dabigatran (Pradaxa)
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Indications
- anticoagulation for non-valvular atrial fibrillation
- stroke prevention[6][7][10][12]
- prevents 5 more strokes per 1000 patients than warfarinm[22]
- lower risk of stroke & death than warfarin[31]
- annual risk of death lower than with warfarin (2.7% vs 8.5%)[41]
- superior to warfarin in Asians[42];
- reduced risks for ischemic stroke/systemic embolism, intracranial hemorrhage, & all-cause mortality at 1 year[42]
- venous thromboembolism/deep vein thrombosis[5][25][28]
- prophylaxis for venous thromboembolism/deep vein thrombosis
- after total knee replacement[2] (off-label)
- after total hip replacement[3] (off-label)[17]
- prophylaxis for recurrent acute coronary syndromes?
- probably not; associated with higher risk of acute coronary syndrome than warfarin (0.9% vs 0.2%)[25]
- lowers risk of major vascular complications in patients with myocardial injury after non-cardiac surgery[47]
* safe & effective in elderly[33]
Contraindications
- not for use in anticoagulant 'bridge' therapy in the perioperative period[14]
- mechanical heart valve[24]
- ESRD[27]
- pregnancy
- valvular heart disease
- severe obesity
- high-risk antiphospholipid antibody syndrome[27]
Dosage
- 110 or 150 mg PO BID
- switch from warfarin when INR is < 2.0
- stop dabatrigan at least one day prior to surgery (or 3 days in patients with renal insufficiency)
- restart dabigatran 24 hours after surgery or longer if high risk of postoperative bleeding[14]
- 110 mg dose associated with lower risk of bleeding but higher risk of stroke[16]
Storage:
- moisture-sensivitive
- keep in the original bottle WITH desiccant in the bottle cap
- do not put in pill organizer[12][34]
- good for <60 days after bottle open[15]; within 4 months[34]
Dosage adjustment in renal failure
- 110 mg BID may be more appropriate for patients with renal insufficiency
- 75 mg BID for creatinine clearance of 15-30 ml/min
- potential benefit of monitoring anticoagulant activity & adjusting dose to minimize risk/benefit ratio[36]
- contraindicated in patients with ESRD
- do not use with creatinine clearance < 15 ml/min (AF) or < 30 ml/min (VTE)[27]
Pharmacokinetics
- renal clearance: 80%
- time to maximum concentration: 2 hours
- 1/2life: 12-17 hours
- protein_binding: 35%[27]
Adverse effects
- higher risk of any bleeding than warfarin (33% vs 27%)[37]
- lower annual risk of bleeding vs warfarin (2.4% vs 5.0%)[41]
- major bleeding (conflicting reports)
- reports of serious bleeding[23]
- similar to enoxaparin, warfarin[19][23]
- safer than warfarin[26]
- lower risk of intracranial hemorrhage in the elderly (> 75 years of age) than warfarin (0.6% vs 1.8%)[37]
- fewer intracranial bleeds than warfarin (0.39 vs. 0.77/100 person-years)[45][48]
- higher risk of GI bleed than warfarin[31][37]
- lower risk of hospitalization for GI bleed & for intracranial hemorrhage than with rivaroxaban[42][43]
- similar risks for ischemic stroke & bleeding as warfarin but lower risk for death in nursing home residents (RR=0.7-0.8)[50]
- elevated serum transaminases (similar to enoxaparin) (3-4%), returning to baseline afer cessation[2]
- GI: dyspepsia, nausea, heartburn, bloating
- increased risks for acute coronary syndrome & myocardial infarction (HR=1.33; absolute risk 0.27%)[21][35];
- 2 more myocardial infactions per 1000 patients than warfarin vs 5 fewer strokes per 1000 patients than warfarin[22]
- increased risk or myocardial infarction with dabigatran vs warfarin (0.77 vs. 0.43/100 person-years)[45]
- discontinuation due to adverse effects may be more common with dabigatran than warfarin[35]
- less risk of osteoporotic fracture than with warfarin (0.7 vs 1.1 per 100 person-years)[44]
Overdose or dabigatran-associated hemorrhage
- idarucizumab (Praxbind) for dabigatran overdose[39][40]
- idarucizumab reverses dabigatran across spectrum of renal failure[49]
- prior to idarucizumab (Praxbind), no known antidote
- stop dabigatran
- administer fresh frozen plasma until bleeding stops
- activated prothrombin concentrate complex 50-100 units/kg IV
- 4-factor prothrombin complex concentrate[46]
- prothombin complex concentrate does NOT reverse the anticoagulant effect of dabigatran[20]
- activated charcoal within 2 hours of dabigatran dose
- hemodialysis[27]
Laboratory
Mechanism of action
- direct thrombin inhibitor
- dabigatran caps contain tartaric acid to improve absorption (this may result in dyspepsia)
Notes
- recall 75 mg & 150 mg tablets March 2023 due to the presence of a nitrosamine[51]
- cost 2010, $240/month[9]
More general terms
References
- ↑ Veterans Administration
