Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled
Adrian A Root1, Angel Y S Wong2, Yonas Ghebremichael-Weldeselassie3
1Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
Insights
This study found limited evidence of a short-term link between clarithromycin-based Helicobacter pylori treatment and myocardial infarction. No long-term cardiovascular risks were identified for this common antibiotic regimen.
Area of Science:
- Pharmacovigilance
- Cardiovascular Epidemiology
- Gastroenterology
Background:
- Previous research suggests a potential long-term association between clarithromycin use and cardiovascular events.
- This study specifically examines this risk within the context of Helicobacter pylori treatment (HPT).
Purpose of the Study:
- To investigate the association between clarithromycin-containing HPT and cardiovascular events.
- To differentiate between short-term and long-term risks following HPT.
Main Methods:
- Utilized the UK Clinical Practice Research Datalink (CPRD) database.
- Employed a self-controlled case series (SCCS), case-time-control (CTC), and propensity score-adjusted cohort study design.
- Assessed outcomes including myocardial infarction (MI), arrhythmia, stroke, and mortality within three years post-exposure.
Main Results:
- The SCCS analysis showed an incidence rate ratio of 1.43 (95% CI 0.99, 2.09) for MI within 90 days of clarithromycin-containing HPT.
- No significant association was found for MI within 1 year (IRR 1.07) or for other cardiovascular outcomes in the long term.
- CTC and cohort study results corroborated these findings.
Conclusions:
- Some evidence suggests a short-term association between clarithromycin-containing HPT and first myocardial infarction.
- No significant long-term association was observed between clarithromycin-containing HPT and major cardiovascular events or mortality.
Aim:
Some previous studies suggest a long term association between clarithromycin use and cardiovascular events. This study investigates this association for clarithromycin given as part of Helicobacter pylori treatment (HPT).
Methods:
Our source population was the Clinical Practice Research Datalink (CPRD), a UK primary care database. We conducted a self-controlled case series (SCCS), a case-time-control study (CTC) and a propensity score adjusted cohort study comparing the rate of cardiovascular events in the 3 years after exposure to HPT containing clarithromycin with exposure to clarithromycin free HPT. Outcomes were first incident diagnosis of myocardial infarction (MI), arrhythmia and stroke. For the cohort analysis we included secondary outcomes all cause and cardiovascular mortality.
Results:
Twenty-eight thousand five hundred and fifty-two patients were included in the cohort. The incidence rate ratio of first MI within 1 year of exposure to HPT containing clarithromycin was 1.07 (95% CI 0.85, 1.34, P = 0.58) and within 90 days was 1.43 (95% CI 0.99, 2.09 P = 0.057) in the SCCS analysis. CTC and cohort results were consistent with these findings.
Conclusions:
There was some evidence for a short term association for first MI but none for a long term association for any outcome.
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