Welcome to the 23 rd Annual Statewide Geriatric Medicine Conference: Improving the Health of Our Elders: Topics in Geriatric Medicine

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1 Welcome to the 23 rd Annual Statewide Geriatric Medicine Conference: Improving the Health of Our Elders: Topics in Geriatric Medicine This is your course syllabus, which you are required to bring to all sessions. Please remember to sign in at the registration desk each day, as well as at the Saturday Workshops. Registration envelope includes: Participant and any additional paid guest badges MUST BE WORN TO ALL FUNCTIONS/MEALS Additional Dinner tickets for Saturday night (if paid separately)

2 This program is Sponsored by: The Consortium of Ohio Geriatric Academic Programs: The Offices of Geriatric Medicine/Gerontology at: Case Western Reserve University, School of Medicine Northeast Ohio Medical University The Ohio State University College of Medicine Ohio University Heritage College of Osteopathic Medicine University of Cincinnati, College of Medicine The University of Toledo, College of Medicine and Life Sciences Wright State University, Boonshoft School of Medicine Supported by: Ohio Geriatrics Society Office of Continuing Medical Education at the Ohio University College of Osteopathic Medicine (OU-COM)

3 ACKNOWLEDGEMENT We gratefully acknowledge the support of this activity from: Amgen Avanir Pharmaceuticals, Inc. Boehringer Ingelheim Pharmaceuticals Central Ohio Geriatrics, LLC Cleveland Clinic KeyBank Ohio Geriatric Society (OGS) Optimer Pharmaceuticals, Inc. Please be sure to visit our exhibitor booths:

4 Central Ohio Geriatrics, LLC is a practice dedicated to serving seniors throughout central Ohio. Our services include home care, assisted living, skilled rehabilitation, long-term care, hospice, and wellness programs. We provide comprehensive, evidence-based healthcare tailored to the individual needs of our patients and centered on their goals of care. We are devoted to improving the quality of life, independence, and overall well-being of our patients. Our staff includes 5 physicians and 6 physician extenders who are passionate about working with geriatric patients. Central Ohio Geriatrics, LLC 590 Newark-Granville Road, Suite A, Granville, Ohio Toll free: (888) Fax: (740)

5 ACCREDITATIONS The University of Toledo is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The University of Toledo designates this live activity for a maximum of 12 AMA PRA Category 1 Credits. Physicians should claim only credit commensurate with the extent of their participation in the activity. This Live activity, 23 rd Annual Statewide Geriatric Medicine Conference 2012, with a beginning date of October 12, 2012, has been reviewed and is acceptable for up to Prescribed credits by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. The Ohio University College of Medicine is approved by the American Osteopathic Association as an accredited continuing medical education provider. This program anticipates being approved for 12 AOA Category 2-A credits. The Ohio Board of Nursing will accept, at face value, the number of hours awarded for an educational activity that has been approved for CE, provided it was approved by a nationally accredited system of CE approval. The AAPA accepts certificates of participation for educational activities certified for Category 1 credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 Credit from organizations accredited by ACCME or a recognized state medical society. EVALUATION Evaluation is an important component of continuing education programs. In addition to providing feedback to the program planners and faculty, it provides information to improve future programs. Please consider evaluation of this symposium an integral part of your participation in this meeting.

6 TO OBTAIN YOUR CME CREDIT Providing you returned your Completed Evaluation at the end of the program (Name MUST be included and legible) Your CME Certificate will be available to print online Wednesday, October 17, Go to cme.utoledo.edu Click on DIRECT LINK TO LOGIN Login: Username: lastnamefirstname (no commas, no spaces) Password: zip code (Your password is your zip code provided upon registration, unless you specified a certain password in your profile) Once you are logged in choose credit transcripts in left margin Scroll down until you see the 23 rd Annual Statewide Geriatric Medicine Symposium Click the certificate icon to the right of the program name and print.