- ↑ 2.0 2.1 2.2 Eriksson BL et al, Oral dabigatran etexilate vs subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: The RE-MODEL randomized trial. J Thromb Haemost 2007, 5:2178 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17764540
Bauer KA Targeted inhibition of coagulation: Oral agents show promise in phase III trials. J Thromb Haemost 2007, 5:2175 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17764539 - ↑ 3.0 3.1 Prescriber's Letter 15(8): 2008 New Drugs on the Horizon: Pradaxa (Dabigatran) and Xarelto (Rivaroxaban) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240805&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Connolly SJ et al, Dabigatran versus Warfarin in Patients with Atrial Fibrillation N Engl J Med 2009 Sep 17; 361:1139 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19717844 <Internet> http://content.nejm.org/cgi/content/full/NEJMoa0905561
- ↑ 5.0 5.1 Schulman S et al Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism N Engl J Med 2009 December 6 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19966341 <Internet> http://content.nejm.org/cgi/content/full/NEJMoa0906598
- ↑ 6.0 6.1 Boehringer Ingelheim Pharmaceuticals, Inc. New Release FDA Advisory Committee Unanimously Recommends Approval of Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation http://www.prnewswire.com/news-releases/fda-advisory-committee-unanimously-recommends-approval-of-dabigatran-etexilate-for-stroke-prevention-in-atrial-fibrillation-103372294.html
- ↑ 7.0 7.1 FDA News Release, Oct. 19, 2010 FDA approves Pradaxa to prevent stroke in people with atrial fibrillation http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm
- ↑ Prescriber's Letter 17(11): 2010 New Drug: Pradaxa (Dabigatran) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=261101&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 9.0 9.1 Freeman JV et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med 2010 Nov 1 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21041570 <Internet> http://www.annals.org/content/early/2010/11/03/0003-4819-154-1-201101040-00289.long
- ↑ 10.0 10.1 Diener HC et al Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: A subgroup analysis of the RE-LY trial. Lancet Neurol 2010 Dec; 9:1157 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21059484
Lane DA and Lip GY. Dabigatran in atrial fibrillation: Balancing secondary stroke prevention against bleeding risk. Lancet Neurol 2010 Dec; 9:1140 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21059485 - ↑ Prescriber's Letter 18(1): 2011 COMMENTARY: New Drug: Pradaxa (Dabigatran) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270101&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 12.0 12.1 12.2 Wann LS et al 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran) A Report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines Circulation Feb 15, 2011 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21321155 <Internet> http://circ.ahajournals.org/cgi/reprint/CIR.0b013e31820f14c0v1
- ↑ Prescriber's Letter 18(3): 2011 Helping Patients Store and Use Dabigatran Appropriately Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270318&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 14.0 14.1 14.2 Prescriber's Letter 18(3): 2011 Should Dabigatran Be Used for Bridging? Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270310&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 15.0 15.1 FDA MedWatch Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249005.htm
- ↑ 16.0 16.1 Beasley BN et al Anticoagulant Options - Why the FDA Approved a Higher but Not a Lower Dose of Dabigatran N Engl J Med April 13, 2011 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21488759 <Internet> http://healthpolicyandreform.nejm.org/?p=14213&query=home
Hylek EM. Therapeutic potential of oral factor Xa inhibitors. N Engl J Med 2010; 363:2559-2561. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21175319 - ↑ 17.0 17.1 Prescriber's Letter 18(6): 2011 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270608&pb=PRL Off-Label Use of Dabigatran (subscription needed) http://www.prescribersletter.com
- ↑ Prescriber's Letter 18(9): 2011 Reversing Dabigatran and Rivaroxaban Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270912&pb=PRL
Prescriber's Letter 19(1): 2012 Reversing Dabigatran and Rivaroxaban Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280102&pb=PRL (subscription needed) http://www.prescribersletter.com (subscription needed) http://www.prescribersletter.com - ↑ 19.0 19.1 FDA MedWatch: 12/07/2011 Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm
- ↑ 20.0 20.1 Eerenberg ES et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: A randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011 Oct 4; 124:1573. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21900088
