Photo courtesy of Pfizer
and Bristol-Myers Squibb
LONDON—An educational program designed to improve adherence to the anticoagulant apixaban proved ineffective in a phase 4 trial of patients with atrial fibrillation (AF).
But that’s because adherence was high whether patients completed the program or not.
This suggests current measures used to inform patients about apixaban may be sufficient to ensure treatment adherence, researchers said.
They presented these findings at the ESC Congress 2015 (abstract 2191).
The research, known as the AEGEAN trial, was sponsored by Bristol-Myers Squibb, the company co-developing apixaban (Eliquis) with Pfizer.
“We used the best possible tools for the educational program, including the usual staff and procedures of the anticoagulation clinics, and all of this was useless,” said study investigator Gilles Montalescot, MD, PhD, of Hospitalier Universitaire Pitié-Salpêtrière in Paris, France.
“However, the trial showed very good adherence to apixaban, leaving little room for improvement with an educational program, suggesting one more advantage of prescribing non-vitamin K antagonists (VKAs) over VKAs in that there is apparently no need for additional education and information.”
Dr Montalescot and his colleagues conducted this study in 1162 AF patients receiving apixaban as stroke prophylaxis.
Roughly half of the patients (n=579) completed an educational program promoting treatment adherence, and the other half (n=583) received the usual information about their disease and the treatment.
The educational program included a patient information booklet explaining AF and anticoagulant treatment for stroke prevention, reminder tools (eg, a key ring and mobile phone alerts), and access to a virtual clinic utilizing staff from existing VKA monitoring clinics.
The researchers assessed differences between the 2 patient groups with regard to treatment adherence (defined as continuous, twice-daily dosing, with an occasional missed dose allowed) and treatment persistence (defined as absence of discontinuation for 30 consecutive days) over a 6-month observational period.
Adherence/persistence was measured using an electronic device that holds a blister pack of medication and records each time the pack is removed.
The researchers found no additional value of the educational program for either outcome.
At 24 weeks, the adherence rate was 88.5% in the control group and 88.3% in the education group (P=0.89). Treatment persistence rates were 90.5% and 91.1%, respectively (P=0.76).
For the second part of this study, the researchers are investigating long-term treatment adherence and the value of an educational program beyond 6 months.
“Future studies may want to test more aggressive and more costly educational programs,” Dr Montalescot noted. “But, in the meantime, the adherence and persistence rates we measured are quite reassuring with the common practice and usual mode of prescription of this medication.”
