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Thursday, October 10, 2019

Aristotle trial,bad data from China,but apixaban probably still better than warfarin

In 2011, the Aristotle trial was published in the NEJM.It demonstrated aprixaban's superiority over warfarin in the treatment of non-valvular atrial fibrillation (AF)- fewer strokes, less bleeding and apparently a decreased over all death rate. But wait. The  FDA did not quickly approve apixaban.

One major problem was questionable  data from a China trial site which included mixed up medication distribution and some possibility of fraudulent data. Critics also noted that  there was no mortality benefit noted in the European cohort and that 35% of the warfarin group did not achieve a therapeutic INR.

After considerable back and forth between the drug companies and the FDA apixaban ( Eliquis) was approved for  treatment of non-valvular AF but not the claim that the overall mortality was reduced.

That should have been the end of it but recently an analysis of a number of meta analyses revealed that the original  Aristotle data ( including  the tainted China  cohort) was included.A number of these MAs claimed a benefit for Apixaban that is said to have  vanished when the questionable data were excluded.

Even with the flawed trial apixaban is preferable to warfarin for non-valvular AF.In the treatment arm, there were fewer strokes driven mainly by fewer hemorrhagic strokes there being only a slight advantage to apixaban in regard to ischemic strokes.Apixaban is safer and dietary and medications interactions much less of a problem than with warfarin and no needed for frequent follow up blood tests.

After Homer quit his job at the Kwik E mart,Abu said:

"He slept,he stole,he was rude to customers.Still there goes the best damned employee a convenience store ever had."

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