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To evaluate the safety and effectiveness of the long-term administration of diazoxide in patients with hyperinsulinemic hypoglycemia, a post-marketing surveillance study was conducted. Between 2008 and 2015, with a maximum observation period of 7 yr, 384 patients were monitored; 117 (30.5%) experienced at least one adverse drug reaction (ADR). The most commonly observed ADR was hypertrichosis (8.6%). The incidence of water retention-related ADRs and cardiac failure-related ADRs was 8.3% and 3.4%, respectively, and many of these occurred within the first 2 mo of treatment. The mean fasting blood glucose level was 44.9 mg/dL at baseline and was maintained at &gt; 70 mg/dL, the control target, for 4 yr. A total of 113 infants &lt; 1 yr of age were evaluated for the prognosis for intelligence, and a majority (77.9%) were assessed as "normal" at the final evaluation. Most ADRs occurred at an early stage of treatment and blood glucose levels were well controlled during long-term administration. The proportion of "normal" patients tended to be higher in those who started treatment at a younger age. However, because of the exploratory nature of this analysis, potential effects of coexisting or underlying diseases and the age of onset or diagnosis should not be ignored.

clinical pediatric endocrinology

Safety and effectiveness, including intelligence prognosis, of diazoxide in pediatric patients with hyperinsulinemic hypoglycemia: special survey in Japan (long-term, all-case survey)