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In this episode I’ll:

1. Discuss an article comparing apixaban with warfarin in patients with severe renal impairment.

2. Answer the drug information question “Should high dose methylprednisolone be given for intraoperative spinal cord injury?”

3. Share a resource for understanding CMS quality measures.

Article

Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment

Lead author: Brooke E. Stanton

Published online in Pharmacotherapy January 2017

Background

When a new medication comes to market, renal dosing guidelines are rarely based on randomized controlled trials. Instead, pharmacokinetic studies are usually extrapolated to provide renal dosing guidelines. This is exactly what happened with apixaban. Clinical trials of apixaban excluded patients with a CrCl less than 25 mL/minute or a serum creatinine concentration (SCr) greater than 2.5 mg/dL. The FDA used pharmacokinetic data to base its approval of apixaban use in patients with a CrCl less than 15 mL/minute or hemodialysis. The authors of this study sought to examine the safety and effectiveness of apixaban versus warfarin in patients with severe renal impairment.

Methods

The study was a retrospective, matched cohort study in a single community hospital. 73 patients with severe renal impairment who received apixaban were matched 1:1 with 73 patients with severe renal impairment who received warfarin. The primary outcome was major bleeding, and the secondary outcomes included the composite of bleeding (major bleeding, clinically relevant non-major bleeding, and minor bleeding) in addition to documented ischemic stroke or recurrent venous thromboembolism.

Results

Although the patients who received apixaban had numerically fewer bleeding events, this difference was not statistically significant. The risk of stroke between groups was identical.

Conclusion

The authors concluded:

Apixaban appears to be a reasonable alternative to warfarin in patients with severe renal impairment.

Discussion

Using apixaban in patients with severe renal impairment makes me nervous, even though only 27% of the medication is eliminated in the urine.

Do you use apixaban in patients with end-stage renal disease? — Pharmacy Joe ?? (@PharmacyJoe) February 8, 2017

A recent case report described a 65-year-old patient with end-stage renal disease who had massive gastrointestinal bleeding while on apixaban. This matched cohort study does provide better evidence to base a judgment on than a case report or pharmacokinetic study. Although I have no data to support it, I would feel more comfortable checking at least one anti-Xa level once the apixaban has reached steady state.

Drug information question

Q: Should high dose methylprednisolone be given for intraoperative spinal cord injury?

A: No one knows, but you can bet the surgeon will request it.

Intraoperative spinal cord injury is a nightmare scenario for surgeons. It may occur accidentally from an instrument or screw being misplaced during surgery. Most data on using methylprednisolone to treat spinal cord injury comes from the National Acute Spinal Cord Injury Study (NASCIS) which only looked at blunt, closed spinal cord injury.

I cannot find any prospective data on using methylprednisolone in open spinal cord trauma that may occur intraoperatively. The potential risks of postoperative GI bleeding, infection and hyperglycemia from using methylprednisolone will probably be overshadowed in the surgeon’s mind by the theoretical benefit of reducing the spinal cord injury. If requested, the NASCIS protocol calls for a methylprednisolone bolus dose of 30 mg/kg of body weight over 15 minutes, followed by a 45-minute pause, and then a 23-hour continuous infusion of 5.4 mg/kg/hr.

Resource

Pharmacists are often involved in helping hospitals achieve success on the quality measures set forth by the Centers for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC). Examples of such measures include those for the Surgical Care Improvement Project or Community Acquired Pneumonia treatment. Often, success hinges on a detailed knowledge of the rules related to the measures. If you find yourself in need of knowing the exact rules for any CMS/TJC quality measures, you can read the current specifications manual found on the website qualitynet.org.

If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies.

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