Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly
Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly
复制标题
DOI：
10.1210/jc.87.1.99
复制
发表时间：
2002-01-01
影响因子：
5.8
通讯作者：
Zgliczynski, W
中科院分区：
文献类型：
--
作者：
Caron, P;Beckers, A;Zgliczynski, W
兰瑞肽Autogel是一种新的长效水性制剂兰瑞肽用于治疗肢端肥大症，并通过小容量预充式注射器深静脉注射给药。本研究的目的是评价这种新型长效制剂在大量既往对兰瑞肽30 mg im（缓释微粒制剂）有反应的肢端肥大症患者中的疗效和安全性。107名患者（54名男性和53名女性;平均年龄54 ± 1.2岁）每28天通过深层皮下注射给予兰瑞肽Autogel。所有患者在进入研究前均接受兰瑞肽（30 mg）治疗至少3个月，并且在每14天（48%）、10天（32%）或7天（20%）至少4次后续肌内注射后，平均GH水平低于10 ng/ml。治疗从每14、10或7天注射一次兰瑞肽30 mg转换为每28天分别注射60、90或120 mg兰瑞肽Autogel。三次固定剂量注射兰瑞肽Autogel后，平均兰瑞肽水平与稳态时兰瑞肽30 mg的水平相似。在兰瑞肽Autogel治疗期间，肢端肥大症症状的控制与先前兰瑞肽30 mg治疗期间达到的控制相当。3次注射兰瑞肽Autogel后，平均GH（2.87 +/- 0.22 ng/ml）和IGF-I（317 +/- 15 ng/ml）值与兰瑞肽30 mg治疗结束时记录的值相当（GH，2.82 +/- 0.19 ng/ml; IGF-I，323 +/- 16 ng/ml）。在兰瑞肽30 mg和兰瑞肽Autogel治疗期间，分别有33%和39%的患者达到GH水平低于2.5 ng/ml和年龄/性别标准化IGF-I。兰瑞肽30 mg治疗期间分别有38%、22%和18%的患者报告腹泻、腹痛和恶心，兰瑞肽Autogel治疗期间分别有29%、17%和9%的患者报告腹泻、腹痛和恶心。总之，本临床研究表明，兰瑞肽Autogel至少与兰瑞肽30 mg一样有效且耐受性良好。因此，这种新型长效兰瑞肽制剂兰瑞肽Autogel通过小容量预充式注射器深层皮下注射给药，可能会提高需要长期生长抑素类似物治疗的患者的药物治疗可接受性。
Lanreotide Autogel is a new long-acting aqueous preparation of lanreotide for the treatment of acromegaly and is administered by deep se injection from a small volume, prefilled syringe. The aim of this study was to evaluate the efficacy and safety of this new long-acting formulation in a large population of acromegalic patients previously responsive to lanreotide 30 mg, im (sustained release microparticle formulation). Lanreotide Autogel was administered by deep se injection every 28 d to 107 patients (54 males and 53 females; mean age, 54 +/- 1.2 yr). All patients had been treated with lanreotide (30 mg) for at least 3 months before study entry and had a mean GH level less than 10 ng/ml after at least 4 subsequent im injections every 14 d (48%), 10 d (32%), or 7 d (20%). Treatment was switched from lanreotide 30 mg injected every 14, 10, or 7 d to 60, 90, or 120 mg lanreotide Autogel, respectively, every 28 d. After three fixed dose injections of lanreotide Autogel, mean lanreotide levels were similar to those obtained at steady state with lanreotide 30 mg. During lanreotide Autogel treatment, the control of acromegalic symptoms was comparable with that previously achieved during lanreotide 30 mg treatment. After 3 injections of lanreotide Autogel, mean GH (2.87 +/- 0.22 ng/ml) and IGF-I (317 +/- 15 ng/ml) values were comparable with those recorded at the end of lanreotide 30 mg treatment (GH, 2.82 +/- 0.19 ng/ml; IGF-I, 323 +/- 16 ng/ml). GH levels below 2.5 ng/ml and age-/sex-normalized IGF-I were achieved in 33% and 39% of patients during lanreotide 30 mg and lanreotide Autogel treatment, respectively. Diarrhea, abdominal pain, and nausea were reported by 38%, 22%, and 18% of patients during lanreotide 30 mg treatment and by 29,%, 17%, and 9% of patients, respectively, during lanreotide Autogel treatment. In conclusion, this clinical study shows that lanreotide Autogel is at least as efficacious and well tolerated as lanreotide 30 mg. This new long-acting lanreotide formulation, lanreotide Autogel, which is administered from a small volume, prefilled syringe by deep sc injection, is therefore likely to improve the acceptability of medical treatment for patients requiring long-term somatostatin analog therapy.