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Edoxaban versus dalteparin for venous thromboembolism associated with cancer

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Dr B├╝ller speaks with ecancer at the 2017 ASH annual meeting about a randomised, open-label, blinded outcome assessment trial evaluating the efficacy and safety of LMWH/edoxaban versus dalteparin for venous thromboembolism associated with cancer.

The standard of treatment in patients with cat cancer associates from buses is low molecular weight heparin and low molecular happened need to be given once a day as a subcutaneous injection and the guidelines actually tell us that it should be given for six months and if the cancer is active actually longer which in the reality may mean eight nine ten you know

Quite quite a long time and although it has been shown to be very effective compared to warfarin the main disadvantage is these these injections so what we did in the hawks i-vt cancer study we compared standard of low molecular weight heparin once a day subcutaneous injection with edocs a man a doctor bond is a direct 10a inhibitor and that’s given as a single

Drug single pill per day immense and some of the patients that were involved in that clear to us about the numbers of the cohorts yes so we randomized a total of a thousand 50 so 500 no more than 500 in in bay but in both groups quite quite comparable if you like to have some of the the data it actually you know ninety-eight percent of these patients had active

Cancer a 50 percent had metastases at the time of entry into the trial and 72 patients actively received nc and anti-cancer therapy so you really and that’s the unique thing that we need to realize here is you’re in the setting all the like active cancer complicated by a thrombosis both the patient and the oncologist want to get rid of this problem because they

Want to treat the patient for the primary disease which is cancer and so therefore in our trial what we did is we actually took the combined outcome of a recurrence which is an unwanted outcome and a major bleed as a combined or comp vodka and this is unique because it usually is either going for efficacy or for safety in this case after consulting with with many

Patients and colleges worldwide will came to the conclusion that both these complications are are unwanted and that was the reason to actually make that into our primary outcome and when it came to the results could you tell us about those our hope was to show non-inferiority and the answer is we did very convincingly short non-inferiority and this is important

Because another unique element of the trial that is everybody was treated for six months but we followed these patients for one year if the physician made a decision to continue treatment beyond six months that was up to their decision and in actual fact many many patient’s went on to eight nine or even full 12 months so our primary outcome was the recurrence of

Vitas from us or bleeding over that entire one-year period that was a primary act and that was clearly non-inferior second is we looked at six months was one of the sensitivity analysis to actually compare all the way up to six months and then finally traditionally there is an on protocol analysis and also those two sensitivity analysis came to the same conclusion

Which is clearly non-inferiority and whether any other advantages associated with the oldest apart from not having to deal with injections yeah i actually you know we monitored why patient stopped treatment and and there was quite a substantial number of patients that were randomized through the long like wait happened that stopped after a while well with an oral

Pill yes you do have some patients with nausea but that’s a rare let’s say occasion and so therefore and this is important in the interpretation of this study it’s a comparison of two regimen so the standard regimen is these injections works very good and the pill of course has its advantage and the whole thing is what in the end for these motions is going to be

Much more acceptable that’s obvious that with a pill that’s a no-brainer we’ll change practice overnight because until this study we were stuck with subcutaneous injection because that was the best treatment that’s in all the guidelines and we now have an alternative there’s one interesting observation in that study is that there were there were less recurrences

If you look at the components of the primary radical there were less recurrences within dr. mann and it was slightly more bleeding in the end it was that 13 12 13 percent that was non-inferior however when we looked and this was not a unique element in the design of the study we looked at the severity of bleeding when they present it and that were 12 passions and

12 patients in each group so although you had this slight disbalance in terms of the bleeds that are clinically very significant and in our an emergency that was identical so i think the bottom line is dear colleagues if you four have the patients katsura so with cancer associated thrombosis a oral course of edocs of an sixty milligram once a day you can lower the

Dose to thirty in some patients depending on the reno status but basically we have now a very attractive alternative you

Transcribed from video
Edoxaban versus dalteparin for venous thromboembolism associated with cancer By ecancer