{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T02:07:01Z","timestamp":1778810821818,"version":"3.51.4"},"reference-count":30,"publisher":"The Endocrine Society","issue":"7","license":[{"start":{"date-parts":[[2025,5,9]],"date-time":"2025-05-09T00:00:00Z","timestamp":1746748800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001665","name":"French National Agency for Research ANR","doi-asserted-by":"publisher","award":["22-CE17-0025"],"award-info":[{"award-number":["22-CE17-0025"]}],"id":[{"id":"10.13039\/501100001665","id-type":"DOI","asserted-by":"publisher"}]},{"name":"GBE Association"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Neonatal diabetes mellitus (NDM) is a rare condition usually related to an identifiable genetic cause. Sulfonylurea therapy can ensure metabolic control, obviating the need for insulin while also improving neurodevelopmental outcomes. An oral glyburide suspension (OGS; AMGLIDIA) designed for pediatric use was introduced recently to eliminate the drawbacks of using crushed tablets.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the long-term effectiveness and safety of the OGS for NDM.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>Retrospective cohort study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Setting<\/jats:title>\n                  <jats:p>Fifteen centers in France.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients<\/jats:title>\n                  <jats:p>Consecutive patients started on OGS for NDM in 2015 through 2024.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Intervention<\/jats:title>\n                  <jats:p>OGS therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Main outcome measures<\/jats:title>\n                  <jats:p>Glycated hemoglobin (HbA1c) values during OGS therapy; growth; and serious adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 27 patients, 22 had KCNJ11 mutations, 4 had ABCC8 mutations, and 1 had a 6q24 anomaly. Median follow-up during OGS therapy was 2.7 years (range, 2 months\u20139 years). At baseline, median HbA1c was 6.5% (5.8\u20137.9) overall and 6.5%, 6.4%, and 8.9% in the KCNJ11, ABCC8, and 6q24 subgroups, respectively. The median starting glyburide dose was 0.15\u2005mg\/kg\/day (range, 0.1-0.185). HbA1c decreased nonsignificantly over time in all subgroups (P = .382), prompting in a small OGS dosage decrease. The last recorded HbA1c value was 6.3%, 5.9%, and 7.4% in the KCNJ11, ABCC8, and 6q24 subgroups, respectively. Serious adverse events were rare, with hypoglycemia in 2 patients during periods of decreased food intake and diarrhea in 1 patient.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The OGS was effective in maintaining excellent metabolic control in the long term. The safety profile was good. The OGS should be considered for the first-line treatment of NDM.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/jendso\/bvaf083","type":"journal-article","created":{"date-parts":[[2025,5,9]],"date-time":"2025-05-09T05:44:38Z","timestamp":1746769478000},"source":"Crossref","is-referenced-by-count":2,"title":["Safety and Effectiveness of Oral Glyburide Suspension in Neonatal Diabetes Mellitus: French Retrospective Cohort Study"],"prefix":"10.1210","volume":"9","author":[{"given":"Ines","family":"Ben Rhaiem","sequence":"first","affiliation":[{"name":"Pediatric Endocrinology, Gynecology, and Diabetology Department, Necker-Enfants Malades University Hospital, Assistance Publique-H\u00f4pitaux de Paris, ENDO-ERN (European Reference Network) and PRISIS French National Rare Disorder Centre (Rare Disorders of Insulin Secretion and Sensitivity) , 75015 Paris 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