Low‐dose diazoxide is safe and effective in infants with transient hyperinsulinism
Authors' conclusion
Diazoxide doses <5 mg/kg/day are effective in THI. While the nature of the association between diazoxide and NEC was unclear, other adverse events were mild. We suggest considering starting doses as low as 2-3 mg/kg/day in THI to balance the side effect risk while maintaining euglycaemia.
Study context
- Population
- Infants with transient hyperinsulinism (duration <6 months) treated with low-dose diazoxide, October 2015 to February 2021; 77% male, 33% preterm, 52% SGA
- Participants
- 73 infants
- Exposure
- Cohort 1 vs Cohort 2 vs >3500 g
- Cohort 1n = 15
- Outcome
- Effective diazoxide dose
Methodological detailsweight-based dosing cohorts
- Weight-based dosing cohorts
Main finding
As reported in the abstract
Mean effective diazoxide dose (range 1.5-10)
3 mg/kg/day
Required an increase from starting dose
35%
26/73
Required dose increase, cohort 1
60%
9/15
Observational data: associations, not effects.
Further findings
- Median age at diazoxide start (range 3-43)
- 11 days
- Median treatment duration (0.3-6.8)
- 4 months
- No difference between cohorts
Safety
- Adverse events
- 13 patients (18%)
- Oedema
- 12%
- Hyponatraemia
- 5%
- Suspected necrotising enterocolitis
- 2 infants
- Pulmonary hypertension
- 0
Original publication
Low‐dose diazoxide is safe and effective in infants with transient hyperinsulinism. Clin Endocrinol (Oxf). Published 7 December 2023. doi:10.
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