Archive for the ‘Pradaxa (dabigatran)’ Category
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 »
Stephan Moll, MD writes…
1. Pradaxa (Dabigatran)
- Today, August 28th, 2013, it was announced that the FDA is reviewing the application by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here.
- At present, in the US, Pradaxa is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.
2. Eliquis (Apixaban)
- On July 11th , 2013 the company making Eliquis applied for FDA approval of their drug for DVT and PE prevention after hip and knee replacement surgery – details here.
- The company has not yet filed for approval of the drug for DVT and PE treatment.
- At present, in the US, Eliquis is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.
3. Xarelto (Rivaroxaban)
- Xarelto is, at present the only one of the new oral anticoagulants that is FDA-approved for the treatment of DVT and PE. It is also approved for (a) DVT and PE prevention after hip and knee replacement surgery, and (b) for prevention of stroke and other arterial clots in patients with irregular heart beat.
- This new oral anticoagulant by the Japanese company Daiichi is not FDA-approved at this time and no FDA review of data is pending.
Disclosure: I have consulted for Janssen, Daiichi, Boehringer Ingelheim.
Last updated: Sept 1st, 2013
Stephan Moll, MD writes… A major international coagulation conference, the bi-annual meeting of the International Society for Thrombosis and Haemostasis (ISTH; www.isth.org), took place in Amsterdam, Holland, from June 29th to July 4th, 2013. The clinically relevant highlights about thrombosis and anticoagulation are summarized below. Read the rest of this entry »
Stephan Moll writes…
2012 has been a year with significant progress in the field of venous thromboembolism and anticoagulation. The three most noteworthy, clinically relevant developments were probably (a) the publication of the new ACCP (American College of Chest Physician) guidelines on antithrombotic therapy in February 2012; (b) The FDA-approval of rivaroxaban (Xarelto) in November 2012 for the acute treatment of venous thromboembolism (VTE) and long-term secondary prevention; and (c) The FDA-approval of apixaban (Eliquis) in December 2012 for atrial fibrillation and the prevention of arterial thromboembolism. Here I have listed and summarized the 10 top publications of 2012 in the field of venous thromboembolism and anticoaguation as I see them – the ones clinically most relevant.
Disclosure: I have consulted for Janssen, Boehringer-Ingelheim and Daiichi.
Last updated: Feb 7th, 2013
What topics need to be discussed with the patient who wants to start Pradaxa (Dabigatran)? A structured, bulleted checklist may be helpful in your discussion with the patient, to make sure all relevant points are addressed. A suggested list is here. Read the rest of this entry »
The new oral anticoagulant Pradaxa® (Dabigatran) is increasingly being used as an alternative to warfarin. A number of practical management questions are now encountered by the physician, pharmacist, or other health care professional taking care of the patient on Pradaxa®, such as (a) dosing in renal impairment, (b) conversion of a patient on warfarin to Pradaxa®, (c) discontinuation of Pradaxa® at times of surgery, dental work, colonoscopy, or other procedures, or (d) management of bleeding on Pradaxa®. These issues may best be addressed in a health care system by the establishment of a structured treatment algorithm/guide/help for the whole hospital or physician practice. As an example, here is the document that Read the rest of this entry »
When to stop the drug – General comments
The patient on Pradaxa® (Dabigatran) may need interruption of therapy for dental work, a medical procedure such as colonoscopy, or minor or major surgical procedure. As to when exactly to take the last dose of Pradaxa® before the procedure depends on (a) what type of procedure is planned and how much bleeding to expect with it, and (b) whether the patient is at high or low risk for thrombosis if he/she is off anticoagulants for some period of time. Read the rest of this entry »
Major and life-threatening bleeding is expected to occur in some patients treated with Pradaxa® (=Dabigatran). The question will then urgently arise how to best treat such catastrophic bleeding. Read the rest of this entry »