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Clinical Summary

Bleeding risk high in systemic sclerosis patients

Takeaway

  • The risk for major bleeding events was consistently higher in patients with systemic sclerosis (SSc) than the general population in the United Kingdom.

Why this matters

  • No previous studies have investigated the types and risks of bleeding events in patients with SSc.

Study design

  • 1314 patients with SSc and 19,992 matched SSc-free comparison cohort were followed until December 2013 using The Health Improvement Network UK primary care database (2000-2012).
  • Funding: Bayer AG.

Key results

  • Patients with SSc vs general population had higher incidence rates [95% CI] per 1000 person-years for:
    • any bleeding (15.5 [13.0-18.6] vs 12.9 [12.3-13.5]),
    • haemorrhagic stroke (0.5 [0.1-1.2] vs 0.3 [0.2-0.4]),
    • gastrointestinal bleeding (4.1 [2.9-5.8] vs 3.3 [3.0-3.6]),
    • pulmonary haemorrhage (2.5 [1.5-3.8] vs 1.7 [1.5-1.9]), and
    • urogenital bleeding (8.4 [6.5-10.6] vs 7.5 [7.0-7.9]).
  • After adjustment for confounders, patients with SSc vs general population had a higher risk for:
    • any bleeding (HR, 1.21; 95% CI, 1.00-1.46),
    • haemorrhagic stroke (HR, 1.51; 95% CI, 0.54-4.21),
    • pulmonary haemorrhage (HR, 1.50; 95% CI, 0.96-2.35),
    • gastrointestinal bleeding (HR, 1.08; 95% CI, 0.75-1.54), and
    • urogenital bleeding (HR, 1.28; 95% CI, 1.00-1.64).
  • The risk was more frequently higher in patients with SSc with organ involvement than those without organ involvement and in those with diffuse cutaneous SSc.

Limitations

  • Insufficient information in the database to classify patients with SSc into 2 major subtypes.

References


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