Setmelanotide for the treatment of acquired hypothalamic obesity (Registro nro. 22731)
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| 000 -Cabecera | |
|---|---|
| Campo de control interno | 03518nam a2200313 4500 |
| 001 - Número de control | |
| control field | ESSALUD |
| 005 - Fecha y hora de la última transacción | |
| Campo de control | 20260804150103.0 |
| 007 - Tipo material - Descripcion fisica - info general | |
| Tipo material - Descripcion fisica - info general | ta |
| 008 - Elementos de Longitud Fija - Información General | |
| Elementos de Longitud Fija - Información | t pe ||||| |||| 00| 0 spa d |
| 040 ## - Origen de la Catalogación | |
| Origen de la Catalogación | BMG |
| 041 ## - Idioma | |
| Idioma | eng |
| 100 ## - Autor | |
| Autor | Miller, Jennifer L. |
| Rol del Autor | Autor |
| 9 (RLIN) | 53703 |
| 245 ## - Titulo | |
| Titulo | Setmelanotide for the treatment of acquired hypothalamic obesity |
| 300 ## - Páginas | |
| Paginación | páginas: 138-150 |
| 520 ## - Resumen | |
| Resumen | Background: A phase 2 trial of setmelanotide, a melanocortin-4 receptor agonist, showed substantial weight loss in patients with acquired hypothalamic obesity, but additional data are needed.<br/>Methods: We conducted a phase 3 trial in which participants were randomly assigned in a 2:1 ratio to receive setmelanotide (at a dose of 1.5 to 3.0 mg) or placebo administered subcutaneously once daily for 52 weeks after a dose-escalation period. Persons at least 4 years of age were potentially eligible for the trial if they had acquired hypothalamic obesity, which was defined by a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) that was at or above the 95th percentile for age and sex (for participants <18 years of age) or at least 30 (for participants ≥18 years of age) and a history of a hypothalamic tumor, lesion, or injury. The primary end point was the mean percent change in BMI from baseline to 52 weeks after the end of the dose-escalation period. Secondary end points included the mean change in the weekly average of the maximal daily hunger score (range, 0 to 10, with higher scores indicating more severe hunger), assessed in participants at least 12 years of age. Results: From April 26, 2023, to March 18, 2025, a total of 120 participants were assigned to receive setmelanotide (81 participants) or placebo (39 participants). The mean (±SD) age was 19.9±13.8 years (range, 4 to 66). Among participants 18 years of age or older, the mean BMI was 41.2±9.7; the mean BMI z score among those younger than 18 years of age was 3.61±1.66. The least-squares mean (LSM) change in BMI at 52 weeks was −16.5% (95% confidence interval [CI], −19.3 to −13.8) with setmelanotide and 3.3% (95% CI, −0.6 to 7.2) with placebo (P<0.001), and the LSM change in the weekly average of maximal daily hunger scores was −2.73 (95% CI, −3.28 to −2.18) in the setmelanotide group and −1.45 (95% CI, −2.23 to −0.67) in the placebo group (P=0.009). Adverse events were reported in 100% of the participants in the setmelanotide group and in 90% of those in the placebo group, and serious adverse events were reported in 28% and 8%, respectively. The most common adverse events with setmelanotide were skin hyperpigmentation, nausea, vomiting, and headache.<br/>Conclusions: Setmelanotide led to significantly greater reductions in BMI and hunger than placebo at 52 weeks among participants 4 to 66 years of age with acquired hypothalamic obesity.<br/> |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | MEDICINA CLÍNICA |
| 9 (RLIN) | 33681 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | OBESIDAD |
| 9 (RLIN) | 1238 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ENDOCRINOLOGÍA |
| 9 (RLIN) | 36891 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | PEDIATRIA |
| 9 (RLIN) | 6401 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ENFERMEDAD HIPOTALÁMICO-HIPOFISARIA |
| 9 (RLIN) | 53704 |
| 700 ## - Autor Personal | |
| Autor Personal | Van Santen, Hanneke M. |
| 9 (RLIN) | 53705 |
| 700 ## - Autor Personal | |
| Autor Personal | Phillips, Susan A. |
| 9 (RLIN) | 53706 |
| 700 ## - Autor Personal | |
| Autor Personal | Hamilton, Jill |
| 9 (RLIN) | 53707 |
| 700 ## - Autor Personal | |
| Autor Personal | Aberle, Jens |
| 9 (RLIN) | 53708 |
| 700 ## - Autor Personal | |
| Autor Personal | Sathyapalan, Thozhukat |
| 9 (RLIN) | 53709 |
| 700 ## - Autor Personal | |
| Autor Personal | Mohamed, Zainaba |
| 9 (RLIN) | 53710 |
| 773 0# - Revista (Relacion con el numero) | |
| Host Biblionumber | 22717 |
| Host Itemnumber | 22635 |
| Ciudad, Editorial | Massachusetts NEJM Group |
| Codigo barras item/ejemplar | NEJM002 |
| Titulo de la Revista | The New England Journal of Medicine |
| Número de control de registro | ESSALUD |
| ISSN | 0028-4793 |
| 942 ## - Elementos de Koha | |
| Tipo de Documento | Artículos |
| Fecha procesamiento | 2026-07-30 |
| Catalogador | sqb |
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