Department of EndocrinologyDiabetology and Metabolism, University Hospital Basel, Basel, Switzerland.
Max-Planck-Institute for Metabolism ResearchCologne, Germany.
Eur J Endocrinol. 2017 Mar;176(3):349-358. doi: 10.1530/EJE-16-0653. Epub 2017 Jan 10.
Patients receiving glucocorticoid treatment are prone to develop metabolic complications. In preclinical studies, metformin prevented the development of the metabolic syndrome during glucocorticoid excess. We herein investigated the metabolic effect of metformin during glucocorticoid treatment in non-diabetic patients.
In a double-blind, placebo-controlled trial, patients starting glucocorticoid treatment (prednisone, prednisolone or methylprednisolone) for four weeks were randomised to concomitantly receive metformin (850 mg once daily for one week followed by 850 mg twice daily for three weeks) or placebo. All patients underwent a standardised oral glucose tolerance test at baseline and after four weeks. The primary endpoint was change in the 2-h area under the curve (AUC) of glucose during the oral glucose tolerance test between baseline and four weeks.
29 of 34 randomised non-diabetic patients completed the trial (17 metformin and 12 placebo). In patients allocated to placebo, median glucose 2-h AUC increased from baseline to four weeks (836 (IQR 770-966) to 1202 (1009-1271) mmol/L per min; P = 0.01). In contrast, glucose levels remained similar to baseline in the metformin group (936 (869-1003) to 912 (825-1011) mmol/L per min; P = 0.83). This change within four weeks was different between both groups (P = 0.005). Glucocorticoid equivalent doses were similar in both groups (placebo: 980.0 (560.0-3259.8) mg/28 days; metformin: 683.0 (437.5-1970.5) mg/28 days; P = 0.26).
In this first randomised controlled trial of metformin targeting metabolic complications in patients needing glucocorticoid therapy, we observed a beneficial effect of metformin on glycaemic control. Metformin thus seems to be a promising drug for preventing metabolic side effects during systemic glucocorticoid treatment.
接受糖皮质激素治疗的患者易发生代谢并发症。在临床前研究中,二甲双胍可预防糖皮质激素过量时代谢综合征的发生。本研究旨在探讨二甲双胍在非糖尿病患者糖皮质激素治疗中的代谢作用。
在一项双盲、安慰剂对照试验中,接受为期四周糖皮质激素(泼尼松、泼尼松龙或甲泼尼龙)治疗的患者被随机分为同时接受二甲双胍(第 1 周每天 850mg,单次给药;第 2-3 周每天 850mg,2 次给药)或安慰剂治疗。所有患者在基线和四周时均进行标准化口服葡萄糖耐量试验。主要终点为口服葡萄糖耐量试验中 2 小时血糖曲线下面积(AUC)在基线至四周的变化。
34 名随机非糖尿病患者中 29 名完成了试验(17 名接受二甲双胍,12 名接受安慰剂)。接受安慰剂治疗的患者,中位血糖 2 小时 AUC 从基线至四周增加(836(IQR 770-966)至 1202(1009-1271)mmol/L/min;P=0.01)。相比之下,二甲双胍组的血糖水平与基线相似(936(869-1003)至 912(825-1011)mmol/L/min;P=0.83)。两组在四周内的这种变化不同(P=0.005)。两组的糖皮质激素等效剂量相似(安慰剂:980.0(560.0-3259.8)mg/28 天;二甲双胍:683.0(437.5-1970.5)mg/28 天;P=0.26)。
在这项针对需要糖皮质激素治疗的患者代谢并发症的二甲双胍首次随机对照试验中,我们观察到二甲双胍对血糖控制有有益的作用。因此,二甲双胍似乎是预防全身糖皮质激素治疗代谢副作用的一种有前途的药物。