Blandine Gatta-Cherifi, Kamel Mohammedi, Tanguy Cariou, Christine Poitou, Philippe Touraine, Gerald Raverot, Thierry Brue, Philippe Chanson, Frédéric Illouz, Solange Grunenwald, Olivier Chabre, Emmanuel Sonnet, Thomas Cuny, Jerôme Bertherat, Sébastien Czernichow, Eric Frison, Antoine Tabarin
{"title":"艾塞那肽对颅咽管瘤相关肥胖症成人患者体重减轻和饮食行为的影响:CRANIOEXE 随机安慰剂对照试验。","authors":"Blandine Gatta-Cherifi, Kamel Mohammedi, Tanguy Cariou, Christine Poitou, Philippe Touraine, Gerald Raverot, Thierry Brue, Philippe Chanson, Frédéric Illouz, Solange Grunenwald, Olivier Chabre, Emmanuel Sonnet, Thomas Cuny, Jerôme Bertherat, Sébastien Czernichow, Eric Frison, Antoine Tabarin","doi":"10.1093/ejendo/lvae024","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>A major issue in the management of craniopharyngioma-related obesity (CRO) is the ineffectiveness of the current therapeutic approaches.</p><p><strong>Objective: </strong>To study the efficacy of glucagon-like peptide-1 analogs compared with placebo in adults with obesity CRO.</p><p><strong>Design: </strong>A double-blind multicenter superiority randomized clinical in trial in two parallel arms.</p><p><strong>Setting: </strong>Eleven French University Hospital Centers.</p><p><strong>Participants: </strong>Adults with CRO (body mass index > 30 kg/m²) without the sign of recurrence of craniopharyngioma in the past year.</p><p><strong>Interventions: </strong>Exenatide or placebo injected subcutaneously twice a day during 26 weeks.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the mean change in body weight at week 26 in the intention-to-treat population. Secondary outcomes were eating behavior, calories intake, energy expenditure, cardiovascular, metabolic risk factor, quality of life, and the tolerance profile.</p><p><strong>Results: </strong>At week 26, weight decreased from baseline by a mean of -3.8 (SD 4.3) kg for exenatide and -1.6 (3.8) kg for placebo. The adjusted mean treatment difference was -3.1 kg (95% confidence interval [CI] -7.0 to 0.7, P = 0.11). Results were compatible with a higher reduction of hunger score with exenatide compared with placebo (estimated treatment difference in change from baseline to week 26: -2.3, 95% CI -4.5 to -0.2), while all other outcomes did not significantly differ between groups. Adverse events were more common with exenatide versus placebo, and occurred in, respectively, 19 (95%) participants (108 events) and 14 (70%) participants (54 events).</p><p><strong>Conclusions and relevance: </strong>Combined with intensive lifestyle interventions, a 26-week treatment with exenatide was not demonstrated superior to placebo to treat craniopharyngioma-related obesity.</p>","PeriodicalId":11884,"journal":{"name":"European Journal of Endocrinology","volume":null,"pages":null},"PeriodicalIF":5.3000,"publicationDate":"2024-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial.\",\"authors\":\"Blandine Gatta-Cherifi, Kamel Mohammedi, Tanguy Cariou, Christine Poitou, Philippe Touraine, Gerald Raverot, Thierry Brue, Philippe Chanson, Frédéric Illouz, Solange Grunenwald, Olivier Chabre, Emmanuel Sonnet, Thomas Cuny, Jerôme Bertherat, Sébastien Czernichow, Eric Frison, Antoine Tabarin\",\"doi\":\"10.1093/ejendo/lvae024\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>A major issue in the management of craniopharyngioma-related obesity (CRO) is the ineffectiveness of the current therapeutic approaches.</p><p><strong>Objective: </strong>To study the efficacy of glucagon-like peptide-1 analogs compared with placebo in adults with obesity CRO.</p><p><strong>Design: </strong>A double-blind multicenter superiority randomized clinical in trial in two parallel arms.</p><p><strong>Setting: </strong>Eleven French University Hospital Centers.</p><p><strong>Participants: </strong>Adults with CRO (body mass index > 30 kg/m²) without the sign of recurrence of craniopharyngioma in the past year.</p><p><strong>Interventions: </strong>Exenatide or placebo injected subcutaneously twice a day during 26 weeks.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the mean change in body weight at week 26 in the intention-to-treat population. Secondary outcomes were eating behavior, calories intake, energy expenditure, cardiovascular, metabolic risk factor, quality of life, and the tolerance profile.