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Category: Volume 08 Issue 10 October 2020
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Title: An Observational Study Comparing Effectiveness and Safety of Dabigatran versus Warfarin in Patients of Non Valvular Atrial Fibrillation in a Tertiary Care Hospital of West Bengal

Authors: Subhajit Paul, Amit Kumar Ghosh, Sankar Paul Chowdhury, Shilanjan Roy

 DOI: https://dx.doi.org/10.18535/jmscr/v8i10.40

Abstract

Objectives: This study aims to evaluate effectiveness and safety of dabigatran versus warfarin in patients of non valvular atrial fibrillation in clinical practice in a tertiary care hospital of west Bengal, India by comparing the number of ischaemic stroke, bleeding events and other adverse events.

Methods: A prospective longitudinal observational study was conducted over 16 months (January 2018-April 2019). The study population comprised patients diagnosed of non valvular atrial fibrillation, receiving either dabigatran or warfarin with CHA2DS2-VASC SCORE ≥2 and patients of hyperthyroidism, treated for last one year, presenting with persistent atrial fibrillation in euthyroid state. They were divided into two groups & followed for 1 year to observe number of ischaemic strokes, thromboembolic events, bleeding events. After baseline investigations, in warfarin group INR was checked until stable therapeutic range (2-3) reached, then every 2ndmonthly both groups are followed. Relevant statistical tests were utilized for data analysis.

Results: Total 150 patients were studied. Only 2 patients (2.7%) out of 74 patients in dabigatran showed event of ischaemic stroke and in warfarin group the number of ischaemic events were 8 (10.5%) out of 76 patients. So numerically dabigatran more effectively can prevent ischaemic stroke (p value 0.098).2 patients (2.7%) in group A and 4 patients (5.3%) in group B were having minor bleeding episodes(p value 0.681).

Conclusion: Dabigatran 110 mg twice daily dose seems better than warfarin INR adjusted dose regarding effectiveness and safety profile in non valvular atrial fibrillation in Indian perspective in absolute number of ischaemic stroke and bleeding episodes.

Keywords: Non valvular atrial fibrillation, CHA2DS2-VASc score, Warfarin , Dabigatran, INR.

References

  1. Michaud FG, Stevenson GW, Supraventricular Tachy arrhythmias. In : Kasper DL, Hauser SL, Longo DL, Jameson JL, Loscalzo J, Fauci AS , editors. Harrison's principles of internal medicine, 20th edition. Newyork: McGraw Hills education ; c 241 .p. 1476.
  2. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European journal of cardio-thoracic surgery. 2016 Nov 1;50(5):e1-88.
  3. January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Journal of the American College of Cardiology. 2014 Dec 2;64(21):e1-76.
  4. Diener HC, Connolly SJ, Ezekowitz MD, Wallentin L, Reilly PA, Yang S, Xavier D, Di Pasquale G, Yusuf S, RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. The Lancet Neurology. 2010 Dec 1;9(12):1157-63.
  5. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. The Lancet. 2014 Mar 15;383(9921):955-62.
  6. Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, et al. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: The RE-LY Atrial Fibrillation Registry. Circulation 2014; 129:1568-76.
  7. Larsen TB, Rasmussen LH, Skjøth F, Due KM, Callréus T, Rosenzweig M, Lip GY. Efficacy and safety of dabigatran etexilate and warfarin in “real-world” patients with atrial fibrillation: a prospective nationwide cohort study. Journal of the American College of Cardiology. 2013 Jun 4;61(22):2264-73.
  8. Seeger JD, Bykov K, Bartels DB, Huybrechts K, Zint K, Schneeweiss S. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thrombosis and haemostasis. 2015;114(12):1277-89.
  9. Romanelli RJ, Nolting L, Dolginsky M, Kym E, Orrico KB. Dabigatran versus warfarin for atrial fibrillation in real-world clinical practice: a systematic review and meta-analysis. Circulation: Cardiovascular Quality and Outcomes. 2016 Mar;9 (2):126-34.
  10. Yap LB, Eng DT, Sivalingam L, Rusani BI, Umadevan D, Muhammad Z, Koh KW, Aisha B, Hashim MI, Rebo R, Hussin A. A comparison of dabigatran with warfarin for stroke prevention in atrial fibrillation in an Asian population. Clinical and Applied Thrombosis/Hemostasis. 2016 Nov;22(8):792-7.
  11. Schulman S, Shortt B, Robinson M, Eikelboom JW. Adherence to anticoagulant treatment with dabigatran in a real‐world setting. Journal of thrombosis and haemostasis. 2013 Jul;11(7):1295-9.
  12. Pink J, Lane S, Pirmohamed M, Hughes DA. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses. Bmj. 2011 Oct 31;343:d6333.

Corresponding Author

Subhajit Paul

Post Graduate Trainee, Department of Pharmacology, R.G.Kar Medical College & Hospital, Kolkata