Hermans Michel, Van Gaal Luc, Rézette Ingrid, Daci Evis, MacDonald Karen, Denhaerynck Kris, Vancayzeele Stefaan, De Meester Lut, Clemens Andreas, Yee Brian, Abraham Ivo
Cliniques Universitaires Saint-Luc, Avenue Hippocrate 55, B-1200 Bruxelles, Belgium.
Universitair Ziekenhuis Antwerpen, Wilrijkstraat 10, B-2650 Edegem, Belgium.
Prim Care Diabetes. 2016 Dec;10(6):425-433. doi: 10.1016/j.pcd.2016.05.008. Epub 2016 Jul 4.
To evaluate the real-world effectiveness of vildagliptin and vildagliptin/metformin, combined with patient engagement, on glycemic outcomes. Patient engagement included both clinicians' engaging patients through education and counseling; and patients' self-engagement through disease awareness, lifestyle changes, and medication adherence.
Prospective, observational, open-label, multi-center, pharmacoepidemiologic study of type 2 diabetes mellitus (T2DM) patients treated de novo with vildagliptin or vildagliptin/metformin. Data were collected at baseline (treatment initiation), 105±15d, and ≥145d.
The evaluable sample included 896 mainly male (58%), overweight (mean±SD BMI=30.3±5.4kg/m), in later middle age (mean±SD age=64±11years) patients. Over the three visits, mean(±SD) HbA1c levels declined from 8.1%(±1.0) to 7.3%(±1.0) to 7.2%(±0.9); HbA1c control rates rose from 7% to 36% to 43%. Mean±SD FPG levels decreased from 170(±49) to 141(±41) to 139(±42)mg/dL; control rates increased from 12% to 39% to 43% (all p<0.0001). Weight decreased nominally by 2kg (p=0.0290) and BMI by 0.8kg/m (p<0.0001). Modeling showed patient engagement activities by clinicians and by patients to be major determinants of glycemic outcomes. No unknown safety signals were detected.
Vildagliptin and vildagliptin/metformin are effective and safe oral agents in the management of T2DM, especially if part of a treatment program with active patient engagement by clinicians and empowered patients.
评估维格列汀及维格列汀/二甲双胍联合患者参与度对血糖控制效果的真实世界有效性。患者参与度包括临床医生通过教育和咨询促使患者参与；以及患者通过疾病认知、生活方式改变和药物依从性实现自我参与。
对初治的2型糖尿病（T2DM）患者使用维格列汀或维格列汀/二甲双胍进行前瞻性、观察性、开放标签、多中心药物流行病学研究。在基线（治疗开始）、105±15天和≥145天时收集数据。
可评估样本包括896例主要为男性（58%）、超重（平均±标准差BMI = 30.3±5.4kg/m²）、中年后期（平均±标准差年龄 = 64±11岁）的患者。在三次访视中，平均（±标准差）糖化血红蛋白（HbA1c）水平从8.1%（±1.0）降至7.3%（±1.0）再降至7.2%（±0.9）；HbA1c控制率从7%升至36%再升至43%。平均±标准差空腹血糖（FPG）水平从170（±49）降至141（±41）再降至139（±42）mg/dL；控制率从12%升至39%再升至43%（所有p<0.0001）。体重名义上下降2kg（p = 0.0290），BMI下降0.8kg/m²（p<0.0001）。模型显示临床医生和患者的参与活动是血糖控制效果的主要决定因素。未检测到未知的安全信号。
维格列汀和维格列汀/二甲双胍是治疗T2DM的有效且安全的口服药物，特别是作为临床医生积极促使患者参与且患者主动参与的治疗方案的一部分时。