</p><p><strong>Results: </strong>At week 26, weight decreased from baseline by a mean of -3.8 (SD 4.3) kg for exenatide and -1.6 (3.8) kg for placebo. The adjusted mean treatment difference was -3.1 kg (95% confidence interval [CI] -7.0 to 0.7, P = 0.11). Results were compatible with a higher reduction of hunger score with exenatide compared with placebo (estimated treatment difference in change from baseline to week 26: -2.3, 95% CI -4.5 to -0.2), while all other outcomes did not significantly differ between groups. 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引用次数: 0
摘要
研究目的我们的目的是研究GLP-1类似物与安慰剂相比对颅咽管瘤相关肥胖症(CRO)成人患者的疗效:设计:我们在法国11所大学医院中心开展了一项双盲多中心优效随机临床试验:经过 4 周的磨合期后,40 名在过去一年中没有复发迹象的 CRO(体重指数大于 30 kg/m²)成人患者被随机分配接受艾塞那肽(20 人)或安慰剂(20 人)皮下注射,每天两次。意向治疗人群的主要结果是第26周时体重的平均变化。次要结果包括饮食行为、卡路里摄入量、能量消耗、心血管、代谢风险因素、生活质量和耐受情况:第26周时,艾塞那肽治疗组的体重与基线相比平均下降了-3.8(标准差4.3)公斤,安慰剂治疗组的体重与基线相比平均下降了-1.6(3.8)公斤。调整后的平均治疗差异为-3.1千克(95% CI -7.0至0.7,P = 0.11)。结果显示,与安慰剂相比,艾塞那肽能更大程度地降低饥饿感评分(从基线到第26周的变化估计治疗差异为-2.3(95% CI -4.5至-0.2)),而所有其他结果在组间无显著差异。与安慰剂相比,艾塞那肽的不良反应更常见,分别有19名(95%)参与者(108起)和14名(70%)参与者(54起)发生:结论:结合强化生活方式干预措施,在治疗颅咽管瘤相关肥胖症方面,为期26周的艾塞那肽治疗未被证明优于安慰剂。
Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial.
Importance: A major issue in the management of craniopharyngioma-related obesity (CRO) is the ineffectiveness of the current therapeutic approaches.
Objective: To study the efficacy of glucagon-like peptide-1 analogs compared with placebo in adults with obesity CRO.
Design: A double-blind multicenter superiority randomized clinical in trial in two parallel arms.
Setting: Eleven French University Hospital Centers.
Participants: Adults with CRO (body mass index > 30 kg/m²) without the sign of recurrence of craniopharyngioma in the past year.
Interventions: Exenatide or placebo injected subcutaneously twice a day during 26 weeks.
Main outcomes and measures: The primary outcome was the mean change in body weight at week 26 in the intention-to-treat population. Secondary outcomes were eating behavior, calories intake, energy expenditure, cardiovascular, metabolic risk factor, quality of life, and the tolerance profile.
Results: At week 26, weight decreased from baseline by a mean of -3.8 (SD 4.3) kg for exenatide and -1.6 (3.8) kg for placebo. The adjusted mean treatment difference was -3.1 kg (95% confidence interval [CI] -7.0 to 0.7, P = 0.11). Results were compatible with a higher reduction of hunger score with exenatide compared with placebo (estimated treatment difference in change from baseline to week 26: -2.3, 95% CI -4.5 to -0.2), while all other outcomes did not significantly differ between groups. Adverse events were more common with exenatide versus placebo, and occurred in, respectively, 19 (95%) participants (108 events) and 14 (70%) participants (54 events).
Conclusions and relevance: Combined with intensive lifestyle interventions, a 26-week treatment with exenatide was not demonstrated superior to placebo to treat craniopharyngioma-related obesity.
期刊介绍:
European Journal of Endocrinology is the official journal of the European Society of Endocrinology. Its predecessor journal is Acta Endocrinologica.
The journal publishes high-quality original clinical and translational research papers and reviews in paediatric and adult endocrinology, as well as clinical practice guidelines, position statements and debates. Case reports will only be considered if they represent exceptional insights or advances in clinical endocrinology.
Topics covered include, but are not limited to, Adrenal and Steroid, Bone and Mineral Metabolism, Hormones and Cancer, Pituitary and Hypothalamus, Thyroid and Reproduction. In the field of Diabetes, Obesity and Metabolism we welcome manuscripts addressing endocrine mechanisms of disease and its complications, management of obesity/diabetes in the context of other endocrine conditions, or aspects of complex disease management. Reports may encompass natural history studies, mechanistic studies, or clinical trials.
Equal consideration is given to all manuscripts in English from any country.