WP6 negative control study: The risk of myocardial infarction not associated with the use of antibiotics: A study using a US database

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

  Other
• If ‘other’, further details on the scope of the study:
  Negative control
• 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:
  (J01) ANTIBACTERIALS FOR SYSTEMIC USE

  ANTIBACTERIALS FOR SYSTEMIC USE
• Medical condition to be studied:
  Myocardial infarction

Population studied

• Short description of the study population:
  Patients of all ages with an active or died registration status during the study period of January 1st, 2004 to December 31st, 2009 in the Invision Data Mart. Patients must have attained one year of enrolment in the database at the beginning of the study period.
• 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:
  80000

Study design details

• Main study objective:
  to assess the absence of association between antibiotics use and myocardial infarction by replicationg a nested case-control design in a US claims database (LabRx)
• Outcomes:
  To estimate the risk of myocardial infarction associated with antibiotics exposure (users and non-users)To estimate the risk of myocardial infarction associated with various antibiotics classesTo estimate the risk of myocardial infarction associated with specific individual antibioticsTo assess the effect of dose and duration of use for specific individual antibiotics, To replicate the analysis using a population-based case-control design
• Data analysis plan:
  We will compute odds ratios (OR) and 95% confidence intervals of first occurrence of acute myocardial infarction associated with current use of antibiotics (as a group and different classes and individual drugs when possible) as compared to non-use with conditional logistic regression. Age, sex, calendar year, and other variables will be introduced in the model to control for potential confounding. Also, dose and duration-relationships will be examined.

Documents

Study results

PROTECT WP6 ATB AMI REPORT 21072014_final