Risk of peripheral neuropathy with systemic fluoroquinolone exposure: population-based nested case-control study

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:
  (J01MA) Fluoroquinolones

  Fluoroquinolones
• Medical condition to be studied:
  Neuropathy peripheral

Population studied

• Short description of the study population:
  Adults aged 18 years or over identified from THIN database between January 1, 1999 and December 31, 2015 issued at least one prescription of co-amoxiclav or fluoroquinolone antibiotic product with a systemic route of administration.
• 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:
  50000

Study design details

• Main study objective:
  Estimate the risk of incident peripheral neuropathy associated with systemic fluoroquinolone exposure in primary care using systemic co-amoxiclav exposure as a negative control.
• Outcomes:
  Incident peripheral neuorpathy cases recorded within primary care electronic medical records using Read codes.
• Data analysis plan:
  Cases and controls will be identified from a cohort of adults prescribed antibiotics within the THIN database. Conditional logistic regression will be used to estimate odds ratios (that will approximate incidence rate ratios with risk set sampling) for the association between systemic fluoroquinolone and co-amoxiclav exposure and incident peripheral neuropathy in adults without diabetes. Adjustment will be made for age, sex, calendar time, general practice, comorbidity (charlson score), history of SLE, sjogrens, shingles, amyloidosis Lyme disease, and exposure to phenytoin, metronidazole, and nitrofurantoin therapy.