A new study published in JAMA Internal Medicine has shown a short-term increased risk of neuropsychiatric events tied with Helicobacter pylori (H. pylori) therapy containing clarithromycin.
Angel Y. S. Wong, from the University of Hong Kong, and colleagues, aimed to study the association between clarithromycin-containing H. pylori therapy and acute neuropsychiatric events through a self-controlled case series study. Using data from the Clinical Data analysis and Reporting System database in Hong Kong, the team examined H. pylori therapy containing clarithromycin in the outpatient setting. Enrolled patients were aged ≥18 years at study entry and had exposure to both clarithromycin-containing H. pylori therapy and their first documented neuropsychiatric events between January 1, 2003–December 31, 2012. In addition, a post-hoc nested case-control analysis was done in patients receiving H. pylori therapy containing clarithromycin.
The primary outcome was composite neuropsychiatric events; secondary outcomes included psycotic events and cognitive impairment. Risk periods were defined as 14-days pre-exposure period, current use (Days 1–14 since prescription start), and recent use (Days 15–30).
Out of the 66,559 total patients, first recorded composite neuropsychiatric events during the study period were noted in 1,824 patients. An increased age-adjusted incidence rate ratio (IRR) of 4.12 (95% CI: 2.94–5.76) during current use was seen but not in recent use (IRR 0.95, 95% CI: 0.49–1.83) and 14-day pre-exposure period (IRR 1.63, 95% CI: 0.96–2.77) vs. baseline.
The risk of psychotic events and cognitive impairment both rose during current use vs. baseline though the levels returned to baseline 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 1,000 prescriptions, respectively,” reported Wong. Study findings demonstrate a short-term increased risk of neuropsychiatric events correlated with H. pylori therapy containing clarithromycin.
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