Tsimihodimos Vasilis, Bargiota Alexandra, Pagkalos Emmanouil M, Manes Christos, Papas Aggelos, Karamousouli Eugenia, Voss Bernd, Elisaf Moses S
Department of Internal Medicine, School of Medicine, University of Ioannina, Ioannina, Greece.
Department of Endocrinology and Metabolic Diseases, University of Thessaly School of Medicine, Larissa, Greece.
Exp Clin Endocrinol Diabetes. 2020 Apr;128(4):224-230. doi: 10.1055/a-0824-6607. Epub 2019 Jan 22.
Metformin, in the absence of contraindications or intolerance, is recommended as first-line treatment for patients with type 2 diabetes mellitus (T2DM). This observational, retrospective study assessed the real-world adequacy of glycaemic control in Greek patients with T2DM initiating metformin monotherapy at maximum tolerated dose.
Included patients received metformin monotherapy for ≥24 months; relevant patient data were collected immediately prior to metformin initiation (baseline) and at other prespecified time points. The primary objective was to report, after 9 months of metformin treatment, the percentage of patients with baseline glycated haemoglobin (HbA) levels ≥6.5% (≥48 mmol/mol) achieving HbA<6.5%. Secondary objectives included the assessment of time spent with poor glycaemic control and time to treatment intensification. A sensitivity analysis assessed the percentage of patients with baseline HbA≥7% (≥53 mmol/mol) achieving HbA<7% (<53 mmol/mol).
Of the enrolled patients (N=316), 247 had baseline HbA ≥6.5%; following 9 months on metformin, 90 (36.4%) patients achieved HbA<6.5% (mean HbA change-1.3% [-14 mmol/mol]). Median time of exposure to HbA ≥6.5% was 23.4 months and time to treatment intensification was 28.0 months. The sensitivity analysis revealed that the proportion of patients achieving HbA<7.0% was 50% (mean HbApy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.
在无禁忌证或不耐受的情况下，二甲双胍被推荐作为2型糖尿病（T2DM）患者的一线治疗药物。这项观察性、回顾性研究评估了希腊T2DM患者起始最大耐受剂量二甲双胍单药治疗时血糖控制的真实达标情况。
纳入的患者接受二甲双胍单药治疗≥24个月；在起始二甲双胍治疗前（基线）及其他预定时间点收集相关患者数据。主要目标是报告二甲双胍治疗9个月后，基线糖化血红蛋白（HbA）水平≥6.5%（≥48 mmol/mol）的患者中HbA<6.5%的比例。次要目标包括评估血糖控制不佳的时间以及治疗强化的时间。一项敏感性分析评估了基线HbA≥7%（≥53 mmol/mol）的患者中HbA<7%（<53 mmol/mol）的比例。
在纳入的患者（N = 316）中，247例患者基线HbA≥6.5%；二甲双胍治疗9个月后，90例（36.4%）患者HbA<6.5%（平均HbA变化-1.3% [-14 mmol/mol]）。HbA≥6.5%的中位暴露时间为23.4个月，治疗强化时间为28.0个月。敏感性分析显示，HbA<7.0%的患者比例为50%（长达24个月的平均HbApy。克服临床惰性可改善疾病结局，并可能减轻经济负担。
