Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study
Pasireotide Versus Octreotide in Acromegaly: A Head-to-Head Superiority Study
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DOI：
10.1210/jc.2013-2480
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发表时间：
2014-03-01
影响因子：
5.8
通讯作者：
Sheppard, M.
中科院分区：
文献类型：
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作者：
Colao, A.;Bronstein, M. D.;Sheppard, M.
背景：生化控制可降低肢端肥大症患者的发病率并延长其预期寿命。使用目前的药物治疗，包括金标准奥曲肽长效释放（LAR），许多患者无法实现生化控制。目的：我们的目的是在初次接受医学治疗的肢端肥大症患者中证明帕瑞肽 LAR 相对于奥曲肽 LAR 的优越性。设计和设置：我们在 27 个国家的 84 个地点进行了一项前瞻性、随机、双盲研究。患者：总共 358 名患有肢端肥大症的患者。医学上未见的肢端肥大症（口服葡萄糖耐量试验（OGTT）后 GH > 5 μg/L 或 GH 最低值 >= 1 μg/L 且 IGF-1 高于正常上限）被纳入。患者既往接受过垂体手术但未接受任何药物治疗，或者磁共振成像显示新发可见垂体腺瘤。 干预措施：患者接受帕瑞肽 LAR 40 mg/28 天 (n = 176) 或奥曲肽 LAR 20 mg/28 天 (n = 182) 治疗 12 个月。在第 3 个月和第 7 个月，如果 GH >= 2.5 μg/L 和/或 IGF-1 高于正常上限，则允许滴定至帕瑞肽 LAR 60 mg 或奥曲肽 LAR 30 mg，但不是强制性的。 主要结果指标：主要结果指标是每个治疗组中生化控制（GH）的患者比例
Context: Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control.Objective: Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly.Design and Setting: We conducted a prospective, randomized, double-blind study at 84 sites in 27 countries.Patients: A total of 358 patients with medically naive acromegaly (GH > 5 mu g/L or GH nadir >= 1 mu g/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging.Interventions: Patients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH >= 2.5 mu g/L and/or IGF-1 was above the upper limit of normal.Main Outcome Measure: The main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH