Fluoroquinolones and the risk of tendon injury: a systematic review and meta-analysis

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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:
  Systematic review and meta-analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01MA) Fluoroquinolones

  Fluoroquinolones
• Medical condition to be studied:
  Tendon injury

Population studied

• Short description of the study population:
  Patients of all ages and genders treated with fluoroquinolones.
• Age groups:
  • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1345580

Study design details

• Main study objective:
  Assess the risk of tendon injuries associated with the use of systemic fluoroquinolones, as well as to explore risk variations due to risk factors, study designs and methodological quality of included studies.
• Outcomes:
  Assess the risk of tendon injuries associated with the use of systemic fluoroquinolones.
• Data analysis plan:
  A meta-analysis will be performed by pooling odds ratios (ORs) with their 95% confidence intervals (CIs), using the DerSimonian and Laird random-effects model. If the studies presented more than one risk estimate, the most adjusted one would be used. The effect size estimates available for the shortest time intervals between fluoroquinolones prescription and tendon injury diagnosis or treatment will be used in the overall risk estimate. The I2 statistic test will be used to assess heterogeneity between studies. An I2 estimate > 50% will be considered indicative of substantial heterogeneity. The publication bias will be visually examined by a funnel plot and statistically evaluated by Egger’s regression asymmetry test. Stata (version 13.1) will be used to perform statistics.