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Pradaxa and Xarelto :
Coming Soon to Your Practice!!
®
®
A Peer-Reviewed Publication
Written by Leslie S.T. Fang, MD, PhD
Abstract
Pradaxa® (dabigatran) and Xarelto® (rivaroxaban)
are two new oral anticoagulants that are striving to
replace Coumadin® in the management of patients
with non-valvular atrial fibrillation. The drugs have
rapid onset of action, are taken in a fixed dose, do
not require PT/INR monitoring and there are no
dietary restrictions for the patients on these agents.
This has led to a rapid adoption by physicians. It is
therefore important for the dental professional to
understand the mechanism of action of these drugs
in order to intelligently manage these patients
when they need dental intervention. The pros and
cons of interruption of therapy are discussed as
they apply to patients needing simple and complex
dentistry. Medical consultation is mandatory prior
to interruption of anticoagulant therapy.
Publication date: Oct. 2013
Expiration date: Sept. 2016
Educational Objectives:
At the conclusion of this educational activity the
participant will be able to:
1. Describe Pradaxa® (dabigatran) and Xarelto®
(rivaroxaban) and why are they increasingly
prescribed
2. Discuss how these newer oral anticoagulants
differ from Coumadin®
3. Manage simple and complex dental
procedures in a patient on newer oral
anticoagulants
4. Safely utilize drugs commonly prescribed
by dentists for patients on newer oral
anticoagulants
5. Describe the drugs commonly prescribed by
dentists which should be avoided in patients
on newer oral anticoagulants
Author Profile
Leslie S.T. Fang received his PhD degree in Physiology and Biophysics from the
University of Illinois, Champaign-Urbana. He did his medical training at Harvard
Medical School and is board certified in Internal Medicine and Nephrology. He
has been on the staff of Massachusetts General Hospital and on the faculty of
Harvard Medical School. A clinician and a teacher, he maintains an active international practice in Internal Medicine and Nephrology and is a leading teacher
at Harvard Medical School. He has received numerous awards for excellence in
teaching from Harvard Medical School and has served and chaired the Medical
Internship Selection Committee at the Massachusetts General Hospital for two
decades. He is the co-author of the major textbook Principle and Practice of Oral
Medicine, Oral Medicine Secrets and has been heavily involved in the clinical
teaching of Oral Medicine. Dr. Fang. He has been the featured speaker at many
of the major dental meetings and can be reached at [email protected] .
Author Disclosure
Leslie S.T. Fang is the founder and the Executive Chairman of FerruMax
Pharmaceutical, a biotechnology company.
Supplement to PennWell Publications
PennWelldesignatesthisactivityfor1ContinuingEducationalCredit
DentalBoardofCalifornia:Provider4527,courseregistrationnumberCA#01-4527-13088
“ThiscoursemeetstheDentalBoardofCalifornia’srequirementsfor1unitofcontinuingeducation.”
ThePennWellCorporationisdesignatedasanApprovedPACEProgramProviderbythe
AcademyofGeneralDentistry.Theformalcontinuingdentaleducationprogramsofthis
programproviderareacceptedbytheAGDforFellowship,Mastershipandmembership
maintenancecredit.Approvaldoesnotimplyacceptancebyastateorprovincialboardof
dentistryorAGDendorsement.Thecurrenttermofapprovalextendsfrom(11/1/2011)to
(10/31/2015) Provider ID# 320452.
This educational activity was developed by PennWell’s Dental Group with no commercial support.
This course was written for dentists, dental hygienists and assistants, from novice to skilled.
Educational Methods: This course is a self-instructional journal and web activity.
Provider Disclosure: PennWell does not have a leadership position or a commercial interest in any products or services
discussed or shared in this educational activity nor with the commercial supporter. No manufacturer or third party has had
any input into the development of course content.
Requirements for Successful Completion: To obtain 1 CE credit for this educational activity you must pay the required
fee, review the material, complete the course evaluation and obtain a score of at least 70%.
CE Planner Disclosure: Heather Hodges, CE Coordinator does not have a leadership or commercial interest with products or
services discussed in this educational activity. Heather can be reached at [email protected]
Educational Disclaimer: Completing a single continuing education course does not provide enough information to result
in the participant being an expert in the field related to the course topic. It is a combination of many educational courses and
clinical experience that allows the participant to develop skills and expertise.
Registration: The cost of this CE course is $20.00 for 1 CE credit.
Cancellation/Refund Policy: Any participant who is not 100% satisfied with this course can request a full refund by
contacting PennWell in writing.
