Drugs associated with Spontaneous Coronary Artery Dissection: a WHO pharmacovigilance database disproportionality analysis

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-Non case study

Study drug and medical condition

• Medical condition to be studied:
  Coronary artery dissection
• Additional medical condition(s):
  spontaneous coronary artery dissection (SCAD)

Population studied

• 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:
  15000000

Study design details

• Main study objective:
  To estimate risk of SCAD for drugs of the database with at least 3 cases of SCAD
• Outcomes:
  RIsk of SCAD
• Data analysis plan:
  Descriptive statistics will be used to compare characteristics between reports. Using a case/non-case design, we will estimate ROR for each drug of interest. Moreover, we will conduct sensitivity analyses to assess the robustness of the signals. We will restrict analysis to reports declared by a healthcare physician. To take in account the potential confusion bias induced by the population characteristics exposed to a given drug we will modify the comparator group by using all cases reported with drugs belonging to the corresponding ATC class 3 level.