Loading your page…
Frontiers in pharmacology
By Li Y, Xie H and Tan L.
To evaluate the temporal association between voriconazole and hypomagnesemia in pediatric patients with hematologic diseases using prescription sequence symmetry analysis (PSSA) and to assess the utility of hospital information system (HIS)-based active drug safety surveillance.
Ward brings these articles into the same app as your cards and questions. One free account for Ward, Suture, Osler and Prognia.
Inpatient data were extracted from the Children's Hospital of Chongqing Medical University from November 2013 to December 2024. The first year served as a data integrity verification window and the subsequent approximately 10-year period as the formal analysis phase. Patients with hematologic diseases were identified using ICD-10 codes C81-C96, D45-D47, and D60-D61. Each patient contributed the first voriconazole prescription and first hypomagnesemia event (Mg2+ < 0.6 mmol/L). The primary analysis used a 365-day washout period, 90-day exposure window, and 7-day blackout period. Adjusted sequence ratios (aSRs) with 95% confidence intervals (CIs) were estimated, with 10 parameter sensitivity analyses, monitoring-intensity correction, four control analyses, and stratified analyses by concomitant medications.
Among 536 eligible patients, 364 (67.9%) had serum magnesium measurements. The post-exposure sequence comprised 58 patients and the reverse sequence eight patients, yielding an aSR of 5.76 (95% CI: 2.75-12.06). Median time to hypomagnesemia after voriconazole initiation was 28 days (IQR: 20-43), and 32/58 events (55.2%) occurred within 30 days. Exploratory dose-response analysis showed no association between weight-based voriconazole dose and hypomagnesemia occurrence (P = 0.437). All parameter sensitivity analyses produced aSRs >3.9; after correction for monitoring intensity, the aSR was 3.33 (95% CI: 1.59-6.98); in a sensitivity grid, the association remained statistically significant for monitoring-intensity ratios up to 2.75. All four control analyses agreed with their prespecified expectations. Associations remained significant in the PPI and aminoglycoside strata, whereas the loop-diuretic non-user stratum showed the same direction but was not statistically significant.
Voriconazole initiation was temporally associated with subsequent hypomagnesemia in pediatric patients with hematologic diseases. PSSA may complement spontaneous reporting systems for detecting laboratory-defined safety signals. Weekly serum magnesium monitoring should be considered during the first 30 days of voriconazole therapy. These findings support a temporal association but do not establish causality.
Published in Frontiers in pharmacology. The abstract is shown as published and remains the work of its authors; read the full article at the source.
Prognia lists this article for reference and education. It is not medical advice. Always read the original and follow current guidelines and local protocols before acting on it.
