title: Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled study designs.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  There was some evidence for a short term association for first MI but none for a long term association for any outcome.
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Adrian A
authors.identifier: 0000-0003-4243-2250
authors.initials: AA
authors.lastname: Root
authors.affiliation: Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong.
authors.forename: Angel Y S
authors.initials: AY
authors.lastname: Wong
authors.affiliation: Department of Mathematics and Statistics, Faculty of Mathematics, Computing and Technology, The Open University, Milton Keynes, Buckinghamshire, MK7 6AA, UK.
authors.forename: Yonas
authors.initials: Y
authors.lastname: Ghebremichael-Weldeselassie
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Liam
authors.initials: L
authors.lastname: Smeeth
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Krishnan
authors.initials: K
authors.lastname: Bhaskaran
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Stephen J W
authors.initials: SJ
authors.lastname: Evans
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Ruth
authors.initials: R
authors.lastname: Brauer
authors.affiliation: Research Department of Practice and Policy, School of Pharmacy, University College London, London, WC1N 1AX, UK.
authors.forename: Ian Chi Kei
authors.initials: IC
authors.lastname: Wong
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Vidya
authors.initials: V
authors.lastname: Navaratnam
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Douglas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000209:etiology; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D016208:Databases, Factual; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology* / Q000209:etiology; D057216:Propensity Score; D006113:United Kingdom / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017291:Clarithromycin
keywords: adverse drug reaction; cardiovascular disease; clarithromycin; pharmacoepidemiology