7 FACULTY Caleb Adler, MD, Associate Professor of Psychiatry and Neuroscience, Co-Director of Bipolar Disorders Research, Assistant Director Center for Imaging Research, University of Cincinnati, College of Medicine Brian S. Appleby, MD, Active Staff, Lou Ruvo Center for Brian Health, Active Staff, Department of Psychiatry and Psychology, Neurological Institute, Cleveland Clinic Christopher Bernheisel, MD, Assistant Professor, University of Cincinnati; Program Director, Family Medicine, The Christ Hospital, University of Cincinnati Derrick Cetin, DO, Associate Professor, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Staff Bariatric Medicine, Cleveland, Bariatric and Metabolic Institute, Cleveland Clinic Foundation Robert J. Cluxton, Jr., PharmD, MBA, Professor of Pharmacy Practice and Family Medicine, The James L. Winkle College of Pharmacy, University of Cincinnati Thomas M. File, Jr, MD, MsC, MACP, FIDSA, FCCP, Professor Internal Medicine, Chair Infectious Disease Section, Northeast Ohio Medical University; Chair, Infectious Disease Division, Summa Health System Jen-Tzer Gau, MD, PhD, Associate Professor, Department of Geriatric Medicine/Gerontology, Ohio University Heritage College of Osteopathic Medicine Nancy A. Istenes, DO, CMD, Associate Professor, Internal Medicine, Northeast Ohio Medical University; Medical Director, Long-Term and Transitional Care Services; Medical Director Summa Homecare Summa Health System Karissa Y. Kim, PharmD, CACP, BCPS, Clinical Associate Professor Pharmacy Practice, Introductory Pharmacy Practice Experience Coordinator, University of Cincinnati, James L. Winkle College of Pharmacy Cynthia Kuttner-Sands, MD, CMD, Chair, Department of Geriatrics, Ohio University Heritage College of Osteopathic Medicine Carol A. Langford, MD, MHS, FACP, Harold C. Schott Chair, Director, Center for Vasculitis Care and Research Department of Rheumatic and Immunologic Diseases, Cleveland Clinic Amanda Lathia, MD, MPhil, Assistant Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University Larry W. Lawhorne, MD, Professor and Chair, Department of Geriatrics, Wright State University, Boonshoft School of Medicine Clare Logan, PA-C, Assistant Professor, Geriatric Medicine, University of Cincinnati, College of Medicine Donald O. Mack, MD, FAAFP, CMD, Assistant Professor, Department of Family Medicine, The Ohio State University, College of Medicine Jennifer Rose V. Molano, MD, Assistant Professor of Neurology, The University of Cincinnati, College of Medicine Cynthia G. Olsen, MD, FAAFP, CMD, Professor, Geriatric Medicine, Acting Chair, Family Medicine,, Wright State University, Boonshoft School of Medicine Jeffrey D. Schlaudecker, MD, Associate Residency Director, Family Medicine, Assistant Director, Inpatient Family Medicine, Assistant Professor, Family Medicine, The Christ Hospital/University of Cincinnati Quratulain Syed, MD, Assistant Professor, Cleveland Clinic Center for Geriatric Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University Christine Taylor, PhD, Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Director, Faculty Development, Cleveland Clinic Michael B. Wells, MD, Assistant Professor, Ophthalmology, Department of Ophthalmology and Visual Sciences, Wexner Medical Center at The Ohio State University Bill Zafirau, MD, Clinical Assistant Professor, Family and Community Medicine, Northeast Ohio Medical University; Medical Director, Cleveland Clinic at Home

