Pradaxa and Xarelto : Coming Soon to Your Practice!!

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1 Earn 1 CE credit This course was written for dentists, dental hygienists, and assistants. 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 Expiration date: Sept 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 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# ThiscoursemeetstheDentalBoardofCalifornia srequirementsfor1unitofcontinuingeducation. ThePennWellCorporationisdesignatedasanApprovedPACEProgramProviderbythe AcademyofGeneralDentistry.Theformalcontinuingdentaleducationprogramsofthis programproviderareacceptedbytheagdforfellowship,mastershipandmembership maintenancecredit.approvaldoesnotimplyacceptancebyastateorprovincialboardof dentistryoragdendorsement.thecurrenttermofapprovalextendsfrom(11/1/2011)to (10/31/2015) Provider ID# 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 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.

2 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 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. Indications for new 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. 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 (surface contact) F XII HMWK F XI F XIIa KAL F IX F XIa Prothrombin (F II) Fibrinogen (F I) Coumadin F IXa F VIIIa +PF-3 F Va +PF-3 Fx F Xa EXTRINSIC (tissue damage) F VII Tissue factor F VIIa Xarelto Pradaxa Thrombin (F IIa) Fibrin

3 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) Requires regular blood tests Some dietary restrictions Pradaxa (dabigatran) No need for regular blood monitoring tests No restrictions Xarelto (rivaroxaban) No need for regular blood monitoring tests 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

4 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 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, (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)

5 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 Author Disclosure Leslie S.T. Fang is the founder and the Executive Chairman of FerruMax Pharmaceutical, a biotechnology company. Online Completion Use this page to review the questions and answers. Return to and sign in. If you have not previously purchased the program select it from the Online Courses listing and complete the online purchase. Once purchased the exam will be added to your Archives page where a Take Exam link will be provided. Click on the Take Exam link, complete all the program questions and submit your answers. An immediate grade report will be provided and upon receiving a passing grade your Verification Form will be provided immediately for viewing and/or printing. Verification Forms can be viewed and/or printed anytime in the future by returning to the site, sign in and return to your Archives Page. Questions 1. Why is there a need for these new oral anticoagulants, Pradaxa and Xarelto? a. Convenience b. Safety c. Cost 2. Pradaxa is: a. A direct thrombin inhibitor b. A vitamin K inhibitor c. A Factor Xa inhibitor d. none of the above 3. Xarelto is: a. A direct thrombin inhibitor b. A vitamin K inhibitor c. A Factor Xa inhibitor d. none of the above 4. Pradaxa is prescribed: a. As a fixed dose at 150 mg BID b. As a fixed dose at 10 mg QHS c. No monitoring blood tests are necessary d. a and c 5. Xarelto is prescribed: a. As a fixed dose at 150 mg BID b. As a fixed dose at 10 mg QHS c. No monitoring blood tests are necessary d. 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 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 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 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 12. With the transient discontinuation of Pradaxa or Xarelto just prior to the procedure, the patient should have: a. No bleeding diathesis b. Modest bleeding diathesis c. Local hemostatic measures d. b and c 13. Which of the following properties of Xarelto and Pradaxa are true? a. Act close to the fibrin clot b. No dietary restrictions c. Predictable anticoagulation 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. Oxidized cellulose b. Extra sutures c. Topical thrombin

6 ANSWER SHEET Pradaxa and Xarelto : Coming Soon to Your Practice!! Name: Title: Specialty: Address: City: State: ZIP: Country: Telephone: Home ( ) Office ( ) Lic. Renewal Date: AGD Member ID: 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 Educational Objectives 1. DescribePradaxa (dabigatran)andxarelto (rivaroxaban)andwhyaretheyincreasinglyprescribed 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 Course Evaluation 1. Were the individual course objectives met? Objective #1: Yes No Objective No Yes #4: Objective #2: Yes No Objective #5: Yes No Objective #3: Yes No Pleaseevaluatethiscoursebyrespondingtothefollowingstatements,usingascaleofExcellent =5toPoor =0. 2. To what extent were the course objectives accomplished overall? Please rate your personal mastery of the course objectives How would you rate the objectives and educational methods? How do you rate the author s grasp of the topic? Please rate the instructor s effectiveness Was the overall administration of the course effective? Please rate the usefulness and clinical applicability of this course Please rate the usefulness of the supplemental webliography Do you feel that the references were adequate? Yes No 11. Would you participate in a similar program on a different topic? Yes No 12. If any of the continuing education questions were unclear or ambiguous, please list them. 13. Was there any subject matter you found confusing? Please describe. 14. How long did it take you to complete this course? 15. What additional continuing dental education topics would you like to see? If not taking online, mail completed answer sheet to Academy of Dental Therapeutics and Stomatology, A Division of PennWell Corp. P.O. Box 116, Chesterland, OH or fax to: (440) For IMMEDIATE results, go to and click on the button Take Tests Online. Answer sheets can be faxed with credit card payment to (440) , (216) , or (216) Payment of $20.00 is enclosed. (Checks and credit cards are accepted.) If paying by credit card, please complete the following: MC Visa AmEx Discover Acct. Number: Exp. Date: Charges on your statement will show up as PennWell AGD Code 016 PLEASE PHOTOCOPY ANSWER SHEET FOR ADDITIONAL PARTICIPANTS. COURSE EVALUATION and PARTICIPANT FEEDBACK We encourage participant feedback pertaining to all courses. Please be sure to complete the survey included with the course. Please all questions to: INSTRUCTIONS All questions should have only one answer. Grading of this examination is done manually. Participants will receive confirmation of passing by receipt of a verification form. Verification of Participation forms will be mailed within two weeks after taking an examination. COURSE CREDITS/COST All participants scoring at least 70% on the examination will receive a verification form verifying 1 CE credit. The formal continuing education program of this sponsor is accepted by the AGD for Fellowship/Mastership credit. Please contact PennWell for current term of acceptance. Participants are urged to contact their state dental boards for continuing education requirements. PennWell is a California Provider. The California Provider number is The cost for courses ranges from $20.00 to $ PROVIDER INFORMATION PennWell is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE Provider may be directed to the provider or to ADA CERP at cotocerp/. The PennWell Corporation is designated as an Approved PACE Program Provider by the Academy of General Dentistry. The formal continuing dental education programs of this program provider are accepted by the AGD for Fellowship, Mastership and membership maintenance credit. Approval does not imply acceptance by a state or provincial board of dentistry or AGD endorsement. The current term of approval extends from (11/1/2011) to (10/31/2015) Provider ID# Customer Service RECORD KEEPING PennWell maintains records of your successful completion of any exam for a minimum of six years. Please contact our offices for a copy of your continuing education credits report. This report, which will list all credits earned to date, will be generated and mailed to you within five business days of receipt. Completing a single continuing education course does not provide enough information to give the participant the feeling that s/he is 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. CANCELLATION/REFUND POLICY Any participant who is not 100% satisfied with this course can request a full refund by contacting PennWell in writing by the Academy of Dental Therapeutics and Stomatology, a division of PennWell PX1013DE

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