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

Tendon rupture
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

40000
Study design details

Main study objective

To quantify the risk of tendon rupture associated with systemic oral fluroquinolone exposure from primary care

Outcomes

Tendon rupture, Interaction with systemic corticosteroid therapy

Data analysis plan

From a cohort of patients administered antibiotic therapy, cases of tendon rupture will be matched to controls on age, gender and calendar time using risk set sampling. Odds ratios will be calculated for the association between current fluoroquinolone exposure and risk of any tendon rupture and the most frequent types of tendon rupture, using pre-specified risk windows. Adjustment for confounders including body mass index, comorbidity (charslon index), age, smoking status, prior history of tendon rupture and oral corticosteroid therapy will be undertaken. Interaction between fluoroquinolone exposure and oral corticosteroid therapy will be undertaken on the multiplicative scale.