Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japa
Not Applicable
- Conditions
- Stevens-Johnson syndrome (SJS) Toxic epidermal necrolysis (TEN)
- Registration Number
- JPRN-UMIN000035031
- Lead Sponsor
- Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
- Brief Summary
There were increased odds of SJS/TEN in the new users of carbamazepine (OR 68.00, 95% confidence interval [CI] 8.49 to 8792.29) and lamotrigine (OR 36.00, 95% CI 3.84 to 4770.48). The ALDEN score was more than probable for 100% of cases exposed to lamotrigine or carbamazepine. The 90-day cumulative incidences of SJS/TEN per 100,000 new users were 93.83 for carbamazepine and 84.33 for lamotrigine. We found no significant elevated odds in the users of other anticonvulsants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 355
Inclusion Criteria
Not provided
Exclusion Criteria
Cohort study: None Matched case-control study: Patients who did not have an observational period of >180 days prior to the index date
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method