Dabigatran individuals tolerated both doses well,but they experienced acetovanillone a significantly higher incidence of dyspepsiacompared with those receiving warfarin.There were no reports of hepatotoxicity in either dabigatrangroup, in contrast to previous studies that compared ximelagatranand warfarin.12 The rate of myocardial infarctionwas greater in both dabigatran groups; even so, since thiswas also seen in earlier ximelagatran/warfarin studies, thisfinding may possibly not be relevant.12 Given these final results, the authorsconcluded that in individuals with atrial fibrillation, dabigatran 110mg was associated with rates of stroke similar to those as -sociated with warfarin but with less danger of significant hemorrhage.Dabigatran 150 mg was associated with lower rates of strokeand rates of hemorrhage similar to those associated with warfarin.
12RE-MODEL. This randomized, double-blind, non-inferioritytrialcompared dabigatran etexilate 150 or 220mg once day-to-day with enoxaparin 40 mg subcutaneously oncedaily for the prevention of VTE following total knee replacement.14 Patients receiving dabigatran started with half of adose 1 to four hours following surgery, then continued withfull-dose therapy acetovanillone once day-to-day thereafter. Patients receivingenoxaparin started full-dose therapy the evening before surgery.Both groups continued therapy for six to 10 days andwere observed for three months.The major endpoint was a composite of total VTE and mortalityduring therapy, and also the major safety outcome wasthe incidence of bleeding events.14 The major 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 considerable difference in significant bleeding amongthe CI994 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% 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 final results, the authors concluded that dabigatranetexilate 150 or 220 mg was at least as productive as enoxaparinwith a similar safety profile following knee replacementsurgery.
14 RE-MODEL did not have a study site in North America.The FDA-approved dose of enoxaparin in the setting ofknee replacement is 30 mg subcutaneouslyevery 12hours.RE-NOVATE. To compare the HSP efficacy of dabigatran andenoxaparin for preventing VTE after hip-replacement surgery,investigators enrolled 3,494 individuals in a double-blind non-inferiority trial. Patients received either dabigatran 220 or 150mg once day-to-day or enoxaparin 40 mg SQ once day-to-day for 28 to 35days. As in RE-MODEL, individuals receiving dabigatran weregiven half of a dose 1 to four hours after surgery and also a fulldose once day-to-day thereafter. Patients who received enoxaparinwere started on full-dose therapy the evening before surgery.The major outcome was a composite total VTE and deathfrom all causes during therapy, occurring at the followingrates: 6.
7% with enoxaparin and 6% with dabigatran 220 mgand 8.6% for dabigatran 150 mg.15 Bleeding, the major safety outcome, did not differstatistically among the groups; even so, there was onefatal bleeding episode in each dabigatran group and no fatalbleeding episodes with enoxaparin.15Adverse-event profiles were similar among all three groups,resulting in discontinuation CI994 of therapy in 6% of individuals 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 productive as enoxaparin in decreasing the danger of VTE followinghip replacement surgery and had a similar safety profile.
15This trial did not have a North America study site; the FDAapproveddose of enoxaparin used for hip replacement is either30 mg SQ every single 12 hours or 40 mg SQ once day-to-day.RE-MOBILIZE. This randomized, double-blind, active acetovanillone controlled,non-inferiority study compared dabigatran etexilate150 or 220 mg once day-to-day with the approved North Americanenoxaparin dose of 30 mg SQ twice day-to-day for the prevention ofVTE following total knee replacement.16 Patients who wereassigned to either dabigatran group received half of a dose sixto 12 hours after surgery, followed by a full dose once dailythereafter. Patients receiving enoxaparin began therapy themorning following surgery.The major efficacy outcome was a composite of total VTEevents and CI994 all-cause mortality during therapy, whereas theprimary safety outcome was the incidence of bleeding events.Data from 1,896 individuals were analyzed.16 The incidence of VTEand death during therapy occurred in 31.1% with the dabigatran220-mg individuals, 33.7
Thursday, April 11, 2013
acetovanillone CI994 Basics Described
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acetovanillone,
CI994,
fk228,
ML-161
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