An Observational Study of Upper Gastrointestinal Tract (UGIT) Bleeding Events in Patients Taking Duloxetine and NSAIDs (F1J-MC-B040)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06AX21) duloxetine

  duloxetine
• Medical condition to be studied:
  Upper gastrointestinal haemorrhage

Population studied

• Short description of the study population:
  All patients in Truven Health Analytics Marketscan (THAM) (Commercial Claims and Encounter and Medicare Supplemental) database from 1 January, 2007 to 31 December, 2011 with an inpatient admission with a length of stay >24 hours during the intake period of 1 January, 2008 to 30 September, 2011 who were ≥18 years of age at the time of admission, and who had at least 1 year of continuous eligibility prior to and 3 months after their admission date.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  33571

Study design details

• Main study objective:
  To examine whether concomitant use of duloxetine and prescription NSAIDs is associated with a synergistic effect on the risk of UGI bleedingSecondary objective: To study the risk of UGI bleeding associated with duloxetine exposure without concomitant NSAIDs Secondary objective: To characterize the severity of UGI bleeding cases across all study populations.
• Outcomes:
  Upper GI bleeding
• Data analysis plan:
  Truven Health Analytics Marketscan database was examined for hospital admissions of adult patients indexed from 1 January 2007 to 31 December 2011. Cases were patients with UGI hemorrhage or peptic ulcer disease. Controls were randomly selected from the remainingadmissions to match 10:1 with cases based on age, gender, and admission date. Prescription medication exposure groups of interest were: 1) no exposure to duloxetine, NSAIDs or aspirin, 2) duloxetine only, 3) NSAIDs or aspirin only, 4) duloxetine + NSAIDs or aspirin. Logistic regression and Relative Excess Risk due to Interaction (RERI) was utilized to estimate any increased risk of UGI bleeding for patients prescribed these medications across these groups.

Documents

Study results

Duloxetine EMA Final_v2_HL_encepp