2型糖尿病合并动脉粥样硬化性心血管疾病患者降糖药物应用专家共识Chinese expert consensus on anti-diabetic agents in treating patients with type 2 diabetes and atherosclerotic cardiovascular disease
洪天配,母义明,纪立农,郭晓蕙,朱大龙,童南伟,霍勇,谌贻璞,赵冬,焦凯,李全民,李焱,李艳波,李玉秀,刘建英,彭永德,秦映芬,苏青,汤旭磊,向光大,杨刚毅,叶山东,张波
摘要(Abstract):
动脉粥样硬化性心血管疾病(ASCVD)包括冠心病、缺血性卒中及外周动脉疾病,是2型糖尿病(T2DM)患者致死和致残的主要原因。目前国内外糖尿病防治指南均推荐,对于T2DM患者,必须加强高血糖、高血压、血脂异常、肥胖等多重心血管危险因素的综合管理,以最大限度降低心血管事件和死亡风险。近年来,由于美国FDA的强制性要求,全球已完成或正在开展一系列新型降糖药物的心血管结局研究(CVOT)。已经公布的两项CVOT显示,在伴有心血管疾病或高危因素的T2DM患者中,恩格列净和利拉鲁肽可显著降低心血管事件和死亡风险。因此,本共识建议,对于T2DM合并ASCVD患者,在选择降糖药物时,除关注降糖疗效外,还应特别注意心血管安全性问题;对于血糖控制不佳的这类患者,在二甲双胍等标准治疗的基础上可考虑优先选择具有明确心血管获益证据的降糖药物(如利拉鲁肽或恩格列净)治疗。
关键词(KeyWords): 糖尿病,2型;动脉粥样硬化性心血管疾病;降糖药物
基金项目(Foundation):
作者(Author): 洪天配,母义明,纪立农,郭晓蕙,朱大龙,童南伟,霍勇,谌贻璞,赵冬,焦凯,李全民,李焱,李艳波,李玉秀,刘建英,彭永德,秦映芬,苏青,汤旭磊,向光大,杨刚毅,叶山东,张波
参考文献(References):
- [1]Yang W,Lu J,Weng J,et al.Prevalence of diabetes among men and women in China.N Engl J Med,2010,362:1090-1101.
- [2]Xu Y,Wang L,He J,et al.Prevalence and control of diabetes in Chinese adults.JAMA,2013,310:948-959.
- [3]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版).中华糖尿病杂志,2014,22:S2-S42.
- [4]Task Force Members,Rydén L,Grant PJ,et al.ESC Guidelines on diabetes,pre-diabetes,and cardiovascular diseases developed in collaboration with the EASD:the Task Force on diabetes,prediabetes,and cardiovascular diseases of the European Society of Cardiology(ESC)and developed in collaboration with the European Association for the Study of Diabetes(EASD).Eur Heart J,2013,34:3035-3087.
- [5]Hu DY,Pan CY,Yu JM,et al.The relationship between coronary artery disease and abnormal glucose regulation in China:the China Heart Survey.Eur Heart J,2006,27:2573-2579.
- [6]中华医学会糖尿病学分会糖尿病慢性并发症调查组.全国住院糖尿病患者慢性并发症及其相关危险因素10年回顾性调查分析.中国糖尿病杂志,2003,11:232-237.
- [7]张斌,向红丁,毛微波,等.北京、上海、天津、重庆四城市住院2型糖尿病患者糖尿病慢性并发症及相关大血管疾病的流行病学分析.中国医学科学院学报,2002,24:452-456.
- [8]Ji L,Hu D,Pan C,et al.Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients.Am J Med,2013,126:925.e11-e 22.
- [9]中华医学会心血管病学分会流行病学组,中国医师协会心血管内科医师分会,中国老年学学会心脑血管病专业委员会.糖代谢异常与动脉粥样硬化性心血管疾病临床诊断和治疗指南.中华心血管病杂志,2015,43:488-506.
- [10]中国成人血脂异常防治指南修订联合委员会.中国成人血脂异常防治指南(2016年修订版).中国循环杂志,2016,31:937-953.
- [11]American Diabetes Association.Standards of medical care in diabetes-2017.Diabetes Care,2017,40(Suppl 1):S1-S135.
- [12]中华医学会内分泌学分会.中国2型糖尿病合并肥胖综合管理专家共识.中华内分泌代谢杂志,2016,32:623-627.
- [13]UK Prospective Diabetes Study(UKPDS)Group.Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes(UKPDS 34).Lancet,1998,352:854-865.
- [14]Holman RR,Paul SK,Bethel MA,et al.10-year follow-up of intensive glucose control in type 2 diabetes.N Engl J Med,2008,359:1577-1589.
- [15]Duckworth W,Abraira C,Moritz T,et al.Glucose control and vascular complications in veterans with type 2 diabetes.N Engl J Med,2009,360:129-139.
- [16]The Action to Control Cardiovascular Risk in Diabetes Study Group.Effects of intensive glucose lowering in type 2 diabetes.N Engl J Med,2008,358:2545-2559.
- [17]ADVANCE Collaborative Group,Patel A,Mac Mahon S,et al.Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.N Engl J Med,2008,358:2560-2572.
