Márquez-Rodríguez Eduardo, Brea-Andrea Eduardo, Rajmet-Hace Victoria Alejandro, Salinas-Salinas Javier, Mariño-Rojas Fabiola
Instituto Jalisciense de Metabolismo, Guadalajara, México.
IMSS del Estado de México y Municipios, Toluca, México.
Gac Med Mex. 2016 Jul-Aug;152(4):457-64.
The multinational EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed the effectiveness and tolerability of vildagliptin versus other oral antihyperglycemic drugs (OAD) when added to monotherapy in patients in the real-world setting.
Prospective, real-world observational study. The primary endpoint (PEP) was the proportion of patients achieving a reduction in HbA1c > 0.3% without peripheral edema, hypoglycemia, discontinuation, dueto gastrointestinal event, or weight gain > 5%. The secondary endpoint (SEP) was the proportion of patient achieving HbA1c < 7% (at month 12), without proven hypoglycemia or weight gain (≥ 3%).
Of the 3,523 patients enrolled in Mexico, 2,847 were in the vildagliptin and 676 in the comparator cohort. The PEP was reached in 61.8 and 53.2% in the vildagliptin and comparator cohorts, respectively. The unadjusted odds ratio was 1.42 (95% CI: 1.19-1.68) in favor of vildagliptin. A similar advantage for vildagliptin-based therapies was seen for the SEP. The percentage was lower in the vildagliptin (n = 145; 5.0%) than in the comparator group (n = 95; 14.0%).
Vildagliptin, added to a first-line OAD monotherapy, allows patients to reach target HbA1c without experiencing significant adverse events.
多国EDGE（维格列汀与维格列汀/二甲双胍控制糖尿病疗效）研究评估了在现实环境中，维格列汀与其他口服降糖药（OAD）联合用于单药治疗患者时的有效性和耐受性。
前瞻性、现实观察性研究。主要终点（PEP）是在无外周水肿、低血糖、因胃肠道事件停药或体重增加>5%的情况下，糖化血红蛋白（HbA1c）降低>0.3%的患者比例。次要终点（SEP）是在无确诊低血糖或体重增加（≥3%）的情况下，糖化血红蛋白<7%（第12个月时）的患者比例。
在墨西哥纳入的3523例患者中，2847例接受维格列汀治疗，676例为对照队列。维格列汀组和对照队列达到主要终点的比例分别为61.8%和53.2%。未调整的优势比为1.42（95%置信区间：1.19 - 1.68），支持维格列汀。对于次要终点，基于维格列汀的治疗也有类似优势。维格列汀组的百分比（n = 145；5.0%）低于对照组（n = 95；14.0%）。
维格列汀添加到一线OAD单药治疗中，可使患者达到糖化血红蛋白目标，且无明显不良事件发生。
