MD, University of Illinois at Chicago Department of Medicine Section of Endocrinology, Diabetes, and Metabolism, 1747 West Roosevelt Road, Room 517, Chicago, Illinois 60608.
J Clin Endocrinol Metab. 2013 Oct;98(10):4047-54. doi: 10.1210/jc.2013-2262. Epub 2013 Aug 22.
Acromegaly is caused by excessive GH secretion and IGF-I overproduction. The goals of treatment are to reduce GH and IGF-I values to normal and relieve the associated symptoms.
The purpose of this article was to demonstrate that an octreotide implant (84 mg) is safe and efficacious in patients with acromegaly who were responsive to prior monthly octreotide long-acting release (LAR) injections.
This was a phase 3, open-label study. Before treatment, subjects received a stable monthly dose of octreotide LAR injections (10-40 mg) for ≥ 3 months. Randomization was in a 3:1 ratio to either a 6-month octreotide implant or monthly octreotide LAR injections.
This was a multicenter, international study conducted in private or institutional practices.
Enrollment included 163 subjects (aged ≥ 18 years) with acromegaly.
The efficacy, safety, and tolerability of the octreotide implant during 24 weeks of treatment was evaluated.
After 24 weeks, the success rate of the implant for maintenance of IGF-I and GH levels was 86% (95% confidence interval, 80.3%) compared with a rate of 84% (95% confidence interval, 73.8%) for octreotide LAR. Serum octreotide concentrations after implant insertion increased within 8 days and peaked between days 14 and 28. The overall safety of the octreotide implant and octreotide LAR were similar. Diarrhea and headache were more frequent with the implant, whereas cholecystitis and hypertension were more frequent with octreotide LAR.
In this pivotal phase 3 study, the octreotide implant maintained reduced blood levels of GH and IGF-I with continuous octreotide release over 6 months, which was well tolerated.
肢端肥大症是由 GH 分泌过多和 IGF-I 过度产生引起的。治疗的目的是降低 GH 和 IGF-I 值至正常水平并缓解相关症状。
本文旨在证明在对先前每月给予的奥曲肽长效释放（LAR）注射有反应的肢端肥大症患者中，使用奥曲肽植入物（84mg）是安全有效的。
这是一项 3 期、开放标签研究。在治疗前，受试者接受了稳定的每月剂量奥曲肽 LAR 注射（10-40mg），持续至少 3 个月。随机分为 3:1 的比例，分别接受 6 个月的奥曲肽植入物或每月的奥曲肽 LAR 注射。
这是一项在私人或机构实践中进行的多中心、国际研究。
纳入了 163 名（年龄≥18 岁）肢端肥大症患者。
评估奥曲肽植入物在 24 周治疗期间的疗效、安全性和耐受性。
24 周后，植入物维持 IGF-I 和 GH 水平的成功率为 86%（95%置信区间，80.3%），而奥曲肽 LAR 的成功率为 84%（95%置信区间，73.8%）。植入后 8 天内血清奥曲肽浓度增加，第 14 天至第 28 天达到峰值。奥曲肽植入物和奥曲肽 LAR 的总体安全性相似。植入物更常见腹泻和头痛，而奥曲肽 LAR 更常见胆囊炎和高血压。
在这项关键的 3 期研究中，奥曲肽植入物通过持续释放奥曲肽在 6 个月内维持了 GH 和 IGF-I 的降低血药水平，具有良好的耐受性。
