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首页> 美国卫生研究院文献>Wiley-Blackwell Online Open >Effects of exenatide once weekly plus dapagliflozin exenatide once weekly alone or dapagliflozin alone added to metformin monotherapy in subgroups of patients with type 2 diabetes in the DURATION‐8 randomized controlled trial
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Effects of exenatide once weekly plus dapagliflozin exenatide once weekly alone or dapagliflozin alone added to metformin monotherapy in subgroups of patients with type 2 diabetes in the DURATION‐8 randomized controlled trial

机译：在DURATION‐8随机对照试验中艾塞那肽每周一次加用达格列净艾塞那肽每周一次或单独使用达格列净在二甲双胍单药联合二甲双胍治疗中的作用

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This analysis assessed whether responses with exenatide once weekly plus dapagliflozin (n = 231), exenatide once weekly alone (n = 230), or dapagliflozin alone (n = 233) differed in key patient subpopulations of the DURATION‐8 trial. Potential treatment‐by‐subgroup interactions for changes in glycated haemoglobin (HbA1c) and body weight after 28 weeks were evaluated among subgroups determined by baseline HbA1c, age, sex, body mass index, type 2 diabetes duration, race, ethnicity and estimated glomerular filtration rate (eGFR). Exenatide once weekly plus dapagliflozin reduced HbA1c and body weight across all subgroups: least‐squares mean reductions ranged from −8.4 to −26.1 mmol/mol (−0.77% to −2.39%) for HbA1c and from −2.07 to −4.55 kg for body weight. Potential treatment‐by‐subgroup interactions (P < .10) were found for HbA1c change by age (P = .016) and eGFR (P = .097). Age subgroup analysis findings were not consistent with expected mechanistic effects, with the small number of patients aged ≥65 years (n = 74 vs n = 499 for patients aged <65 years) limiting the interpretability of the interaction term. In the exenatide once weekly plus dapagliflozin and dapagliflozin groups, but not the exenatide once weekly group, HbA1c reductions were greater among patients with eGFR ≥90 vs ≥60 to <90 mL/min/1.73 m2 (least‐squares mean reductions of −23.6 vs −19.0 mmol/mol [−2.16% vs −1.74%], −17.3 vs −12.0 mmol/mol [−1.58% vs −1.10%], and −17.7 vs −16.9 mmol/mol [−1.62% vs −1.55%] for the respective treatments); this was consistent with the mechanism of action of dapagliflozin. A potential treatment‐by‐subgroup interaction was observed for change in body weight by sex (P = .099), with greater weight loss for women vs men across all treatments (range −2.56 to −3.98 kg vs −0.56 to −2.99 kg). In conclusion, treatment with exenatide once weekly plus dapagliflozin reduced HbA1c and body weight across all patient subgroups and was more effective than exenatide once weekly or dapagliflozin alone in all adequately sized subgroups.
机译：这项分析评估了DURATION-8试验的主要患者亚群中，每周一次艾塞那肽加dapagliflozin（n = 231），单独使用艾塞那肽（n da = 230）或单独dapagliflozin（n = 233）的反应是否有所不同。在基线基线HbA1c，年龄，性别，体重指数，2型糖尿病病程，种族，种族和估计的肾小球滤过确定的亚组中，评估了28周后糖化血红蛋白（HbA1c）和体重变化的潜在亚组间相互作用费率（eGFR）。艾塞那肽每周一次加达格列净降低所有亚组的HbA1c和体重：HbA1c的最小二乘均值降低范围为-8.4至-26.1 mmol / mol（-0.77％至-2.39％），而身体范围为-2.07至-4.55 kg重量。发现HbA1c随年龄变化（P = .016）和eGFR（P = .097）的亚组间潜在治疗相互作用（P <.10）。年龄亚组分析结果与预期的机械作用不一致，年龄≥65岁的患者人数少（n = 74 vs n <= 499，<65岁的患者）限制了交互作用项的可解释性。在每周一次的艾塞那肽加达格列净和达格列净治疗组中，但在每周一次的艾塞那肽组中，eGFR≥90vs≥60的患者中HbA1c降低更大，至<90 mL / min / 1.73 m 2 （最小二乘平均减少量分别为-23.6 vs -19.0 mmol / mol [-2.16％vs -1.74％]，-17.3 vs -12.0 mmol / mol [-1.58 vs-1.10％]和-17.7 vs -16.9 mmol /摩尔[-1.62％vs -1.55％]；这与达格列净的作用机理一致。观察到按性别分组治疗的潜在相互作用，随性别的变化（P = .099），在所有治疗中，女性对男性的体重减轻更大（范围从−2.56至-3.98 kg到-0.56至-2.99 kg ）。总之，在所有患者亚组中，每周一次用艾塞那肽加达格列净治疗可以降低HbA1c和体重，并且比每周一次艾塞那肽或单独使用达格列净在所有适当大小的亚组中更有效。

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