When selecting patients’ once-daily oral anticoagulant, consider both their lifestyle factors AND clinical concerns

  • Peter, 61
  • PAROXYSMAL NVAF
  • At risk for stroke

Peter’s lifestyle factors:

  • Business executive
  • Frequent flyer
  • Often inconvenient for him to take medicine with food

Food intake can affect bioavailability:

In NOACs that require food intake, missed meals can result in lower drug availability1


Once-daily LIXIANA® (edoxaban) offers patients an easy-to-use oral anticoagulant

One tablet provides 24-hour anticoagulation2,3

No mealtime dosing required4
  • Can be taken with or without meals

Peter’s clinical concerns:


Height/Weight/BMI:
1.80 m/88 kg/27.1
Comorbidities:
High cholesterol, type 2 diabetes, hypertension
Renal functions:
CrCl 91 mL/min
Stroke risk:
Moderate (CHA2DS2-VASc score=2)5,*
Bleeding risk:
Low (HAS-BLED score=1); but the patient is aware that his risk may increase with treatment5,†

Bleeding is a concern with anticoagulant treatment:

Peter heard some patients have increased bleeding and is worried that he will be one of them







Once-daily LIXIANA® (edoxaban) was superior to well-managed warfarin in reducing the risk of major bleeding6,‡

Superior 20% relative risk reduction (RRR) in major bleeding vs well-managed warfarin in patients with NVAF (HR, 0.80; 95% CI, 0.71 to 0.91; P<0.001 for superiority)6

  • Patients taking warfarin were in the therapeutic INR range (2.0 to 3.0) for 68.4% of the time (in therapeutic range, according to a published clinical database, is 53.7%)6,8

Only LIXIANA® (edoxaban) offers once-daily convenience with no mealtime dosing required AND superiority vs warfarin in reducing major bleeding.

Only LIXIANA® (edoxaban) offers once-daily convenience with no mealtime dosing required AND superiority vs warfarin in reducing major bleeding.

  • *

    A validated measure for assessing stroke risk. The CHA2DS2 scoring is calculated by assigning 1 point each for a history of congestive heart failure, hypertension, diabetes mellitus, vascular disease, age 65 to 74 years, or female sex and by assigning 2 points for history of stroke/transient ischemic attack/thromboembolic event, or age 75 years or older.5

  • HAS-BLED is a clinical prediction tool in bleeding risk evaluation in AF patients that assigns 1 point for the presence of hypertension (uncontrolled systolic blood pressure >160 mm Hg), abnormal renal and/or liver function, previous stroke, bleeding history or predisposition, labile international normalized ratios, elderly, and concomitant drugs and/or alcohol excess.5

  • Major bleeding was defined as overt bleeding that met one of the following criteria:

    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraocular, intraspinal, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or
    3. A fall in haemoglobin of at least 2.0 g/dL (or a fall in haematocrit of at least 6.0% in the absence of haemoglobin data), adjusted for transfusions.7
  • Louise, 81
  • PERSISTENT NVAF
  • At risk for stroke

Louise’s clinical concerns:


Height/Weight/BMI:
1.66 m/51 kg/18.5
Comorbidities:
Heart failure with reduced ejection fraction; osteoarthritis, anemia
Renal functions:
CrCl 39 mL/min
Stroke risk:
High (CHA2DS2-VASc score=4)1
Bleeding risk:
High (HAS-BLED score=3)1

Bleeding risk is correlated with age:

Patients 75 years of age or older face a 2-FOLD INCREASE in bleeding risk compared to patients <75 years of age2,3,*


Once-daily LIXIANA® (edoxaban) was superior to well-managed warfarin in reducing the risk of major bleeding4,†

Significant 25% relative risk reduction (RRR) in major bleeding vs well-managed warfarin in patients 80 years of age or older with NVAF (HR, 0.75; 95% CI, 0.58 to 0.98; P<0.001)6

  • Patients taking warfarin were in the therapeutic INR range (2.0 to 3.0) for 68.4% of the time (in therapeutic range, according to a published clinical database, is 53.7%)4,7

Louise’s lifestyle factors:

  • Elderly
  • Lives independently
  • Sometimes forgetful

Many elderly patients struggle with compliance3:

67% of elderly patients are NONCOMPLIANT with chronic cardiovascular medications, as estimated by adherence rates at 1 year8


Once-daily LIXIANA® (edoxaban) offers patients an easy-to-use oral anticoagulant

One tablet provides 24-hour anticoagulation9,10

No mealtime dosing required11
  • Can be taken with or without meals

Only LIXIANA® (edoxaban) offers both superiority vs warfarin in reducing major bleeding AND convenient once-daily dosing in NVAF patients.

Only LIXIANA® (edoxaban) offers both superiority vs warfarin in reducing major bleeding AND convenient once-daily dosing in NVAF patients.

  • *

    13,559 patients with nonvalvular AF were identified in 1996 through 1997 in the Kaiser Permanente of Northern California database. Subjects were identified by searching clinical databases for International Classification of Diseases, Ninth Revisions, Clinical Modification (ICD-9) codes and followed through September 2003.2

  • Major bleeding was defined as overt bleeding that met one of the following criteria:

    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraocular, intraspinal, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or
    3. A fall in haemoglobin of at least 2.0 g/dL (or a fall in haematocrit of at least 6.0% in the absence of haemoglobin data), adjusted for transfusions.5

References:

  1. Lane DA, Lip GYH. Use of the CHA2DS2-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126(7):860-865.
  2. Fang MC, Go AS, Chang Y, et al. A new risk scheme to predict warfarin-associated hemorrhage: the ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study. J Am Coll Cardiol. 2011;58(4):395-401.
  3. Gage BF, Yan Y, Milligan PE, et al. Clinical classification schemes for predicting hemorrhage: results from the National Registry of Atrial Fibrillation (NRAF). Am Heart J. 2006;151(3):713-719.
  4. Giugliano RP, Ruff CT, Braunwald E, et al; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
  5. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3(4):692-694.
  6. Kato ET, Giugliano RP, Ruff CT, et al. Efficacy and safety of edoxaban in elderly patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. J Am Heart Assoc. 2016;5:e003432(Supplemental Material).
  7. Dlott JS, George RA, Huang X, et al. National assessment of warfarin anticoagulation therapy for stroke prevention in atrial fibrillation. Circulation. 2014;129(13):1407‐1414.
  8. Chapman RH, Petrilla AA, Benner JS, Schwartz JS, Tang SS. Predictors of adherence to concomitant antihypertensive and lipid-lowering medications in older adults: a retrospective, cohort study. Drugs Aging. 2008;25(10):885-892.
  9. Wolzt M, Samama MM, Kapiotis S, Ogata K, Mendell J, Kunitada S. Effect of edoxaban on markers of coagulation in venous and shed blood compared with fondaparinux. Thromb Haemost. 2011;105(6):1080-1090.
  10. Zahir H, Matsushima N, Halim AB, et al. Edoxaban administration following enoxaparin: a pharmacodynamic, pharmacokinetic, and tolerability assessment in human subjects. Thromb Haemost. 2012;108(1):166-175.
  11. LIXIANA Summary of Product Characteristics 2015. Daiichi Sankyo Europe GmbH.