Dabigatran patients tolerated both doses well,but they skilled a considerably faah inhibitor greater incidence of dyspepsiacompared with those receiving warfarin.There were no reports of hepatotoxicity in either dabigatrangroup, in contrast to prior studies that compared ximelagatranand warfarin.12 The rate of myocardial infarctionwas greater in both dabigatran groups; nevertheless, simply because thiswas also noticed in earlier ximelagatran/warfarin studies, thisfinding may possibly not be relevant.12 Offered these outcomes, the authorsconcluded that in patients with atrial fibrillation, dabigatran 110mg was connected with rates of stroke equivalent to those as -sociated with warfarin but with much less danger of key hemorrhage.Dabigatran 150 mg was connected with reduced rates of strokeand rates of hemorrhage equivalent to those connected with warfarin.
12RE-MODEL. This randomized, double-blind, non-inferioritytrialcompared dabigatran etexilate 150 or 220mg when daily with enoxaparin 40 mg subcutaneously oncedaily for the prevention of VTE following total knee replacement.14 Individuals faah inhibitor receiving dabigatran started with half of adose 1 to four hours following surgery, then continued withfull-dose therapy when daily thereafter. Individuals receivingenoxaparin started full-dose therapy the evening just before surgery.Both groups continued therapy for six to 10 days andwere observed for three months.The main endpoint was a composite of total VTE and mortalityduring therapy, and the main safety outcome wasthe incidence of bleeding events.14 The main endpoint occurredin 37.7% with the enoxaparin group and in 36.
4% of thedabigatran 220-mg groupandin 40.5% with the dabigatran 150-mg group.There was no significant difference in key bleeding amongthe three therapy groups. None with the reportedbleeding events were fatal.14Specific aspects of tolerability were not reported in this trial,but adverse drug events led to discontinuation of therapy ata rate of 3.7% small molecule libraries in both dabigatran groups and at a rate of 4.6% inthe enoxaparin group.The median duration of therapy was eight days for bothdabigatran groups and seven days for enoxaparin. There wasno difference in the incidence of elevated liver enzymes in anyof the groups.14Based on these outcomes, the authors concluded that dabigatranetexilate 150 or 220 mg was at the very least as efficient as enoxaparinwith a equivalent safety profile following knee replacementsurgery.
14 RE-MODEL did not have a study website in North America.The FDA-approved dose of enoxaparin in the setting NSCLC ofknee replacement is 30 mg subcutaneouslyevery 12hours.RE-NOVATE. To compare the efficacy of dabigatran andenoxaparin for preventing VTE after hip-replacement surgery,investigators enrolled 3,494 patients inside a double-blind non-inferiority trial. Individuals received either dabigatran 220 or 150mg when daily or enoxaparin 40 mg SQ when daily for 28 to 35days. As in RE-MODEL, patients receiving dabigatran weregiven half of a dose 1 to four hours after surgery along with a fulldose when daily thereafter. Individuals who received enoxaparinwere started on full-dose therapy the evening just before surgery.The main outcome was a composite total VTE and deathfrom all causes in the course of therapy, occurring at the followingrates: 6.
7% with enoxaparin and 6% with dabigatran 220 mgand 8.6% for dabigatran 150 mg.15 Bleeding, the main safety outcome, did not differstatistically among the groups; nevertheless, there was onefatal bleeding episode in each dabigatran group and no fatalbleeding episodes with enoxaparin.15Adverse-event profiles were equivalent among all three groups,resulting in discontinuation of therapy in 6% of small molecule libraries patients receivingdabigatran 220 mg and enoxaparin and in 8% of patientsreceiving dabigatran 150 mg.The median duration of therapy was 33 days. No differencewas observed in the frequency of liver enzyme elevations.15 The RE-NOVATE authors stated that dabigatran wasas efficient as enoxaparin in lowering the danger of VTE followinghip replacement surgery and had a equivalent safety profile.
15This trial did not have a North America study website; the FDAapproveddose of enoxaparin applied for hip replacement is either30 faah inhibitor mg SQ every 12 hours or 40 mg SQ when daily.RE-MOBILIZE. This randomized, double-blind, active controlled,non-inferiority study compared dabigatran etexilate150 or 220 mg when daily using the approved North Americanenoxaparin dose of 30 mg SQ twice daily for the prevention ofVTE following total knee replacement.16 Individuals who wereassigned to either dabigatran group received half of a dose sixto 12 hours after surgery, followed by a full dose when dailythereafter. Individuals receiving enoxaparin began therapy themorning following surgery.The main efficacy outcome was a composite of total VTEevents and all-cause mortality in the course of therapy, whereas theprimary safety outcome was the incidence of bleeding events.Data from 1,896 patients were analyzed.16 The incidence of VTEand death in the course of therapy small molecule libraries occurred in 31.1% with the dabigatran220-mg patients, 33.7
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