The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial.
The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial.
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DOI：
10.7326/0003-4819-152-6-201003160-00004
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发表时间：
2010-03-16
影响因子：
39.2
通讯作者：
TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team
中科院分区：
文献类型：
--
作者：
Goldfine AB;Fonseca V;Jablonski KA;Pyle L;Staten MA;Shoelson SE;TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team
水杨酸酯是水杨酸的非乙酰化前药，在小型研究中已显示可降低血糖浓度。比较不同剂量双水杨酯治疗2型糖尿病的疗效和安全性。计算机生成随机化和集中分配的平行随机试验。患者和研究者，包括那些评估结果和进行分析的人，对分组设盲。（ClinicalTrials.gov注册号：NCT 00392678）美国3家私人诊所和14所大学。空腹血糖浓度≤ 12.5 mmol/L（≤225 mg/dL）且血红蛋白A1 c（HbA 1c）水平为7.0%-9.5%的18 - 75岁患者，接受饮食、运动和稳定剂量口服药物治疗至少8周。经过4周的单盲导入期后，患者被随机分配接受安慰剂或双水杨酸酯，剂量为3.0，3.5或4.0 g/d，持续14周（各27例患者）。HbA 1c的变化是主要结局。副作用和冠状动脉风险和肾功能指标的变化是次要结局。3个双水杨酯治疗组中HbA 1c水平较基线降低0.5%或以上的患者比例较高（P = 0.009）。与安慰剂相比，3.0 g/d、3.5 g/d和4.0 g/d的平均HbA 1c变化分别为-0.36%（P = 0.02）、-0.34%（P = 0.02）和-0.49%（P = 0.001）。其他血糖控制指标在3个双水杨酯组中也得到改善，循环甘油三酯和脂联素浓度也得到改善。轻度低血糖在双水杨酯组更常见;记录的事件仅发生在服用磺脲类药物的患者中。与安慰剂组相比，所有双水杨酯组的尿白蛋白浓度均升高。除此之外，药物耐受性良好。研究的患者数量和试验持续时间不足以推荐使用双水杨酯治疗2型糖尿病。双水杨酸可降低2型糖尿病患者的HbA 1c水平并改善血糖控制的其他标志物，因此可能提供一种新的治疗途径。该药物的肾脏和心脏安全性需要进一步评估。国立糖尿病、消化和肾脏疾病研究所，国立卫生研究院。
Salsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies. To compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes. Parallel randomized trial with computer-generated randomization and centralized allocation. Patients and investigators, including those assessing outcomes and performing analyses, were masked to group assignment. (ClinicalTrials.gov registration number: NCT00392678) 3 private practices and 14 universities in the United States. Persons aged 18 to 75 years with fasting plasma glucose concentrations of 12.5 mmol/L or less (≤225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% treated by diet, exercise, and oral medication at stable doses for at least 8 weeks. After a 4-week, single-masked run-in period, patients were randomly assigned to receive placebo or salsalate in dosages of 3.0, 3.5, or 4.0 g/d for 14 weeks (27 patients each) in addition to their current therapy. Change in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes. Higher proportions of patients in the 3 salsalate treatment groups experienced decreases in HbA1c levels of 0.5% or more from baseline (P = 0.009). Mean HbA1c changes were −0.36% (P = 0.02) at 3.0 g/d, −0.34% (P = 0.02) at 3.5 g/d, and −0.49% (P = 0.001) at 4.0 g/d compared with placebo. Other markers of glycemic control also improved in the 3 salsalate groups, as did circulating triglyceride and adiponectin concentrations. Mild hypoglycemia was more common with salsalate; documented events occurred only in patients taking sulfonylureas. Urine albumin concentrations increased in all salsalate groups compared with placebo. The drug was otherwise well tolerated. The number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time. Salsalate lowers HbA1c levels and improves other markers of glycemic control in patients with type 2 diabetes and may therefore provide a new avenue for treatment. Renal and cardiac safety of the drug require further evaluation. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.
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影响因子：
82.9
作者：
Arkan, MC;Hevener, AL;Karin, M
通讯作者：
Karin, M
影响因子：
56.9
作者：
JURIVICH, DA;SISTONEN, L;MORIMOTO, RI
通讯作者：
MORIMOTO, RI
影响因子：
56.9
作者：
KOPP, E;GHOSH, S
通讯作者：
GHOSH, S
影响因子：
13.2
作者：
Coll, E;Botey, A;Darnell, A
通讯作者：
Darnell, A
影响因子：
8.2
作者：
Koska, J.;Ortega, E.;Bunt, J. C.;Gasser, A.;Impson, J.;Hanson, R. L.;Forbes, J.;de Courten, B.;Krakoff, J.
通讯作者：
Krakoff, J.