The latest data dabigatran real-world analysis and publication of specific reversal agent idarucizumab

Recently, one from the more than 44,000 patients on dabigatran (Thai complete full ®) analysis of the real world and the two most recent data on specific reversal agents idarucizumab dabigatran in the 2015 American Heart Association (AHA) Scientific Sessions on the announcement.
The former is aimed to assess dabigatran compared with warfarin, a new interim analysis for safety and efficacy of long-term studies of routine clinical practice results. The meta-analysis of data from two large US commercial health insurance company database, compared with warfarin therapy in patients with atrial fibrillation, receiving dabigatran treatment of patients with non-valvular atrial fibrillation stroke and major bleeding events less .
"In addition to clinical trials outside, rich health insurance available data provides us with an excellent opportunity to broaden knowledge about oral anticoagulant use and patient outcomes," principal investigator John Seeger (PharmD, DrPH, of Harvard Medical School teaching affiliated Brigham Department of Medicine Women's Hospital) said. "These real-world data to further define the safety and efficacy of dabigatran patients and their use in conventional therapy, and consistent with the results of RE-LY® pivotal clinical trials."
The primary outcome was all-Thai Bi ® and stroke and the incidence of serious bleeding during warfarin therapy, which involves both the insurance database collected over 32 months, involving 44,672 cases of atrial fibrillation (propensity index matched 22,336 for the first time to accept the Thai Bi Full ® and warfarin-treated patients) data -Truven MarketScan (18,276 patients / group) and Optum Clinformatics (4,060 patients / group). Thai ® treatment group report complete full 65 strokes (incidence of 0.73 / 100 patient-years), and warfarin therapy group report 78 (incidence of 1.08 / 100 patient-years) compared with warfarin, Thai complete whole ® 28% lower risk of stroke (HR 0.72; 95% CI 0.52 - 1.00). In addition, the Thai ® treatment group completed the full report of 395 major bleeding events (incidence rate of 4.47 / 100 patient-years), while the contrast of warfarin treatment group reports 459 major bleeding events (incidence rate of 6.42 / 100 patient-years), That said, compared with warfarin, Thai complete whole ® reduced the risk of major bleeding events by 26% (HR 0.74; 95% CI 0.64 - 0.84). Thai ® treatment group report complete full 238 gastrointestinal bleeding events (incidence of 2.69 / 100 patient-years), while warfarin-treated patients from 213 (incidence of 2.97 / 100 patient-years) (HR 0.95; 95% CI 0.79 - 1.14).
While there are two on the AHA released the latest data on dabigatran idarucizumab of specific reversal agent. One pair of the ongoing Phase III interim analysis data RE-VERSE AD ™ trials showed that the administration may at any time after the restart idarucizumab alternative antithrombotic treatment. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab treatment after the introduction of an alternative antithrombotic therapy (such as heparin) time range is from 0.2 to 77.2 days, whereas for patients requiring emergency surgery or interventional procedures is 0 days to 40.8 days. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab restart time after treatment dabigatran treatment is 1.3 to 90.6 days, and require emergency surgery or interventional procedures in patients time is 1 to 63.31 days.
"Consideration should be given appropriate time to restart as soon as possible antithrombotic therapy to reduce the potential risk of stroke in patients with non-valvular atrial fibrillation," Thomas Jefferson University in Philadelphia, vice provost, professor of emergency medicine and RE-VERSE AD ™ principal investigator Dr. Charles Pollack He said: "The results of this interim analysis of a phase III study RE-VERSE AD ™ broadens the doctors start anticoagulant therapy again at the need to give idarucizumab rare emergency situations, the role reversal of dabigatran after cognition."
Idarucizumab second report included a study of coagulation factor complex [for example, recombinant coagulation factor Ⅶa, 3- or 4-factor prothrombin complex concentrate (PCC) and activated PCC] in vitro efficacy studies idarucizumab presence. The results show, idarucizumab reversal of the anticoagulant effect of dabigatran against clotting factor complex [3]. This result is very important because often the management of acute bleeding in patients using these drugs. The study also showed that the use has been listed idarucizumab not inhibit other anticoagulants (direct factor Xa inhibitor, heparin or other direct thrombin inhibitor) anticoagulant effect.