Educational Objectives:
Indications for new oral anticoagulants
At the conclusion of this educational activity the participant will be able to:
1. Describe Pradaxa® (dabigatran) and Xarelto®
(rivaroxaban) and why are they increasingly prescribed
2. Discuss how these newer oral anticoagulants differ
from Coumadin®
3. Manage simple and complex dental procedures in a
patient on newer oral anticoagulants
4. Safely utilize drugs commonly prescribed by dentists
for patients on newer oral anticoagulants
5. Describe the drugs commonly prescribed by dentists
which should be avoided in patients on newer oral
anticoagulants
Many patients are on the oral anticoagulant Coumadin® (warfarin) for atrial fibrillation, deep venous thrombophlebitis and
pulmonary embolism.
Atrial fibrillation puts patients at 5 times the risk for stroke
and Coumadin® decreases the risk significantly. However, overanticoagulation can result in bleeding complications, including hemorrhagic stroke. Patients on Coumadin® are therefore
carefully monitored by PT/INR and the doses of the drug are
continuously changing according to the INR value. Patients and
physicians have found this process tedious and inconvenient.
There has; therefore, been a continuous search for agents that can
more precisely titrate the degree of anticoagulation. As a result
drugs have been developed that can be given in a fixed dose and
do not require continuous monitoring.
These new oral anticoagulants, Pradaxa® (dabigatran) and
Xarelto® (rivaroxaban), have been approved for use in patients
with non-valvular atrial fibrillation and for prophylaxis against
deep venous thrombophlebitis after hip and knee surgery.
Abstract
Pradaxa® (dabigatran) and Xarelto® (rivaroxaban) are two
new oral anticoagulants that are striving to replace Coumadin® in the management of patients with non-valvular atrial
fibrillation. The drugs have rapid onset of action, are taken in
a fixed dose, do not require PT/INR monitoring and there
are no dietary restrictions for the patients on these agents.
This has led to a rapid adoption by physicians. It is therefore important for the dental professional to understand the
mechanism of action of these drugs in order to intelligently
manage these patients when they need dental intervention.
The pros and cons of interruption of therapy are discussed as
they apply to patients needing simple and complex dentistry.
Medical consultation is mandatory prior to interruption of
anticoagulant therapy.
Introduction
When new drugs that are likely to gain significant utilization
in the populace appears on the marketplace, particularly those
that are associated with bleeding diathesis, it is important for the
dental professionals to be familiar with these drugs and to understand the best way of managing these patients when they need
dental intervention.
While the majority of dentists are comfortable in the management of patients on Coumadin®, they are probably just beginning
to see patients coming in on the two newer oral anticoagulants,
Pradaxa® (dabigatran) and Xarelto® (rivaroxaban). These agents
have now been approved for use in anticoagulating patients with
non-valvular atrial fibrillation.
In order to be able to intelligently manage these patients, an
understanding of the indications for Pradaxa® (dabigatran) and
Xarelto® (rivaroxaban), their mechanisms of action, their advantages and disadvantages is important.
Similar to the management of patients on Coumadin® (warfarin), these drugs can be continued for simple dental procedures.
In instances where complicated dental procedures are planned,
consultation with the patient’s physician is critical to discuss the
feasibility of temporarily withholding these drugs to avoid excessive bleeding.
112
10. 2013 | www.DENTALECONOMICS.com
Mechanism of action of traditional and newer
oral anticoagulants
The new oral anticoagulants work at sites different from coumadin and are gaining acceptance because of their ease of use.
Coumadin® interferes with coagulation by acting on 4 vitamin-K dependent coagulation factors (Figure 1). These factors
are quite sensitive to changes in vitamin K availability. Minor
changes in diet or the use of antibiotics can affect these factors. It
is therefore important to meticulously manage the level of anticoagulation (measured by PT/INR) in patients on Coumadin® and
doses have to be carefully adjusted.
Unlike Coumadin®, both Pradaxa® and Xarelto® act at sites
quite close to the formation of the fibrin clot (Figure 1). The level
of anticoagulation is therefore more predictable and both drugs
can be given at a fixed dose without monitoring of blood tests.
There are also no dietary restrictions with either agent (Table
1). Patients and physicians find these features attractive and an
increasing number of patients are now on Pradaxa® and Xarelto®.
Figure 1. Sites of action of Coumadin, Xarelto and Pradaxa
INTRINSIC
EXTRINSIC
(surface contact)
F XII
HMWK
(tissue damage)
Coumadin
F XIIa
KAL
F VIIa
F XIa
F XI
F IX
F VII
Tissue factor
F IXa
F VIIIa
+PF-3
F Va
+PF-3
Prothrombin (F II)
Fibrinogen (F I)
Xarelto
Fx
F Xa
Pradaxa
Thrombin (F IIa)
Fibrin
In clinical trials, both agents have been as, or more efficacious
than Coumadin® in the prevention of stroke in patients with nonvalvular atrial fibrillation. In these trials, where patients have
been carefully screened, the bleeding complications were similar
to those observed with Coumadin®.
