新版ADA糖尿病诊疗标准强烈推荐使用他汀类药物

美国糖尿病学会（ADA）于2014年12月23日在线发布了糖尿病医学诊疗标准（修订版）。依据ADA颁布的糖尿病患者管理2015年更新标准，不论患者心血管疾病风险谱高低，大多数糖尿病患者都应该接受至少中等强度的他汀类药物治疗。

2015年ADA糖尿病诊疗标准对ADA官方推荐的糖尿病患者应用他汀类药物的治疗评价方法进行了修订，新版修订标准中推荐依据患者心血管疾病风险谱决定是否使用他汀类药物治疗，而非根据患者血清低密度脂蛋白（LDL）胆固醇水平决定。这些变化使得ADA立场与美国心脏病学会（ACC）和美国心脏学会（AHA）2013年底发布的成人降胆固醇治疗指南中所倡导的方法相一致。(J. Am. Coll. Cardiol. 2014;63:2889-934).

ADA专业实践委员会主席，美国奥克兰市北加州凯撒医疗机构研究员和初级保健医师，Richard W. Grant教授透露道，这部最新的修订标准是由14名专家组成的一个工作小组制定。在新版指南中，对糖尿病患者使用他汀类药物治疗的相关推荐意见进行了大幅修订，其中最主要的、也是变化最大的地方在于我们该如何给予糖尿病患者使用他汀类药物治疗。

Grant教授在接受采访时指出，我们赞同2013年ACC/AHA胆固醇治疗指南中推荐的意见，是否起始他汀类药物治疗应根据患者心血管疾病风险决定，结果发现，几乎所有的2型糖尿病患者都需要使用他汀类药物治疗。

这部最新版修订标准中，推荐所有年龄40至75岁的糖尿病患者，以及即使没有其他心血管疾病危险因素，但年龄超过75岁的糖尿病患者都应接受中等强度的他汀类药物治疗。(Diabetes Care 2015;38:S1-S94).

对于那些被诊断患有心血管疾病的糖尿病患者，以及那些年龄40至75岁，且合并其他心血管疾病危险因素的糖尿病患者，应接受高强度他汀类药物治疗。而对于那些年龄超过75岁，且合并心血管疾病危险因素的糖尿病患者，在新版修订标准中要求使用中等强化或高强度他汀类药物治疗。

但是，对于那些年龄小于40岁，且无心血管疾病或心血管疾病危险因素的糖尿病患者，新版修订标准中没有要求使用他汀类药物治疗。如果患者年龄小于40岁，但合并心血管疾病危险因素，则要求使用中等强度或高强度他汀类药物治疗，如果这些患者合并心血管疾病，则要求使用高强度他汀类药物治疗。

在ADA推荐意见中，心血管风险极低的年轻糖尿病患者无需使用他汀类药物治疗，这个观点可能与2013年ACC/AHA胆固醇治疗指南中推荐的意见有些出入。对于这个患者人群而言，新版修订标准中的推荐意见是，他汀类药物治疗需要个体化，应基于降低动脉粥样硬化性心血管疾病风险方面获益、他汀类药物治疗潜在的不良反应、药物间的相互作用、以及患者意愿综合考虑。

2015年ADA糖尿病医学诊疗修订标准中还包含了许多其他要点，包括对糖尿病患者的舒张压控制目标进行修订，从之前的80mmHg放宽至90mmHg。收缩压控制目标在2014年ADA糖尿病医学诊疗修订标准基础上就行修订，放宽至低于140mmHg。

Grant教授指出，现有文献中大部分最佳证据都支持将舒张压控制目标放宽至90mmHg，仅有较低级别的证据支持将舒张压控制目标定为小于80mmHg。

Grant教授等也注意到，新版修订标准中糖尿病患者血压控制目标定为小于140/90mmHg，这一标准与2014年美国第8届高血压全国联合委员会最初制定的推荐意见相一致。(JAMA 2014;311:507-20).

