Rate of Serious Adverse Events Associated with Diazoxide Treatment of Patients with Hyperinsulinism
| Autor: | Jonathan Nedrelow, Paul S. Thornton, Lisa Truong, Courtney Reynolds, Tyler Hamby |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Neutropenia Hypertension Pulmonary Endocrinology Diabetes and Metabolism First line Population 030209 endocrinology & metabolism 03 medical and health sciences 0302 clinical medicine Endocrinology Risk Factors Hyperinsulinism medicine Diazoxide Humans Adverse effect education Retrospective Studies education.field_of_study 030219 obstetrics & reproductive medicine business.industry Infant Newborn Infant Drug agency medicine.disease Pulmonary hypertension Pediatrics Perinatology and Child Health Female business medicine.drug |
| Zdroj: | Hormone Research in Paediatrics. 91:25-32 |
| ISSN: | 1663-2826 1663-2818 |
| DOI: | 10.1159/000497458 |
| Popis: | Introduction: Diazoxide is the first line and only Federal Drug Agency approved pharmacological agent for the treatment of hyperinsulinism. Its use has increased over the years to include patients with various genetic forms of hyperinsulinism, perinatal stress hyperinsulinism and infants of diabetic mothers with more babies than ever being exposed to this therapy. Methods: We performed a retrospective analysis of 194 patients with hyperinsulinism in our clinic and looked for those who had experienced serious adverse events (SAE) including pulmonary hypertension and neutropenia. We compared the rates of SAE in the different types of hyperinsulinism. Results: Out of 194 patients with hyperinsulinism, 165 (85.1%) were treated with diazoxide. There were 17 SAEs in 16 patients including 8 cases of pulmonary hypertension and 8 of neutropenia. These data show that overall the frequency of SAE associated with diazoxide use is 9.7%, but that those with perinatal stress hyperinsulinism have a much higher rate than those with genetic forms of hyperinsulinism (16.7 vs. 3.6%; p = 0.01). We also found diazoxide is associated with pulmonary hypertension (4.8% of patients treated). Although more patients with perinatal stress hyperinsulinism (7.6%) were affected than genetic hyperinsulinism (1.2%), the difference was not significant (p = 0.088). Conclusion: The rate of SAEs associated with (not necessarily caused by) diazoxide has been demonstrated. The rate of SAE in newborns with perinatal stress hyperinsulinism is significantly higher than that of otherwise healthy babies with genetic forms of hyperinsulinism, suggesting that caution should be used when prescribing diazoxide to this population. This information should help balance the risk benefit of treatment and provide guidance on screening for these complications in the population of treated patients. |
| Databáze: | OpenAIRE |
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