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Adverse events associated with azathioprine treatment in korean pediatric inflammatory bowel disease patients
Ji Young Chun1, Ben Kang, Yoo Min Lee
1Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Insights
Azathioprine treatment for pediatric inflammatory bowel disease in Korea frequently caused adverse events, most commonly bone marrow suppression. Close monitoring is essential for these young patients to manage potential side effects effectively.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
- Immunosuppressive Therapy
Background:
- Inflammatory bowel disease (IBD) management in pediatric populations often requires immunosuppressive agents.
- Azathioprine is a commonly used thiopurine drug for maintaining remission in pediatric IBD.
- Understanding the adverse event profile of azathioprine in Korean children is crucial for optimizing treatment.
Purpose of the Study:
- To determine the incidence and clinical course of adverse events linked to azathioprine therapy.
- To analyze the specific types of adverse reactions observed in Korean pediatric IBD patients.
- To provide data for informed clinical decision-making regarding azathioprine use.
Main Methods:
- Retrospective review of medical records for 174 pediatric IBD patients treated with azathioprine.
- Data collection spanned from January 2002 to December 2012 at Samsung Medical Center, Seoul, Korea.
- Adverse events, their management (dose reduction/discontinuation), and specific reactions were documented.
Main Results:
- Over half of patients (56.3%) experienced adverse events, leading to dose reduction in 17.8% and discontinuation in 10.3%.
- Bone marrow suppression, particularly leukopenia, was the most frequent adverse event (27.0%), necessitating dose reduction in 12.6% and discontinuation in 4.6%.
- Other significant adverse events included gastrointestinal disturbances (15.5%), hair loss (12.1%), and pancreatitis (7.5%).
Conclusions:
- Azathioprine treatment in Korean pediatric IBD patients is associated with a substantial frequency of adverse events, predominantly bone marrow suppression.
- The findings underscore the necessity for vigilant monitoring of pediatric patients receiving azathioprine for IBD.
- Early identification and management of adverse events are critical for safe and effective long-term therapy.
Purpose:
This study was aimed to evaluate the frequency and course of adverse events associated with azathioprine treatment in Korean pediatric patients with inflammatory bowel disease.
Methods:
Total of 174 pediatric patients (age range, 1 to 19 years) with inflammatory bowel disease who received azathioprine in order to maintain remission at Samsung Medical Center (Seoul, Korea) from January 2002 through December 2012 were included in this study. Medical records of these subjects were retrospectively reviewed regarding the development of adverse events associated with azathioprine treatment.
Results:
Ninety-eight patients (56.3%) of 174 patients experienced 136 episodes of adverse events, requiring dose reduction in 31 patients (17.8%), and discontinuation in 18 patients (10.3%). The mean dose of azathioprine that had been initially administered was 1.32±0.42 mg/kg/day. Among the adverse reactions, bone marrow suppression developed in 47 patients (27.0%), requiring dose reduction in 22 patients (12.6%) and discontinuation in 8 patients (4.6%). Other adverse events that occurred were gastrointestinal disturbance (15.5%), hair loss (12.1%), pancreatitis (7.5%), arthralgia (6.9%), hepatotoxicity (2.9%), skin rash/allergic reactions (2.9%), headache/dizziness (2.3%), sepsis (0.6%), and oral mucositis (0.6%).
Conclusion:
Bone marrow suppression, especially leukopenia was most commonly associated with azathioprine treatment in Korean pediatric inflammatory bowel disease patients. Close observation for possible adverse events is required in this population with inflammatory bowel diseases who are under treatment with azathioprine.
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