Battinelli EM. Reversal of new oral anticoagulants. Circulation 2011 Oct 4; 124:1508. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21969317 - ↑ 21.0 21.1 Uchino K et al Dabigatran Association With Higher Risk of Acute Coronary Events Meta-analysis of Noninferiority Randomized Controlled Trials Arch Intern Med. Published online January 9, 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22231617 <Internet> http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.1666
- ↑ 22.0 22.1 Prescriber's Letter 19(3): 2012 COMMENTARY: Dabigatran and Risk of Myocardial Infarction CHART: Comparison of Oral Antithrombotics Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280321&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 23.0 23.1 23.2 FDA MedWatch. Nov 2, 2012 Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm
- ↑ 24.0 24.1 FDA MedWatch: Dec 19, 2012 Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332949.htm
Eikelboom JW et al. for the RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013 Sep 1 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23991661 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1300615
Hylek EM. Dabigatran and mechanical heart valves - Not as easy as we hoped. N Engl J Med 2013 Sep 1 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23991659 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1310399 - ↑ 25.0 25.1 25.2 Schulman S et al Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism N Engl J Med 2013; 368:709-718February 21, 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23425163 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1113697
Connors JM Extended Treatment of Venous Thromboembolism. N Engl J Med 2013; 368:767-769February 21, 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23425170 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1215678 - ↑ 26.0 26.1 26.2 Southworth MR et al. Dabigatran and postmarketing reports of bleeding. N Engl J Med 2013 Apr 4; 368:1272. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23484796
Berger R, Salhanick SD, Chase M, Ganetsky M. Hemorrhagic complications in emergency department patients who are receiving dabigatran compared with warfarin. Ann Emerg Med. 2013 Apr;61(4):475-9 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23522810 - ↑ 27.0 27.1 27.2 27.3 27.4 27.5 Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 19 American College of Physicians, Philadelphia 2012, 2015, 2022
- ↑ 28.0 28.1 28.2 Boehringer Ingelheim Pharmaceuticals, Inc. Press Release April 7, 2014 FDA Approves Pradaxa (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism. http://www.prnewswire.com/news-releases/fda-approves-pradaxa-dabigatran-etexilate-mesylate-for-treatment-and-reduction-in-the-risk-of-recurrence-of-deep-venous-thrombosis-and-pulmonary-embolism-254175631.html
- ↑ Eikelboom JW, Wallentin L, Connolly SJ Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011 May 31;123(21):2363-72. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21576658
- ↑ 30.0 30.1 30.2 Geriatric Review Syllabus, 8th edition (GRS8) Durso SC and Sullivan GN (eds) American Geriatrics Society, 2013
- ↑ 31.0 31.1 31.2 FDA MedWatch May 13, 2014 Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm
- ↑ Wood Shelly. Medscape May 13, 2014 FDA Review Finds No Increased Risk of MI With Dabigatran (Pradaxa) http://www.medscape.com/viewarticle/825080
- ↑ 33.0 33.1 Sardar P et al. New oral anticoagulants in elderly adults: Evidence from a meta-analysis of randomized trials. J Am Geriatr Soc 2014 May; 62:857 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24786913 <Internet> http://onlinelibrary.wiley.com/doi/10.1111/jgs.12799/abstract
- ↑ 34.0 34.1 34.2 Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=300622&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 35.0 35.1 35.2 Cairns J. ACP Journal Club. Review: Dabigatran increases MI and reduces mortality compared with warfarin, enoxaparin, or placebo. Ann Intern Med. 2012;156(12):JC6-JC11. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22711112
Adam SS, McDuffie JR, Ortel TL, Williams JW Jr. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review. Ann Intern Med. 2012;157(11):796-807 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22928173 - ↑ 36.0 36.1 Cohen D Dabigatran: how the drug company withheld important analyses. BMJ 2014;349:g4670 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25055829 <Internet> http://www.bmj.com/content/349/bmj.g4670
Charlton B, Redberg R The trouble with dabigatran. BMJ 2014;349:g4681 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25055830 <Internet> http://www.bmj.com/content/349/bmj.g4681 - ↑ 37.0 37.1 37.2 37.3 37.4 37.5 Hernandez I et al Risk of Bleeding With Dabigatran in Atrial Fibrillation. JAMA Intern Med. Published online November 03, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25365537 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=1921753
