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Adopting rivaroxaban (Xarelto): The pros and the cons

Nov 8, 2011 16:28 EST


Now that Xarelto has been FDA approved and is becoming available in pharmacies across the US, how should we adopt this new drug?

To read my comparative review of the literature, download this slideset.

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Your comments
Adopting rivaroxaban (Xarelto): The pros and the cons
# 1 of 6
November 11, 2011 01:41 (EST)
Steve Kimmel

Great blog.  Very thoughtful and balanced presentation of the data.

One clarification to make: the TTR is calculated using a linear interpolation so it does not consider someone out of range until the next INR is draw.  For example, if INR is 3.2 today and next INR is checked in 4 days and is 2.8, the INR is assumed to have gone from 3.1 to 3.0 to 2.9 to 2.8 over the 4 day period and the TTR would be 75% (i.e., 3 days in range and 1 day out of range).

One question: given the short half life of rivoraxaban, are you concerned about the once a day dosing at all?

 

Thanks. 

# 2 of 6
November 19, 2011 04:31 (EST)
Peter

Wow, I think that you missed some key points with a weak analysis.

It's clear that Rivaroxaban has a better renal strategy since the approved dose was actually used in the trial, unlike Dabigatran.

 

Actually, Dabigatran has more troublesome drug-to-drug interactions, such as with anti-arrhythmics like amiodarone.

 You did not even mention the increased rate of dyspepsia since with Dabigatran.

 You also did not mention the recent failed medical prophylaxis trial with Dabigatran or the successful ACS trial with Rivaroxaban.

 

Clearly, there are not great differences between these two medications in stroke prevention, except for their completely different MOA, but once a day is a big deal. Renal dosing for patients with moderate dysfunction is helpful. Dyspepsia, if avoidable, is also an advantage.

You kept harping on the evening meal.  Rivaroxaban's absorption is affected by food, not the time of day, but only at the 15 & 20mg dose.

# 3 of 6
November 20, 2011 06:48 (EST)
DrSethdb

Steve, thanks for your comments

I agree that dyspepsia and GI bleeding are Dabigatran's most significant limitation and I think its the most improtant difficulty in choosing the pros and cons of the soon to be 4 drugs for thromboembolic protection in AF.  I thank you for emphasizing that point.

I dont agree based on my reading of the package inserts about the drug interactions of Pradaxa and Xarelto.

I don't agree with your statement:  "It's clear that Rivaroxaban has a better renal strategy since the approved dose was actually used in the trial, unlike Dabigatran"

All the trials did not test patients with the CrCL that was appoved by the FDA. All 3 trials excluded patients with CrCL < 30.  I dont think it makes sense to use either of the 2 new approved drugs with CrCl < 30 since we have no data on those patients.  The specific statement from ROCKET AF supplement on trial EXCLUSION in NEJM is Calculated CLCR <30 mL/min at the screening visit.

 I do think the evening meal issue is significant for my patients - perhaps different for yours - most of my patients do not eat their evening meal at a consistent time each day, so I think this will be a potential problem to monitor with regular discussions at follow-up or ignore and hope for the best, but either way a concern since we have no way to monitor levels - thanks again for your post.

# 4 of 6
November 21, 2011 07:09 (EST)
Dante

Very imformative, thank you.

I noticed Rivaroxaban attempted the NVAF back in the beginning of 2008.

What are your thoughts on why the FDA has waited so long to approve this medication for indication?

# 5 of 6
November 21, 2011 10:40 (EST)
DrSethdb
ROCKET AF completed enrollment in June 2009 and terminated in May 2010.  I think this is actually pretty fast by usual FDA standards to go from trial completion to market approval in 18 minths.
# 6 of 6
December 9, 2011 01:20 (EST)
Mark
One thing we may want to keep in mind is that a "bad" (such as non-compliant) warfarin patient will likely make a "bad" Pradaxa or Xarelto patient because likely they will not adhere to recommended dosing of any of them.  Warfarin may be safer if patients forget a dose or two r/t longer half-life.  But then again, am I being bias because I run a Anticoagulation Clinic?  Appreciate others thoughts on this. 

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About Dr Seth Bilazarian
Seth Bilazarian MD has been a Clinical and Interventional Cardiologist at Pentucket Medical Associates in Massachusetts since 1993. He is board certified in Internal Medicine, Cardiovascular Medicine, Nuclear Cardiology, Vascular Ultrasound, Interventional Cardiology, and Vascular and Endovascular Medicine.

Dr Bilazarian performs coronary and peripheral interventions at Lahey Clinic and Massachusetts General Hospital. He has been an investigator in the interventional laboratory for new devices including drug-eluting stents, distal protection devices, imaging devices (OCT and InfraRed), and anticoagulant pharmacotherapy.

Dr Bilazarian is an active participant in clinical trials in congestive heart failure, hypertension, coronary disease prevention, prediabetes management, anemia, atrial fibrillation, and anticoagulation/antiplatelet therapies in the outpatient setting. He has authored numerous papers and book chapters in clinical cardiology. He was appointed as a physician advisor to the circulatory device panel of the FDA in 2008.
About this blog
My intent is to create a forum for dialogue on issues pertinent to private practice cardiology around topics such as:

  • Integration of new data and guidelines on inpatient and outpatient practice in clinical and interventional cardiology
  • Practice approaches to the extra clinical issues in dealing with managed care insurers
  • Strategies for navigating the restrictions of pharmacy benefits managers (PBMs) on pharmacologic therapies for our patients
  • Experiences with restrictions on testing and imaging
The video blog (VLOG) will provide an opportunity to share broadly different approaches to the common conundrums we face in caring for patients. My hope is that this forum will provide useful data points for practice outside of tertiary and academic centers and a look inside community hospitals and physician?s practice patterns in the office, starting with mine.