Aix-Marseille Université, Institut National de la Santé et de la Recherche Médicale (INSERM), U1251, Marseille Medical Genetics (MMG), 13005, Marseille, France.
Assistance Publique-Hôpitaux de Marseille (AP-HM), Department of Endocrinology, Hôpital de la Conception, Centre de Référence des Maladies Rares de l'hypophyse HYPO, 13005, Marseille, France.
Endocrine. 2019 Mar;63(3):563-572. doi: 10.1007/s12020-018-1792-0. Epub 2018 Nov 24.
To explore the effects of pegvisomant (PEGV) on glucose metabolism in patients with acromegaly within ACROSTUDY, an international, observational, prospective safety surveillance study.
Patients were retrospectively divided into two cohorts, with (DM group) or without diabetes mellitus (no-DM). Parameters of glucose metabolism and IGF-I values were analyzed yearly both cross-sectionally for 4 years (yrs) and longitudinally at 1 and 4-5 yrs of PEGV treatment.
Among 1762 patients, 510 (28.9%) had DM before PEGV start. At cross-sectional analyses, in the DM group mean blood glucose was 140.0 ± 58.7 mg/dl at baseline, 116.4 ± 44.8 mg/dl at year 1 and 120.0 ± 44.3 mg/dl at yr 4. Mean HbA1c was 6.6 ± 1.2 % at yr 1 vs. 7.0 ± 1.4 % at baseline. HbA1c was above 6.5% in 61.9% at baseline and ranged from 45.4 to 53.8% at subsequent yearly time points. At the 4-yr longitudinal analysis, in the DM group (n = 109), mean blood glucose decreased by 20.2 mg/dl at yr 4, mean HbA1c was 7.0 ± 1.5% at baseline vs. 6.8 ± 1.4%. Patients achieved IGF-I normalization in 52.1% and 57.4% of cases in the DM and no-DM groups, respectively at 1 year. The mean daily PEGV dose (mg/day) was higher in the DM group (18.2 vs. 15.3) while the absolute change of IGF-I values from baseline was similar in both groups. PEGV was well tolerated in both groups without any unexpected AEs.
Patients with DM had a moderate decrease in mean fasting glucose values during PEGV treatment.
在一项国际性、观察性、前瞻性安全性监测研究 ACROSTUDY 中，探讨培维索孟（Pegvisomant，PEGV）对肢端肥大症患者葡萄糖代谢的影响。
患者回顾性地分为两组，有（DM 组）或没有糖尿病（非 DM 组）。每年进行一次 IGF-I 值和葡萄糖代谢参数的横断分析，共进行 4 年，并在 PEGV 治疗 1 年和 4-5 年后进行纵向分析。
在 1762 例患者中，510 例（28.9%）在开始 PEGV 前患有糖尿病。在横断分析中，DM 组患者的基线空腹血糖为 140.0±58.7mg/dl，第 1 年为 116.4±44.8mg/dl，第 4 年为 120.0±44.3mg/dl。平均 HbA1c 第 1 年为 6.6±1.2%，基线为 7.0±1.4%。HbA1c 在基线时超过 6.5%的患者占 61.9%，随后每年的范围为 45.4%至 53.8%。在 4 年的纵向分析中，DM 组（n=109）患者在第 4 年时空腹血糖降低了 20.2mg/dl，HbA1c 为 7.0±1.5%，基线为 6.8±1.4%。DM 组和非 DM 组患者在第 1 年时分别有 52.1%和 57.4%的患者 IGF-I 恢复正常。DM 组的平均每日 PEGV 剂量（mg/天）较高（18.2 比 15.3），但两组的 IGF-I 值从基线的绝对变化相似。两组患者均耐受良好，无任何意外不良事件。
DM 患者在接受 PEGV 治疗期间空腹血糖均值有中度下降。
