Archive for the ‘Pradaxa (dabigatran)’ Category
The ACCP Chest Guidelines have been the main guide over the last more than 2 decades for evidence-based recommendations on best management of anticoagulants for various indications, including DVT and PE. The 10th edition of the chapter on DVT and PE management was published in Jan 2016 [ref 1]. Unfortunately, the guideline is not available for non-subscribers. Read the rest of this entry »
Stephan Moll, MD writes…. Today (Jan 8th, 2015) the FDA approved yet another new oral anticoagulant, Savaysa (edoxaban), for the treatment of DVT and PE, as well as for atrial fibrillation. The FDA press release is here (link). Savaysa is the 4th of the NOACS now approved for VTE treatment. This table summarizes the differences, advantages and disadvantages comparing the 4 drugs. The detailed drug package insert with dosing information is here (link). Read the rest of this entry »
Stephan Moll, MD writes (on Nov 7th, 2014)… A N Engl J Med publication this week [ref 1] reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants. Read the rest of this entry »
Stephan Moll, MD writes… Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE. The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE. Read the rest of this entry »
Stephan Moll, MD writes… Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials. The dose is 150 mg twice daily for patients with a GFR > 30 ml/min. Due to the design of the RECOVER and RECOVER II trials, the drug is approved to be used in the patient with acute DVT or PE only AFTER 5-10 days of a parenteral anticoagulant have been given – not immediately from day zero onwards. The full package insert is here. The press release from Boehringer-Ingelheim is here. The FDA approval status of the four big new oral anticoagulants for the various indications is summarized in this table.
Disclosures: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last updated: April 7th, 2014
Stephan Moll, MD writes… LMWH (low molecular weight heparin) is the preferred anticoagulant in the pregnant patient. LMWH and warfarin are safe in the woman who is beast-feeding.
Rivaroxaban (Xarelto), dabigatran (Pradaxa) and apixaban (Eliquis) should not be used during pregnancy or while breastfeeding.
Stephan Moll, MD writes… On Dec 19th the FDA accepted the application by Bristol-Myers Squibb (BMS) and Pfizer for review of Eliquis (apixaban) for the treatment of DVT and PE. The press release of BMS is here. The goal date for a decision by the FDA is August 25, 2014. Read the rest of this entry »
Stephan Moll, MD writes… Patients who are on warfarin for a history of DVT or PE may inquire whether a switch to one of the new oral anticoagulants is appropriate. Similarly, many physicians initiate this discussion with their patients.
This is, obviously, a detailed discussion and an individualized decision with a number of factors to be considered. We have developed a two-page “Comparison of Oral Blood Thinners” handout for patients, to assist with and summarize the discussion. This sheet allows a structured discussion with the patient about the pros and cons of the various anticoagulant choices. The reader is welcome to print this resource and use it as a handout for his/her patients.
Disclosure: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last Updated: Dec 19th, 2013
Stephan Moll, MD writes…
Interesting publication this week in Circulation: “Management and outcomes of major bleeding during treatment with dabigatran or warfarin” (Majeed A et al; published online Sept 30,2013; full publication is here). The management and prognosis of major bleeding in patients treated with dabigatran or warfarin was compared, pooling data of the major bleeds that occurred in 5 phase III dabigatran trials. 1,121 major bleeds occurred in 27,419 patients treated with warfarin or dabigatran.
The noteworthy findings:
- Patients with major bleeding on dabigatran (Pradaxa) do not fare worse than patients with major bleed on warfarin (regarding 30 day mortality). They may actually fare a little better, as evidence by a shorter stay in the intensive care unit. That is reassuring when discussing the choice of the anticoagulant (warfarin versus dabigatran) with a patient.
- There were (as we already knew from previous publications) significantly less intracranial bleeds on dabigatran than on warfarin; however, there were more GI bleeds on dabigatran (supplemental table 1). This is noteworthy, as many would view an intracranial bleed as more worrisome and detrimental than a gastrointestinal bleed.
- Warfarin reversal is done suboptimally in clinical practice: In patients with major bleeding on warfarin, (i) only 30 % of patients received vitamin K and (ii) only 1.2 % of patients received a prothrombin complex concentrate (PCC); 30 % received FFP. This is noteworthy, as guidelines (ACCP 2012) suggest that in case of major bleeding on warfarin PCCs be given rather than plasma (FFP); and vitamin K should be standard of care in warfarin reversal. The observation in this Circulation publication reflects that reversal of warfarin therapy is often suboptimally done, even though appropriate tools exist, i.e. vitamin K and PCCs (see also Clot Connect’s Kcentra discussion here).
Disclosure: I have consulted for Boehringer-Ingelheim.
Last updated: Oct 2nd, 2013
Stephan Moll, MD writes… Today, Sept 1st, 2013, the New England Journal of Medicine published the phase 3 clinical trial of edoxaban versus warfarin in the treatment of DVT and PE [ref 1]. It showed that edoxaban was as effective as warfarin and led to less clinically relevant bleeding. Read the rest of this entry »