Association between oral anticoagulants and osteoporosis: Real-world data mining using a multi-methodological
Satoshi Yokoyama1, Shoko Ieda2, Mirai Nagano1
1Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, 3-4-1 Kowakae, Higashi-osaka, Osaka 577-8502, Japan.
International Journal of Medical Sciences
|March 17, 2020
Summary
Warfarin use, unlike direct oral anticoagulants (DOACs), is significantly linked to osteoporosis risk in both men and women. This finding comes from multi-methodological analysis of real-world data, clarifying previous uncertainties.
Area of Science:
- Pharmacovigilance and Pharmacoepidemiology
- Bone Metabolism and Osteoporosis Research
- Cardiovascular Drug Safety
Background:
- Warfarin and direct oral anticoagulants (DOACs) are key antithrombotic agents.
- Previous research on warfarin's association with osteoporosis risk yielded conflicting results.
- Emerging reports suggest a potential link between DOACs and osteoporosis.
Purpose of the Study:
- To investigate the association between oral anticoagulant use (warfarin and DOACs) and osteoporosis.
- To analyze real-world data using diverse methodologies and databases for robust findings.
- To clarify the safety profile of antithrombotic therapies concerning bone health.
Main Methods:
- Utilized US FDA Adverse Event Reporting System (FAERS) and Japanese JMDC claims database (2004-2017).
- Employed disproportionality analysis (DPA) calculating Reporting Odds Ratio (ROR) and Information Component (IC).
- Applied Sequence Symmetry Analysis (SSA) to calculate adjusted Sequence Ratio (SR) for temporal association.
Main Results:
- Disproportionality analysis identified significant signals for warfarin and osteoporosis (ROR: 1.43, IC: 0.50).
- Sequence symmetry analysis confirmed a significant association between warfarin and osteoporosis or bisphosphonate use.
- The association between warfarin and osteoporosis was consistent across sexes.
Conclusions:
- Multi-methodological data mining confirms warfarin use is significantly associated with osteoporosis.
- Direct oral anticoagulants (DOACs) did not show a significant association with osteoporosis in this analysis.
- Warfarin's association with osteoporosis is independent of patient sex.
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