164 CHAPTER 8 Off-label reduced and on-label non-reduced NOAC dose 550 518 412 123 98 734 9,885 338 369 2,890 5,796 183 338 941 1,181 2,336 1,114 3,670 4,879 8,549 2,551 1,013 3,564 1,609 3,285 Off-label reduced dose (n) 2,790 4,881 4,241 409 477 6,376 13,141 907 746 4,194 7,798 294 907 3,241 1,196 4,185 8,872 3,259 4,760 8,019 9,341 5,621 14,962 3,717 5,140 On-label nonreduced dose (n) 16.5 9.6 8.9 23.1 17.0 10.3 42.9 27.1 33.1 40.8 42.6 38.4 27.1 22.5 49.7 35.8 11.2 53.0 50.6 51.6 21.5 15.3 19.2 30.2 39.0 OLRD of patients with an indication for an on-label nonreducced NOAC dose (%) * In case articles concern the same author, a note is added after the author to indicate what makes the articles distinct. Substudies are indented and greyed out. Studies included in the meta-analysis are underlined and presented against a white background; ǂ median instead of mean; ◦ CrCl instead of eGFR. 1 Austria, Belgium, Germany, Ireland, Italy, Portugal, Spain, Switzerland, The Netherlands, United Kingdom; 2 FDA or concomitant use of a dual P-gp-Cyp3A4 inhibitor (including ketoconazole, fluconazole, itraconazole, cobicistat, conivaptan, indinavir, voriconazole, posaconazole, nefzadone HCL, ritonavir, saquinavir, telithromycin); 3 age ≥70 years, CrCl of 30-50 mL/min, prior GI-bleeding, or concomitant use of oral P-gp inhibitors; 4 D: elderly >70 years, CrCl 30-50 mL/min, concomitant use of P-gp inhibitors, history of GI-bleeding, R: CrCl 15-49 mL/min, A: ARISTOTLE, E: body weight ≤60 kg, CrCl 15-50 mL/min, concomitant use of P-gp inhibitors; 5 old age (≥75 years old), renal dysfunction (glomerular filtration rate <50 mL/ min), or low body weight (<50 kg); 6 D: 110 mg b.i.d.: CrCl 30-50 mL/min, age ≥70 years and a prior history of bleeding, R: 10 mg o.d.: CrCl 15-50 mL/min, A: 2.5 mg b.i.d.: ARISTOTLE, E: 30 mg o.d.: CrCl 15-50 mL/min or body weight <60 kg; 7 D: age ≥70 years, CrCl 30-50 mL/min, concomitant P-gp inhibitors, or history of GI-bleeding, R: SPC, A: ARISTOTLE, E: SPC; 8 eGFR<30 mL/min/1.73 m2; 9 serum creatinine level ≥1.5 mg/ dL; 10 only patients with CrCl ≥50 mL/min; 11 eGFR <60 instead of eGFR <50; 12 stroke; 13 ischemic stroke; 14 stroke, TIA or thromboembolism; 15 ischemic stroke or TIA; 16 stroke or TIA; 17 thromboembolism (arterial); 18 peripheral artery disease; 19 MI and/or peripheral artery disease and/or aortic plaque; 20 MI or arteriosclerosis obliterans; 21 chronic renal failure; 22 renal disease (ICD-9 and ICD-10 codes): moderate (stage III) or severe (stage IV, V); 23 chronic kidney disease (i.e. presence of ICD-10 codes for chronic kidney disease); 24 CrCl <50 mL/ min; 25 renal disorder; 26 insufficient kidney function; 27 chronic dialysis, renal transplantation or serum creatinine >200 mmol/L; 28 haemodialysis; 29 i.e. aspirin; 30 i.e. aspirin, cilostazol, clopidogrel, ticlopidine. A: apixaban; ADP: adenosine diphosphate; AF: atrial fibrillation; b.i.d.: bis in die (i.e. twice a day); CAD: coronary artery disease; CrCl: creatinine clearance; D: dabigatran; E: edoxaban; eGFR: estimated glomerular filtration rate; EHR: electronic health record; ESC: European Society of Cardiology; FDA: Food and Drugs Administration; GI: gastrointestinal; ICD: International Classification of Diseases and Related Health Problems; kg: kilogram; MI: myocardial infarction; n.a.: not applicable; NOAC: non-vitamin K antagonist oral anticoagulant; n.r.: not reported; NSAID: non-steroidal antiinflammatory drug; o.d.: omnie die (i.e. once a day); OLRD: off-label reduced dosing; P-gp: P-glycoprotein; PI: platelet inhibitor; PR: prospective registry; R: rivaroxaban; SC: specialist care; SPC: Summary of Product Characteristic; TIA: transient ischemic attack; USA: United States of America; VKA: vitamin K antagonist.
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