对于糖尿病患者血糖控制目标，新版修订标准中推荐餐前血糖目标放宽至80mg/dL至130mg/dL，餐前血糖控制目标的下限由70mg/dL增加至80mg/dL。这一变化反映了血液中糖化血红蛋白A1c水平相对应血糖水平的最新研究数据。

在新版修订标准中，将亚裔美国人超重和肥胖筛查的BMI切点定为23kg/m2，较之间的切点25kg/m2有明显的提高。

此外，Grant教授还阐述道，在新增的专注于妊娠期间糖尿病患者管理章节中，整合了既往已经发布的不同指南共识中的相关信息。这一章节详细讨论了妊娠糖尿病患者的管理，以及妊娠之前已合并1型或2型糖尿病患者的管理方面内容。

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Most patients with diabetes should receive at least a moderate statin dosage regardless of their cardiovascular disease risk profile, according to the American Diabetes Association’s annual update to standards for managing patients with diabetes.

 

 “Standards of Medical Care in Diabetes–2015” also shifts the ADA’s official recommendation on assessing patients for statin treatment from a decision based on blood levels of low density lipoprotein (LDL) cholesterol to a risk-based assessment. That change brings the ADA’s position in line with the approach advocated in late 2013 by guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) (J. Am. Coll. Cardiol. 2014;63:2889-934).

The ADA released the revised standards online Dec. 23.

The statin use recommendation is “a major change, a fairly big change in how we provide care, although not that big a change in what most patients are prescribed,” said Dr. Richard W. Grant, a primary care physician and researcher at Kaiser Permanente Northern California in Oakland and chair of the ADA’s Professional Practice Committee, the 14-member panel that produced the revised standards.

“We agreed [with the 2013 ACC and AHA lipid guidelines] that the decision to start a statin should be based on a patient’s cardiovascular disease risk, and it turns out that nearly every patient with type 2 diabetes should be on a statin,” Dr. Grant said in an interview.

The revised standards recommend a “moderate” statin dosage for patients with diabetes who are aged 40-75 years, as well as those who are older than 75 years even if they have no other cardiovascular disease risk factors (Diabetes Care 2015;38:S1-S94). 

The dosage should be intensified to “high” for patients with diagnosed cardiovascular disease, and for patients aged 40-75 years with other cardiovascular disease risk factors. For patients older than 75 years with cardiovascular disease risk factors, the new revision calls for either a moderate or high dosage.

However, for patients younger than 40 years with no cardiovascular disease or risk factors, the revised standards call for no statin treatment, a moderate or high dosage for patients younger than 40 years with risk factors, and a high dosage for those with cardiovascular disease. 

The ADA’s recommendation for no statin treatment of the youngest and lowest-risk patients with diabetes is somewhat at odds with the 2013 ACC and AHA recommendations. For this patient group, those recommendations said, “statin therapy should be individualized on the basis of considerations of atherosclerotic cardiovascular disease risk-reduction benefits, the potential for adverse effects and drug-drug interactions, and patient preferences.”

The new standards revision contains several other changes, including:
 

• The recommended goal diastolic blood pressure for patients with diabetes was revised to less than 90 mm Hg, an increase from the 80–mm Hg target that had been in place. That change follows a revision in the ADA’s 2014 standards that increased the systolic blood pressure target to less than 140 mm Hg.

Changing the diastolic target to less than 90 mm Hg was primarily a matter of following the best evidence that exists in the literature, Dr. Grant said, because only lower-grade evidence supports a target of less than 80 mm Hg.

The revised standards also note that the new targets of less than 140/90 mm Hg put the standards “ in harmonization” with the 2014 recommendations of the panel originally assembled at the Eighth Joint National Committee (JAMA 2014;311:507-20).

• The recommended blood glucose target when measured before eating is now 80-130 mg/dL, with the lower limit increased from 70 mg/dL. That change reflects new data that correlate blood glucose levels with blood levels of hemoglobin A1c.

• The revision sets the body mass index cutpoint for screening overweight or obese Asian Americans at 23 kg/m2, an increase from the prior cutpoint of 25 kg/m2.

• A new section devoted to managing patients with diabetes during pregnancy draws together information that previously had been scattered throughout the standards document, Dr. Grant explained. The section discusses gestational diabetes management, as well as managing women who had preexisting type 1 or type 2 diabetes prior to becoming pregnant.

Dr. Grant had no disclosures.