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水杨酸酯可改善伴有心血管疾病稳定他汀类药物治疗危险因素的超重糖尿病患者的血糖:一项 30 个月的随机安慰剂对照试验。

Salsalate improves glycaemia in overweight persons with diabetes risk factors of stable statin-treated cardiovascular disease: A 30-month randomized placebo-controlled trial.

机构信息

Joslin Diabetes Center, Boston, Massachusetts.

Harvard Medical School, Boston, Massachusetts.

出版信息

Diabetes Obes Metab. 2017 Oct;19(10):1458-1462. doi: 10.1111/dom.12940. Epub 2017 Jul 6.

DOI:10.1111/dom.12940
PMID:28295931
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5599319/
Abstract

OBJECTIVE

To assess long-term efficacy and safety of salsalate to improve glycemia in persons with diabetes risk, who are overweight with statin-treated, stable coronary heart disease.

METHODS

Glycemic status was assessed in 192 persons without diabetes at baseline in a pre-specified secondary analysis from Targeting INflammation Using SALsalate in CardioVascular Disease (TINSAL-CVD), a multi-center, double-masked, randomized (1:1), placebo-controlled, parallel clinical trial.

RESULTS

Participants were mostly Caucasian males, age 60±7 years, BMI 31.4±3.0 kg/m , fasting glucose 92.8±11.0 mg/dL, and HbA1c 5.8±0.3%. Reductions in mean fasting glucose -5.70 mg/dL (95%CI: -7.44 to -3.97 mg/dL, P<0.001), HbA1c -0.11% (95%CI: -0.210 to -0.002%, P=0.046) and glycated serum protein -81.8 μg/mL (95%CI: -93.7 to -69.9 μg/mL, P<0.001) were demonstrated in salsalate compared to placebo-assigned groups over 30 months. Reductions in fasting glucose and glycated serum protein were greater with salsalate compared to placebo in participants with prediabetes compared to a normoglycemic sub-group (P =0.018). Salsalate lowered total white blood cell counts (mean difference -0.7x10 /μL, 95%CI: -1.0 to -0.4 x10 /μL, P<0.001) and increased adiponectin (mean difference 1.8 μg/mL, 95%CI: 0.9 to 2.6 μg/mL, P<0.001) and albuminurea (16.7 μg/mg, 95%CI: 6.4 to 27.1 μg/mg, P<0.001) compared to placebo, consistent with previous results for patients with type 2 diabetes taking salsalate for shorter times.

CONCLUSIONS

Salsalate improves glycemia in obese persons at increased risk for diabetes, and hence may decrease risk of incident type 2 diabetes. Salsalate may inform new therapeutic approaches for diabetes prevention, but renal safety may limit clinical utility.

摘要

目的

评估柳氮磺吡啶改善患有稳定型冠心病且经他汀类药物治疗的超重糖尿病高危人群血糖的长期疗效和安全性。

方法

在靶向炎症使用柳氮磺吡啶治疗心血管疾病(TINSAL-CVD)的一项多中心、双盲、随机(1:1)、安慰剂对照、平行临床试验的预先指定的二次分析中,在基线时评估了 192 名无糖尿病的患者的血糖状态。

结果

参与者主要为白种人男性,年龄 60±7 岁,BMI 31.4±3.0kg/m ,空腹血糖 92.8±11.0mg/dL,糖化血红蛋白 5.8±0.3%。与安慰剂组相比,柳氮磺吡啶组的平均空腹血糖降低了-5.70mg/dL(95%CI:-7.44 至-3.97mg/dL,P<0.001),糖化血红蛋白降低了-0.11%(95%CI:-0.210 至-0.002%,P=0.046),糖化血清蛋白降低了-81.8μg/mL(95%CI:-93.7 至-69.9μg/mL,P<0.001)。与血糖正常亚组相比,在患有糖尿病前期的参与者中,柳氮磺吡啶组的空腹血糖和糖化血清蛋白降低幅度大于安慰剂组(P=0.018)。与安慰剂相比,柳氮磺吡啶降低了总白细胞计数(平均差异-0.7x10 /μL,95%CI:-1.0 至-0.4 x10 /μL,P<0.001),增加了脂联素(平均差异 1.8μg/mL,95%CI:0.9 至 2.6μg/mL,P<0.001)和白蛋白尿(16.7μg/mg,95%CI:6.4 至 27.1μg/mg,P<0.001),与服用柳氮磺吡啶时间较短的 2 型糖尿病患者的先前结果一致。

结论

柳氮磺吡啶可改善糖尿病高危肥胖人群的血糖,从而可能降低 2 型糖尿病的发病风险。柳氮磺吡啶可能为糖尿病预防提供新的治疗方法,但肾脏安全性可能限制其临床应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4cf/5599319/df4b33cf8206/nihms862052f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4cf/5599319/f26bd2ee0b4b/nihms862052f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4cf/5599319/df4b33cf8206/nihms862052f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4cf/5599319/f26bd2ee0b4b/nihms862052f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4cf/5599319/df4b33cf8206/nihms862052f2.jpg

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