Cilostazol Treatment of Claudication in Diabetic Patients
Cilostazol Treatment of Claudication in Diabetic Patients
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西洛他唑治疗糖尿病患者跛行
DOI：
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发表时间：
2002
影响因子：
2.3
通讯作者：
Peter Zhang
中科院分区：
文献类型：
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作者：
M. Rendell;A. Cariski;N. Hittel;Peter Zhang
总结目标：比较西洛他唑在8项（6项安慰剂对照和2项活性对照）随机、双盲III期试验的糖尿病和非糖尿病患者中的疗效和安全性。设计图：我们仅纳入了试验数据集中接受西洛他唑100 mg每日两次（216例糖尿病患者/599例非糖尿病患者）或安慰剂（220/616）的患者。使用标准的踏车运动方案，通过绝对跛行距离（ACD）来测量疗效。结果如下：在糖尿病和非糖尿病患者中，西洛他唑上级优于安慰剂（估计治疗效果分别为1.15，95%置信区间，1.05-1.25，p = 0.001; 1.24，1.18 -1.31，p < 0.0001）。糖尿病受试者和非糖尿病受试者之间的反应无统计学差异。在疗效分析中，基线ACD最低的西洛他唑治疗糖尿病受试者（但基线ACD较大的受试者除外）比基线时多行走约34%，而非糖尿病受试者多行走23%。糖尿病患者和非糖尿病患者使用西洛他唑的不良事件特征无显著差异。西洛他唑治疗的糖尿病患者未发生过多出血事件。试验持续时间为12至24周。结论：糖尿病和非糖尿病间歇性跛行患者对西洛他唑的反应良好，总体反应无显著差异。伴有最严重跛行的糖尿病患者的反应优于那些受影响较小的患者，但非糖尿病患者的反应随着基线ACD的增加而增加。两个人群的不良事件发生率相当，尽管糖尿病患者的发病率可能更高。西洛他唑是治疗糖尿病和非糖尿病人群跛行的安全有效的药物。
Summary Objective: To compare the efficacy and safety of cilostazol in diabetic and non-diabetic patients from eight (six placebo- and two active-controlled) randomised, double-blind phase III trials. Design: We only included patients from the trial data set receiving cilostazol 100 mg twice daily (216 diabetic/599 non-diabetic) or placebo (220/616). Efficacy was measured by absolute claudication distance (ACD), using standard treadmill exercise protocols. Results: Among diabetic and non-diabetic patients, cilostazol was superior to placebo (estimated treatment effect 1.15, 95% confidence interval, 1.05-1.25, p = 0.001; and 1.24,1.18-1.31, p < 0.0001, respectively). There was no statistical difference in response between diabetic and non-diabetic subjects. In the efficacy analysis, cilostazol-treated diabetic subjects with the lowest baseline ACD (but not those with greater baseline ACD) walked approximately 34% farther than at baseline, whereas their non-diabetic counterparts walked 23% farther. There was no significant difference in the adverse event profile of the diabetic and non-diabetic patients on cilostazol. No excess haemorrhagic events occurred in cilostazol-treated diabetic patients. Trial duration varied from 12 to 24 weeks. Conclusions: Diabetic and non-diabetic patients with intermittent claudication respond favourably to cilostazol, with no significant difference in their overall response. Diabetic individuals with the most severe claudication respond better than those less affected, but the response of non-diabetic patients increases as baseline ACD increases. Adverse event incidence was comparable in the two populations, although diabetic patients might be expected to experience greater morbidity. Cilostazol is a safe and effective treatment for claudication in diabetic and non-diabetic populations.