雷米普利预防糖尿病的作用有限

2006-10-14 00:00 来源:丁香园 作者:cplamst 译
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    美国纽约路透社(健康专栏)10月11日电 以前的研究显示雷米普利能够阻止前驱糖尿病患者发展为糖尿病,与此相反,一项随访3年的多中心前瞻性临床研究(雷米普利与罗格列酮预防糖尿病的评价试验,DREAM试验)显示:雷米普利在降低空腹血糖受损或糖耐量减低患者糖尿病的发病率与死亡率方面并不优于安慰剂。但是,该研究表明雷米普利可以促进血糖恢复正常水平,从而改善糖代谢。这项研究发表在10月12日的《新英格兰杂志》上。

    研究人员称:以前评价血管紧张素转换酶抑制剂(雷米普利)的研究均选用了伴有心血管高危因素的患者,而且没有对血糖水平进行标准评价,使得心血管危险因素可能干扰试验结果。而DREAM试验则选用30岁及以上不伴有心血管疾病的空腹血糖受损(空腹血糖:110-126 mg/dl)或糖耐量降低(口服糖后2小时血糖:140-200 mg/dl)的患者。

    2623名受试者被随机分配到雷米普利(15mg/日)治疗组和安慰剂治疗组。平均随访3年后,两组受试者在糖尿病的发病率与死亡率上没有显著性差异,同样,平均空腹血糖水平也没有显著性差异。但是,与安慰剂组相比,雷米普利治疗组中,空腹血糖水平与口服糖后2小时血糖水平正常的人数显著性增加(42.5%对38.2%,危险比为1.16,p = 0.0001)。此外,雷米普利治疗组平均口服糖后2小时血糖水平(135.1 mg/dl)比安慰组(140.5mg/dl)低(p = 0.01)。当然,研究人员也表示该试验随访时间短可能导致没有观察到两组受试者在糖尿病的发病率及死亡率上的差异。

    研究人员总结说:“从雷米普利使血糖恢复正常水平的作用及目前其他有效的相关资料来看,阻断肾素-血管紧张素系统的药物对改善糖代谢有一定作用。但目前尚无常规应用雷米普利来预防糖尿病的证据。

    对此,《新英格兰杂志》副主编Julie R. Ingelfinger博士和Caren G. Solomon博士也表示赞同。他们在该研究的述评中提到:“控制饮食和加强锻炼仍然是目前降低糖尿病发病率的最佳手段。” 


 Ramipril of Limited Benefit in Preventing Diabetes

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NEW YORK (Reuters Health) Oct 11 - Contrary to previous research suggesting that ramipril may check the progression to diabetes in pre-diabetics, 3-year results of a multinational, prospective trial failed to show that ramipril is superior to placebo in reducing the incidence of diabetes or death in a cohort of patients with impaired fasting glucose levels or impaired glucose tolerance.

However, ramipril may improve glucose metabolism by promoting regression to normoglycemia, according to investigators participating in the DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication) trial.

In their report in the New England Journal of Medicine for October 12, the trialists note that other studies evaluating the effects of the angiotensin-converting-enzyme (ACE) inhibitor ramipril were focused on patients with or at high risk for cardiovascular disease, and did not include standard assessments of glucose levels.

The ramipril arm of the DREAM trial included individuals age 30 and over who had impaired fasting glucose levels between 110 and 126 mg/dL or a glucose level of 140 to 200 mg/dL 2 hours after an oral glucose load (impaired glucose tolerance) and were free of cardiovascular disease.

The researchers randomly assigned 2623 patients to ramipril, up to 15mg/day, and 2646 to placebo.

After a median of 3 years follow-up, there were no significant differences between groups in deaths or the development of diabetes. Similarly, median fasting plasma glucose levels were unaffected by group assignment.

However, significantly more patients treated with ramipril had normal fasting plasma glucose levels and normal 2-hour plasma glucose levels (42.5% versus 38.2%, hazard ratio 1.16, p = 0.0001), compared with placebo. Moreover, median 2-hour post-load plasma glucose levels were lower in the ramipril group (135.1 versus 140.5, p = 0.01).

The investigators acknowledge that the trial's duration may have been too short to catch more significant differences in progression to diabetes or mortality.

They conclude: "The effect (of ramipril) with respect to regression to normoglycemia and the totality of the available data suggest that drugs that block the renin-angiotensin system may have a modest, favorable effect on glucose metabolism."

Still, the DREAM team advises that "for now, routine use of ramipril for the express purpose of preventing diabetes is not indicated."

New England Journal of Medicine deputy editors Dr. Julie R. Ingelfinger and Dr. Caren G. Solomon concur. "Ongoing attention to diet and exercise remains our best hope for reducing the rising rate of diabetes," they write in an accompanying editorial.

N Engl J Med 2006; 355:1441-1562,1608-1610.

【译者按】DREAM试验关于罗格列酮的评价部分请参考蓝色幻想站友编译的药物可能延缓糖尿病的发生

    先前的研究(参考雷米普利可降低糖尿病的危险性)的确混杂了心血管风险因素,因为许多心血管的危险因素也是糖尿病的危险因子(如老年、肥胖、高脂血症等),因此该研究(雷米普利可降低糖尿病的危险性)不能解释到底是雷米普利的作用,还是组间不平衡的心血管危险因子所导致该试验结果,故而存在缺陷。

    而DREAM试验关于罗格列酮的评价(参考药物可能延缓糖尿病的发生),受试者也定期接受了健康饮食和生活方式的建议,而饮食与生活方式的调整已被证实能显著降低糖尿病的发病率。因此该评价试验结果中也可能混杂该因素的影响。 相比之下,DREAM试验关于雷米普利的评价(即本帖编译的报道),除了随访时间相对较短外,其他干扰因素不太明显。


编辑:蓝色幻想

编辑: 张靖

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