8 MODERATORS Larry W. Lawhorne, MD Professor and Chair Department of Geriatrics Wright State University, Boonshoft School of Medicine Donald O. Mack, MD, FAAFP, CMD Assistant Professor, Department of Family Medicine The Ohio State University, College of Medicine Elizabeth O Toole, MD Professor of Medicine, Bioethics and Family Medicine Case Western Reserve University, School of Medicine Director, Division of Geriatrics and Palliative Care MetroHealth Medical Center Cynthia G. Olsen, MD, FAAFP, CMD Professor, Geriatric Medicine, Acting Chair, Family Medicine Wright State University, Boonshoft School of Medicine PLANNING COMMITTEE MEMBERS A special thanks to the members of our planning committee listed below who contributed their time and effort to ensure the success of this program: Sandra Buty, The Ohio State University College of Medicine Jen-Tzer Gau, M.D. Ohio University Heritage College of Osteopathic Medicine Cletus Iwuagwu, M.D., The University of Toledo, College of Medicine and Life Sciences Larry W. Lawhorne, M.D., Wright State University, Boonshoft School of Medicine Linda Mauger, The Ohio State University College of Medicine Barbara Messinger-Rapport, M.D., Ph.D., Cleveland Clinic Deborah Meyer, Ph.D., RN, Ohio University Heritage College of Osteopathic Medicine Cynthia G. Olsen, M.D., FAAFP, CMD, Wright State University, Boonshoft School of Medicine Elizabeth O Toole, M.D., Case Western Reserve University, School of Medicine Barbara Palmisano, M.A., R.N., Northeast Ohio Medical University Kelly Randall, Wright State University, Boonshoft School of Medicine Becky Roberts, The University of Toledo, College of Medicine and Life Sciences Margaret B. Sanders, M.A., LSW, Northeast Ohio Medical University Gregg Warshaw, M.D., University of Cincinnati, College of Medicine

9 DISCLOSURES Faculty Disclosures Dr Adler discloses he receives research support from AstraZeneca and Eli Lilly, is a Consultant and on the Speaker s Bureau for Merck. Also receives research support (multi-site trials) from AstraZeneca, Eli Lilly, Pfizer, Otsuka, Forest, Sunovion, Novartis, GlaxoSmithKline, Amylin and Takeda. Dr. Appleby discloses he receives grant/research support from Forrest Pharmaceuticals. Dr File discloses he receives research funding from Pfizer, Boehringer Ingelheim, Gilead and Tibotec. Is a consultant for Astellas, Bayer, Cempra, DaiichiSankyo, Forrest, GlaxoSmithKline, Merck, and Pfizer. Is on the scientific advisory board for Durata, Nabriva, Rib-X and Tetraphas. Drs. Bernheisel, Cetin, Cluxton, Gau, Istenes, Kim, Kuttner-Sands, Langford, Lathia, Lawhorne, Mack, Molano, Olsen, Schlaudecker, Syed, Taylor, Wells, Zafirau and Clare Logan have no financial interest or other relationship with any manufacturer of commercial product or service to disclose. Moderator Disclosures Drs. Lawhorne, Mack, O Toole, Olsen have no financial interest or other relationship with any manufacturer of commercial product or service to disclose. Planning Committee Disclosures Dr Messinger Rapport discloses she is on the Speaker s Bureau for Novartis No other Planning Committee member has any financial interest or other relationship with any manufacturer of commercial product or service to disclose.

10 Agenda Friday Evening, October 12, 2012 Improving the Health of out Elders: Topics in Geriatric Medicine 6:00-6:45pm Conference Registration and Wine Hors d oeuvres Reception (for paid families and participants only (2 nd level) 6:45-7:00 pm Welcome and Introduction, Cynthia G. Olsen, MD, FAAFP, CMD 7:00-8:30 pm Symposium I: What s New in Geriatric Pharmacotherapy?(2 nd level ballroom) Moderator: Cynthia G. Olsen, MD, FAAFP, CMD 7:00-7:30 pm New Oral Anticoagulants : How to Use Safely in Older Adults Karissa Y. Kim, PharmD, CACP, BCPS 7:30-8:00 pm Literature Update: Evidenced Based Pharmacotherapy Robert J. Cluxton, Jr., PharmD, MBA 8:00-8:30 pm Antimicrobial Stewardship in Long Term Care Facilities Thomas M. File, Jr, MD, MSc, MACP, FIDSA, FCCP 8:30-9:00 pm Discussion and Questions 9:00 pm Adjournment Saturday Morning, October 13, :15 am Breakfast for paid families and participants only (4 th level) 7:30 am Registration/Daily Sign-In (2 nd level) 8:00-10:00 am Symposium II: Neuro-Psychiatric Disorders Update (2 nd level Ballroom) Moderator: Larry W. Lawhorne, MD 8:00-8:30 am Frontotemporal Dementia: An Overview Brian S. Appleby, MD 8:30-9:00 am Treating the Aged Patient with Chronic Mental Illness Caleb Adler, MD 9:00-9:30 am Sleep in Older Adults Jennifer Rose V. Molano, MD 9:30-10:00 am Discussion and Questions 10:00-10:30 am Break 10:30-12:30 pm Symposium III: Issues in Elder Care (2 nd level Ballroom) Moderator: Elizabeth O Toole, MD 10:30-11:00 am Dermatology Issues in Geriatrics: Part III Cynthia G. Olsen, MD, FAAFP, CMD 11:00-11:30 am Liability Issues: Should I Really be Worried? Larry W. Lawhorne, MD 11:30-12:00 pm Age-Related Macular Degeneration: Overview and Current Management Strategies Michael B. Wells, MD 12:00-12:30 pm Discussion & Questions 12:30 pm General Luncheon Buffet for paid families and participants only (4 th level) Or Annual Meeting of the Ohio Geriatrics Society and Buffet (3 rd level Morgan Room)

