m. 86% with the total populationhad a CHADS2 score of 3 or higher.Individuals were randomised to rivaroxaban 20 mgonce everyday, or dose-adjusted warfarintitrated CAL-101 to a target INR of 2.5. The per-protocol, astreatedprimary analysis was designed CAL-101 to determinewhether rivaroxaban was noninferior to warfarin forthe main end point of stroke or systemic embolism;when the noninferiority criteria were satisfied, then superioritywas analysed within the intent-to-treat population.Rivaroxaban was similar to warfarin for the primaryefficacy endpoint of prevention of stroke andsystemic embolism. The stricterintention-to-treat analysis also showed rivaroxabanwas similar to warfarin but did not reach statisticalsignificance for superiority: event rate 2.12 versus2.42 per 100 patient years for rivaroxaban versuswarfarin; HR 0.
88, 95% CI 0.74–1.03, P ??0.117 forsuperiority. Superiority Gefitinib was only demonstrated in theper-protocol analysis of patients who continued toreceive therapy for the 40-month trial period: eventrate 1.70 versus 2.15 per 100 patient years for rivaroxabanversus warfarin; HR 0.79, 95% CI 0.65–0.95,P ??0.015 for superiority.Significant and nonmajor clinically relevant bleedingwas similar with rivaroxaban and warfarin:event rate 14.91 versus 14.52 per 100 patient yearsfor rivaroxaban versus warfarin; HR 1.03, 95% CI0.96–1.11, P ??0.442. The rivaroxaban group demonstratedsignificantly less fatal bleeding, intracranial haemorrhage. Nevertheless, significantlymore patients receiving rivaroxaban had a haemoglobindecrease of 2 g/dL or moreand required a blood transfusion.
The number of patients experiencing a seriousadverse event was similar within the two groupsas was thedocumentation of an adverse event requiring discontinuationof the study drug. Premature discontinuation rateswere also comparable, at roughly 23%. A higherpercentage of patients taking rivaroxaban experiencedepistaxis, and VEGF the rates of ALTelevation were exactly the same in both groups.ApixabanThe AVERROES study was designed to evaluate theuse of apixaban for stroke prophylaxis by comparingit to aspirin in patients unsuitable for warfarin.111 Thestudy enrolled 5600 patients with AF who were eitherintolerant of or unsuitable for warfarin and comparedapixaban 5 mg twice dailywith aspirin 81–324 mg/day.The study was prematurely due to an acceptablesafety profile and benefit in favour of apixaban.
Aftera year, patients taking apixaban were discovered to havea 55% reduction within the main endpoint of strokeor systemic embolism. The rate ofmajor bleeding was similar in both groups: 1.4% peryear for apixaban and 1.2% per year for aspirin. Aspirin was theless well-tolerated therapy.112The ARISTOTLE Gefitinib trial has compared apixaban towarfarin in patients with atrial fibrillation.113 It is arandomised phase III, double-blind, international trialcomparing apixaban 5 mg twice/day versus warfarintitrated to an INR among 2 and 3 in over 18,000patients.114 The main outcome was strokeor systemic embolism,and the trial was designed to test for noninferiority.Secondary objectives included an analysis for superioritywith respect to the main outcome and to therates of significant bleeding and all-cause mortality.
Thefollow-up period was 1.8 years.The rate with the main outcome in ARISTOTLEwas 1.27% per year within the apixaban group versus1.60% per year within the warfarin group. This was mainly driven by a reductionin haemorrhagic stroke, as the rates of ischaemicstroke were comparable with warfarin: 0.97% peryear within the apixaban group versus 1.05% per year inthe warfarin group. Conversely, rate CAL-101 of haemorrhagicstroke was 0.24% per year within the apixaban groupversus 0.47% per year within the warfarin group. Apixabandemonstrated a benefit with regards to all-causemortality compared to warfarin: rates of death fromany trigger were 3.52% within the apixaban group versus3.94% within the warfarin group. Apixaban was discovered tobe safer than warfarin in regard to significant bleeding:2.13% per year within the apixaban group versus 3.
09%per year within the warfarin group. Drug Gefitinib discontinuationoccurred less frequently with apixaban compared towarfarin: 25.3% versus 27.5%. The averagetime spent in therapeutic INR was 62.2% for thewarfarin-treated patients. The reported adverse andserious adverse effects were similar in both groupsof patients.Patient Values and PreferencesAn critical consideration when deciding on a therapeuticstrategy for stroke prophylaxis in patientswith AF is that of patient preference. Individuals will,normally speaking, be taking the prescribed therapiesfor the duration of their lives so it can be crucialthat they are adequately informed. Evidence suggeststhat well-informed patients are more compliantwith therapy115 and have better outcomes.116 The predominantconcern of patients is that of stroke,117 andmany are willing to accept slightly elevated bleedingrisks to avoid a stroke. Physicians often bemore concerned with hospital admissions, whereaspatients are in the end worried about death.118 TheAF-AWARE study also discovered that
Wednesday, April 17, 2013
How You Can Get Good At Gefitinib CAL-101 Like A Champ
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