临床应用兰瑞肽联合卡麦角林或聚乙二醇妥明治疗肢端肥大症:ACROCOMB研究

Manuel Puig-Domingo , Alfonso Soto , Eva Venegas , Ricardo Vilchez , Concepción Blanco , Fernando Cordido , Tomás Lucas , Mónica Marazuela , Rosa Casany , Guillem Cuatrecasas , Carmen Fajardo , María Ángeles Gálvez , Silvia Maraver , Tomás Martín , Enrique Romero , Miguel Paja , Antonio Picó , Ignacio Bernabeu , Eugenia Resmini , on behalf of the ACROCOMB study group
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引用次数: 0

摘要

目的描述兰瑞肽联合治疗肢端肥大症的实际应用。患者和方法CROCOMB是一项西班牙回顾性观察性研究,研究对象为2006年至2011年间接受兰瑞肽联合治疗的活动性肢端肥大症患者。对西班牙44个内分泌科的108名患者分别进行了分析:61名患者接受了兰瑞肽/卡麦角林治疗(卡麦角啉队列),47名患者接受兰瑞肽/聚乙二醇单体治疗(聚乙二醇单体队列)。在卡麦角林队列中,先前的药物治疗是生长抑素类似物(SSA)单药治疗(40[66%]患者)或多巴胺激动剂(7[11%]患者。在这两个队列中,有12名患者既往未接受治疗,4名患者既往治疗未知/缺失。在卡麦角林和聚乙二醇组中,联合治疗的中位持续时间分别为1.6年(0.1-6)和2.1年(0.4-6.3)。基线时,卡麦角林队列中胰岛素生长因子(IGF)-I的中位数为正常(ULN)的149%上限(15-505%),聚乙二醇单体队列中为156%ULN上限(15-534%),并降至104%ULN(13-557%)p<;0.001和86%ULN(23–345%)p<;0.0001,研究结束时(EOS)。在EOS时,48%的兰瑞肽/卡麦角林治疗的患者和70%的兰瑞肽/聚乙二醇治疗的患者获得了正常的IGF-I年龄调整值。两组患者的肝脏、心脏或血糖参数均无显著变化。结论在临床实践中,当单药治疗不足时,兰瑞肽联合治疗是肢端肥大症患者的有用选择;特别是,在未用SSA或单独使用培维索曼控制的患者中,兰瑞肽和培维索曼特的组合具有很高的疗效并且耐受性良好。
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Use of lanreotide in combination with cabergoline or pegvisomant in patients with acromegaly in the clinical practice: The ACROCOMB study

Purpose

To describe real-world use of lanreotide combination therapy for acromegaly.

Patients and methods

ACROCOMB is a retrospective observational Spanish study of patients with active acromegaly treated with lanreotide combination therapy between 2006 and 2011. 108 patients treated at 44 Spanish Endocrinology Departments were analyzed separately: 61 patients received lanreotide/cabergoline (cabergoline cohort) and 47 lanreotide/pegvisomant (pegvisomant cohort).

Results

Patient median age was 50.8 years in the cabergoline cohort and 42.7 years in the pegvisomant cohort. Prior medical treatments were somatostatin analogue (SSA) monotherapy (40 [66%] patients) or dopamine agonists (7 [11%] patients) in the cabergoline cohort and SSA (29 [62%] patients) or pegvisomant monotherapy (16 [34%] patients) in the pegvisomant cohort. Across both cohorts 12 patients were previously untreated, and prior therapy was unknown/missing in 4 patients. Median duration of combined treatment was 1.6 years (0.1–6) and 2.1 years (0.4–6.3) in the cabergoline and pegvisomant cohorts, respectively. At baseline, median insulin growth factor (IGF)-I values were 149% upper limit of normal (ULN) (15–505%) in the cabergoline cohort and 156% ULN (15–534%) in the pegvisomant cohort, and decreased to 104% ULN (13–557%) p < 0.001 and 86% ULN (23–345%) p < 0.0001, respectively, at end of study (EOS). Normal age-adjusted values of IGF-I were obtained in 48% of lanreotide/cabergoline-treated patients and 70% of lanreotide/pegvisomant-treated patients at EOS. There were no significant changes in hepatic, cardiac or glycaemic parameters in either cohort.

Conclusion

In clinical practice lanreotide treatment combinations are useful options for patients with acromegaly when monotherapy is insufficient; particularly, the combination of lanreotide and pegvisomant in patients not controlled with either SSA or pegvisomant alone has high efficacy and is well-tolerated.

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