Ingelheim, Germany, Friday 24th August 2012 – In the absence of a head-to-head study, a comprehensive analysis published in Thrombosis and Hemostasis,1 looks into the efficacy and cost-effectiveness of Pradaxa® for stroke prevention in patients with non-valvular atrial fibrillation in an indirect comparison to rivaroxaban. The analysis, based on two large scale trials including more than 32.000 patients combined, suggests that patients treated with Pradaxa® may have lower rates of ischaemic stroke and intracranial haemorrhage (ICH), and also accumulate lower costs from acute care and long-term follow-up over their lifetime than patients treated with rivaroxaban. 1

The authors conducted a formal indirect treatment comparison between Pradaxa® and rivaroxaban (according to the Markov model).

The analysis has to be viewed in light of the absence of a head-to-head study. The current interest in healtheconomic aspects of new treatments may encourage further scientific assessments to confirm the findings. Boehringer Ingelheim would endorse and support further investigation.

In the analysis the authors conclude: 1

  • Pradaxa® may provide a lower risk of stroke (RR=0.62; 95% CI 0.45-0.87) than rivaroxaban
  • Pradaxa® may provide a lower risk of intracranial haemorrhage (ICH) (RR=0.38; 95% CI 0.21-0.67) than rivaroxaban

Looking at events per 100 patient-years, the model predicts that over a lifetime horizon, AF patients may experience 1

  • Considerably fewer ICH with Pradaxa® than with rivaroxaban (0.33 vs. 0.71)
  • Less ischaemic strokes with Pradaxa® than with rivaroxaban (3.40 vs. 3.96)
  • More quality-of-life-years with Pradaxa® than with rivaroxaban (6.17 vs. 6.01)

When assessing the costs of care, the analysis implies that patients treated with Pradaxa® incur lower costs of acute care and long term follow-up per patient, which, according to the authors, more than offset differences in drug costs. 1 The study shows consistent conclusions to previous analysis evaluating novel oral anticoagulant treatments in the Canadian market. 2

The indirect comparison model is based on data from ROCKET AF 3 where patients were treated with rivaroxaban and Pradaxa® clinical event rates as observed in the safety-on-treatment population 4 in RE-LY®, a prospective, randomized, open-label trial with blinded endpoint evaluation, comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. 5,6 The Pradaxa® data were adjusted mainly to reflect the higher level of warfarin control in RE-LY®) (the mean TTR (TTR = time in therapeutic range) was 64% in RELY® and 55% in ROCKET-AF) and simulated dosing corresponding to the approved Canadian treatment algorithm 7 for Pradaxa.

Dr Anuraag Kansal a research scientist in Health Economics, United BioSource Corporation, headquartered in the US said, "As more anticoagulation therapies become available, there is a need to understand the clinical and economic differences between new therapies. This research tells us that the benefits of dabigatran etexilate accrue steadily over time and that the novel oral anticoagulant continues to offer effective stroke protection for patients living with AF."