Efficacy and safety of pasireotide treatment in acromegaly: A systematic review and single arm meta-analysis.

IF 3.3 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Pituitary Pub Date : 2024-10-01 DOI:10.1007/s11102-024-01461-5

Turkan Aliyeva, Juliana Muniz, Gustavo Meira Soares, Sarah Firdausa, Lubna Mirza

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引用次数: 0

Abstract

Background: Acromegaly is a rare chronic endocrine disorder associated with significant comorbidities. Many patients fail to achieve biochemical control with current medical therapies, including surgery and first-generation somatostatin ligands (fg-SRLs). We aimed to perform a systematic review and single-arm meta-analysis to evaluate the efficacy of the multi-receptor somatostatin ligand pasireotide in patients with active or uncontrolled acromegaly.

Methods: We systematically searched PubMed, Embase, and Cochrane databases for studies that assessed the efficacy of pasireotide in patients with acromegaly and reported the outcomes of (1) biochemical control and its composite indicators; (2) normalized IGF-1 level and (3) low GH level. For the statistical analysis, we used R software.

Results: We included nine studies with a total of 590 patients: four clinical trials and five observational cohorts. 82.2% of the overall population consisted of inadequately controlled acromegaly patients. After a follow-up of 12 months, the pooled biochemical control rate was 26.50% (95% CI 14.87-42.66). The prevalence of normalized IGF-1 and low GH levels was 36.27% (95% CI 29.15-43.39) and 34.76% (95% CI 24.58-44.95), respectively. Additionally, biochemical response rates were sustained throughout the extension phase of these studies. In a pooled analysis including four studies with extension phase results, the prevalence of biochemical control rate was 29.03% (95% CI 11.49-46.58) with 76 events out of 281 patients. The most commonly reported adverse events were gastrointestinal disturbances in 31.26% (95% CI 7.44-72.01) and hyperglycemia in 29.55% (95% CI 21.80-37.29) of patients. The incidence of new-onset diabetes mellitus significantly increased after pasireotide treatment, with a rate of 23.36% (95% CI 19.58-27.13).

Conclusion: Pasireotide demonstrates biochemical control in patients with active or uncontrolled acromegaly. Although a high rate of hyperglycemic adverse events and diabetes mellitus related to the treatment were observed, most of them were manageable.

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帕西瑞肽治疗肢端肥大症的疗效和安全性：系统综述和单臂荟萃分析。

背景：肢端肥大症是一种罕见的慢性内分泌疾病，伴有严重的并发症。许多患者无法通过目前的药物疗法（包括手术和第一代体生长激素配体（fg-SRLs））达到生化控制。我们旨在进行一项系统性综述和单臂荟萃分析，以评估多受体体生长抑素配体帕西洛肽对活动性或未受控制的肢端肥大症患者的疗效：我们在PubMed、Embase和Cochrane数据库中系统检索了评估帕司瑞奥肽对肢端肥大症患者疗效的研究，并报告了以下结果：(1)生化控制及其综合指标；(2)正常化IGF-1水平；(3)低GH水平。统计分析使用了 R 软件：我们纳入了九项研究，共有 590 名患者：四项临床试验和五项观察性队列。82.2%的研究对象为未得到充分控制的肢端肥大症患者。随访 12 个月后，汇总的生化控制率为 26.50%（95% CI 14.87-42.66）。IGF-1和低GH水平恢复正常的比例分别为36.27%（95% CI 29.15-43.39）和34.76%（95% CI 24.58-44.95）。此外，生化应答率在这些研究的延长阶段一直保持不变。在一项包括四项延长期研究结果的汇总分析中，生化控制率为 29.03%（95% CI 11.49-46.58），281 名患者中发生了 76 起事件。最常报告的不良反应是胃肠功能紊乱，占 31.26%（95% CI 7.44-72.01），高血糖占 29.55%（95% CI 21.80-37.29）。帕司瑞奥肽治疗后，新发糖尿病的发生率显著增加，为23.36%（95% CI 19.58-27.13）：结论：帕司瑞肽可控制活动性或未受控肢端肥大症患者的生化指标。结论：帕司瑞肽可控制活动性或未控制的肢端肥大症患者的生化指标，虽然与治疗相关的高血糖不良反应和糖尿病的发生率较高，但大多数都是可控的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pituitary 医学-内分泌学与代谢

CiteScore

7.10

自引率

7.90%

发文量

审稿时长

6 months

期刊介绍： Pituitary is an international publication devoted to basic and clinical aspects of the pituitary gland. It is designed to publish original, high quality research in both basic and pituitary function as well as clinical pituitary disease. The journal considers: Biology of Pituitary Tumors Mechanisms of Pituitary Hormone Secretion Regulation of Pituitary Function Prospective Clinical Studies of Pituitary Disease Critical Basic and Clinical Reviews Pituitary is directed at basic investigators, physiologists, clinical adult and pediatric endocrinologists, neurosurgeons and reproductive endocrinologists interested in the broad field of the pituitary and its disorders. The Editorial Board has been drawn from international experts in basic and clinical endocrinology. The journal offers a rapid turnaround time for review of manuscripts, and the high standard of the journal is maintained by a selective peer-review process which aims to publish only the highest quality manuscripts. Pituitary will foster the publication of creative scholarship as it pertains to the pituitary and will provide a forum for basic scientists and clinicians to publish their high quality pituitary-related work.