban)] didn’t include hemodialysis (HD) patients, but they’re able to recommend [Eliquis (apixaban)] use in HD patients with no dose adjustment. How?
You must dig deep to find the answer. The [Eliquis] package insert mentions a single-dose pharmacokinetic study in HD patients. If you dig a little further, you’ll eventually find it, and you’ll find out it only involved 8 patients….
What happens if you give multiple doses? [Eliquis (apixaban)] dosing is 5 mg BID in most patients. Does it accumulate in HD? We don’t know; it hasn’t been studied.
All we currently have is data from a single-dose trial in 8 patients. And that’s the point I’m trying to make. [Eliquis (apixaban)] may very well be safe and effective in HD, but we don’t actually know. It might be safe, but not effective, or it might be effective, but not safe. It also may be neither.
As for his mention of that eight (8) patient study, he referenced this medical journal article, “Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis.”, published in the May 2016 print edition of The Journal of Clinical Pharmacology.
Of course, this clinical pharmacist’s concern about — or skepticism of, perhaps — Eliquis use in the setting of hemodialysis piqued our interest.
The only thing we were able to readily find on-point was this item, “Apixaban in Hemodialysis”, on the ClinicalTrials.gov website, which provided us some rather limited information:
- This study has been completed.
- Sponsor: Jewish General Hospital
- First received: January 12, 2016
- Last updated: August 29, 2016
- No Study Results Posted on ClinicalTrials.gov for this Study
So, it seems, there is not much publicly available data about the safety of using Eliquis in the setting of hemodialysis. Yet, such use was apparently approved by the FDA.[Read this article in full at original source]
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