临床荟萃 ›› 2022, Vol. 37 ›› Issue (12): 1061-1073.doi: 10.3969/j.issn.1004-583X.2022.12.001
• 循证研究 • 下一篇
收稿日期:
2022-07-26
出版日期:
2022-12-20
发布日期:
2023-01-18
通讯作者:
王润青
E-mail:wrq010914@163.com
Wang Runqing1(), Wang Qian2, Liao Jianxiong1
Received:
2022-07-26
Online:
2022-12-20
Published:
2023-01-18
Contact:
Wang Runqing
E-mail:wrq010914@163.com
摘要:
目的 2型糖尿病是一种慢性疾病,而心血管事件是2型糖尿病常见的并发症,已有大型研究表明钠-葡萄糖共转运体抑制剂(SGLT2i)对改善2型糖尿病患者心血管结局具有一定作用。本文通过系统评价,间接比较了5种不同的SGLT2i对2型糖尿病并发不良心血管事件的疗效作用。方法 检索PubMed、Web of science、Cochrane Library、中国知网、万方、维普数据库,收集相关文献,检索时限为建库至2022年7月,由两位研究员独立筛选文献,并提取相应数据,以心力衰竭住院和心血管死亡复合结局为主要结局指标,以心力衰竭住院、心血管死亡和全因死亡为次要结局指标,使用Stata 16.0以及network程序包进行网状meta分析。结果 共检索到340篇文献,最终纳入11篇文献,包括62 904例患者,涉及5种干预手段,分别为:恩格列净、索格列净、达格列净、埃格列净和卡格列净。5种不同的SGLT2i在改变2型糖尿病患者的心力衰竭住院和心血管死亡复合结局、心血管死亡、心力衰竭住院和全因死亡方面差异无统计学意义(P>0.05)。与安慰剂相比,5种不同的SGLT2i均可显著改善2型糖尿病患者心力衰竭住院结局;恩格列净和索格列净在改善心力衰竭住院和心血管死亡复合结局方面差异有统计学意义;而在改善心血管死亡或全因死亡结局方面,安慰剂和5种不同的SGLT2i之间的差异均无统计学意义。结论 在改善2型糖尿病患者心力衰竭住院和心血管死亡复合结局和心力衰竭住院结局方面,恩格列净和索格列净有较显著的获益趋势,而针对心血管死亡或全因死亡结局,5种不同的SGLT2i与安慰剂间的差异无统计学意义,具体机制和原因仍需大型研究进行探索和验证。
中图分类号:
王润青, 王谦, 廖健雄. SGLT2抑制剂对2型糖尿病患者心血管结局影响的网状meta分析[J]. 临床荟萃, 2022, 37(12): 1061-1073.
Wang Runqing, Wang Qian, Liao Jianxiong. A network meta-analysis of SGLT2 inhibitors on cardiovascular outcomes in patients with type 2 diabetes[J]. Clinical Focus, 2022, 37(12): 1061-1073.
纳入研究 | 年份 | 样本量(例) | 干预措施 | 结局指标 | |||
---|---|---|---|---|---|---|---|
试验组 | 对照组 | 试验组 | 对照组 | ||||
江耀辉[ | 2022 | 671 | 1 310 | 达格列净 | 安慰剂和其他常规治疗 | ①②③④ | |
唐晓笛[ | 2021 | 100 | 100 | 达格列净 | 其他常规治疗 | ①④ | |
Adel[ | 2022 | 45 | 48 | 恩格列净 | 安慰剂 | ①② | |
EMPEROR-Reduced[ | 2021 | 927 | 929 | 恩格列净 | 安慰剂 | ①②③④ | |
SCORED[ | 2021 | 5 292 | 5 292 | 索格列净 | 安慰剂 | ①②③④ | |
VERTIS-CV trial[ | 2020 | 5 499 | 2 747 | 埃格列净 | 安慰剂 | ①②③④ | |
CANVAS Program[ | 2017 | 5 795 | 4 347 | 卡格列净 | 安慰剂 | ①②③④ | |
EMPA-REG[ | 2015 | 4 680 | 2 340 | 恩格列净 | 安慰剂 | ①②③④ | |
DECLARE-TIMI 58[ | 2019 | 8 585 | 8 575 | 达格列净 | 安慰剂 | ①②③④ | |
SOLOIST-WHF[ | 2021 | 608 | 614 | 索格列净 | 安慰剂 | ①②③④ | |
CREDENCE trial[ | 2020 | 2 202 | 2 199 | 卡格列净 | 安慰剂 | ①③④ |
表1 文献的基本特点
纳入研究 | 年份 | 样本量(例) | 干预措施 | 结局指标 | |||
---|---|---|---|---|---|---|---|
试验组 | 对照组 | 试验组 | 对照组 | ||||
