Background Evidence from controlled trials has shown that lanreotide autogel is effective in achieving biochemical and symptom control in patients with acromegaly. However, it is important to better understand the real-world patient population receiving lanreotide autogel treatment. Methods In this non-interventional study the long-term treatment response to lanreotide autogel in adult patients with acromegaly from office-based centers or clinics in Germany, Austria and Switzerland was studied. Assessments included growth hormone and insulin-like growth factor-I levels, symptoms, quality of life, lanreotide plasma levels and tumor somatostatin receptor subtype expression. The primary endpoint was achievement of full biochemical control, defined as growth hormone ≤2.5 µg/L and insulin-like growth factor I normalization at month 12. Results 76 patients were enrolled from 21 sites. 7/51 (13.7%) patients of the efficacy population had full biochemical control at baseline, 15/33 (45.5%) at month 12 and 10/26 (38.5%) at month 24 of treatment. At 12 months of treatment higher rates of biochemical control were observed in the following subgroups: older patients (>53 years [median]), females, treatment-naïve patients, and patients with a time since diagnosis of longer than 1.4 years (median). No clinically relevant differences in acromegaly symptoms or quality of life scores were observed. Median fasting blood glucose and glycated hemoglobin levels remained unchanged throughout the study. No new safety signals were observed. Overall tolerability of treatment with lanreotide autogel was judged by 80.8% of the enrolled patients at month 12 as ‘very good’ or ‘good’. Conclusion Treatment with lanreotide autogel in a real-world setting showed long-term effectiveness and good tolerability in patients with acromegaly.

中文翻译：

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在德国、奥地利和瑞士的常规临床实践中，兰瑞肽 Autogel 治疗肢端肥大症患者的多中心、观察性研究

背景 来自对照试验的证据表明，兰瑞肽自凝胶可有效控制肢端肥大症患者的生化和症状。然而，更好地了解接受兰瑞肽自凝胶治疗的真实世界患者群体非常重要。方法 在这项非干预性研究中，研究了来自德国、奥地利和瑞士的办公室中心或诊所的成年肢端肥大症患者对兰瑞肽自凝胶的长期治疗反应。评估包括生长激素和胰岛素样生长因子-I 水平、症状、生活质量、兰瑞肽血浆水平和肿瘤生长抑素受体亚型表达。主要终点是实现完全生化控制，定义为生长激素≤2.5 µg/L 和胰岛素样生长因子 I 在第 12 个月正常化。结果 共纳入 21 个中心的 76 名患者。7/51 (13.7%) 的疗效群体患者在基线时完全生化控制，15/33 (45.5%) 在治疗的第 12 个月和 10/26 (38.5%) 在治疗的第 24 个月。在治疗 12 个月时，在以下亚组中观察到较高的生化控制率：老年患者（> 53 岁 [中位数]）、女性、初治患者和自诊断时间超过 1.4 年的患者（中位数） . 没有观察到肢端肥大症症状或生活质量评分的临床相关差异。在整个研究过程中，中位空腹血糖和糖化血红蛋白水平保持不变。没有观察到新的安全信号。在第 12 个月时，80.8% 的入选患者将兰瑞肽自凝胶治疗的总体耐受性判断为“非常好”或“好”。