The Biostatistics Center, The George Washington University, Rockville, MD 20852, USA.
Clin J Am Soc Nephrol. 2011 May;6(5):1032-40. doi: 10.2215/CJN.09291010. Epub 2011 Mar 31.
In ADOPT (A Diabetes Outcomes Prevention Trial), initial monotherapy with rosiglitazone provided more durable glycemic control than metformin or glyburide in patients with recently diagnosed type 2 diabetes. Herein, we examine differences in albumin excretion, renal function (estimated GFR), and BP over 5 years between treatment groups.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A total of 4351 recently diagnosed, drug-naïve patients with type 2 diabetes were treated and followed for up to 5 years with rosiglitazone, metformin, or glyburide and were examined with periodic assessments of albumin/creatinine ratio (ACR), modification of diet in renal disease (MDRD)-estimated GFR, and BP.
The ACR rose slowly with metformin. It fell with rosiglitazone and less so with glyburide over the first 2 years, and then rose slowly over time. Estimated GFR (eGFR) with all therapies rose into the high normal range over the first 3 to 4 years, more so with rosiglitazone, and then declined, more so with glyburide. Systolic BP was stable over time, values with rosiglitazone being lower, and diastolic BP declined over time, more so with rosiglitazone than with metformin or glyburide. There was no difference among groups in the incidence of emergent albuminuria (ACR ≥30 mg/g), hypertension, or impaired eGFR (<60 ml/min per 1.73 m(2)).
Over a 5-year period, initial monotherapy with rosiglitazone retards the rise of ACR compared with metformin, preserves eGFR compared with glyburide, and lowers BP relative to both comparators.
在 ADOPT(一项糖尿病结局预防试验)中,与二甲双胍或格列吡嗪相比,初治的 2 型糖尿病患者接受罗格列酮单药治疗可更持久地控制血糖。在此,我们检测了治疗组在 5 年内白蛋白排泄、肾功能(估算肾小球滤过率)和血压的差异。
设计、地点、参与者和测量方法:共 4351 例新诊断、未用药的 2 型糖尿病患者接受罗格列酮、二甲双胍或格列吡嗪治疗,并随访 5 年,定期评估白蛋白/肌酐比值(ACR)、肾脏病膳食改良试验(MDRD)估算肾小球滤过率和血压。
与二甲双胍相比,ACR 随格列吡嗪缓慢升高。ACR 在前 2 年随罗格列酮而下降,随格列吡嗪则下降较少,随后随时间缓慢升高。所有治疗组的估算肾小球滤过率(eGFR)在最初 3 至 4 年内升高至正常高值,罗格列酮升高更明显,随后下降,格列吡嗪下降更明显。收缩压随时间稳定,罗格列酮组的收缩压较低,舒张压随时间下降,罗格列酮组较二甲双胍或格列吡嗪组下降更明显。各组间新发白蛋白尿(ACR≥30mg/g)、高血压或肾功能受损(<60ml/min/1.73m2)的发生率无差异。
在 5 年期间,与二甲双胍相比,罗格列酮初始单药治疗可延缓 ACR 的升高,与格列吡嗪相比可保留 eGFR,并使血压相对降低。