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

Adrian A Root; Angel Y S Wong; Yonas Ghebremichael-Weldeselassie; Liam Smeeth; Krishnan Bhaskaran; Stephen J W Evans; Ruth Brauer; Ian Chi Kei Wong; Vidya Navaratnam; Ian Douglas

doi:10.1111/bcp.12983

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

Adrian A Root, Angel Y S Wong, Yonas Ghebremichael-Weldeselassie, Liam Smeeth, Krishnan Bhaskaran, Stephen J W Evans, Ruth Brauer, Ian Chi Kei Wong, Vidya Navaratnam, Ian Douglas

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	512-21
Number of pages	10
Journal	British Journal of Clinical Pharmacology
Volume	82
Issue number	2
DOIs	https://doi.org/10.1111/bcp.12983
Publication status	Published - Aug 2016
Externally published	Yes

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Root, A. A., Wong, A. Y. S., Ghebremichael-Weldeselassie, Y., Smeeth, L., Bhaskaran, K., Evans, S. J. W., Brauer, R., Wong, I. C. K., Navaratnam, V., & Douglas, I. (2016). Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled study designs. British Journal of Clinical Pharmacology, 82(2), 512-21. https://doi.org/10.1111/bcp.12983

@article{3226741f66fb42ff9f728cd7c4c5c257,

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

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

author = "Root, {Adrian A} and Wong, {Angel Y S} and Yonas Ghebremichael-Weldeselassie and Liam Smeeth and Krishnan Bhaskaran and Evans, {Stephen J W} and Ruth Brauer and Wong, {Ian Chi Kei} and Vidya Navaratnam and Ian Douglas",

note = "{\textcopyright} 2016 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society.",

year = "2016",

month = aug,

doi = "10.1111/bcp.12983",

language = "English",

volume = "82",

pages = "512--21",

journal = "British Journal of Clinical Pharmacology",

issn = "0306-5251",

publisher = "John Wiley & Sons",

number = "2",

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Root, AA, Wong, AYS, Ghebremichael-Weldeselassie, Y, Smeeth, L, Bhaskaran, K, Evans, SJW, Brauer, R, Wong, ICK, Navaratnam, V & Douglas, I 2016, 'Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled study designs', British Journal of Clinical Pharmacology, vol. 82, no. 2, pp. 512-21. https://doi.org/10.1111/bcp.12983

TY - JOUR

T1 - Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled study designs

AU - Root, Adrian A

AU - Wong, Angel Y S

AU - Ghebremichael-Weldeselassie, Yonas

AU - Smeeth, Liam

AU - Bhaskaran, Krishnan

AU - Evans, Stephen J W

AU - Brauer, Ruth

AU - Wong, Ian Chi Kei

AU - Navaratnam, Vidya

AU - Douglas, Ian

PY - 2016/8

Y1 - 2016/8

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Anti-Bacterial Agents/adverse effects

KW - Cardiovascular Diseases/epidemiology

KW - Case-Control Studies

KW - Child

KW - Child, Preschool

KW - Clarithromycin/adverse effects

KW - Cohort Studies

KW - Databases, Factual

KW - Female

KW - Helicobacter Infections/drug therapy

KW - Humans

KW - Infant

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/epidemiology

KW - Propensity Score

KW - United Kingdom/epidemiology

KW - Young Adult

U2 - 10.1111/bcp.12983

DO - 10.1111/bcp.12983

M3 - Article

C2 - 27090996

SN - 0306-5251

VL - 82

SP - 512

EP - 521

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

IS - 2

ER -

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

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