Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension.
Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension.
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DOI：
10.1007/s11102-009-0191-1
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发表时间：
2010
期刊：
影响因子：
3.8
通讯作者：
Marek, Josef
中科院分区：
文献类型：
--
作者：
Melmed, Shlomo;Cook, David;Schopohl, Jochen;Goth, Miklos I.;Lam, Karen S. L.;Marek, Josef
这项研究旨在评估生长抑素类似物兰瑞肽28天缓释自凝胶制剂(LAN-AUTOGELE)在未选定的肢端肥大症患者中的长期疗效和安全性。这项研究包括四个阶段：洗涤；与安慰剂进行双盲比较，使用单一随机剂量(60、90或120毫克)的兰-AutoGel；单盲、固定剂量阶段，用于四次注射(安慰剂组被重新分配为积极治疗)；以及八次注射，剂量根据生化反应量身定制。分别在第4、13、14、15、16、32和52周测定血清生长激素(GH)和胰岛素样生长因子-1(IGF-1)水平。108名患者入选，99名患者完成52周的治疗。在第一次注射四周后，接受兰-自动凝胶治疗的患者中有63%的患者的血清生长激素水平比基线下降了50%，而接受安慰剂的患者中这一比例为0%(P<0.001)。在四次注射后，72%的患者GH水平下降了50%；49%的患者GH水平达到≤2.5%ng/ml；54%的患者≤-1正常化；38%的患者达到GH水平和IGF1水平2.5ng/ml和正常化IGF1的综合标准。到52周时，相应的比例分别为82、54、59和43%。在不需要将剂量增加到120 mg的患者中，85%的患者实现了生化控制(综合标准)。所有患者对治疗的耐受性良好。结论：Lan-AutoGel能有效控制肢端肥大症患者GH和IGF-1的高分泌，且起效快。
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response. Serum samples were assessed for growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, at weeks 4, 13, 14, 15, 16, 32 and 52. 108 patients were enrolled and 99 completed 52 weeks’ treatment. Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001). After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels ≤ 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level ≤ 2.5 ng/ml and normalized IGF-1. The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion). Treatment was well tolerated by all patients. In conclusion, Lan-Autogel was effective in controlling GH and IGF-1 hypersecretion in patients with acromegaly and showed a rapid onset of action.
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影响因子：
5.8
作者：
Jaquet, P;Saveanu, A;Ouafik, LH
通讯作者：
Ouafik, LH
影响因子：
5.8
作者：
Caron, P;Beckers, A;Zgliczynski, W
通讯作者：
Zgliczynski, W
影响因子：
3.8
作者：
Holdaway, I M;Rajasoorya, C
通讯作者：
Rajasoorya, C
影响因子：
3.2
作者：
Lucas T;Astorga R;Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly
通讯作者：
Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly
影响因子：
5.8
作者：
Baldelli, R;Colao, A;Tamburrano, G
通讯作者：
Tamburrano, G