Dabigatran data withheld: BMJ
It says the company had data from a subgroup analysis of the RE-LY trial about increased safety of the drug if it was used with blood monitoring. While the trial protocol did not require monitoring of blood levels with dabigatran, internal documents obtained by the journal reveal an analysis of blood levels showed dabigatran had a fivefold interindividual variation in blood plasma concentration.
The documents show the company found that if plasma levels were measured and the dose adjusted, major bleeds could be reduced 30—40% compared with well-controlled warfarin.
Modelling projected that most patients on