Abstract
Introduction/objectives
To compare the risk of different bleeding outcomes between patients with systemic sclerosis (SSc) and the general population free of SSc.
Methods
Using UK electronic primary care data (2000–2012), 1314 patients with SSc and a matched SSc-free comparison cohort (n = 19,992) were followed until December 2013 to identify bleeding, confirmed following manual review of patient records including free text comments. Incidence rates were calculated and Cox regression used to estimate adjusted hazard ratios (HRs; SSc cohort vs. matched general population cohort) adjusted for confounders.
Results
One hundred and twenty-seven bleeding events occurred in the SSc cohort and 1762 in the general population cohort; incidence rates per 1000 person-years for the SSc cohort and general population cohort were 0.5 versus 0.3 for hemorrhagic stroke, 4.1 versus 3.3 for gastrointestinal bleeding, 2.5 versus 1.7 for pulmonary hemorrhage, 8.4 versus 7.5 for urogenital bleeding, and 15.5 versus 12.9 for any of the aforementioned bleedings. Adjusted HRs (95% confidence intervals) were 1.21 (1.00–1.46) for any bleeding, 1.51 (0.54–4.21) for hemorrhagic stroke, 1.50 (0.96–2.35) for pulmonary hemorrhage, 1.08 (0.75–1.54) for gastrointestinal bleeds, and 1.28 (1.00–1.64) for urogenital bleeds. HRs were more often higher in SSc patients with organ involvement than without organ involvement and in those with diffuse cutaneous SSc.
Conclusion
Our results are consistent with a moderately increased risk of bleeding in SSc patients. Further evidence from large SSc patient cohorts is needed to confirm this finding.
Key Points • The risk of experiencing a major bleed may be higher among patients with SSc than the general population. • Further large and well-designed studies are needed to corroborate our findings. |
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Data availability
The datasets analyzed during the current study are available from the corresponding author upon reasonable request.
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The authors acknowledge and thank Susan Bromley, EpiMed Communications Ltd. (Oxford, UK) for editorial support funded by Bayer AG.
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This study was funded by Bayer AG.
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AM is a full-time employee of Bayer Consumer Care AG, Basel, Switzerland. LAGR, AG-P, and MES work for CEIFE, which have received research funding from Bayer AG. LAGR has received honoraria for serving on advisory boards for Bayer AG. The authors declare no non-financial conflict of interests.
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This study used anonymized primary care electronic health records. No clinical subjects were involved and therefore informed consent was not applicable.
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Michel, A., González-Pérez, A., Sáez, M.E. et al. Risk of bleeding events among patients with systemic sclerosis and the general population in the UK: a large population-based cohort study. Clin Rheumatol 39, 19–26 (2020). https://doi.org/10.1007/s10067-019-04588-0
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DOI: https://doi.org/10.1007/s10067-019-04588-0