- [18]Marso SP,Daniels GH,Brown-Frandsen K,et al.Liraglutide and cardiovascular outcomes in type 2 diabetes.N Engl J Med,2016,375:311-322.
- [19]Zinman B,Wanner C,Lachin JM,et al.Empagliflozin,cardiovascular outcomes,and mortality in type 2 diabetes.N Engl J Med,2015,373:2117-2128.
- [20]Home PD,Pocock SJ,Beck-Nielsen H,et al.Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes(RECORD):a multicentre,randomised,open-label trial.Lancet,2009,373:2125-2135.
- [21]Dormandy JA,Charbonnel B,Eckland DJ,et al.Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study(PROspective pioglit Azone Clinical Trial In macro Vascular Events):a randomised controlled trial.Lancet,2005,366:1279-1289.
- [22]Erdmann E,Harding S,Lam H,et al.Ten-year observational follow-up of PROactive:a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes.2016,18:266-273.
- [23]The ORIGIN Trial Investigators.Basal insulin and cardiovascular and other outcomes in dysglycemia.N Engl J Med,2012,367:319-328.
- [24]Green JB,Bethel MA,Armstrong PW,et al.Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes.N Engl J Med,2015,373:232-242.
- [25]Scirica BM,Bhatt DL,Braunwald E,et al.Saxagliptin and cardiovascular outcomesin patients with type 2 diabetes mellitus.N Engl J Med,2013,369:1317-1326.
- [26]White WB,Cannon CP,Heller SR,et al.Alogliptin after acute coronary syndromein patients with type 2 diabetes.N Engl J Med,2013,369:1327-1335.
- [27]Pfeffer MA,Claggett B,Diaz R,et al.Lixisenatide in patients with type 2 diabetes and acute coronary syndrome.N Engl J Med,2015,373:2247-2257.
- [28]Varvaki Rados D,Catani Pinto L,Reck Remonti L,et al.The association between sulfonylurea use and all-cause and cardiovascular mortality:A meta-analysis with trial sequential analysis of randomized clinical trials.PLo S Med,2016,13:e1001992.
- [29]Group NS,Holman RR,Haffner SM,et al.Effect of nateglinide on the incidence of diabetes and cardiovascular events.N Engl J Med,2010,362:1463-1476.
- [30]Schweizer A,Dejager S,Foley JE,et al.Assessing the cardiocerebrovascular safety of vildagliptin:meta-analysis of adjudicated events from a large phase III type 2 diabetes population.Diabetes Obes Metab,2010,12:485-494.
- [31]Raz I,Wilson PW,Strojek K,et al.Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes:the HEART2D trial.Diabetes Care,2009,32:381-386.
- [32]Raz I,Ceriello A,Wilson PW,et al.Post hoc subgroup analysis of the HEART2D trial demonstrates lower cardiovascular risk in older patients targeting postprandial versus fasting/premeal glycemia.Diabetes Care,2011,34:1511-1513.
- [33]van de Laar FA,Lucassen PL,Akkermans RP,et al.Alphaglucosidase inhibitors for patients with type 2 diabetes:results from a Cochrane systematic review and meta-analysis.Diabetes Care,2005,28:154-163.
- [34]Cai X,Gao X,Yang W,et al.DPP-4 inhibitor treatment in Chinese type 2 diabetes patients:A meta-analysis.Diabetes Technol Ther,2016,18:784-793.
- [35]Kim YG,Hahn S,Oh TJ,et al.Differences in the Hb A1clowering efficacy of glucagon-like peptide-1 analogues between Asians and non-Asians:a systematic review and meta-analysis.Diabetes Obes Metab,2014,16:900-909.
- [36]Inzucchi SE,Bergenstal RM,Buse JB,et al.Management of hyperglycemia in type 2 diabetes,2015:a patient-centered approach:update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes.Diabetes Care,2015,38:140-149.
- [37]高颖,杨光燃,周迎生,等.心血管疾病合并糖尿病口服降糖药物应用专家共识.中华内科杂志,2014,53:833-838.
- [38]KDIGO.Section 2:AKI Definition.Kidney Int Suppl(2011),2012,2:19-36.
- [39]Zannad F,Cannon CP,Cushman WC,et al.Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE:a multicentre,randomised,double-blind trial.Lancet,2015,385:2067-2076.
- [40]Masoudi FA,Inzucchi SE,Wang Y,et al.Thiazolidinediones,metformin,and outcomes in older patients with diabetes and heart failure:an observational study.Circulation,2005,111:583-590.
- [41]Frier BM,Schernthaner G,Heller SR.Hypoglycemia and cardiovascular risk.Diabetes Care,2011,34(Suppl 2):S132-S137.
- [42]洪天配,郭晓蕙.2型糖尿病合并慢性肾脏病患者口服降糖药治疗的新进展.2016,24:769-772.
- [43]Davies MJ,Bain SC,Atkin SL,et al.Efficacy and safety of liraglutide versus placebo as add-on to glucose-lowering therapy in patients with type 2 diabetes and moderate renal impairment(LIRA-RENAL):A randomized clinical trial.Diabetes Care,2016,39:222-230.
- [44]Marso SP,Bain SC,Consoli A,et al.Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.N Engl J Med,375:1834-1844.