Diabetologie und Stoffwechsel 2019; 14(S 01): S67
DOI: 10.1055/s-0039-1688302
Poster
Diabetes und Herz
Georg Thieme Verlag KG Stuttgart · New York

Comparative safety and effectiveness of factor-xa inhibitors vs. phenprocoumon in patients with non-valvular atrial fibrillation and diabetes

S Kloss
1   Bayer AG, Real World Evidence, Berlin, Germany
,
H Bonnemeier
2   Universitätsklinikum Schleswig-Holstein, Elektrophysiologie und Rhythmologie, Kiel, Germany
,
D Häckl
3   WIG2, Institut für Gesundheitsökonomie und Gesundheitssystemforschung, Leipzig, Germany
,
T Vaitsiakhovich
1   Bayer AG, Real World Evidence, Berlin, Germany
,
N Schmedt
4   Ingef, Versorgungsforschung und Pharmakoepidemiologie, Berlin, Germany
,
D Enders
4   Ingef, Versorgungsforschung und Pharmakoepidemiologie, Berlin, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
07 May 2019 (online)

Also available at
 

Background:

Data on effectiveness and safety of Factor-Xa inhibitors for patients with non-valvular atrial fibrillation (NVAF) and diabetes in the real-world is scarce. We aimed to compare the risk of effectiveness and safety outcomes in factor-Xa inhibitors vs. phenprocoumon in Germany.

Methods:

We conducted a new user cohort study based on German claims data between January 1st, 2013 and June 30th, 2017. A multiple Cox-regression was performed to calculate confounder-adjusted hazard ratios (HRs) for the risk of ischemic stroke/systemic embolism (IS/SE), intracranial haemorrhage (ICH), fatal bleeding, end stage renal disease or dialysis (ESRD) and acute kidney injury in new users of NOACs (rivaroxaban, apixaban and edoxaban) vs. new users of phenprocoumon.

Results:

The population with NVAF and diabetes comprised 6,997 initiators of rivaroxaban, 5,438 of apixaban, 865 in of edoxaban and 8,545 of phenprocoumon. In the confounder-adjusted analysis, a comparable risk of IS/SE was observed for all NOACs compared to phenprocoumon with a trend towards better effectiveness for rivaroxaban. For the risk of ICH, we observed a numerical benefit for factor-Xa inhibitors over phenprocoumon. Similarly, we observed statistically significant risk reductions related to end stage renal disease for rivaroxaban (68%) and apixaban (40%). For the risk of acute kidney injury, only rivaroxaban showed a reduced risk reduction (28%).

Conclusion:

Our study adds evidence for a comparison of factor-Xa vs. VKA in a diabetes population. Moreover, it indicates a beneficial effect of NOACs on renal function worsening over time when compared to phenprocoumon. Further studies are warranted to consolidate these findings.