A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
Status: | Completed |
---|---|
Conditions: | Cardiology, Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/8/2018 |
Start Date: | November 20, 2017 |
End Date: | June 4, 2018 |
A Self-Controlled Case Series Study of Fluoroquinolones Exposure and Collagen-related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles
tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD)
following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin,
trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with
antibiotics, using a study design that minimizes the impact of confounders not usually
captured in health services databases such as heredity or smoking.
tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD)
following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin,
trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with
antibiotics, using a study design that minimizes the impact of confounders not usually
captured in health services databases such as heredity or smoking.
Inclusion Criteria:
- Have evidence of at least 1 instance of Achilles Tendon Rupture (ATR) or Retinal
Detachment (RD) or Aortic Aneurysm and Dissection (AAD)
- Have at least 1 exposure to Fluoroquinolones or any of the other antibiotics
(amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or
febrile illness not treated with antibiotic
- Have at least 1 year of continuous enrollment with pharmacy benefits prior to the ATR,
RD or AAD
Exclusion Criteria:
ATR, AAD and RD cohorts:
- Participants who experience the index event while within a time-at-risk window for more
than one exposure type. (The exposure types in this study include FQ as a class,
amoxicillin, azithromycin, trimethoprim, trimethroprim/sulfamethoxazole, and febrile
illness not treated with antibiotics. Events while within a time-at-risk window of two or
more exposure types cannot be associated with any one exposure. Participants are therefore
excluded from the study)
For ATR and AAD cohorts:
- Have inherited disorders of connective tissue, specifically: Ehlers-Danlos syndrome,
epidermolysis bullosa, Marfan syndrome, osteogenesis imperfecta
- Have an ATR or AAD event prior to index, during the 1-year pre-index period
For RD cohort:
- Have cataract surgery prior to index
- Have iridotomy or iridectomy prior to index
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