11 Saturday Late Afternoon, October 13, :30-6:25 pm Workshop Sign-In (2 nd level sign in) see goldenrod paper in front pocket for each location Saturday Workshop Discussion Seminars 3:30-5:25 pm A Workshops A. Faculty Workshop: 2 Hours Part I: Christine Taylor, PhD Part II: Jeffrey D. Schlaudecker, MD, Quratulain Syed, MD, Amanda Lathia, MD, MPhil 3:30-4:25 pm B, D 4:30-5:25 pm C, D, E 5:30-6:25 pm B, C, E B. Gerontology: You ve Got the App for That! Christopher Bernheisel, MD C. Improving Function after Illness: What Works? Clare Logan, PA-C D. Care Transitions: From Home To Hospital Nancy A. Istenes, DO, CMD E. Home Care Update 2012 Bill Zafirau, MD Saturday Evening, October 13, :00 pm Dinner Banquet for paid families and participants only (4 th level) 9:00pm BonFire Sunday Morning, October 14, :15 am Breakfast for paid families and participants only (4 th level) 7:45 am Daily Sign-In (2 nd level) 8:00-9:15 am Symposium IV: Rheumatologic Dilemmas in Older Persons (2 nd level Ballroom) Moderator: Donald O Mack, MD, FAAFP, CMD 8:00-8:30am 8:30-9:00am 9:00-9:15am Giant Cell Arteritis and Polymyalgia Rheumatica Carol A. Langford, MD, MHS, FACP Evaluation of Spinal Complains in the Elderly Cynthia Kuttner-Sands, MD, CMD Discussion & Questions 9:15-9:30am Break 9:30-11:30 am Symposium V: Nutritional, Metabolic & GI Issues in Elders (2 nd level Ballroom) Moderator: Cynthia G. Olsen, MD, FAAFP, CMD 9:30-10:00 am The Obese Older Patient: What is the Approach? Derrick Cetin, DO 10:00-10:30 am Feeding Decisions: What Works? What Doesn t Donald O. Mack, MD, FAAFP, CMD 10:30-11:00 am A Practical Approach to Abdominal Pain in the Elderly Jen-Tzer Gau, MD, PhD 11:00-11:30 am Discussion & Questions 11:30 a.m. Adjournment

12 Friday October 12, :00-6:45pm Conference Registration and Reception (2 nd level) 6:45-7:00 pm Welcome and Introduction Cynthia G. Olsen, MD, FAAFP, CMD 7:00-9:00 pm Symposium I: What s New in Geriatric Pharmacotherapy? Moderator: Cynthia G. Olsen, MD, FAAFP, CMD 7:00-7:30 pm New Oral Anticoagulants: How to Use Safely in Older Adults Karissa Y. Kim, PharmD, CACP, BCPS 7:30-8:00 pm Literature Update: Evidenced Based Pharmacotherapy Robert J. Cluxton, Jr., PharmD, MBA 8:00-8:30 pm Antimicrobial Stewardship in Long Term Care Facilities Thomas M. File, Jr, MD, MSc, MACP, FIDSA, FCCP 8:30-9:00 pm Discussion and Questions 9:00 pm Adjournment

