Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled study designs

Br J Clin Pharmacol. 2016 Aug;82(2):512-21. doi: 10.1111/bcp.12983. Epub 2016 Jun 8.


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.

Keywords: adverse drug reaction; cardiovascular disease; clarithromycin; pharmacoepidemiology.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / therapeutic use
  • Cardiovascular Diseases / epidemiology*
  • Cardiovascular Diseases / etiology
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Clarithromycin / adverse effects*
  • Clarithromycin / therapeutic use
  • Cohort Studies
  • Databases, Factual
  • Female
  • Helicobacter Infections / drug therapy
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Myocardial Infarction / epidemiology*
  • Myocardial Infarction / etiology
  • Propensity Score
  • United Kingdom / epidemiology
  • Young Adult


  • Anti-Bacterial Agents
  • Clarithromycin