Clinical Trials of Dabigatran in VTE. In 2008, DE was authorized in Europe being a primary prevention of venous thromboembolic events in grownup patients that have undergone elective total hip substitute or total knee substitute surgical treatment. In October 2010, DE was FDA accepted to reduce the chance of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Now DE is not indicated within the USA for any VTE event; having said that there can be ongoing clinical trials evaluating this potential indication and more, under the REVOLUTION trial system which encompasses every one of the studies described below. Key Prevention Trials. RE-MODEL is a phase III clinical trial, conductedmainly in Europe, that compared enoxaparin forty mg SQ as soon as regular with DE 150 mg and 220 mg the moment regular , for prevention of VTE just after an elective complete knee substitute .
The duration of treatment method was six?10 days. The incidence of VTE was 36.4% and forty.5% for 220 mg and 150 mg doses, respectively, and 37.7% for enoxaparin. The security profile was similar for that 3 groups. These effects showed that both doses of dabigatran have been noninferior to enoxaparin . RENOVATE can be a phase III clinical trial, performed largely in Europe, that in contrast enoxaparin syk kinase inhibitor 40mg SQ once regular with DE 150 mg and 220 mg the moment daily, for your prevention of VTE just after an elective complete hip substitute . The duration with the treatment was 28?35 days. The incidence of VTE was 6% and 8.6% for 220 mg and 150 mg doses, respectively, and six.7% for enoxaparin. The incidence of significant bleeding was not substantially various amid the 3 groups.
The results showed that both selective PI3K inhibitor dose of DE was noninferior to enoxaparin . RENOVATE II may be a phase III clinical trial that in contrast enoxaparin 40mg SQ once daily with DE 220 mg when every day for your prevention of VTE soon after THR, for the duration of a time period of treatment of 28?35 days. RENOVATE II is similar to RENOVATE and aims to more evaluate the efficacy and security of DE 220 mg dose in a extra diverse population, which include patients from North America. The results showed that DE was as helpful as enoxaparin for avoiding VTE and death from all triggers and superior to enoxaparin for decreasing the risk of significant VTE . The incidence of significant bleeding and adverse effects was very similar concerning the two groups . REMOBILIZE is often a phase III study, carried out mainly in USA and Canada, that compared enoxaparin 30mg SQ twice every day with DE 150 mg and 220 mg once day-to-day, for prevention of VTE after an elective TKR.
The duration of remedy was 12?15 days. The incidence of VTE was 31.1% and 33.7% for 220 mg and 150 mg doses, respectively, and 25.3% for enoxaparin. This trial demonstrated that dabigatran was inferior to enoxaparin; nonetheless the safety profile was equivalent . Therapy Trials. RECOVER is actually a phase III clinical trial that evaluated the use of DE for 6-month therapy of acute symptomatic VTE, like a replacement for VKAs.