13 Symposium I What s New in Geriatric Pharmacotherapy? Moderator: Cynthia G. Olsen, MD, FAAFP, CMD Professor, Geriatric Medicine Acting Chair, Family Medicine Wright State University, Boonshoft School of Medicine Moderator Disclosure: Dr. Olsen has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

14 New Oral Anticoagulants: How to Use Safely in Older Adults Karissa Y. Kim, PharmD, CACP, BCPS Learning Objective: Describe the mechanism of action of the new and emerging oral anticoagulant drugs. Discuss the adverse effects with the new and emerging oral anticoagulant drugs. Discuss the clinical applications for the new and emerging anticoagulant drugs in older adults. Speaker Disclosure: Dr. Kim has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

15 9/26/2012 New Oral Anticoagulants How to Use Safely in Older Adults Karissa Y. Kim, PharmD,CACP,BCPS Clinical Associate Professor University of Cincinnati James L. Winkle College of Pharmacy 1 Objectives: Describe the mechanism of action of the new and emerging oral anticoagulant drugs. Discuss the adverse effects with the new and emerging oral anticoagulant drugs. Discuss the clinical applications for the new and emerging and anticoagulant drugs in older adults. 2 History of Anticoagulants 1930 s 1950 s 1980 s 2010 Heparin VKA s LMWH DTI s Oral DTI/FXa Inhibitor Indirect FXa Inhibitor Warfarin Coumadin Miradon Dicoumarol Lovenox Fragmin Innohep Arixtra Argatroban Lepirudin Angiomax Ximelagatran Exanta Desirudin Iprivask 3 1

16 9/26/2012 Coagulation cascade Kamal A H et al. Mayo Clin Proc. 2007;82: Mayo Foundation for Medical Education and Research Dabigatran etexilate (Pradaxa ) Direct thrombin (IIa) inhibitor Prodrug Bioavailability: 6.5% Elimination: Renal 80% T1/2: hours Indication: stroke and blood clots in nonvavlular AF Dose: 150 mg BID Renal impairment CLcr ml/min: 75 mg BID CLcr < 15 ml/min: not recommended 5 Dabigatran Adverse Effects Bleeding Dyspepsia MI associated with an increased risk of MI or ACS (Arch Intern Med. 2012:172: ) No antidote 6 2

17 9/26/2012 RE-VOLUTION Phase III Primary DVT Prevention Atrial Fibrillation VTE Treatment VTE Secondary Prevention > 27,000 total patients 7 RE-LY: Dabigatran Etexilate vs. Warfarin in AF P=0.003 P=0.31 Dabigatran 150 mg is SUPERIOR to warfarin. Dabigatran 110 mg is NON- INFERIOR to warfarin. %/pt. yr P< P<0.001 N=18,113 pts (mean CHADS 2 = 2.1) Blinded dabigatran vs. unblinded warfarin 64% time-in-range for warfarin Median f/u = 2 yrs NEJM 2009;361: RE-COVER: Dabigatran etexilate vs. Warfarin for Treatment of VTE HR 0.63 Dabigatran 150 mg bid is NON-INFERIOR to warfarin. N=2564 pts with VTE Initial treatment: IV UFH or LMWY Randomized, double-blind, double-placebo design Duration 6 months NEJM 2009;361:

18 9/26/2012 Factors that Contribute to Excess Bleeding with Dabigatran Advanced age Low body y weight Poor renal function Lack of antidote 10 Plots of risks of intracranial (A) and extracranial (B) bleeding by treatment allocation according to age categories (<55, 55 to 64, 65 to 74, 75 to 84, and 85 years). Warfarin Dabigatran 150 mg Dabigatran 110 mg Dabigatran 150 mg Dabigatran 110 mg Warfarin Eikelboom J W et al. Circulation 2011;123: Copyright American Heart Association New Beer s Criteria: Dabigatran Greater risk of bleeding than with warfarin in adults aged 75 or older Lack of evidence for efficacy and safety in individuals with CrCl < 30 ml/min Recommendation: Use with caution in adults aged 75 or if CrCl < 30 ml/min 12 4

