Clinical Pharmacology of Oral Octreotide Capsules for the Treatment of Acromegaly.

TouchREVIEWS in endocrinology Pub Date : 2024-04-01 Epub Date: 2024-01-22 DOI:10.17925/EE.2024.20.1.9
Meliha Melin Uygur, Marta Villanova, Stefano Frara, Andrea Giustina
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Abstract

The primary goal of acromegaly treatment is to normalize biochemical parameters as it significantly reduces the risks of complications and comorbidities associated with the disease. First-line medical treatment is commonly represented by injectable somatostatin analogues (SRLs) after surgery. In June 2020, with the integration of Transient Permeation Enhancer® technology, oral octreotide capsules (OOCs) received regulatory approval from the US Food and Drug Administration for long-term maintenance treatment in patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide. We reviewed the clinical pharmacological data on the development and clinical use of OOCs. The pharmacokinetic and pharmacodynamic data on OOCs showed a dose-dependent increase in octreotide levels and remarkable suppression of growth hormone secretion. The efficacy and safety of OOCs were investigated in four clinical trials conducted on patients with complete or partially controlled acromegaly. The trials resulted in the maintenance of biochemical control after switching from injectable SRLs to OOCs, with a comparable side-effect profile. Moreover, the acromegaly symptoms improved in patients on OOC. The data showed a patient preference to continue in the OOC arm for the extension phase of the trials. From the clinical pharmacological perspective, oral formulation of octreotide has the advantage of efficacy and safety with respect to injectable octreotide.

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口服奥曲肽胶囊治疗肢端肥大症的临床药理学。
肢端肥大症治疗的首要目标是使生化指标恢复正常,因为这可以大大降低与该疾病相关的并发症和合并症的风险。一线药物治疗通常以手术后注射用体生长抑素类似物(SRL)为代表。2020 年 6 月,口服奥曲肽胶囊(OOCs)整合了瞬时渗透增强剂® 技术,获得了美国食品药品管理局的监管批准,用于对奥曲肽或兰瑞肽治疗有反应且耐受的肢端肥大症患者的长期维持治疗。我们回顾了有关 OOCs 开发和临床应用的临床药理数据。OOCs 的药代动力学和药效学数据显示,奥曲肽水平的升高呈剂量依赖性,生长激素分泌受到显著抑制。在对完全或部分受控的肢端肥大症患者进行的四项临床试验中,对 OOCs 的疗效和安全性进行了研究。试验结果表明,从注射用 SRLs 转为 OOCs 后,生化控制得以维持,且副作用不相上下。此外,使用 OOC 的患者的肢端肥大症症状也有所改善。数据显示,在试验的延长阶段,患者更倾向于继续服用口服OCT。从临床药理角度来看,口服奥曲肽制剂在疗效和安全性方面均优于注射奥曲肽。
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