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

Root, Adrian; Wong, Angel; Ghebremichael‐Weldeselassie, Yonas; Smeeth, Liam; Bhaskaran, Krishnan; Evans, Stephen; Brauer, Ruth; Wong, Ian Chi Kei; Navaratnam, Vidya; Douglas, Ian

doi:10.1111/bcp.12983

Cited by 21 publications

(31 citation statements)

References 13 publications

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“…Despite different follow-up periods (14 and 30 days), both studies showed no significant difference of risk of stroke during risk period versus baseline [37,44].…”

Section: Strokementioning

confidence: 81%

“…For short-term stroke (Fig.7), the overall RR was 1.45 (95% CI 0.92-2.29) in two self-controlled case series analyses [37,44]. Despite different follow-up periods (14 and 30 days), both studies showed no significant difference of risk of stroke during risk period versus baseline [37,44].…”

Section: Strokementioning

confidence: 90%

“…There were six cohort studies reporting a short-term risk of arrhythmia associated with macrolides [22,32,34,36,37,44] and no increased risk was observed (RR 1.36, 95% CI 0.97-1.92) (Fig.6). No RCT was identified in reporting the short-term risk of arrhythmia associated with macrolides.…”

Section: Arrhythmiamentioning

confidence: 99%

“…One case-control study [56] which separately reported the OR for each type of macrolides and one case-time-control study [44] were identified to report the long-term risk of arrhythmia (Fig.6). …”

Section: Arrhythmiamentioning

confidence: 99%

“…The pooled estimate did not give an increased risk (OR 1.18; 95% CI 0.96-1.44). Six cohort studies or self-controlled case series analysis [15,22,33,37,44,56] reported that the pooled estimate for long-term arrhythmia was 1.10 (95% CI 0.99-1.21) with heterogeneity of 69%. However, when results from at least two studies with the same follow-up periods were combined, no increased risk could be found (data not shown).…”

Section: Arrhythmiamentioning

confidence: 99%

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Managing Cardiovascular Risk of Macrolides: Systematic Review and Meta-Analysis

et al. 2017

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(150-250 words, 250 words)Introduction It was postulated that antibiotics including macrolides could be used for secondary prevention of coronary heart disease but recent studies showed that macrolides increase the cardiovascular risk. We aimed to review the evidence of cardiovascular risk associated with macrolides regarding duration of effect and risk factors; and explore the potential effect of statins for the prevention of cardiovascular events due to macrolide use.Methods Several electronic databases(PubMed, EMBASE, Cochrane library) were searched to identify eligible studies. Observational studies and randomized controlled trials(RCTs) that investigated the association between macrolides and cardiovascular events in adults aged≥18 years were included. Meta-analysis was conducted to investigate the short and long-term risks of cardiovascular mortality, myocardial infarction, arrhythmia and stroke. Methodological quality was assessed by the Newcastle-Ottawa scale and the Cochrane Collaboration's tool. The body of evidence was evaluated by the Grading of Recommendations Assessment, Development, and Evaluation guidelines.Results Observational studies were found to have short-term risk of cardiovascular outcomes including cardiovascular mortality, myocardial infarction and arrhythmia associated with macrolides but no risk was found in RCTs. However no association for long-term risk (>3 years) was observed in observational studies or RCTs. LimitationsThe included studies reported different units of denominators for absolute risk and used different outcome definitions, which might increase the heterogeneity. ConclusionsMore studies are required to investigate the short-term cardiovascular outcomes associated with different types of macrolides. Future studies are warranted to evaluate the effect of statins for preventing excess acute cardiovascular events associated with clarithromycin or other macrolides. Keypoints The short-term risk of cardiovascular outcomes associated with macrolides was found in observational studies but not in randomised controlled trials. No long-term cardiovascular risk (>3 years) associated with macrolides was observed.2  There was limited evidence for the use of statins to prevent excess acute cardiovascular events associated with clarithromycin or other macrolides.

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“…Despite different follow-up periods (14 and 30 days), both studies showed no significant difference of risk of stroke during risk period versus baseline [37,44].…”

Section: Strokementioning

confidence: 81%

Section: Strokementioning

confidence: 90%

Section: Arrhythmiamentioning

confidence: 99%

Section: Arrhythmiamentioning

confidence: 99%

Section: Arrhythmiamentioning

confidence: 99%

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Managing Cardiovascular Risk of Macrolides: Systematic Review and Meta-Analysis

et al. 2017

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Evaluating the use of methods to mitigate bias from non‐transient medications in the case‐crossover design: A systematic review

Huang

Tadrous

et al. 2023

Pharmacoepidemiology and Drug

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Purpose The case‐crossover design is a self‐controlled study design used to compare exposure immediately preceding an event occurrence with exposure in earlier control periods. The design is most suitable for transient exposures in order to avoid biases that can be problematic when using the case‐crossover design for non‐transient (i.e., chronic) exposures. Our goal was to conduct a systematic review of case‐crossover studies and its variants (case‐time‐control and case‐case‐time‐control) in order to compare design and analysis choices by medication type. Methods We conducted a systematic search to identify recent case‐crossover, case‐time‐control, and case‐case‐time‐control studies focused on medication exposures. Articles indexed in MEDLINE and EMBASE using these study designs that were published between January 2015 and December 2021 in the English language were identified. Reviews, methodological studies, commentaries, articles without medications as the exposure of interest, and articles with no available full text were excluded. Study characteristics including study design, outcome, risk window, control window, reporting of discordant pairs, and inclusion of sensitivity analyses were summarized overall and by medication type. We further evaluated the implementation of recommended methods to account for biases introduced by non‐transient exposures among articles that used the case‐crossover design on a non‐transient exposure. Results Of the 2036 articles initially identified, 114 articles were included. The case‐crossover was the most common study design (88%), followed by the case‐time‐control (17%), and case‐case‐time‐control (3%). Fifty‐three percent of the articles included only transient medications, 35% included only non‐transient medications, and 12% included both. Across years, the proportion of case‐crossover articles evaluating a non‐transient medication ranged from 30% in 2018 to 69% in 2017. We found that 41% of the articles that evaluated a non‐transient medication did not apply any of the recommended methods to account for biases and more than half of which were conducted by authors with no previous publication history of case‐crossover studies. Conclusion Using the case‐crossover design to evaluate a non‐transient medication remains common in pharmacoepidemiology. Researchers should apply appropriate design and analysis choices when opting to use a case‐crossover design with non‐transient medication exposures.

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