19 9/26/2012 Who should NOT receive dabigatran? ACC/AHA patients with excellent INR control with warfarin may have little to gain by switching to dabigatran. Age 75 Similar or a higher risk of extracranial bleeding on dabigatran than warfarin 13 Who should NOT receive dabigatran? Recurrent extracranial bleeding or with pre-existing coagulopathy Not rapidly reversible Renal dysfunction Drug accumulation Mechanical valves No data Non-adherent 14 Conversion to/from Dabigatran Manufacturer Recommendations Warfarin to dabigatran Stop warfarin and start dabigatran when INR < 2 Dabigatran to warfarin DC dabigatran 3 d after starting warfarin. CLcr ml/min: DC dabigatran 2 d after starting warfarin. CL ml/min: DC dabigatran 1 d after starting warfarin. LMWH/Fondaparinux to dabigatran IV heparin to dabigatran Dabigatran to parenteral anticoagulant DC parenteral anticoagulant and give dabigatran 0-2 h before next parenteral dose would have been given Administer 1 st dose of dabigatran at time of IV infusion.dc CLcr > 30 ml/min: Start parenteral anticoagulant 12 h after the last dose of dabigatran CLcr < 30 ml/min: Start parenteral anticoagulant 24 h after the last dose of dabigatran 15 5

20 9/26/2012 Perioperative Management Dabigatran Calculated creatinine clearance ml/min Standard risk of bleeding High risk of bleeding >50 1 day 2 days days 4 days 30 4 days 6 days Blood 2012;119: Coagulation cascade Kamal A H et al. Mayo Clin Proc. 2007;82: Mayo Foundation for Medical Education and Research Rivaroxaban (Xarelto ) Oral factor Xa Inhibitor Bioavailability: % Elimination: 35% renal T1/2: 5-9 hours VTE prophylaxis in knee or hip replacement 10 mg daily Stroke and embolism prevention in AF 20 mg daily with evening meal 15 mg daily with evening meal (CrCL ml/min) 18 6

21 9/26/2012 Rivaroxban Adverse Effects Bleeding No antidote 19 ROCKET AF: Rivaroxabn vs. Warfarin in AF Rivaroxaban is NON-INFERIOR to warfarin. P=0.58 P=0.117 P=0.02 N=14,171 pts (mean CHADS2 = 3.5) Non-inferiority 58% time-in-range for warfarin N Engl J Med 2011; 365: EINSTEIN-DVT The primary efficacy outcome was the first symptomatic VTE event 2.1% of those on rivaroxaban (n=1731) 3% of those on usual care (n=1718) HR 0.68 (95% CI ); p< N Engl J Med 2010; 363:

22 9/26/2012 Who should NOT receive rivaroxaban? Recurrent extracranial bleeding or with pre-existing coagulopathy Not rapidly reversible Renal dysfunction Drug accumulation Mechanical valves No data Non-adherent 22 Who may be candidates for rivaroxaban? Unexplained poor warfarin control. Poor level of control because of unavoidable drug-drug d interactions. ti New patient s with AF. 23 Conversion to/from Rivaroxaban Manufacturer Recommendations Warfarin to rivaroxaban Stop warfarin and start rivaroxaban when INR < 3 Rivaroxaban to warfarin DC rivaroxaban 4 d after starting warfarin. CLcr ml/min: DC rivaroxaban 3 d after starting warfarin. CL ml/min: DC rivaroxaban 2 d after starting warfarin. LMWH/Fondaparinux to rivaroxaban IV heparin to rivaroxaban Rivaroxaban to parenteral anticoagulant DC parenteral anticoagulant and give rivaroxaban 0-2 h before next parenteral dose would have been given Administer 1 st dose of rivaroxaban at time of IV infusion.dc DC rivaroxaban and start parenteral anticoagulant at the time that the next rivaroxaban dose would have been taken. 24 8