江耀辉[ | 2022 | 671 | 1 310 | 达格列净 | 安慰剂和其他常规治疗 | ①②③④ | |
唐晓笛[ | 2021 | 100 | 100 | 达格列净 | 其他常规治疗 | ①④ | |
Adel[ | 2022 | 45 | 48 | 恩格列净 | 安慰剂 | ①② | |
EMPEROR-Reduced[ | 2021 | 927 | 929 | 恩格列净 | 安慰剂 | ①②③④ | |
SCORED[ | 2021 | 5 292 | 5 292 | 索格列净 | 安慰剂 | ①②③④ | |
VERTIS-CV trial[ | 2020 | 5 499 | 2 747 | 埃格列净 | 安慰剂 | ①②③④ | |
CANVAS Program[ | 2017 | 5 795 | 4 347 | 卡格列净 | 安慰剂 | ①②③④ | |
EMPA-REG[ | 2015 | 4 680 | 2 340 | 恩格列净 | 安慰剂 | ①②③④ | |
DECLARE-TIMI 58[ | 2019 | 8 585 | 8 575 | 达格列净 | 安慰剂 | ①②③④ | |
SOLOIST-WHF[ | 2021 | 608 | 614 | 索格列净 | 安慰剂 | ①②③④ | |
CREDENCE trial[ | 2020 | 2 202 | 2 199 | 卡格列净 | 安慰剂 | ①③④ |
[1] | 中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2020年版)[J]. 中华糖尿病杂志, 2021, 13(4): 315-409. |
[2] | 郑刚. 心力衰竭发病机制研究新进展[J]. 中华老年心脑血管病杂志, 2018, 20(4): 428-431. |
[3] |
Abdul-Ghani MA, Norton L, Defronzo RA. Role of sodium-glucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes[J]. Endocr Rev, 2011, 32(4): 515-531.
doi: 10.1210/er.2010-0029 pmid: 21606218 |
[4] |
O'meara E, Mcdonald M, Chan M, et al. CCS/CHFS heart failure guidelines: Clinical trial update on functional mitral regurgitation, SGLT2 inhibitors, ARNI in HFpEF, and tafamidis in amyloidosis[J]. Can J Cardiol, 2020, 36(2): 159-169.
doi: S0828-282X(19)31514-4 pmid: 32036861 |
[5] |
Hutton B, Catalá-López F, Moher D. The PRISMA statement extension for systematic reviews incorporating network meta-analysis: PRISMA-NMA[J]. Med Clin (Barc), 2016, 147(6): 262-266.
doi: 10.1016/j.medcli.2016.02.025 URL |
[6] | 江耀辉, 王喆, 郑汝杰, 等. 达格列净对冠心病合并2型糖尿病患者临床结局的影响[J]. 中国循环杂志, 2022, 37(3): 250-255. |
[7] | 唐晓笛, 樊瑛. 钠-葡萄糖协同转运蛋白抑制剂对合并射血分数保留型心力衰竭的2型糖尿病患者的心血管保护作用研究[J]. 临床心血管病杂志, 2021, 37(1): 68-72. |
[8] |
Adel SMH, Jorfi F, Mombeini H, et al. Effect of a low dose of empagliflozin on short-term outcomes in type 2 diabetics with acute coronary syndrome after percutaneous coronary intervention[J]. Saudi Med J, 2022, 43(5): 458-464.
doi: 10.15537/smj.2022.43.5.20220018 pmid: 35537720 |
[9] |
Anker SD, Butler J, Filippatos G, et al. Effect of empagliflozin on cardiovascular and renal outcomes in patients with heart failure by baseline diabetes status: Results from the EMPEROR-reduced trial[J]. Circulation, 2021, 143(4): 337-349.
