SGLT2抑制剂、DPP-4抑制剂和磺酰脲类药物在糖尿病酮症酸中毒方面的安全性比较

2022-08-23 liangying MedSci原创

与DPP-4抑制剂和磺酰脲类药物相比,新开SGLT2抑制剂的2型糖尿病患者发生糖尿病酮症酸中毒的比例更高。

随机对照试验(RCT)表明,钠-葡萄糖共转运蛋白-2(SGLT-2)降低了2型糖尿病患者的心肌梗死、心力衰竭、肾功能衰竭、心血管死亡率和潜在全因死亡率。然而,它们的使用也伴随着几个重要的安全问题,包括可能增加糖尿病酮症酸中毒(DKA)的风险。

近日,有一项研究评估了SGLT2抑制剂二肽基肽酶4 (DPP-4)抑制剂磺酰脲类药物在2型糖尿病患者中与糖尿病酮症酸中毒的关系。

研究者进行了一项新的用户主动对照队列研究,进行了两两比较:1)SGLT2抑制剂DPP-4抑制剂;2)SGLT3抑制剂磺脲类药物。主要结果是入院时出现糖尿病酮症酸中毒。通过倾向得分匹配调整混杂因素。我们使用Cox比例风险回归和稳健方差估计来估计风险比(HRs)和相应的95%CI。

在队列1中(SGLT2抑制剂的n=85125,DPP-4抑制剂的n=85125),SGLT2DPP4抑制剂的每1000人年糖尿病酮症酸中毒发病率分别为6.0和4.3。在队列2中(SGLT2抑制剂的n=72436,磺脲类药物的n=72 436),每1000人年糖尿病酮症酸中毒的发病率分别为SGLT2磺脲类的6.3和4.5。在Cox比例风险回归模型中,与DPP-4抑制剂(校正HR[aHR]1.63;95%置信区间1.36,1.96)和磺脲类药物(aHR 1.56;95%可信区间1.30,1.87)相比,使用SGLT2抑制剂与糖尿病酮症酸中毒的发生率更高。

糖尿病酮症酸中毒病理生理机制

另一项加拿大观察性药物效应研究网络(CNODES)开展了一项大型人群队列研究,评估SGLT-2抑制剂DPP-4抑制剂在2型糖尿病患者中发生DKA的风险。研究者利用时间条件倾向评分将208757名SGLT-2抑制剂的新用户与208757名DPP-4抑制剂的接受者进行匹配。

在370454人年的随访中,总共有521名患者被诊断为DKA与DPP-4抑制剂相比,SGLT-2抑制剂与DKA风险增加相关。达格列净的分子特异性HR为1.86,恩帕格列净为2.52,卡格列净为3.58。年龄和性别没有改变关联,事先接受胰岛素似乎可以降低风险。

2型糖尿病患者接受SGLT-2抑制剂与糖尿病酮症酸中毒风险之间的关联

除了之前接受胰岛素治疗的患者比未接受胰岛素治疗的患者风险更低外,结果与性别、年龄或受体类型(事件与流行的新使用者)是一致的,并且在敏感性分析中是可靠的此外,数据中所有3种SGLT-2抑制剂都观察到风险增加,其中卡格列净显示出最高的效果估计。

与接受SGLT-2抑制剂和DPP-4抑制剂相关的糖尿病酮症酸中毒的风险比

总之,这些研究证明SGLT-2抑制剂与DKA风险增加相关,且与DPP-4抑制剂和磺酰脲类药物相比,新开SGLT2抑制剂的2型糖尿病患者发生糖尿病酮症酸中毒的比例更高。值得注意的是,在所有分子特异性分析中均观察到风险增加,其中卡格列净的效果估计最高。由于SGLT-2抑制剂在预防心血管和肾脏疾病方面的有益作用可能会在未来几年增加其摄取量,所以医生应意识到DKA这种潜在不良作用

参考文献:

1.Ghadeer K. Dawwas, James H. Flory, Sean Hennessy, Charles E. Leonard, James D. Lewis; Comparative Safety of Sodium–Glucose Cotransporter 2 Inhibitors Versus Dipeptidyl Peptidase 4 Inhibitors and Sulfonylureas on the Risk of Diabetic Ketoacidosis. Diabetes Care 1 April 2022; 45 (4): 919–927.

2. Douros, Antonios; Lix, Lisa M.; Fralick, Michael; et al. Sodiumâ Glucose Cotransporter-2 Inhibitors and the Risk for Diabetic Ketoacidosis. Annals of Internal Medicine, 173(6), 417–425. doi:10.7326/M20-0289.

