title: Erythropoiesis-stimulating agents are not associated with increased risk of thrombosis in patients with myelodysplastic syndromes.
abstract: BACKGROUND
  There are limited reports of thrombosis among myelodysplastic syndrome patients exposed to erythropoiesis stimulating agents. It is not clear whether erythropoiesis stimulating agents are associated with an increased risk of thrombosis in myelodysplastic syndromes, as they are among patients with solid tumors.
  
  
  METHODS
  The association between use of erythropoiesis stimulating agent and transient thrombosis risk in patients with myelodysplastic syndromes was assessed in a case-crossover study nested within a cohort of incident myelodysplastic syndrome patients. Using the US Surveillance, Epidemiology, and End Results Medicare-linked database, cases with an incident diagnosis of deep vein thrombosis were identified. Using conditional logistical regression, the odds of exposure to erythropoiesis stimulating agents in the 12 weeks prior to the incident deep vein thrombosis (hazard period) was compared to the exposure odds in a prior 12-week comparison period.
  
  
  RESULTS
  Within the cohort of eligibles with myelodysplastic syndromes (n = 5,673) there were 212 incident cases of deep vein thrombosis events. Mean age was 76.2 (standard deviation = ± 8.6) years. Use of erythropoiesis stimulating agents was not associated with deep vein thrombosis in the crude nor the adjusted models (OR = 1.21, 95% CI: 0.60, 2.43). Central venous catheter placement (OR = 6.47, 95% CI: 2.37, 17.62) and red blood cell transfusion (OR = 4.60, 95% CI: 2.29, 9.23) were associated with deep vein thrombosis.
  
  
  CONCLUSIONS
  Despite the link between use of erythropoiesis stimulating agents and thrombosis among patients with solid tumors, this study provides evidence that their safety profile may be different among patients with myelodysplastic syndromes.
authors.affiliation: Center for Drug Safety, University of Maryland School of Pharmacy, Baltimore, Maryland, 220 Arch Street 12 Floor, Baltimore, Maryland, USA. 21201.  sweiss@rx.umaryland.edu.
authors.forename: Sheila Weiss
authors.initials: SW
authors.lastname: Smith
authors.forename: Masayo
authors.initials: M
authors.lastname: Sato
authors.forename: Steven D
authors.initials: SD
authors.lastname: Gore
authors.forename: Maria R
authors.initials: MR
authors.lastname: Baer
authors.forename: Xuehua
authors.initials: X
authors.lastname: Ke
authors.forename: Diane
authors.initials: D
authors.lastname: McNally
authors.forename: Amy
authors.initials: A
authors.lastname: Davidoff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D005260:Female; D006397:Hematinics / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications* / Q000188:drug therapy; D018570:Risk Assessment; D012307:Risk Factors; D018426:SEER Program; D020246:Venous Thrombosis / Q000175:diagnosis / Q000209:etiology*
chemical_list: D006397:Hematinics
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