The presence of any Valvular Heart Disease (VHD) did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with Warfarin
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 10/22/2018
Dabigatran (Pradaxa) was no better than aspirin for prevention of recurrent stroke among patients with an embolic stroke of undetermined source in the RE-SPECT ESUS trial reported at the World Stroke Congress.
- Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
- Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults
16 Pradaxa® US Prescribing Information, 2018.
17 Pradaxa® European Summary of Product Characteristics, 2018.
18 Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
19 Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
20 Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63
SOURCE
Event Rate and Outcome Risk, With vs Without Valvular Heart Disease
| Outcome | Valvular heart disease, event rate/y, % | No valvular heart disease, event rate/y, % | HR (95% CI)* | P |
| Stroke, systemic embolic event | 1.61 | 1.41 | 1.09 (0.88–1.33) | 0.43 |
| Major bleeding | 4.36 | 2.84 | 1.32 (1.16–1.33) | <0.001 |
| Intracranial hemorrhage | 0.51 | 0.41 | 1.20 (0.83–1.74) | 0.32 |
| All-cause mortality | 4.45 | 3.67 | 1.09 (0.96–1.23) | 0.18 |
ORIGINAL RESEARCH ARTICLE
Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial
Michael D. Ezekowitz, Rangadham Nagarakanti, Herbert Noack, Martina Brueckmann, Claire Litherland, Mark Jacobs, Andreas Clemens,Paul A. Reilly, Stuart J. Connolly, Salim Yusuf and Lars Wallentin
http://dx.doi.org/10.1161/CIRCULATIONAHA.115.020950
Results—There were 3950 patients with any VHD:
- 3101 had mitral regurgitation,
- 1179 tricuspid regurgitation,
- 817 aortic regurgitations,
- 471 aortic stenosis and
- 193 mild mitral stenosis.
At baseline patients with any VHD had more
- heart failure,
- coronary disease,
- renal impairment and
- persistent atrial fibrillation.
Patients with any VHD had higher rates of
- major bleeds (HR 1.32; 95% CI 1.16-1.5)
but similar
- stroke or systemic embolism (SEE) rates (HR 1.09; 95% CI 0.88-1.33).
For D110 patients, major bleed rates were lower than warfarin (HR 0.73; 95% CI 0.56-0.95 with and HR 0.84; 95% CI 0.71-0.99 without VHD) and
For D150 similar to warfarin in patients with (HR 0.82; 95% CI 0.64-1.06) or without VHD (HR 0.98; 95% CI 0.83-1.15).
For D150 patients stroke/SEE rates were lower versus warfarin with (HR 0.59; 95% CI 0.37-0.93) and without VHD (HR 0.67; 95% CI 0.52-0.86) and similar to warfarin for D110 irrespective of presence of VHD (HR 0.97 CI 0.65-1.45 and 0.85 CI 0.70-1.10).
For intracranial bleeds and death rates for D150 and D110 were lower vs warfarin independent of presence of VHD.
Conclusions—The presence of any VHD did not influence the comparison of dabigatran with warfarin.
Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique Identifier: NCT00262600.
SOURCES
http://circ.ahajournals.org/content/early/2016/08/05/CIRCULATIONAHA.115.020950
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