Sinclair Alan, Bode Bruce, Harris Stewart, Vijapurkar Ujjwala, Mayer Cristiana, Fung Albert, Shaw Wayne, Usiskin Keith, Desai Mehul, Meininger Gary
Luton & Dunstable University Hospital; Bedfordshire and Hertfordshire Postgraduate Medical School, University of Bedfordshire, Putteridge Bury Campus, Hitchin Road, Luton LU2 8LE, UK.
BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.
Canagliflozin is a sodium glucose co-transporter 2 inhibitor developed for the treatment of patients with type 2 diabetes mellitus (T2DM). The efficacy and safety of canagliflozin were evaluated in patients with T2DM <65 and ≥65 years of age.
Pooled data from 4 randomised, placebo-controlled, 26-week, Phase 3 studies (N = 2,313) evaluating canagliflozin 100 and 300 mg were analysed by age: <65 years (n = 1,868; mean age, 52.8 years) or ≥65 years (n = 445; mean age, 69.3 years). Efficacy evaluations included change from baseline in glycaemic parameters and systolic blood pressure (BP), and percent change from baseline in body weight. Assessment of safety/tolerability included adverse event (AE) reports, incidence of documented hypoglycaemia, and percent change from baseline in fasting plasma lipids.
Canagliflozin 100 and 300 mg reduced HbA1c and fasting plasma glucose relative to placebo in patients <65 and ≥65 years of age. Both canagliflozin doses reduced body weight and systolic BP relative to placebo in patients <65 and ≥65 years of age. Incidence of overall AEs was similar across all treatment groups in patients <65 and ≥65 years of age. Incidences of serious AEs and AE-related discontinuations were similar across all treatment groups in patients <65 years of age and higher with canagliflozin 100 mg than other groups in patients ≥65 years of age. As in patients <65 years of age, incidences of genital mycotic infections and osmotic diuresis-related AEs were higher with canagliflozin relative to placebo in those ≥65 years of age. Incidences of urinary tract infections (UTIs), renal-related AEs, AEs related to volume depletion, and documented hypoglycaemia episodes were similar across all treatment groups in patients ≥65 years of age; no notable trends were observed with canagliflozin 100 and 300 mg relative to placebo in these AEs among patients <65 years of age. Changes in lipid parameters with canagliflozin were similar in both age subsets.
Canagliflozin improved glycaemic control, body weight, and systolic BP, and was generally well tolerated in older patients with T2DM.
ClinicalTrials.gov, NCT01081834; NCT01106677; NCT01106625; NCT01106690.
卡格列净是一种研发用于治疗2型糖尿病（T2DM）患者的钠-葡萄糖协同转运蛋白2抑制剂。对年龄<65岁和≥65岁的T2DM患者评估了卡格列净的疗效和安全性。
对4项随机、安慰剂对照、为期26周的3期研究（N = 2313）的汇总数据进行分析，这些研究评估了100 mg和300 mg卡格列净，按年龄分组：<65岁（n = 1868；平均年龄52.8岁）或≥65岁（n = 445；平均年龄69.3岁）。疗效评估包括血糖参数和收缩压（BP）相对于基线的变化，以及体重相对于基线的变化百分比。安全性/耐受性评估包括不良事件（AE）报告、记录的低血糖发生率，以及空腹血脂相对于基线的变化百分比。
相对于安慰剂，100 mg和300 mg卡格列净在<65岁和≥65岁的患者中均降低了糖化血红蛋白（HbA1c）和空腹血糖。在<65岁和≥65岁的患者中，相对于安慰剂，两种卡格列净剂量均降低了体重和收缩压。在<65岁和≥65岁的患者中，所有治疗组的总体AE发生率相似。在<65岁的患者中，所有治疗组的严重AE和与AE相关的停药发生率相似，而在≥65岁的患者中，100 mg卡格列净组高于其他组。与<65岁的患者一样，在≥65岁的患者中，相对于安慰剂，卡格列净组的生殖器真菌感染和渗透性利尿相关AE的发生率更高。在≥65岁的患者中，所有治疗组的尿路感染（UTI）、肾脏相关AE、与容量耗竭相关的AE以及记录的低血糖发作发生率相似；在<65岁的患者中，相对于安慰剂，100 mg和300 mg卡格列净在这些AE方面未观察到明显趋势。在两个年龄亚组中，卡格列净对血脂参数的影响相似。
卡格列净改善了血糖控制、体重和收缩压，并且在老年T2DM患者中总体耐受性良好。
ClinicalTrials.gov，NCT01081834；NCT01106677；NCT01106625；NCT01106690。
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