23 9/26/2012 Perioperative Management Rivaroxaban Calculated creatinine clearance ml/min Standard risk of bleeding High risk of bleeding >30 1 day 2 days < 30 2 days 4 days Blood 2012;119: Apixaban (Eliquis ) Oral factor Xa inhibitor FDA submitted 11/2010 for AF Bioavailability: 50% Elimination: 25% urine T1/2: hours AF 5 mg BID 2.5-mg doses If 2 or more of the following criteria present: 80 years, 60 kg, or Scr 1.5 mg/dl 26 ARISTOTLE: Apixaban vs. Warfarin in AF %/yr HR=0.79 HR=0.69 HR=0.42 Apixaban superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. N=18,201 (mean CHADS 2 = 2.1) Double-blind, randomized, placebo-controlled Non-inferiority N Engl J Med 2011; 365:

24 9/26/2012 Edoxaban Oral factor Xa inhibitor Bioavailability: 62% Elimination: 50% urine T1/2: 6-11 hours ENGAGE-AF TIMI 28 trial Expected completion mg or 60 mg dialy Non-inferiority Double-blind CHADS Suggestions for Reversal of New Oral Anticoagulants Supportive care Discontinuation of drug Apixaban Dabigatran Rivaroxaban Oral activated charcoal Yes Yes Yes Hemodialysis No Yes No Hemoperfusion with Possible Yes Possible activated charcoal Fresh frozen plasma No No No Activated Factor VIIa Unclear Unclear Unclear 3-factor PCC Unclear Unclear Unclear 4-factor PCC Possible Possible Possible Am J Hematol 2012:87:S141-S Clotting Assay Monitoring Dabigatran Ecarin clotting time Thrombin generation Thrombin time Activity of thrombin Dilute prothrombin time (dpt) aptt Rivaroxaban/Apixaban PT Dilute prothrombin time (dpt) Anti-Xa levels Heptest Measures inhibition of FXa Prothrombinase induced clotting time (PiCT) 30 10

25 9/26/2012 Figure. Classification of established anticoagulants and new anticoagulants that were recently licensed for use or are in advanced stages of clinical development. Tecafarin Copyright American Heart Association Eikelboom J W, Weitz J I Circulation 2010;121:

26 Literature Update: Evidenced Based Pharmacotherapy Robert J. Cluxton, Jr., PharmD, MBA Learning Objectives: Provide a summary of important new research in the area of geriatric pharmacotherapy. Extrapolate how this research may change geriatric practice. Speaker Disclosure: Dr. Cluxton has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

27 9/26/2012 Literature Update: Evidenced Based Pharmacotherapy Robert J. Cluxton Jr., Pharm.D., MBA Professor of Pharmacy Practice & Family Medicine University of Cincinnati Medical Center American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medications in Older Adults JAGS 2012; DOI: /j Updated Beers Criteria First evidenced-based review Quality of Evidence Strength of Recommendation Organized Og by organs system or therapeutic category New section on use with caution Identifies 53 specific medications igeriatrics free APP 1

28 9/26/2012 Organization 3 Categories 1. PIMs and classes to avoid in older adults 2. PIMs and classes to avoid in older adults with certain diseases and syndromes, 3. medications to be used with caution in older adults Removed: lack of evidence or lack of generalizability to elderly propoxyphene (not available) ferrous sulfate, cimetidine, daily fluoxetine, long-term use of stimulants Notables Addituons to Avoid short-acting benzodiazepines (inc. risk of falls, FX, dec. cognition, inc. MV accidents) glyburide (HYPOglycemia) sliding-scale insulin (HYPOglycemia) sliding scale insulin (HYPOglycemia) megesterol (inc risk of thrombosis/death) metoclopramide (inc. risk EPS and TD) dronedarone (use rate control for PAF) Spirinolactone > 25mg (inc. risk HYPERkalemia in HF or Crt Cl < 30 ml/min 2

