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Association Between Acute Neuropsychiatric Events and Helicobacter pylori Therapy Containing Clarithromycin
Angel Y S Wong1, Ian C K Wong2, Celine S L Chui1
1Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
Importance:
There is a concern that Helicobacter pylori therapy containing clarithromycin might be associated with acute neuropsychiatric events.
Objective:
To examine the association between H pylori therapy containing clarithromycin and acute neuropsychiatric events.
Design, Setting, And Participants:
A self-controlled case series study was conducted using the Clinical Data Analysis and Reporting System database in Hong Kong to explore any association. The exposure of interest was H pylori therapy containing clarithromycin in the outpatient setting. Study patients, 18 years or older at cohort entry, must have had both exposure to H pylori therapy containing clarithromycin and their first recorded neuropsychiatric events between January 1, 2003, and December 31, 2012. A post hoc nested case-control analysis was also performed in patients receiving H pylori therapy containing clarithromycin.
Main Outcomes And Measures:
The primary outcome was composite neuropsychiatric events, while secondary outcomes were psychotic events and cognitive impairment. Risk periods in the self-controlled case series analysis were defined as 14-day preexposure period, current use (days 1-14 since prescription start date) and recent use (days 15-30). Age-adjusted incidence rate ratios (IRR) were estimated using the conditional Poisson regression.
Results:
Of 66 559 patients who had at least 1 outpatient prescription of H pylori therapy containing clarithromycin. Their mean (SD) age at cohort entry was 50.8 (14.8 years); their mean age at first exposure was 55.4 (14.8) years, and 30 910 were male (46.4%). A total of 1824 patients had their first recorded composite neuropsychiatric events during the study period. An increased IRR of 4.12 (35 composite neuropsychiatric events during 72 person-years; 95% CI, 2.94-5.76) during current use was observed but not in recent use (9 events during 82 person-years; IRR, 0.95; 95% CI, 0.49-1.83) and 14-day preexposure period (14 events during 72 person-years; IRR, 1.63; 95% CI, 0.96-2.77) vs baseline (1766 events during 16 665 person-years). Similarly, both the risk of psychotic events and cognitive impairment increased during current use vs baseline, although this subsequently returned to baseline incidence levels during recent use. The crude absolute risks of composite neuropsychiatric events, psychotic events, and cognitive impairment during current use were 0.45, 0.12, and 0.12 per 1000 prescriptions, respectively. The nested case-control analysis also gave similar results to that of the self-controlled case series analysis.
Conclusions And Relevance:
This study shows evidence of a short-term increased risk of neuropsychiatric events associated with H pylori therapy containing clarithromycin.
Insights
Clarithromycin-containing Helicobacter pylori therapy is linked to a short-term rise in acute neuropsychiatric events. This includes psychotic events and cognitive impairment, with risks returning to baseline after initial use.
Area of Science:
- Pharmacovigilance
- Infectious Diseases
- Neuroscience
Background:
- Concerns exist regarding potential acute neuropsychiatric events linked to clarithromycin-based Helicobacter pylori (H. pylori) eradication therapies.
- Understanding this association is crucial for patient safety and guiding clinical practice in H. pylori treatment.
Purpose of the Study:
- To investigate the association between H. pylori therapy incorporating clarithromycin and the occurrence of acute neuropsychiatric events.
- To quantify the risk of neuropsychiatric events during and after clarithromycin exposure.
Main Methods:
- A self-controlled case series study utilized Hong Kong's Clinical Data Analysis and Reporting System database (2003-2012).
- Included patients aged 18+ who received H. pylori therapy with clarithromycin and experienced their first neuropsychiatric event within the study period.
- Analyzed composite neuropsychiatric events, psychotic events, and cognitive impairment using conditional Poisson regression, defining risk periods as pre-exposure, current use (days 1-14), and recent use (days 15-30).
Main Results:
- Out of 66,559 patients receiving clarithromycin-based H. pylori therapy, 1,824 experienced neuropsychiatric events.
- A significantly increased incidence rate ratio (IRR) of 4.12 was observed for composite neuropsychiatric events during current use (days 1-14) compared to baseline.
- Increased risks for psychotic events and cognitive impairment were also noted during current use, with risks returning to baseline levels during recent use.
Conclusions:
- The study provides evidence suggesting a short-term elevation in the risk of neuropsychiatric events associated with clarithromycin-containing H. pylori therapy.
- These findings highlight the importance of monitoring for neuropsychiatric side effects during the initial phase of treatment.
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