doi: 10.1161/CIRCULATIONAHA.120.051824 pmid: 33175585 |
[10] |
Bhatt DL, Szarek M, Pitt B, et al. Sotagliflozin in patients with diabetes and chronic kidney disease[J]. N Engl J Med, 2021, 384(2): 129-139.
doi: 10.1056/NEJMoa2030186 URL |
[11] |
Cannon CP, Pratley R, Dagogo-Jack S, et al. Cardiovascular outcomes with ertugliflozin in type 2 diabetes[J]. N Engl J Med, 2020, 383(15): 1425-1435.
doi: 10.1056/NEJMoa2004967 URL |
[12] | Neal B, Perkovic V, Matthews DR. Canagliflozin and cardiovascular and renal events in type 2 diabetes[J]. N Engl J Med, 2017, 377(21): 2099. |
[13] |
Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes[J]. N Engl J Med, 2015, 373(22): 2117-2128.
doi: 10.1056/NEJMoa1504720 URL |
[14] |
Kato ET, Silverman MG, Mosenzon O, et al. Effect of dapagliflozin on heart failure and mortality in type 2 diabetes mellitus[J]. Circulation, 2019, 139(22): 2528-2536.
doi: 10.1161/CIRCULATIONAHA.119.040130 pmid: 30882238 |
[15] |
Bhatt DL, Szarek M, Steg PG, et al. Sotagliflozin in patients with diabetes and recent worsening heart failure[J]. N Engl J Med, 2021, 384(2): 117-128.
doi: 10.1056/NEJMoa2030183 URL |
[16] |
Jardine MJ, Zhou Z, Mahaffey KW, et al. Renal, cardiovascular, and safety outcomes of canagliflozin by baseline kidney function: A secondary analysis of the CREDENCE randomized trial[J]. J Am Soc Nephrol, 2020, 31(5): 1128-1139.
doi: 10.1681/ASN.2019111168 pmid: 32354987 |
[17] |
Zimmet P, Alberti KG, Magliano DJ, et al. Diabetes mellitus statistics on prevalence and mortality: Facts and fallacies[J]. Nat Rev Endocrinol, 2016, 12(10): 616-622.
doi: 10.1038/nrendo.2016.105 pmid: 27388988 |
[18] | Javeed N, Matveyenko AV. Circadian etiology of type 2 diabetes mellitus[J]. Physiology (Bethesda), 2018, 33(2): 138-150. |
[19] |
Kannel WB, Mcgee DL. Diabetes and cardiovascular disease. The Framingham study[J]. JAMA, 1979, 241(19): 2035-2038.
doi: 10.1001/jama.1979.03290450033020 URL |
[20] |
Iribarren C, Karter AJ, Go AS, et al. Glycemic control and heart failure among adult patients with diabetes[J]. Circulation, 2001, 103(22): 2668-2673.
doi: 10.1161/01.cir.103.22.2668 pmid: 11390335 |
[21] |
Marwick TH, Ritchie R, Shaw JE, et al. Implications of underlying mechanisms for the recognition and management of diabetic cardiomyopathy[J]. J Am Coll Cardiol, 2018, 71(3): 339-351.
doi: S0735-1097(17)41633-0 pmid: 29348027 |
[22] |
Qin CX, Sleaby R, Davidoff AJ, et al. Insights into the role of maladaptive hexosamine biosynthesis and O-GlcNAcylation in development of diabetic cardiac complications[J]. Pharmacol Res, 2017, 116: 45-56.
doi: S1043-6618(16)31338-X pmid: 27988387 |
[23] |
Diamant M, Lamb HJ, Smit JW, et al. Diabetic cardiomyopathy in uncomplicated type 2 diabetes is associated with the metabolic syndrome and systemic inflammation[J]. Diabetologia, 2005, 48(8): 1669-1670.
pmid: 15988579 |
[24] |
Tschöpe C, Walther T, Escher F, et al. Transgenic activation of the kallikrein-kinin system inhibits intramyocardial inflammation, endothelial dysfunction and oxidative stress in experimental diabetic cardiomyopathy[J]. FASEB J, 2005, 19(14): 2057-2059.
