Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial.
Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial.
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DOI：
10.1111/j.1365-2265.2006.02595.x
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发表时间：
2006-09
影响因子：
3.2
通讯作者：
Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly
中科院分区：
文献类型：
--
作者：
Lucas T;Astorga R;Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly
贮库型生长抑素类似物作为肢端肥大症的辅助或主要治疗被广泛接受，其长的给药间隔有利于坚持治疗。我们的目的是评估lanreotide Autogel® 120 mg，每4-8周，是否与lanreotide微粒30 mg，每1-2周在控制肢端肥大症方面一样有效。研究前使用兰瑞肽微粒30 mg ≥ 2个月且对治疗有反应的患者被招募到这项开放、前瞻性、多中心III期试验中。注射3 - 5次lanreotide Autogel® 120 mg。在先前每7、10或14天接受兰瑞肽微粒的患者中，分别每4、6或8周注射兰瑞肽Autogel® 120 mg。在末次注射后的一个给药间隔评估GH和胰岛素样生长因子（IGF）-1水平。98例患者入组，93例完成研究。稳态GH浓度显示两种制剂之间的疗效相似（商的95%置信区间上限为77.7%）。兰瑞肽Autogel®组的平均（SE）GH水平低于兰瑞肽微粒组（3.8（0.5）vs 4.3（0.5）ng/ml; P <0.001）。在54%和46%的患者中观察到GH水平<2.5 ng/ml; 40%和35%的患者分别具有GH <2.5 ng/ml和使用兰瑞肽Autogel®和微粒的标准化IGF-1。使用兰瑞肽Autogel®后症状控制更好，治疗被广泛接受。Lanreotide Autogel® 120 mg每4-8周注射一次，在肢端肥大症中至少与Lanreotide微粒30 mg每7-14天注射一次一样有效且耐受性良好。
Depot somatostatin analogues are well accepted as either adjuvant or primary therapy for acromegaly, and their long dosage intervals facilitate adherence to treatment. Our objective was to evaluate whether lanreotide Autogel® 120 mg, every 4–8 weeks, was as effective in controlling acromegaly as lanreotide microparticles 30 mg, every 1–2 weeks. Patients who had used lanreotide microparticles 30 mg, ≥ 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial. Three to five injections of lanreotide Autogel® 120 mg were administered. Lanreotide Autogel® 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively. GH and insulin-like growth factor (IGF)-1 levels were assessed one dosing interval after the final injections. Ninety-eight patients were enrolled and 93 completed. Steady-state GH concentrations demonstrated similar efficacy between the formulations (upper 95% confidence interval of the quotient, 77·7%). Mean (SE) GH levels were lower with lanreotide Autogel® than with lanreotide microparticles (3·8 (0·5) vs 4·3 (0·5) ng/ml; P < 0·001). GH levels < 2·5 ng/ml were observed in 54% and 46% of patients; 40% and 35% having GH < 2·5 ng/ml and normalized IGF-1 with lanreotide Autogel® and microparticles, respectively. Symptoms were controlled better with lanreotide Autogel® and treatment was well accepted. Lanreotide Autogel® 120 mg every 4–8 weeks, is at least as effective and as well tolerated in acromegaly as lanreotide microparticles 30 mg injected every 7–14 days.
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