Pradaxa® is taken twice a day and Xarelto® is taken once a day,
usually in the evening. Pradaxa® is available as 75 mg or 150 mg
capsules, while Xarelto® is available as 15 mg or 20 mg doses.
Both drugs have to be adjusted according to the patient’s renal
function and patients with compromised renal function usually
receive the lower dosage of the drugs.
Table 1. Comparison of the Three Oral Anticoagulants
Coumadin®
(warfarin)
Pradaxa®
(dabigatran)
Xarelto ®
(rivaroxaban)
Requires regular
blood tests
No need for regular
blood monitoring
tests
No need for regular
blood monitoring
tests
Some dietary
restrictions
No restrictions
No restrictions
Dose available
75 mg or 150 mg
10 mg or 15 mg
Taken once a day
Twice a day
Once a day (evening)
Variable dose
according to PT/INR
Fixed dose
Fixed dose
Reversal agents
Patients with significant clinical bleeding on Coumadin® can be
reversed with vitamin K or fresh frozen plasma. There are no
reversal agents for Pradaxa® or Xarelto®. The absence of a
reversal agent makes both of the newer oral agents a less attractive
choice in patients with a known bleeding diathesis.
Fortunately, both agents have relatively short half-lives. In
general, Pradaxa® or Xarelto® are withheld when there is clinically significant bleeding. Patients may need blood transfusion if
there are clinical indications. The drugs are usually restarted at a
lower dose when the bleeding has stopped.
Bleeding complications of the new oral anticoagulants
Like Coumadin®, both Pradaxa® and Xarelto® can be associated
with bleeding complications.
Pradaxa® is 80% cleared by the kidneys. In patients on
Pradaxa®, the risk of bleeding is higher in patients:
• 75 years old or older
• With renal dysfunction
• With a history of gastrointestinal bleeding
• On anti-inflammatory drugs
• On aspirin products
• On ketoconazole
• On dronedarone
Xarelto® has a dual mode of excretion, with 1/3 of the drug
excreted by the kidneys unchanged and 2/3 metabolized by the
liver via the CYP3A4 pathway. Of the metabolic products, half is
excreted by the kidneys and half by the liver via bile. In patients
who are on Xarelto®, the risk of bleeding is higher in patients:
• With renal dysfunction
• With liver dysfunction
• On anti-inflammatory drugs
• On aspirin products
• On concomitant use of drugs that are combined P-gp and
CYP3A4 inhibitors such as ketoconazole and ritonavir
Neither agent is approved for use in pregnant females or nursing mothers.
Dental management of patients on Pradaxa®
and Xarelto®
Figure 2 is a quick reference guide for management of dental
patients in Pradaxa®.
Although the degree of anticoagulation by Pradaxa® and
Xarelto® can be measured by Ecarin Clotting Time (ECT), this
test is rarely necessary since both drugs provide relatively predictable levels of anticoagulation. For the dentist, the only decision
is whether interruption of anticoagulation therapy is necessary.
This is obviously based upon the procedure planned, the clinical
scenario and the likelihood of bleeding complications.
For most non-surgical and simple surgical procedures, it would
be reasonable to proceed with attention to local hemostatic measures without interruption of anticoagulant therapy. This is based
upon an analogy drawn from the management of patients on Coumadin®, where interruption of Coumadin® was found to have more
risk than benefit. However, one should bear in mind that both
Pradaxa® and Xarelto® have much faster onset and washout than
Coumadin®. A patient who is taken off of either agent for 24 hours
has only a very short period without anticoagulation and the risk
of thrombus formation in patients with non-valvular atrial fibrillation during this short window is not very high. It is theoretically
safer to interrupt Pradaxa® or Xarelto® therapy than Coumadin®
therapy. However, the risk benefit ratio of transient interruption of
therapy has not been clearly defined as yet. It is therefore important to include the patient’s physician in any decision with regard to
interruption of anticoagulation. In a patient with significant risk of
thrombosis, the patient has to be managed without interruption of
therapy by careful use of local hemostatic measures.
Local hemostatic measures should include:
• Extra sutures
• Compressive packing and dressing
• Microfibrillar collagen hemostat
• Oxidized cellulose
• 4.8% tranexamic acid mouthwash (ingredient in teabags)
• Topical thrombin
For complex surgical procedures, it would be reasonable to
consult with the patient’s physician to determine if it is safe to
stop the agents on the day before and the morning of the planned
surgical procedures.
