Archive for the ‘Therapy’ Category
Stephan Moll, MD writes (on Dec 8th, 2014)… A publication this week in the New England Journal of Medicine reports on a drug in development that protects patients from blood clots (DVT), without increasing the risk of bleeding. Too good to be true? Possibly, but may be not. Additional studies will have to tell. Read the rest of this entry »
Stephan Moll, MD writes (on Nov 7th, 2014)… A publication this week in the New England Journal of Medicine reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants [ref 1]. Read the rest of this entry »
Stephan Moll, MD writes… For patients stopping blood thinning therapy (anticoagulation) whose deep vein thrombosis (DVT) or pulmonary embolism (PE) was considered unprovoked (i.e. out of the blue and with no obvious triggering, transient cause, such as surgery, hormone use, immobility), aspirin is beneficial in some patients in preventing further clots. A new publication in the journal Circulation re-confirms findings from two previous studies, showing that aspirin reduces the risk of recurrent DVT/PE by more than a third without significantly increasing the risk of bleeding [ref 1,2,3]. 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) the longer-term prevention of recurrent DVT/PE. Read the rest of this entry »
Stephan Moll, MD writes… Major bleeds on blood thinners (such as Coumadin, Jantoven, Eliquis, Pradaxa, Xarelto) and anti-platelet drugs (like aspirin, Plavix, Brilinta, Effient, etc.) occur every so often. Quick action in Emergency Departments is needed in case of such bleeds. Our medical center (University of North Carolina Hospitals, Chapel Hill) has put together an “Emergent Anticoagulation Reversal Guideline” for our local use as a practical, clinical how-to document (PDF here). Since not every medical institution has pharmacists and MDs with clotting expertise available to develop its own guideline, we are making this document available through Clot Connect and invite colleagues and hospitals to take the document if they like, modify it, and apply it to their institution.
Disclosures: I have been a consultant for CSL Behring and Janssen.
Last updated: June 9th, 2014
Bruce L Davidson, MD, writes… Our study published in JAMA Internal Medicine [reference below] used patient information (with no identifying information, so confidentiality was preserved) from the two EINSTEIN clinical studies of acute DVT and acute PE treatment to ask the questions, “What effect does taking aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin, have on bleeding risk if the patient is also taking a blood thinner (anticoagulant)?” Read the rest of this entry »
Stephan Moll, MD writes… Today the FDA approved Pradaxa (dabigatran) for the treatment of DVT and PE. Thus, two of the new oral blood thinners are now FDA-approved for the treatment of DVT and PE: Xarelto (rivaroxaban) and Pradaxa (dabigatran). Due to the design of the clinical trials that lead to the FDA approval, Pradaxa should NOT be given immediately when DVT or PE are diagnosed, but rather after 5-10 days of treatment with an injectable blood thinner (into the skin or a vein; such as Lovenox = enoxaparin; Fragmin = dalteparin; Innohep = tinzaparin; or heparin). A Clot Connect summary of the FDA approval status of the four big new oral blood thinners for the various indications is in this table. Pradaxa’s full medication package insert is here. Today’s press release from Boehringer-Ingelheim about the FA approval is here.
Disclosures: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last updated: April 7th, 2014
Stephan Moll, MD writes…
The injectable low molecular weight heparins (LMWH; e.g. enoxaparin = Lovenox; dalteparin = Fragmin; tinzaparin = Innohep) are the preferred blood thinners in the pregnant patient. Warfarin is to be avoided as it can cause malformations of the fetus and can lead to bleeding in the unborn.
Regarding breastfeeding: the low molecular weight heparins (listed above) and warfarin are safe in the woman who is beastfeeding.
Rivaroxaban (Xarelto), dabigatran (Pradaxa) and apixaban (Eliquis) should not be used during pregnancy or while breastfeeding.
A detailed summary about the safety of each blood thinner during pregnancy and while breast-feeding, based on the ACCP 2012 guidelines [ref], can be found here.
Bates SM, Greer IA, Middeldorp S et al. VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST 2012; 141(2)(Suppl):e691S–e736S.
Disclosure: I have consulted for Janssen and Boehringer-Ingelheim.
Last updated: Jan 23rd, 2014
Stephan Moll, MD writes… Another ‘blood thinner’ medication is now under consideration by the FDA for the treatment of DVT and PE.
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 and for the reduction in the risk of recurrent DVT and PE. The goal date for a decision by the FDA is August 25, 2014. The press release about this submission from BMS is here. Read the rest of this entry »
Stephan Moll, MD writes… The American Society of Hematology (ASH) has identified 3 things that physicians dealing with DVT, PE and blood thinners (anticoagulants) should avoid – published this week in the journal Blood [ref 1]. Read the rest of this entry »