3.Liakos A, Tsapas A, Bekiari E. In type 2 diabetes, SGLT2 inhibitors were linked to diabetic ketoacidosis vs. DPP-4 inhibitors. Ann Intern Med. 2020 Dec 15;173(12):JC70. doi: 10.7326/ACPJ202012150-070. PMID: 33316195.

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content=<a href='/topic/show?id=6bac955861e' target=_blank style='color:#2F92EE;'>#酸中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95586, encryptionId=6bac955861e, topicName=酸中毒)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c5dd27335710, createdName=hywen7335, createdTime=Fri Sep 09 19:01:15 CST 2022, time=2022-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1288700, encodeId=00671288e003e, content=<a href='/topic/show?id=b969e679974' target=_blank style='color:#2F92EE;'>#糖尿病酮症酸中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76799, encryptionId=b969e679974, topicName=糖尿病酮症酸中毒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8346212, createdName=respect, createdTime=Wed Aug 24 02:01:15 CST 2022, time=2022-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319166, encodeId=815b1319166b6, content=<a href='/topic/show?id=14d92231508' target=_blank style='color:#2F92EE;'>#中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22315, encryptionId=14d92231508, topicName=中毒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f13d475, createdName=mashirong, createdTime=Wed Aug 24 02:01:15 CST 2022, time=2022-08-24, status=1, ipAttribution=)]
    2023-06-25 tulenzi
  4. 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  5. 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  6. 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  7. 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createdBy=28b7142, createdName=liuquan, createdTime=Mon Nov 07 07:01:15 CST 2022, time=2022-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793886, encodeId=a4a71e93886cd, content=<a href='/topic/show?id=5a3f1621e7d' target=_blank style='color:#2F92EE;'>#SGLT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16217, encryptionId=5a3f1621e7d, topicName=SGLT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=54f9127, createdName=tulenzi, createdTime=Sun Jun 25 03:01:15 CST 2023, time=2023-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1641227, encodeId=2cec164122ef5, content=<a href='/topic/show?id=8d739553475' target=_blank style='color:#2F92EE;'>#酮症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95534, 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objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95535, encryptionId=862b9553521, topicName=酮症酸)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c6262500044, createdName=1249862am72(暂无昵称), createdTime=Tue May 23 18:01:15 CST 2023, time=2023-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1853035, encodeId=7c551853035bf, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Wed Jul 19 04:01:15 CST 2023, time=2023-07-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676188, encodeId=ad5b16e618891, content=<a href='/topic/show?id=6bac955861e' target=_blank style='color:#2F92EE;'>#酸中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95586, encryptionId=6bac955861e, topicName=酸中毒)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c5dd27335710, createdName=hywen7335, createdTime=Fri Sep 09 19:01:15 CST 2022, time=2022-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1288700, encodeId=00671288e003e, content=<a href='/topic/show?id=b969e679974' target=_blank style='color:#2F92EE;'>#糖尿病酮症酸中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76799, encryptionId=b969e679974, topicName=糖尿病酮症酸中毒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8346212, createdName=respect, createdTime=Wed Aug 24 02:01:15 CST 2022, time=2022-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319166, encodeId=815b1319166b6, content=<a href='/topic/show?id=14d92231508' target=_blank style='color:#2F92EE;'>#中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22315, encryptionId=14d92231508, topicName=中毒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f13d475, createdName=mashirong, createdTime=Wed Aug 24 02:01:15 CST 2022, time=2022-08-24, status=1, ipAttribution=)]
    2023-07-19 jklm09
  8. 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time=2022-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319166, encodeId=815b1319166b6, content=<a href='/topic/show?id=14d92231508' target=_blank style='color:#2F92EE;'>#中毒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22315, encryptionId=14d92231508, topicName=中毒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f13d475, createdName=mashirong, createdTime=Wed Aug 24 02:01:15 CST 2022, time=2022-08-24, status=1, ipAttribution=)]
  9. [GetPortalCommentsPageByObjectIdResponse(id=1642333, encodeId=05431642333b4, content=<a href='/topic/show?id=2e74e3891da' target=_blank style='color:#2F92EE;'>#磺酰脲类#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73891, encryptionId=2e74e3891da, topicName=磺酰脲类)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=592c22907703, createdName=12498dabm84暂无昵称, createdTime=Tue Nov 29 14:01:15 CST 2022, time=2022-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995674, encodeId=665819956e4b7, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, 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  10. 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    2022-08-24 mashirong

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