Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial.
Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial.
复制标题
DOI：
10.1371/journal.pone.0017554
复制
发表时间：
2011-03-11
期刊：
影响因子：
3.7
通讯作者：
DIATOR Study Group
中科院分区：
文献类型：
--
作者：
Martin S;Herder C;Schloot NC;Koenig W;Heise T;Heinemann L;Kolb H;DIATOR Study Group
最近的证据表明，降脂剂阿托伐他汀也是一种有效的免疫调节剂。本研究的目的是探讨阿托伐他汀对新近发病的1型糖尿病患者残余β细胞功能下降的可能影响。随机安慰剂对照糖尿病和阿托伐他汀（DIATOR）试验纳入了德国12个中心的89例新诊断的1型糖尿病和胰岛自身抗体患者（平均年龄30岁，40%为女性）。患者接受安慰剂或80 mg/d阿托伐他汀治疗18个月。作为主要结果刺激血清C肽水平测定后90分钟的标准化液体混合餐。进行了意向治疗分析。在18个月时，两组之间的空腹和刺激C肽水平无显著差异。然而，安慰剂组的中位空腹血清C肽水平从基线下降到12和18个月（从0。34至0.23和0.20 nmol/l，p<0.001），而阿托伐他汀组无显著性下降（从0.34至0.27和0.30 nmol/l，ns）。在基线和12个月之间，中位刺激C肽浓度下降（安慰剂从0.89 nmol/l降至0.71 nmol/l，阿托伐他汀从0.88 nmol/l降至0.73 nmol/l，p<0.01），随后安慰剂组在第18个月时出现重大损失（降至0.48 nmol/l，p = 0.047），但阿托伐他汀组未出现这种情况（降至0.71 nmol/l，ns）。 仅阿托伐他汀组的总胆固醇和C反应蛋白中位数水平降低（p<0.001和p = 0.04）。 两组之间的代谢控制相似。阿托伐他汀治疗没有显著保护β细胞功能，尽管β细胞功能可能下降较慢，值得进一步研究。ClinicalTrials.gov NCT00974740
Recent evidence suggests that the lipid-lowering agent atorvastatin is also a potent immunomodulator. The aim of this study was to investigate the possible effect of atorvastatin on the decline of residual beta cell function in recent-onset type 1 diabetes. The randomised placebo-controlled Diabetes and Atorvastatin (DIATOR) Trial included 89 patients with newly diagnosed type 1 diabetes and islet autoantibodies (mean age 30 years, 40% females), in 12 centres in Germany. Patients received placebo or 80 mg/d atorvastatin for 18 months. As primary outcome stimulated serum C-peptide levels were determined 90 min after a standardized liquid mixed meal. An intent-to-treat analysis was performed. Fasting and stimulated C-peptide levels were not significantly different between groups at 18 months. However, median fasting serum C-peptide levels dropped from baseline to 12 and 18 months in the placebo group (from 0. 34 to 0.23 and 0.20 nmol/l, p<0.001) versus a nonsignificant decline in the atorvastatin group (from 0.34 to 0.27 and 0.30 nmol/l, ns). Median stimulated C-peptide concentrations declined between baseline and 12 months (placebo from 0.89 to 0.71 nmol/l, atorvastatin from 0.88 to 0.73 nmol/l, p<0.01 each) followed by a major loss by month 18 in the placebo group (to 0.48 nmol/l, p = 0.047) but not in the atorvastatin group (to 0.71 nmol/l, ns). Median levels of total cholesterol and C-reactive protein decreased in the atorvastatin group only (p<0.001 and p = 0.04). Metabolic control was similar between groups. Atorvastatin treatment did not significantly preserve beta cell function although there may have been a slower decline of beta-cell function which merits further study. ClinicalTrials.gov NCT00974740
登录
查看更多内容
影响因子：
7.7
作者：
Hanifi-Moghaddam, P;Schloot, NC;Kolb, H
通讯作者：
Kolb, H
影响因子：
4.4
作者：
Blank, Norbert;Schiller, Martin;Lorenz, Hanns-Martin
通讯作者：
Lorenz, Hanns-Martin
影响因子：
7.7
作者：
Lozanoska-Ochser, B;Barone, F;Peakman, M
通讯作者：
Peakman, M
影响因子：
3.2
作者：
Bonnet, Jacques;McPherson, R.;Davignon, Jean
通讯作者：
Davignon, Jean
影响因子：
6.2
作者：
Contreras, JL;Smyth, CA;Eckhoff, DE
通讯作者：
Eckhoff, DE