Bell Kelly F, Katz Arie, Sheehan John J
AstraZeneca, Wilmington, DE, USA.
Risk Manag Healthc Policy. 2016 Oct 14;9:231-241. doi: 10.2147/RMHP.S108586. eCollection 2016.
The use of quality measures attempts to improve safety and health outcomes and to reduce costs. In two Phase III trials in treatment-naive patients with type 2 diabetes, dapagliflozin 5 or 10 mg/d as initial combination therapy with metformin extended-release (XR) significantly reduced glycated hemoglobin (A) from baseline to 24 weeks and allowed higher proportions of patients to achieve A <7% vs dapagliflozin or metformin monotherapy.
A pooled analysis of data from these two studies assessed the effect of dapagliflozin 5 or 10 mg/d plus metformin XR (combination therapy) compared with placebo plus metformin XR (metformin monotherapy) on diabetes quality measures. Quality measures include laboratory measures of A and low-density lipoprotein cholesterol (LDL-C) as well as vital status measures of blood pressure (BP) and body mass index (BMI). The proportion of patients achieving A, BP, and LDL-C individual and composite measures was assessed, as was the proportion with baseline BMI ≥25 kg/m who lost ≥4.5 kg. Subgroup analyses by baseline BMI were also performed.
A total of 194 and 211 patients were treated with dapagliflozin 5- or 10-mg/d combination therapy, respectively, and 409 with metformin monotherapy. Significantly higher proportions of patients achieved A ≤6.5%, <7%, or <8% with combination therapy vs metformin monotherapy (<0.02). Significantly higher proportions of patients achieved BP <140/90 mmHg (<0.02 for each dapagliflozin dose) and BP <130/80 mmHg (<0.02 with dapagliflozin 5 mg/d only) with combination therapy vs metformin monotherapy. Similar proportions (29%-33%) of patients had LDL-C <100 mg/dL across treatment groups. A higher proportion of patients with baseline BMI ≥25 kg/m lost ≥4.5 kg with combination therapy. Combination therapy had a more robust effect on patients with higher baseline BMI.
Initial combination therapy with dapagliflozin 5 or 10 mg/d and metformin improved quality measures relevant to clinical outcomes and diabetes care.
使用质量指标旨在改善安全和健康结局并降低成本。在两项针对初治2型糖尿病患者的III期试验中，达格列净5或10 mg/d作为与缓释二甲双胍的初始联合治疗，从基线到24周显著降低糖化血红蛋白（A1c），与达格列净或二甲双胍单药治疗相比，使更高比例的患者实现A1c<7%。
对这两项研究的数据进行汇总分析，评估达格列净5或10 mg/d加缓释二甲双胍（联合治疗）与安慰剂加缓释二甲双胍（二甲双胍单药治疗）相比对糖尿病质量指标的影响。质量指标包括A1c和低密度脂蛋白胆固醇（LDL-C）的实验室指标以及血压（BP）和体重指数（BMI）的生命体征指标。评估了实现A1c、BP和LDL-C个体及综合指标的患者比例，以及基线BMI≥25 kg/m且体重减轻≥4.5 kg的患者比例。还进行了按基线BMI分层的亚组分析。
分别有194例和211例患者接受达格列净5 - 或10 - mg/d联合治疗，409例患者接受二甲双胍单药治疗。与二甲双胍单药治疗相比，联合治疗使实现A1c≤6.5%、<7%或<8%的患者比例显著更高（P<0.02）。与二甲双胍单药治疗相比，联合治疗使实现BP<140/90 mmHg（各达格列净剂量组P<0.02）和BP<130/80 mmHg（仅达格列净5 mg/d组P<0.02）的患者比例显著更高。各治疗组中LDL-C<100 mg/dL的患者比例相似（29% - 33%）。基线BMI≥25 kg/m的患者中，联合治疗使更高比例的患者体重减轻≥4.5 kg。联合治疗对基线BMI较高的患者效果更强。
达格列净5或10 mg/d与二甲双胍的初始联合治疗改善了与临床结局和糖尿病护理相关的质量指标。