For Pradaxa®, the oral anticoagulant should be withheld the
day before the procedure and the day of the procedure. Pradaxa®
should be resumed the evening after the procedure.
www.DENTALECONOMICS.com | 10.2013
113
Figure 2: Dental management of patients on Dabigatran (Pradaxa)
Reprinted from the Ultimate Cheat Sheets: The Practical Guide for Dentists ®
For Xarelto®, the medication should be withheld the evening before the procedure and resumed on the evening after the procedure.
ONE SHOULD NOT STOP ORAL ANTICOAGULANTS
WITHOUT
DOCUMENTATION
OF
THE
OPINION OF THE MEDICAL CONSULTANTS. If it
is deemed by the consulting physician that the risk of interruption of the oral anticoagulants outweighs the benefit, it is then up
to the dental professional to decide if the intended procedures can
be done safely in the presence of full anticoagulation.
Use of commonly prescribed drugs in dentistry
for patients on Pradaxa® or Xarelto®
As is often the case, the dental professional should be aware of
potential drug-drug interactions with these new oral anticoagulants. Drugs that interfere with the metabolism of these drugs
should be avoided. Similarly, drugs that can increase bleeding
complications should also be avoided.
Table 2 is a quick reference guide for drugs that are safe to use
and drugs that should be avoided in patients on Pradaxa® and Xarelto.® Table 2 includes only drugs commonly prescribed by dentists.
Table 2: Drugs for patients on Darbigatran
In instances where a drug prescribed is not on the list, it would be
important to consult a source such as Lexi-Comp® to be sure there
are no drug-drug interactions with Pradaxa® and Xarelto®.
Acceptance of the newer oral anticoagulants
It is clear that the fixed dosage of these new oral anticoagulants,
the elimination of PT/INR monitoring and the lack of dietary
restrictions is attractive for patients and physicians alike. It is
also clear that there are no concerns over the efficacy of these
drugs. Clinical trials have demonstrated the ability of these
drugs to prevent embolic strokes is similar, if not superior to,
that of Coumadin®. More prescriptions are written on a daily
basis for the newer oral anticoagulants because of these reasons.
However, there are concerns for bleeding complications
with both agents. Although the clinical trials conducted for
FDA drug approval demonstrated bleeding complications to be
at a level similar to Coumadin®, there are increasing concerns
about significant bleeding complications with the newer oral
anticoagulants. When these cases are carefully scrutinized, it
is clear that elderly patients with renal or hepatic compromises
might have received inappropriate doses. Nonetheless, the
absence of a reversal agent makes bleeding in these instances
more problematic.
The eventual acceptance of these drugs will depend upon
the balance between the safety of these drugs and the ease of use.
References
Reprinted from the Ultimate Cheat Sheets:
The Practical Guide for Dentists®
114
10. 2013 | www.DENTALECONOMICS.com
1. Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R,
Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin
L Dabigatran with or without concomitant aspirin compared with
warfarin alone in patients with nonvalvular atrial fibrillation (PETRO
study). Am J Cardiol 100 , 1419-1426 (2007)
2. Soheir S. Adam, MD; Jennifer R. McDuffie, PhD; Thomas L. Ortel,
MD, PhD; and John W. Williams Jr., MD Comparative Effectiveness
of Warfarin and New Oral Anticoagulants for the Management of Atrial
Fibrillation and Venous Thromboembolism: A Systematic Review.
Ann Intern Med. 28 (2012)
Author Profile
Leslie S.T. Fang received his PhD degree
in Physiology and Biophysics from the
University of Illinois, Champaign-Urbana.
He did his medical training at Harvard
Medical School and is board certified in
Internal Medicine and Nephrology. He has
been on the staff of Massachusetts General
Hospital and on the faculty of Harvard Medical School. A
clinician and a teacher, he maintains an active international
practice in Internal Medicine and Nephrology and is a leading
teacher at Harvard Medical School. He has received numerous
awards for excellence in teaching from Harvard Medical School
and has served and chaired the Medical Internship Selection
Committee at the Massachusetts General Hospital for two
decades. He is the co-author of the major textbook Principle
and Practice of Oral Medicine, Oral Medicine Secrets and has
been heavily involved in the clinical teaching of Oral Medicine.
Dr. Fang. He has been the featured speaker at many of the major
dental meetings and can be reached at [email protected].
Author Disclosure
Leslie S.T. Fang is the founder and the Executive Chairman of
FerruMax Pharmaceutical, a biotechnology company.
