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[ADA2012]ORIGIN试验结果解析
——Hertzel Gerstein博士专访
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作者:H.Gerstein 2012/7/27 13:58:00    加入收藏
内容概要:Gerstein博士:可从多个角度回答这个问题。第一是科学性。作为医生和研究者,必须要提出相关的问题并保证得到尽可能明确和准确的回答。这是一项高质量的研究。就此而言,ORIGIN试验无疑是成功的。

  <International Diabetes>: Here in Philadelphia, there seemed to be two kinds of reactions from people listening to the results of the ORIGIN study. There were compliments to the rigor of the study, though there also seemed to be some disappointment, as there was not a reduction of cardiovascular events for the insulin glargine. What would you say to this disappointment?
  Dr. Gerstein: There are a few answers to this question. The first answer is scientific. It is our obligation as physicians and researchers to ask relevant questions and guarantee that they are answered as clearly and accurately as possible. That is the goal of a good research trial. From that respect, ORIGN was successful by any measure. We asked a clear question and the results, as you saw, were very clear. We demonstrated that in patients with IFG, IGT, or early diabetes, giving an injection of insulin glargine for six to seven years has a neutral effect on cardiovascular outcomes, including deaths and cancers. That information is extremely important to any physician who is dealing with diabetic patients. There has been uncertainty and concern over the safety of insulin since it was first used to treat type I diabetes, and more so for type II diabetes. This study clearly answers those concerns. Of course, it would be wonderful to identify therapies that, in addition to lowering glucose levels, would also reduced cardiovascular events. Yet insulin must be used to manage glucose levels in many patients with type II diabetes. There is good evidence that the management of glucose levels in type II diabetes does reduce eye disease and kidney disease and, in some instances, may have a long term effect on heart disease. This tells us is that if you have to use a glucose lowering agent, basal insulin is a good choice. The only side effects of basal insulin glargine are those that we have known about 90 years, such as modest amounts of hypoglycemia and weight gain, but there are no serious, long terms harms.

  《国际糖尿病》:我们发现ORIGIN试验结果公布后,听众有两种反应。一种是称赞试验的严格;而另有一些学者对结果似乎感到失望,因为甘精胰岛素组的心血管事件并未减少。您对此有何评价?
  Gerstein博士:可从多个角度回答这个问题。第一是科学性。作为医生和研究者,必须要提出相关的问题并保证得到尽可能明确和准确的回答。这是一项高质量的研究。就此而言,ORIGIN试验无疑是成功的。我们提出了一个明确的问题,而结果也是明确的,在IFG、IGT或早期糖尿病患者中,注射甘精胰岛素6~7年,心血管结局呈中性结果,包括死亡和癌症。对于管理糖尿病患者的医生来说,这是非常重要的信息。由于胰岛素是治疗1型糖尿病的一线选择,并且在2型糖尿病治疗中也应用越来越多,学界对胰岛素的安全性一直存在担忧。ORIGIN试验明确解除了这些担忧。当然,如果一种治疗在降低血糖之外,还能减少心血管事件,那当然更加完美。然而,许多2型糖尿病患者必须使用胰岛素来控制血糖水平。我们已经有一些好的证据表明,管理好血糖水平可降低2型糖尿病患者眼病和肾病的发生率,甚至可能对心脏病风险产生长期影响。这告诉我们如果必须使用降血糖药物,基础胰岛素是一个好的选择。甘精胰岛素唯一的不良反应,是我们90年前就知道的,如少量的低血糖和体重增加,但并无严重的、长期的损害。

  <International Diabetes>:How do think this changes insulin glargine’s status within medicine?
  Dr. Gerstein: I think it does change insulin’s status in medicine. Insulin glargine is the drug that we use, as it is a delivery device for basal insulin. This tells gives us a very clear safety profile, so physicians and patients can be reassured that use of this drug will not cause any unknown harms, at least over the next six or seven years. That is very important information. Also, using insulin glargine in people without diabetes reduced new diabetes even after it was stopped. This is reassuring to patients. A lot of patients are concerned when they start insulin, as they fear insulin addiction. We showed early in this study that if you are on insulin, you can stop. Even better, if you were on insulin and stopped, your blood sugar would be lower than if you had never taken it in the first place. This provides reassurance for people who are worried about starting insulin earlier in the course of their disease. On the other hand, it tells that there will be more hypoglycemia and that is acceptable to choose to not use insulin early on. However, you would not be doing any harm with respect to heart disease or anything of that nature, at least when using available drug standards.

