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June 12, 2026Medical SciencesOpen Access

Age-standardized prevalence of heart failure was significantly higher in clozapine-treated patients compared to the general population in both Japan (OR 3.2, 95% CI 1.4-6.4) and China (OR 6.9, 95% CI 3.6-12.0).

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Why the study?

Does long-term clozapine monotherapy increase the risk of heart failure in patients with schizophrenia compared to the general population?

Population

315 patients with schizophrenia receiving clozapine monotherapy for whom serum NT-proBNP concentration and…

Comparison

Long-term clozapine monotherapy. vs General population.

Design

Cohort

Follow-up

Mean exposure duration 57.5 months and 208.1 months

Authors

RORuri OkuboNYNobutomo YamamotoXSXiaojun Shao

Discussion

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Overview

Clozapine was associated with higher heart failure prevalence; hypothesis-generating for independent cardiotoxicity and prospective monitoring studies.

Key Points

  • This study examines the risk of long-term clozapine-induced cardiotoxicity in schizophrenia patients.
  • Multicenter retrospective cohort study of schizophrenia patients in Japan and China
  • Included cases from 2025 with NT-proBNP concentration and LVEF data
  • Statistical analysis involved blood examinations and echocardiography results.
  • Heart failure prevalence was higher in clozapine patients versus the general population (OR 3.2 in Japan, OR 6.9 in China)
  • Identified risk factors for stage-B heart failure include prolonged exposure, higher plasma clozapine levels, and increased monocytes
  • Over 70% of heart failure cases did not present metabolic complications, indicating HFpEF likely.

Structured PICO

Does long-term clozapine monotherapy increase the risk of heart failure in patients with schizophrenia compared to the general population?

P
Population
315 patients with schizophrenia receiving clozapine monotherapy (99 Japanese, 216 Chinese) for whom serum NT-proBNP concentration and LVEF derived from echocardiography were available.
I
Intervention
Long-term clozapine monotherapy (mean exposure duration 57.5 ± 4.0 months in Japan, 208.1 ± 11.0 months in China).
C
Comparator
General population (for age-standardized prevalence comparison).
O
Outcome
Prevalence of heart failure (including asymptomatic stage-B heart failure).safety

Long-term clozapine use is associated with a significantly increased risk of late-onset, asymptomatic heart failure (likely HFpEF), suggesting a need for routine NT-proBNP monitoring in this population.

Cite This Study

Okubo et al. (2026) studied this question.

synapsesocial.com/papers/6a2bd1386550ea4541ffe986https://doi.org/10.3390/medsci14020306
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