- ↑ 38.0 38.1 Chang H-Y et al. Risk of gastrointestinal bleeding associated with oral anticoagulants: Population based retrospective cohort study. BMJ 2015;350:h1585 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25911526 <Internet> http://www.bmj.com/content/350/bmj.h1585
Abraham NS et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: Population based cohort study. BMJ 2015;350:h1857 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25910928 <Internet> http://www.bmj.com/content/350/bmj.h1857
Vaughan Sarrazin MS and Rose A. Safety of new oral anticoagulants. BMJ 2015;350:h1679 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25911527 <Internet> http://www.bmj.com/content/350/bmj.h1679 - ↑ 39.0 39.1 Pollack CV et al Idarucizumab for Dabigatran Reversal N Engl J Med. June 22, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26095746 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1502000
Pollack CV, Jr. Reilly PA, van Ryn J et al Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. July 11, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28693366 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1707278 - ↑ 40.0 40.1 FDA News Release. October 16, 2015 FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm
- ↑ 41.0 41.1 41.2 Larsen TB et al Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ 2016;353:i3189 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27312796 Free full text <Internet> http://www.bmj.com/content/353/bmj.i3189
- ↑ 42.0 42.1 42.2 42.3 Chan YH, Kuo CT, Yeh YH et al. Thromboembolic, bleeding, and mortality risks of rivaroxaban and dabigatran in Asians with nonvalvular atrial fibrillation. J Am Coll Cardiol 2016 Sep 27; 68:1389. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27659460 Free Article
Ruff C. The reality of "real-world" data: More questions than answers. J Am Coll Cardiol 2016 Sep 27; 68:1402 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27659461 - ↑ 43.0 43.1 Graham DJ, Reichman ME, Wernecke M et al Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation. JAMA Intern Med. Published online October 03, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27695821 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2560376
Parks AL, Redberg RF Comparing Non-Vitamin K Oral Anticoagulants. Where We Are Now. JAMA Intern Med. Published online October 03, 2016 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27695820 archinte.jamanetwork.com/article.aspx?articleid=2560371 - ↑ 44.0 44.1 Lau WC, Chan EW, Cheung CL et al Fractures Among Patients With Nonvalvular Atrial Fibrillation. JAMA. 2017;317(11):1151-1158 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28324091 <Internet> http://jamanetwork.com/journals/jama/article-abstract/2612616
- ↑ 45.0 45.1 45.2 Go AS, Singer DE, Toh S et al. Outcomes of dabigatran and warfarin for atrial fibrillation in contemporary practice: A retrospective cohort study. Ann Intern Med 2017 Nov 14 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29132153
- ↑ 46.0 46.1 Anderson I, Cifu AS. Management of Bleeding in Patients Taking Oral Anticoagulants. JAMA. 2018;319(19):2032-2033. May 15, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29800198 https://jamanetwork.com/journals/jama/fullarticle/2681178
- ↑ 47.0 47.1 Devereaux PJ, Duceppe E, Guyatt G et al Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo- controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29900874
- ↑ 48.0 48.1 Vinogradova Y, Coupland C, Hill T, Hippisley-Cox J Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care. BMJ 2018;362:k2505 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29973392 https://www.bmj.com/content/362/bmj.k2505
- ↑ 49.0 49.1 Eikelboom JW, van Ryn J, Reilly P et al. Dabigatran reversal with idarucizumab in patients with renal impairment. J Am Coll Cardiol 2019 Oct 8; 74:1760. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31582135 Free Article
- ↑ 50.0 50.1 Alcusky M et al. Comparative safety and effectiveness of direct-acting oral anticoagulants versus warfarin: A national cohort study of nursing home residents. J Gen Intern Med 2020 Aug; 35:2329. PMID: https://www.ncbi.nlm.nih.gov/pubmed/32291717 PMCID: PMC7403286 https://link.springer.com/article/10.1007/s11606-020-05777-3
- ↑ 51.0 51.1 Food & Drug Admnistration Safety Alert. March 22, 2023 Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitroso- dabigatran (NDAB) Impurity. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg
Patient information
dabigatran patient information