  《国际糖尿病》:您认为这些结果是否会改变甘精胰岛素在药物治疗中的地位?
  Gerstein博士:我认为这的确会改变胰岛素在药物治疗中的地位。我们所使用的甘精胰岛素是基础胰岛素的运输装置。这种药物展示了非常明确的安全性,医生和患者可以确信使用该药物不会导致未知的损害,至少在6-7年中不会。这非常重要。此外,无糖尿病的人群使用甘精胰岛素可减少新发糖尿病,即使是停止用药后。这对患者来说是很好的保障。许多患者担心胰岛素成瘾,我们的试验早期就表明,如果你在使用胰岛素,你可以停用。更好的现象是,如果你曾使用胰岛素且已停药,你的血糖仍比你最初从未使用胰岛素的情况更低。这可以打消患者在疾病早期使用胰岛素的忧虑。另一方面,由于有较多的低血糖,选择不过早地使用胰岛素也是可以接受的。但是,就心脏病及其他因素来说,使用胰岛素并不会带来损害,至少使用现行的药物标准不会。

  <International Diabetes>: Do you think this is going to change the way that people are going to prescribe insulin?
  Dr. Gerstein: I think it will, I think it will provide much more confidence for both patients and physicians about the long term safety of insulin. It will not result in a revolution in insulin use, though it should quell a lot of concerns that people have about prescribing insulin. For doctors who look for reasons not to prescribe insulin, this study is clearly needed. In addition, it really makes people think differently about the pathophysiology of heart disease in people with diabetes. This study will force people who are worried about hyperinsulinemia to reevaluate their position. Insulin glargine is not the cause of heart disease in the first place, and one has to rethink one’s approach to it.

  《国际糖尿病》:这是否会改变未来人们处方胰岛素的方式?
  Gerstein博士:我想会的,这将使医生和患者对胰岛素的长期安全性更有信心。虽然这项试验消除了人们对胰岛素的许多担忧,但不会导致胰岛素应用的革新性变化。而对于那些寻求理由不处方胰岛素的医生,这项研究是非常需要的。此外,ORIGIN研究使人们对糖尿病患者发生心脏病的病理生理学产生不同的理解;并将促使担心高胰岛素血症的学者们重新评价其立场。甘精胰岛素不是发生心脏病的原因,人们必须重新审视自己的观点。

  <International Diabetes>: Will this change the way that you prescribe?
  Dr. Gerstein: Personally, it makes it a lot easier to discuss treatment with patients. Patients often express concern for heart disease and cancer with insulin treatment. Before, we did not have evidence to deny this, now there is clear evidence that treatment has a neutral effect on these things. I have a lot more confidence in telling that to patients and it makes my job easier in a lot of ways. I personally prescribe a fair amount of insulin, so I do not know whether I will increase the dosage, but it certainly makes it easier for me when I recommending and discussing it with patients.

  《国际糖尿病》:您会改变处方的方式吗?
  Gerstein博士:就个人观点,这使得医生和患者的讨论变得极为简单。患者常表达对胰岛素治疗中心脏病和癌症风险的担忧。以往,我们没有证据否定这种言论,而现在有了明确的证据表明胰岛素治疗对上述风险的影响是中性的。我有了充分的自信将上述信息告知患者,这为我的工作提供了多方面的便利。我个人非常多地处方胰岛素,我不好说是否将增加剂量,但这的确使我向患者建议胰岛素治疗变得更容

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