Wilding John, Bailey Clifford, Rigney Una, Blak Betina, Beekman Wendy, Emmas Cathy
Diabetes and Endocrinology Research Group, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK.
Life and Health Sciences, Aston University, Birmingham, UK.
Diabetes Ther. 2016 Dec;7(4):695-711. doi: 10.1007/s13300-016-0193-8. Epub 2016 Sep 1.
The present study aimed to describe characteristics of patients with type 2 diabetes (T2D) in UK primary care initiated on dapagliflozin, post-dapagliflozin changes in glycated hemoglobin (HbA), body weight and blood pressure, and reasons for adding dapagliflozin to insulin.
Retrospective study of patients with T2D in the Clinical Practice Research Datalink with first prescription for dapagliflozin. Patients were included in the study if they: (1) had a first prescription for dapagliflozin between November 2012 and September 2014; (2) had a Read code for T2D; (3) were registered with a practice for at least 6 months before starting dapagliflozin; and (4) remained registered for at least 3 months after initiation. A questionnaire ascertained reason(s) for adding dapagliflozin to insulin.
Dapagliflozin was most often used as triple therapy (27.7%), dual therapy with metformin (25.1%) or added to insulin (19.2%). Median therapy duration was 329 days [95% confidence interval (CI) 302-361]. Poor glycemic control was the reason for dapagliflozin initiation for 93.1% of insulin-treated patients. Avoiding increases in weight/body mass index and insulin resistance were the commonest reasons for selecting dapagliflozin versus intensifying insulin. HbA declined by mean of 9.7 mmol/mol (95% CI 8.5-10.9) (0.89%) 14-90 days after starting dapagliflozin, 10.2 mmol/mol (95% CI 8.9-11.5) (0.93%) after 91-180 days and 12.6 mmol/mol (95% CI 11.0-14.3) (1.16%) beyond 180 days. Weight declined by mean of 2.6 kg (95% CI 2.3-2.9) after 14-90 days, 4.3 kg (95% CI 3.8-4.7) after 91-180 days and 4.6 kg (95% CI 4.0-5.2) beyond 180 days. In patients with measurements between 14 and 90 days after starting dapagliflozin, systolic and diastolic blood pressure decreased by means of 4.5 (95% CI -5.8 to -3.2) and 2.0 (95% CI -2.9 to -1.2) mmHg, respectively from baseline. Similar reductions in systolic and diastolic blood pressure were observed after 91-180 days and when follow-up extended beyond 180 days. Results were consistent across subgroups.
HbA, body weight and blood pressure were reduced after initiation of dapagliflozin in patients with T2D in UK primary care and the changes were consistent with randomized clinical trials.
AstraZeneca.
本研究旨在描述英国初级医疗保健中起始使用达格列净的2型糖尿病(T2D)患者的特征、达格列净治疗后糖化血红蛋白(HbA)、体重和血压的变化,以及在胰岛素治疗中加用达格列净的原因。
对临床实践研究数据链中首次处方达格列净的T2D患者进行回顾性研究。符合以下条件的患者纳入本研究:(1)在2012年11月至2014年9月期间首次处方达格列净;(2)有T2D的Read编码;(3)在起始使用达格列净前在某医疗机构注册至少6个月;(4)起始使用后至少注册3个月。通过问卷调查确定在胰岛素治疗中加用达格列净的原因。
达格列净最常作为三联疗法使用(27.7%),与二甲双胍联合作为双联疗法(25.1%)或加用至胰岛素治疗中(19.2%)。中位治疗持续时间为329天[95%置信区间(CI)302 - 361]。血糖控制不佳是93.1%接受胰岛素治疗患者起始使用达格列净的原因。与强化胰岛素治疗相比,避免体重/体重指数增加和胰岛素抵抗是选择达格列净的最常见原因。起始使用达格列净后14 - 90天,HbA平均下降9.7 mmol/mol(95% CI 8.5 - 10.9)(0.89%),91 - 180天后下降10.2 mmol/mol(95% CI 8.9 - 11.5)(0.93%),180天后下降12.6 mmol/mol(95% CI 11.0 - 14.3)(1.16%)。14 - 90天后体重平均下降2.6 kg(95% CI 2.3 - 2.9),91 - 180天后下降4.3 kg(95% CI 3.8 - 4.7),180天后下降4.6 kg(95% CI 4.0 - 5.2)。在起始使用达格列净后14 - 90天进行测量的患者中,收缩压和舒张压分别较基线平均下降4.5(95% CI -5.8至 -3.2)和2.0(95% CI -2.9至 -1.2)mmHg。在91 - 180天后以及随访延长至180天后,观察到收缩压和舒张压有类似程度的下降。各亚组结果一致。
在英国初级医疗保健中,起始使用达格列净后,T2D患者的HbA、体重和血压均有所降低,且这些变化与随机临床试验结果一致。
阿斯利康公司。