A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures

被引:7
|
作者
Patel, Charmi A. [1 ]
Bailey, Robert A. [1 ]
Vijapurkar, Ujjwala [2 ]
Meininger, Gary [2 ]
Blonde, Lawrence [3 ]
机构
[1] Janssen Sci Affairs LLC, 1000 Route 202 South, Raritan, NJ 08869 USA
[2] Janssen Res & Dev LLC, 920 US Route 202 South, Raritan, NJ 08869 USA
[3] Ochsner Med Ctr, Dept Endocrinol, Frank Riddick Diabet Inst, Ochsner Diabet Clin Res Unit, 1515 Jefferson Highway, New Orleans, LA 70121 USA
关键词
Canagliflozin; Glimepiride; Quality measures; Post-hoc analysis; Phase; 3; Glycemic control; Blood pressure; Body weight; A1C; DOUBLE-BLIND; EUROPEAN ASSOCIATION; POSITION STATEMENT; POOLED ANALYSIS; INHIBITORS; ADD-ON; MELLITUS; MANAGEMENT; SAFETY; HYPERGLYCEMIA;
D O I
10.1186/s12913-016-1607-z
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background: The randomized, double-blind CANTATA-SU (CANagliflozin Treatment And Trial Analysis Sulfonyl Urea) clinical trial compared the use of canagliflozin (100 mg or 300 mg) and maximally tolerated glimepiride (6-8 mg) over 104 weeks as add-on therapy for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Compared with glimepiride, canagliflozin use was associated with durable reductions in glycated hemoglobin (A1C), blood pressure (BP), and body weight. The aim of this post-hoc analysis of the CANTATA-SU trial was to assess the comparative efficacy of canagliflozin and glimepiride in the attainment of recently updated diabetes-related quality measures (QMs) for up to 104 weeks of treatment. Methods: This post-hoc analysis evaluated the proportions of patients achieving individual diabetes-related QMs using data from the randomized, double-blind, Phase 3 CANTATA-SU trial. Change in A1C from baseline, and proportions of the study population achieving QMs: A1C < 7.0 %, < 8.0 %, and > 9.0 % were assessed. Secondary endpoints included change in BP from baseline, and the proportions of the study population achieving QMs related to BP and body weight. Results: The proportions of patients in the canagliflozin 100 mg, canagliflozin 300 mg, and glimepiride groups meeting criteria for all QMs were similar at baseline. At 52 and 104 weeks of treatment, canagliflozin 100 mg and canagliflozin 300 mg provided better or similar reductions in A1C from baseline and achievement of glycemic control QMs compared with glimepiride. At 52 and 104 weeks of treatment, the attainment of QMs related to reductions in body weight and BP all favored canagliflozin compared with glimepiride. Canagliflozin was associated with lower incidence of documented hypoglycemia and severe hypoglycemia compared with glimepiride. Conclusions: Using the recently adjusted and currently accepted diabetes-related QMs, this analysis observed superior glycemic control with canagliflozin compared with maximally tolerated glimepiride in patients with T2DM who were previously poorly controlled on metformin monotherapy. Compared with maximally tolerated glimepiride, canagliflozin resulted in better achievement of diabetes-related QMs related to weight loss and BP, and was associated with lower incidences of hypoglycemic events.
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页数:12
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