Apixaban for Extended Treatment of Venous Thromboembolism
Hi my name is joy over coughlin and i’m a student pharmacist here at d’youville college today i would like to talk to you about the trial apixaban for extended treatment and venous thromboembolism which was published this year in the new england journal of medicine i chose this trial because my dad suffered from a dvt a few years back and he was on anticoagulant
Therapy for that so i thought this was appropriate and interesting for me to research the primary objective of the study was to compare the efficacy and safety of two different doses of apixaban with placebo for extended treatment of vte the primary outcome measure was the incidence of symptomatic recurrent venous thromboembolism or death by any cause the primary
Safety measure was incidence of major bleeding and an important secondary safety measure it was a composite of major bleeding and clinically relevant non major bleeding the study was a randomized double-blind placebo-controlled multi center and multinational study study drugs were administered over 12 months and patients were randomized into one of three groups
To receive either a pig’s advance to point five milligrams apixaban five milligrams or a placebo all of which were taken twice a day there were few drugs that were prohibited during the study these being dual antiplatelet therapy aspirin at any dose higher than 120 160 five milligrams daily p-glycoprotein and potent inhibitors of cytochrome p450 384 if you look at
The figure on the next page you will notice that 840 were included in the 2.5 milligram wing 813 were included in the 5 milligram wing and 829 were included in the placebo bite eligible patients were those 18 years of age or older with diagnosed symptomatic dvt or pulmonary embolism that were previously treated with anticoagulants inclusion criteria were men and
Women 18 years of age or older clinical diagnosis of dvt or pulmonary embolism previous completion of anticoagulant treatment and no recurrence of venous thromboembolism exclusion criteria were subject with indications for long term treatment with a vitamin k antagonist active bleeding or high risk of serious bleeding short life expectancy uncontrolled high blood
Pressure or kidney and liver dysfunction i study took place over 12 months and included a one-month follow-up and surveillance period in terms of monitoring patients were assessed either by phone or in clinic each month and one time afterwards after 30 days and patients were instructed to report to the study center if experiencing any symptoms that suggested vte
Or any bleeding events if an event was suspected objective assessments were performed and these include a physical assessment and blood tests that drew hemoglobin levels among other things in terms of data analysis it was a 10th intent to treat analysis requiring at least 810 patients in each group to meet a power of 90% as i mentioned earlier there were more than
810 in each wing and those power was set and meant for all outcomes the cochran mantle hansel test was used and this test is used estimate an association between an exposure and an outcome and it was relevant for all of the outcome measures that we had which were all nominal data in terms of the primary outcome measure which was recurrent vte or death from any
Cause apixaban 2.5 milligram patients saw 3.8 percent occurrence of any of either one of these there was a 4.2 percent occurrence in the apixaban 5 milligram group and 11.6% in the placebo group the relative risk versus placebo was the 0.33 for the 2.5 milligram group and point 3 6 for the 5 milligram group and this had a p-value of less than point zero zero zero
One and a confidence interval of 95 percent in terms of tyler ability incidences of major bleeding or 0.2 percent in the 2.5 one point one percent in the 5 milligram way and point 5 percent in the placebo way there was a relative risk of 0.49 with a p-value of 0.3 9 to 5 with a pixabay and 2.5 milligram versus placebo and a risk of 0.25 at the plus with a p-value
Of 0.35 5 1 in the pics of a and 5 milligram per spasibo group incidence is a major or clinically relevant non major bleeding where 3.2 percent in the 2.5 14.3% in the 5 wing and 2.7 percent in the deceiver wing the differences in all of these were statistic insignificant and thus it was determined that of all both doses of the drug were well tolerated with respect
To osebo the author concluded as compared with placebo both the 2.5 milligram dose and the 5 milligram dose of apixaban reduced the risk of venous thromboembolism these benefits were observed with risk with rates of major bleeding that were low and similar to those in the placebo group additional studies will be needed to determine the potential net benefit and
Risk of extending treatment beyond 18 to 24 months strength power of a set and met by a statistical test of appropriate outcome measures of valid inclusion and exclusion criteria were adequate randomization resulted in similar groups length of study was appropriate to show effect treatment regimen was appropriate blinding was sufficient and all this conclusion was
Reported by the results the only limitation that i could find was that they were tribal sponsored by bristol-myers squibb and pfizer leaving a small potential for bias the trial was a prospective randomized trial and powers both set and met therefore it is level one trial with minor limitations firstly as for my recommendation for extended treatment of patients
With vte i would recommend treatment with apixaban two point five milligrams over a picnic sip and five milligrams twice daily but i would recommend either of these drugs over placebo because they both seem to have a clinically significant effect with not without an increased risk in bleeding terms of efficacy recurrent vte or death by any calls was significantly
Lower in the apixaban groups as complete as compared to placebo incidence was three point eight percent in two point five milligram group four point two percent in the five milligram group and eleven point six percent in placebo group this return relative risks of 0.33 with a pixie band two point five verse placebo 0.36 with a pic span five milligram for spasibo
With a 95% confidence interval and p values each less at the point zero zero zero one terms of safety incidences of major bleeding were point two point one and point five percent and the pics have been two point five five m placebo groups respectively there was a relative risk of 0.42 with a p-value of 0.3 9 to 5 with a pick span two point five milligrams reverse
Placebo and a relative risk of 0.25 with a p-value of 0.3 551 in the apixaban five milligrams murska sobota instances a major or clinically relevant non major bleeding where 3.2 percent in the pixum and 2.5 milligram wing 4.3 percent in the apixaban 5 milligram wing and 2.7 percent in the placebo in safety safety parameters did not show clinical significance
Between the three groups and thus it can be considered relatively safe rhenium eliquis and it is the same price for two point five milligrams and five milligrams and the price is sixty tablets for 300 18.4 t seven cents special considerations further studies should be done to assess the efficacy and safety of the two apixaban doses for use in excess of one year
If you have any questions please contact me at my email is c ough j28 at d yc edu thank you
Transcribed from video
Journal Club Presentation By Joe Coughlan
