Deep Vein Thrombosis (DVT) Support Group
Deep-vein thrombosis, also known as deep-venous thrombosis or DVT, is the formation of a blood clot ("thrombus") in a deep vein. It can be caused by something preventing blood from circulating or clotting normally. Join the support group if you are coping with DVT and find others who are going through the same challenges.
Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) said a six-month trial showed the anticlotting drug Eliquis was superior to the current standard of care for patients with acute venous thromboembolism and significantly reduced major bleeding.
The drug makers said Eliquis met the Phase 3 Amplify study's primary safety endpoint of superiority for major bleeding with a 69% relative risk reduction, compared with the current standard care of initial parenteral enoxaparin treatment overlapped with warfarin therapy.
Venous thromboembolism can lead to deep vein thrombosis, or a blood clot in a vein, and pulmonary embolism, a blood clot blocking one or more vessels in the lungs.
The companies said the study also demonstrated comparable results for the primary efficacy and safety endpoints for patients with a deep vein thrombosis or a pulmonary embolism.
Based on the results, Bristol-Myers Squibb and Pfizer plan to seek regulatory approval of Eliquis for the initial and long-term treatment of VTE, as well as for extended prevention of recurrent VTE.
Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug is also approved in the European Union for the prevention of venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery.
The drug makers said Eliquis met the Phase 3 Amplify study's primary safety endpoint of superiority for major bleeding with a 69% relative risk reduction, compared with the current standard care of initial parenteral enoxaparin treatment overlapped with warfarin therapy.
Venous thromboembolism can lead to deep vein thrombosis, or a blood clot in a vein, and pulmonary embolism, a blood clot blocking one or more vessels in the lungs.
The companies said the study also demonstrated comparable results for the primary efficacy and safety endpoints for patients with a deep vein thrombosis or a pulmonary embolism.
Based on the results, Bristol-Myers Squibb and Pfizer plan to seek regulatory approval of Eliquis for the initial and long-term treatment of VTE, as well as for extended prevention of recurrent VTE.
Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug is also approved in the European Union for the prevention of venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery.
My doc switched me over to Xarelto 20 mg. My arms are both now covered with ugly, dark, red/purple bruises. I bleed easily now and take days to heal a scratch. But much less worry about clots killing me. I use Gold Bond Diabetic cream on my paper thin skin. I am 64 years and DXed with Type II in Feb/March when I had the DVT.in my leg and clots in my lungs.
http://patientblog.clotconnect.org/2013/07/01/new-publication-eliquis-apixaban-is-safe-and-effective-in-dvt-and-pe/
The full report breaks down the full details:
http://www.nejm.org/doi/full/10.1056/NEJMoa1302507?query=featured_home&#t=article
Specifically:
"Randomization and Study Treatment
Randomization was performed with the use of an interactive voice-response system and was stratified according to the qualifying diagnosis of either symptomatic proximal deep-vein thrombosis or symptomatic pulmonary embolism (with or without deep-vein thrombosis). Patients were assigned to receive apixaban tablets plus placebo enoxaparin injections and placebo warfarin tablets or conventional therapy with enoxaparin injections and warfarin tablets plus placebo apixaban tablets. The study regimens were to be initiated within 24 hours after randomization.
Patients assigned to the apixaban group received 10 mg of apixaban twice daily for the first 7 days, followed by 5 mg twice daily for 6 months. Patients assigned to the conventional-therapy group received enoxaparin at a dose of 1 mg per kilogram of body weight every 12 hours for at least 5 days and warfarin begun concomitantly and continued for 6 months. The warfarin dose was adjusted to maintain the international normalized ratio (INR) between 2.0 and 3.0. Enoxaparin or placebo was discontinued when a blinded INR of 2.0 or more was achieved.
The study used blinded INR monitoring with a point-of-care device that generated an encrypted code for INR results. Investigators reported the code to the interactive voice-response system and received either an actual INR value (for patients assigned to warfarin) or a sham INR value (for patients receiving apixaban). Evaluation of the INR was required at least monthly, or more frequently if clinically indicated."
I was either taking placebo warfarin or placebo dabigatran, but I was taking one active one.
Even to this day, officially I do not know what I was taking, but since I had major side effects to warfarin, I am 99.9% sure I was on Dabigatran.
(Dabigatran = Pradax or Pradaxa)