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 Dabigatran patients tolerated both doses well,but they knowledgeable a significantly faah inhibitor higher 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, because thiswas also noticed in earlier ximelagatran/warfarin studies, thisfinding may not be relevant.12 Offered these outcomes, the authorsconcluded that in patients with atrial fibrillation, dabigatran 110mg was related with rates of stroke comparable to those as -sociated with warfarin but with less risk of main hemorrhage.Dabigatran 150 mg was related with lower rates of strokeand rates of hemorrhage comparable to those related with warfarin.
12RE-MODEL. This randomized, double-blind, non-inferioritytrialcompared dabigatran etexilate 150 or 220mg once 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 a single to four hours following surgery, then continued withfull-dose treatment once daily thereafter. Individuals receivingenoxaparin started full-dose treatment the evening before surgery.Both groups continued treatment for six to 10 days andwere observed for three months.The principal endpoint was a composite of total VTE and mortalityduring treatment, and also the principal safety outcome wasthe incidence of bleeding events.14 The principal endpoint occurredin 37.7% in the enoxaparin group and in 36.
4% of thedabigatran 220-mg groupandin 40.5% in the dabigatran 150-mg group.There was no significant difference in main bleeding amongthe three treatment groups. None in the reportedbleeding events were fatal.14Specific aspects of tolerability were not reported in this trial,but adverse drug events led to discontinuation of treatment 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 treatment was eight days for bothdabigatran groups and seven days for enoxaparin. There wasno difference within 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 least as productive as enoxaparinwith a comparable safety profile following knee replacementsurgery.
14 RE-MODEL did not have a study web site in North America.The FDA-approved dose of enoxaparin within the setting NSCLC ofknee replacement is 30 mg subcutaneouslyevery 12hours.RE-NOVATE. To evaluate the efficacy of dabigatran andenoxaparin for preventing VTE right after hip-replacement surgery,investigators enrolled 3,494 patients in a double-blind non-inferiority trial. Individuals received either dabigatran 220 or 150mg once daily or enoxaparin 40 mg SQ once daily for 28 to 35days. As in RE-MODEL, patients receiving dabigatran weregiven half of a dose a single to four hours right after surgery along with a fulldose once daily thereafter. Individuals who received enoxaparinwere started on full-dose treatment the evening before surgery.The principal outcome was a composite total VTE and deathfrom all causes during treatment, occurring at the followingrates: 6.
7% with enoxaparin and 6% with dabigatran 220 mgand 8.6% for dabigatran 150 mg.15 Bleeding, the principal safety outcome, did not differstatistically among the groups; nevertheless, there was onefatal bleeding episode in every dabigatran group and no fatalbleeding episodes with enoxaparin.15Adverse-event profiles were comparable among all three groups,resulting in discontinuation of treatment in 6% of small molecule libraries patients receivingdabigatran 220 mg and enoxaparin and in 8% of patientsreceiving dabigatran 150 mg.The median duration of treatment was 33 days. No differencewas observed within the frequency of liver enzyme elevations.15 The RE-NOVATE authors stated that dabigatran wasas productive as enoxaparin in reducing the risk of VTE followinghip replacement surgery and had a comparable safety profile.
15This trial did not have a North America study web site; the FDAapproveddose of enoxaparin applied for hip replacement is either30 faah inhibitor mg SQ every single 12 hours or 40 mg SQ once daily.RE-MOBILIZE. This randomized, double-blind, active controlled,non-inferiority study compared dabigatran etexilate150 or 220 mg once daily with all 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 right after surgery, followed by a full dose once dailythereafter. Individuals receiving enoxaparin began therapy themorning following surgery.The principal efficacy outcome was a composite of total VTEevents and all-cause mortality during treatment, whereas theprimary safety outcome was the incidence of bleeding events.Data from 1,896 patients were analyzed.16 The incidence of VTEand death during treatment small molecule libraries occurred in 31.1% in the dabigatran220-mg patients, 33.7