pmid: 16129698 |
[25] |
Westermann D, Rutschow S, Van Linthout S, et al. Inhibition of p38 mitogen-activated protein kinase attenuates left ventricular dysfunction by mediating pro-inflammatory cardiac cytokine levels in a mouse model of diabetes mellitus[J]. Diabetologia, 2006, 49(10): 2507-2513.
doi: 10.1007/s00125-006-0385-2 pmid: 16937126 |
[26] |
Rajesh M, Bátkai S, Kechrid M, et al. Cannabinoid 1 receptor promotes cardiac dysfunction, oxidative stress, inflammation, and fibrosis in diabetic cardiomyopathy[J]. Diabetes, 2012, 61(3): 716-727.
doi: 10.2337/db11-0477 pmid: 22315315 |
[27] |
Li J, Zhu H, Shen E, et al. Deficiency of rac1 blocks NADPH oxidase activation, inhibits endoplasmic reticulum stress, and reduces myocardial remodeling in a mouse model of type 1 diabetes[J]. Diabetes, 2010, 59(8): 2033-2042.
doi: 10.2337/db09-1800 pmid: 20522592 |
[28] |
Thomas MC. Type 2 diabetes and heart failure: challenges and solutions[J]. Curr Cardiol Rev, 2016, 12(3): 249-255.
doi: 10.2174/1573403x12666160606120254 pmid: 27280301 |
[29] |
Parati G, Esler M. The human sympathetic nervous system: Its relevance in hypertension and heart failure[J]. Eur Heart J, 2012, 33(9): 1058-1066.
doi: 10.1093/eurheartj/ehs041 pmid: 22507981 |
[30] |
Zoccali C, Mallamaci F, Parlongo S, et al. Plasma norepinephrine predicts survival and incident cardiovascular events in patients with end-stage renal disease[J]. Circulation, 2002, 105(11): 1354-1359.
doi: 10.1161/hc1102.105261 pmid: 11901048 |
[31] |
Nitenberg A, Ledoux S, Valensi P, et al. Impairment of coronary microvascular dilation in response to cold pressor--induced sympathetic stimulation in type 2 diabetic patients with abnormal stress thallium imaging[J]. Diabetes, 2001, 50(5): 1180-1185.
pmid: 11334424 |
[32] |
Huynh K, Bernardo BC, Mcmullen JR, et al. Diabetic cardiomyopathy: Mechanisms and new treatment strategies targeting antioxidant signaling pathways[J]. Pharmacol Ther, 2014, 142(3): 375-415.
doi: 10.1016/j.pharmthera.2014.01.003 URL |
[33] |
Bolinder J, Ljunggren Ö, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin[J]. J Clin Endocrinol Metab, 2012, 97(3): 1020-1031.
doi: 10.1210/jc.2011-2260 pmid: 22238392 |
[34] |
Lambers Heerspink H J, De Zeeuw D, Wie L, et al. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes[J]. Diabetes Obes Metab, 2013, 15(9): 853-862.
doi: 10.1111/dom.12127 pmid: 23668478 |
[35] |
Abdul-Ghani M, Del Prato S, Chilton R, et al. SGLT2 inhibitors and cardiovascular risk: Lessons learned from the EMPA-REG outcome study[J]. Diabetes Care, 2016, 39(5): 717-725.
doi: 10.2337/dc16-0041 pmid: 27208375 |
[36] |
Abdul-Ghani MA, Norton L, Defronzo RA. Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus[J]. Am J Physiol Renal Physiol, 2015, 309(11): F889-900.
doi: 10.1152/ajprenal.00267.2015 URL |
[37] |
Odden MC, Amadu AR, Smit E, et al. Uric acid levels, kidney function, and cardiovascular mortality in US adults: National Health and Nutrition Examination Survey (NHANES) 1988-1994 and 1999-2002[J]. Am J Kidney Dis, 2014, 64(4): 550-557.
doi: 10.1053/j.ajkd.2014.04.024 pmid: 24906981 |
[38] | 许藏丹, 赵新, 顾文元. 钠-葡萄糖共转运蛋白2抑制剂对伴有严重肾功能不全的2型糖尿病患者心血管保护作用的Meta分析[J]. 临床荟萃, 2022, 37(1):14-19. |
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