Dabigatran etexilate
From Ganfyd
rINN: Dabigatran etexilate
Other Names
Pradaxa®, BIBR-1048, Rendix®
Pharmacological Information
Pharmacology Images
Dabigatran etexilate in the:
BNF-registration required
BNF for children-registration required
Metabolism & Interactions
Prodrug for dabigatran
Relevant Clinical Literature
Systematic reviews from Pubmed
Other Literature
Please read pharmacological data limitations
An oral, direct thrombin inhibitor (in Phase III trials for acute VTE, wider secondary prevention VTE, ACS, AF). Gained UK licence in April 2008 for thromboprophylaxis following knee and hip arthroplasty.
Contents |
Clinical Use
Large clinical trials are taking place in thromboembolic disease with promising results to date in multiple clinical indications against standard treatment. In those who can not establish stable warfarin anticoagulation it may be superior:
- Thromboprophylaxis in major lower limb orthopaedic surgery[1][2][3]
- AF[4] .
- Deep vein thrombosis from 9 days for up to 6 months after inital monotherapy heparinisation[5]
Indications
- Prevention of venous thromboembolic events (VTE) in adults who have undergone elective total hip or total knee replacement surgery (EU)
Administration
Oral for thromboprophylaxis
- Normal adults:110mg between 1 and 4 hours after surgery, continuing with 220mg daily for 10 days in total knee replacement and 28 to 35 days in hip replacement.
- Dose needs reduction in several common patient groups eg reduce 110mg to 75mg (and 220mg to 150mg) in moderate renal function or more than 75 years.
- The dose in the treatment studies was up to 150 mg twice daily, and to date these are in younger patients with good renal function which are unlikely to be representative of usual patient populations
Clinical Issues
Contra-indications
- Active bleeding
Cautions and Interactions
- Severe renal failure
Side effects
- Bleeding - appears to be less minor bleeding than warfarin for same clinical efficacy
- Dyspepsia - can be a reason for patients discontinuing drug
- Diarrhoea (possible)
Special advice
Pharmacology
Contains micropellets with dabigatran etexilate around a tartaric acid core as low pH needed for good drug absorption.
References
- ↑ Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Kälebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, Büller HR. Dabigatran etexilate versus enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. . 2007 Aug 24.(Epub ahead of print) (Link to article – subscription may be required.)
- ↑ Eriksson BI, Dahl OE, Rosencher N et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial Lancet 2007 ;370:949-956
- ↑ Holmes M, Carroll C, Papaioannou D. Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a single technology appraisal. Health technology assessment (Winchester, England). 2009 Sep; 13 Suppl 2:55-62.(Link to article – subscription may be required.)
- ↑ Dabigatran versus Warfarin in Patients with Atrial Fibrillation NEJM accessed 30 Aug 09 DOI 10.1056/NEJMoa0905561
- ↑ Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. NEJM accessed 06 Dec 09 DOI 10.1056/NEJMoa0906598
