Adherence and outcomes of patients prescribed dabigatran (Pradaxa) in routine clinical practice

To explore and detail clinical experiences of dabigatran, a novel anticoagulant, after it became available in New Zealand in July 2011.

A cohort of patients was recruited from Hutt Hospital and the two largest primary care practices in the Hutt Valley region. They were included if they took at least one dose of dabigatran between July 2011 and April 2012. Participants undertook a questionnaire 3-12 months after starting dabigatran assessing adherence, perceived side-effects and complications. Those presenting due to an adverse event were analysed separately.

Of 102 patients identified, 92 were recruited to this study. At a median of 8 months, 70% of participants were still taking dabigatran, significantly lower than in the RE-LY trial at 12 months (P = 0.0002). The commonest reason given for discontinuation was gastrointestinal (GI) side-effects. Rates of serious adverse outcomes on dabigatran therapy were relatively low. Patients expressed polarised comments, both positive and negative, regarding their experiences of dabigatran.

A high rate of discontinuation of dabigatran, mainly due to GI symptoms, was observed. There does not appear to be any specific predictor of dabigatran tolerance. When prescribed according to guidelines, rates of serious adverse events associated with dabigatran appear to be low.