29 9/26/2012 New drug-diagnosis/syndrome interactions SSRIs and carbamazepine and falls or fractures acetylcholinesterase inhibitors and syncope Anticholinergic overactive bladder medications and chronic constipation H 1 and H 2 antihistamines and delirium Table: Caution in Older Adults lack of evidence ASA for primary prevention Cardiac events if age> 80 dabigatran lack of evidence for efficacy and safety If CrCl < 30 ml/min Inc. risk of bleeding than with warfarin if age > 75. Table: Caution in Older Adults Prasugrel Grt. risk of bleeding in age > 75 Use Caution risk ikmay be offset tby benefit fitin hih highest-risk ik older adults (e.g., prior MI or DM ). 3

30 9/26/2012 Reason For the Study There is a lack of data to determine if the combination of donepezil & memantine has increased benefit BOTTOM LINE CONCLUSIONs donepezil & memantine is costly regimen that shows no added cognitive benefit Overall, patients had significant declines in function, regardless of drug regimen 4

31 9/26/2012 Methods UK 1 yr. MC PC DB trial of 295 Severe AD pts. Compared 4 Groups Placebo (n =73) Continue donepezil (n =73) DC donepezil & start memantine (n =73) Continue donepezil & add memantine (n =76) Methods Inclusion Criteria Community residents living with a caregiver or visited daily by caregiver ON donepezil 10mg for last 6 weeks and continuously for at least 3 months SMMSE exam score : 5 to 13 Exclusion Criteria Did not meet inclusion criteria Were receiving memantine Severe or unstable medical conditions Methods Primary Outcomes Standardized MMSE Scores Bristol ADLS (Caregiver rated) Established minimally clinical important differences SMMSE = 1.4 points BADLS = 3.5 points 5

32 9/26/2012 6

33 9/26/2012 Discussion only 1 of 4 groups (the donepezil group) met or exceeded the authors prespecified minimum clinically important difference (MCID) of 1.4 points for the SMMSE The MCID for the BADSL (3.5 points) was not met or exceeded in any group Limitations population limited Severe AD with a caregiver Study may be underpowered High level of discontinuation for all treatment groups (reported only as <80%) Bias may have been introduced through the inclusion criteria Use of donepezil for 3 months, max dose for 6 weeks Extrapolation Study conclusions CANNOT be extrapolated to: MCI or mild AD patients R id t f N i h Residents of Nursing homes Those who fail or cannot tolerate donepezil or are on other ACHEIs Groups did not differ for serious adverse events or death 7

34 9/26/2012 Schulman S, Parpia S, Stewart C, et al Warfarin dose assessment every 4 weeks versus every 12 weeks in patients with stable international normalized ratios: a randomized trial. Ann Intern Med. 2011;155: Study Design Blinded, Randomized, noninferiority trial 250 patients 18 years of age (median age 70 to 72 y, 70% men) long-term warfarin (therapeutic INR range 20to30or25to35)withastable or ) maintenance dose for 6 months managed clinic for 6 months (PT) measured at the hospital laboratory or designated private laboratory Follow-up: 1 year Intervention Warfarin dose assessment every 12 weeks (n = 124) or every 4 weeks (n = 126). All patients had PT monitored every 4 weeks 8

35 9/26/2012 Intervention MDs in the 4-week group were given true INR values after every monitoring visit Intervention MDs in the 12-week group were given: 1 true INR value for 1 randomly selected 4-week period sham INR values for the other two 4-wks 1.8 to 3.5 for patients with a therapeutic INR range of 2.0 to 3.0, 2.0 to 4.0 for those with a therapeutic INR range of 2.5 to 3.5 unless the INR value was extreme (< 1.5 or 4.5) or the patient had a clinical event or needed perioperative management. Outcomes INR time in therapeutic range (TTR) number of extreme INRs changes in maintenance warfarin dose clinical events (major bleeding thromboembolism, and death) Patient follow-up: 90% (intention-to-treat analysis). 9

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