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Factor Analysis of Changes in Hemoglobin A1c After 12 Months of Sitagliptin Therapy in Patients With Type 2 Diabetes

机译:西格列汀治疗12个月后2型糖尿病患者血红蛋白A1c变化的因素分析

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Background: Sitagliptin, a dipeptidyl peptidase-4 inhibitor, is an effective oral antidiabetic agent as both monotherapy and when combined with insulin. Data from three observational studies performed in patients with type 2 diabetes receiving sitagliptin therapy in the routine clinical setting were integrated to conduct factor analysis of the changes in hemoglobin A1c (HbA1c), body weight, and estimated glomerular filtration rate (eGFR) over 12 months.Methods: Among patients with type 2 diabetes attending medical institutions affiliated with Kanagawa Physicians Association, those using sitagliptin were followed for 1 year. In the ASSET-K and ASSIST-K studies, patients were managed by diabetologists, while they were managed by non-diabetologists in the ATTEST-K study. Patients were not administered insulin in ASSET-K, whereas insulin was administered in ASSIST-K. HbA1c (National Glycohemoglobin Standardization Program), blood glucose (fasting/postprandial), body weight, and renal function (serum creatinine and eGFR) were the efficacy endpoints. Factor analysis was performed by analysis of variance using the magnitude of the change in HbA1c, body weight, and eGFR after 12 months of sitagliptin therapy as response variables, and the study, sex, and age as explanatory variables.Results: Of 1,327 patients registered in ASSET-K (diabetologists/without insulin), 1,167 patients in ASSIST-K (diabetologists/with insulin), and 530 patients in ATTEST-K (non-diabetologists), statistical analysis was carried out on 1,074, 854, and 411 patients, respectively. There were significant inter-study differences in patient characteristics (complications, duration of diabetes, and baseline HbA1c), the sitagliptin dose, and the use of other antidiabetic agents. HbA1c decreased significantly in all three studies. According to factor analysis, the magnitude of the change in HbA1c over 12 months showed significant inter-study differences and was also significantly influenced by the age, duration of diabetes, and baseline HbA1c.Conclusions: Comparison of three observational studies identified differences in patient characteristics, treatment of diabetes (useon-use of insulin), and the level of specialist care (diabetologiston-diabetologist). Despite such differences, consistent reduction of HbA1c by sitagliptin was demonstrated in all three studies. The patients showing most improvement in HbA1c with sitagliptin therapy were older patients with a short duration of diabetes and high baseline HbA1c level.J Clin Med Res. 2016;8(6):461-471doi: http://dx.doi.org/10.14740/jocmr2540w
机译:背景:西格列汀,一种二肽基肽酶4抑制剂,是一种有效的口服降糖药,无论是单一疗法还是与胰岛素联合使用都可以。在三个月的常规临床环境中接受西他列汀治疗的2型糖尿病患者中进行的三项观察性研究数据被整合,进行了12个月内血红蛋白A1c(HbA1c),体重和估计的肾小球滤过率(eGFR)变化的因子分析。方法:在神奈川县医师协会所属的医疗机构就诊的2型糖尿病患者中,使用西他列汀治疗1年。在ASSET-K和ASSIST-K研究中,患者由糖尿病专家管理,而在ATTEST-K研究中由非糖尿病专家管理。患者未在ASSET-K中使用胰岛素,而在ASSIST-K中使用了胰岛素。 HbA1c(国家糖化血红蛋白标准化计划),血糖(空腹/餐后),体重和肾功能(血清肌酐和eGFR)是疗效终点。西他列汀治疗12个月后HbA1c,体重和eGFR的变化幅度作为反应变量,以研究,性别和年龄作为解释变量,通过方差分析进行因子分析。结果:登记的1,327例患者ASSET-K(糖尿病/无胰岛素),1,167 ASSIST-K(糖尿病/有胰岛素)和ATTEST-K(非糖尿病)有530患者,对1,074、854和411位患者进行了统计分析, 分别。在患者特征(并发症,糖尿病持续时间和基线HbA1c),西他列汀剂量以及使用其他抗糖尿病药方面,研究间存在重大差异。在所有三项研究中,HbA1c均显着下降。根据因素分析,HbA1c在12个月内的变化幅度显示出显着的研究间差异,并且还受到年龄,糖尿病持续时间和基线HbA1c的显着影响。结论:三项观察性研究的比较确定了患者特征的差异,糖尿病的治疗(使用/不使用胰岛素)和专科护理水平(糖尿病专家/非糖尿病专家)。尽管存在这些差异,但在所有三项研究中均证明了西他列汀可持续降低HbA1c。西他列汀治疗显示HbA1c改善最大的患者是糖尿病持续时间短,基线HbA1c水平高的老年患者。 2016; 8(6):461-471doi:http://dx.doi.org/10.14740/jocmr2540w

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