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Questions
1. Why is there a need for these new oral anticoagulants, Pradaxa® and Xarelto®?
a.Convenience
b.Safety
c.Cost
d. All of the above
2. Pradaxa® is:
a.
b.
c.
d.
A direct thrombin inhibitor
A vitamin K inhibitor
A Factor Xa inhibitor
none of the above
3. Xarelto® is:
a.
b.
c.
d.
A direct thrombin inhibitor
A vitamin K inhibitor
A Factor Xa inhibitor
none of the above
4. Pradaxa® is prescribed:
a.
b.
c.
d.
As a fixed dose at 150 mg BID
As a fixed dose at 10 mg QHS
No monitoring blood tests are necessary
a and c
5. Xarelto® is prescribed:
a.
b.
c.
d.
As a fixed dose at 150 mg BID
As a fixed dose at 10 mg QHS
No monitoring blood tests are necessary
b and c
6. The major concern over current use of
Coumadin® is:
a.Cost
b. Need for continuous monitoring
c. Bleeding complications
d. b and c
7. Which of the following is true regarding
dental patients on Pradaxa® or Xarelto®?
a. Can be continued for simple procedures
b. Complex procedures do not require physician
consultation
c. Cannot be continued for simple dental procedures
d. None of the above
8. Which of the following is true regarding
the metabolism of Pradaxa®?
a. 80% renally cleared
b. Dose should be adjusted in patients with renal
dysfunction
c. Dose should be adjusted in elderly patients
d. All of the above
9. Which of the following is true regarding
the metabolism of Xarelto®?
a. Dose should be adjusted in patients with renal
dysfunction
b. Dose should be adjusted in patients with liver
dysfunction
c.Xarelto® has a dual mode of excretion
d. All of the above
10. Which of the following is true regarding
the dental management of patients on
Pradaxa®?
a. Drug cannot be stopped without consultation with the
referring physician
b. If Pradaxa® were to be held, it should be held the night
before and the morning of planned procedure
c. It should be resumed the evening after the procedure,
unless there is clinical concern over bleeding
d. All of the above
11. Which of the following is true regarding
the dental management of patients on
Xarelto®?
a. Drug cannot be stopped without consultation with the
referring physician
b. If Xarelto® were to be held, it should be held the night
before planned procedure
c. It should be resumed the evening after the procedure,
unless there is clinical concern over bleeding
d. All of the above
12. With the transient discontinuation of
Pradaxa® or Xarelto® just prior to the
procedure, the patient should have:
a.
b.
c.
d.
No bleeding diathesis
Modest bleeding diathesis
Local hemostatic measures
b and c
13. Which of the following properties of
Xarelto® and Pradaxa® are true?
a.
b.
c.
d.
Act close to the fibrin clot
No dietary restrictions
Predictable anticoagulation
All of the above
14. Which of the following is true regarding
anticoagulant drugs?
a.Coumadin® does not require regular blood tests
b.Pradaxa® is taken once a day
c.Xarelto® has a fixed dose
d.Coumadin® has a fixed dose
15. Local hemostatic measures should include:
a.
b.
c.
d.
Oxidized cellulose
Extra sutures
Topical thrombin
All of the above
www.DENTALECONOMICS.com | 10.2013
115
ANSWER SHEET
Pradaxa® and Xarelto®: Coming Soon to Your Practice!!
Name:
Title:
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Address:E-mail:
City:
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Lic. Renewal Date:
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Requirements for successful completion of the course and to obtain dental continuing education credits: 1) Read the entire course. 2) Complete all information
above. 3) Complete answer sheets in either pen or pencil. 4) Mark only one answer for each question. 5) A score of 70% on this test will earn you 1 CE credit.
6) Complete the Course Evaluation below. 7) Make check payable to PennWell Corp. For Questions Call 216.398.7822
If not taking online, mail completed answer sheet to
Educational Objectives
1. DescribePradaxa®(dabigatran)andXarelto®(rivaroxaban)andwhyaretheyincreasinglyprescribed
Academy of Dental Therapeutics and Stomatology,
A Division of PennWell Corp.
P.O. Box 116, Chesterland, OH 44026
or fax to: (440) 845-3447
2. Discuss how these newer oral anticoagulants differ from Coumadin®
3. Manage simple and complex dental procedures in a patient on newer oral anticoagulants
4. Safelyutilizedrugscommonlyprescribedbydentistsforpatientsonneweroralanticoagulants
5. Describethedrugscommonlyprescribedbydentistswhichshouldbeavoidedinpatientsonneweroralanticoagulants
Course Evaluation
1. Were the individual course objectives met? Objective #1: Yes
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