No Effect of Educational Program on Apixaban Adherence

August 30, 2015

LONDON, UK — A proactive educational program to encourage adherence to the new anticoagulant apixaban (Eliquis, Bristol Myers-Squibb), in the first 6 months of treatment in AF patients made no difference to compliance rates in the Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) study[1].

Dr Gilles Montalescot

Presenting the results at the European Society of Cardiology (ESC) 2015 Congress, Dr Gilles Montalescot (Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtriėre, Paris, France) said the results were encouraging in that both groups showed very high rates of adherence of around 88%. "This leaves little room for improvement with an educational program," he pointed out.

But outside observers were more cautious in the interpretation of the study. Commenting for heartwire from Medscape, Dr Elliot Antman (Brigham and Women's Hospital, Boston, MA) said he was not surprised to see such high rates of compliance at 6 months into the study, but he would be "very interested" to see what happens several years down the line. "Patients receiving new treatment are always sensitized to the importance of taking it properly, but this is a chronic situation and these medications need to be taken for life," he stressed.

Dr Christian Gerdes (Aarhus University Hospital, Denmark) also warned against complacency on the issue of compliance with the new oral anticoagulants (NOACs). "You have to remember that when patients are participating in a study of adherence they are going to be much more compliant than in real life," he told heartwire . "While I am reassured about these data, we cannot be too relaxed about this issue. Compliance is very important with these drugs. While vitamin-K antagonists have a long half-life so it doesn't matter that much if the occasional dose is missed, the NOACs have a very short half-life so missed doses will make a difference."

Unlike vitamin-K antagonists, which have been the mainstay of oral anticoagulation until now, the new oral anticoagulant drugs do not require regular monitoring, which is a major advantage. However, in the absence of routine monitoring there is a risk of poor adherence, and this might be addressed by patient education, Dr Montalescot explained.

The AEGEAN trial included AF patients treated with apixaban who were randomized to either an educational program (n=579) or usual information about the disease and treatment (n=583). Study outcomes were 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.

The educational program included a patient information booklet explaining AF and anticoagulant treatment for stroke prevention, reminder tools (key ring, mobile phone alerts), and access to a virtual clinic with staff from existing anticoagulation clinics. Adherence was measured using an electronic device that holds a blister pack of medication and records each time the pack is removed.

The study found there was no additional value of the educational program on 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), and persistence rates were 90.5% and 91.1% respectively (P=0.76).

The study was sponsored by Bristol-Myers Squibb. Montalescot has received research grants to his institution or consulting/lecture fees from Acuitude, ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie, Boehringer Ingelheim, Bristol-Myers Squibb, Brigham Women's Hospital, Cardiovascular Research Foundation, Celladon, CME Resources, Conway, Daiichi-Sankyo, Eli-Lilly, Europa, Evidera, Fédération Française de Cardiologie, Gilead, GLG, Hopitaux Universitaires Genève, ICAN, Janssen-Cilag, Lead-Up, McKinsey & Company, Medcon International, Menarini, Medtronic, MSD, Pfizer, Recor, Sanofi, Stentys, the Medicines Company, TIMI Study Group, Universitat Basel, WebMD, Williams & Connolly, and Zoll Medical.


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