Crowley Matthew J, Diamantidis Clarissa J, McDuffie Jennifer R, Cameron C Blake, Stanifer John W, Mock Clare K, Wang Xianwei, Tang Shuang, Nagi Avishek, Kosinski Andrzej S, Williams John W
From Durham Veterans Affairs Medical Center and Duke University School of Medicine, Durham, North Carolina.
Ann Intern Med. 2017 Feb 7;166(3):191-200. doi: 10.7326/M16-1901. Epub 2017 Jan 3.
Recent changes to the U.S. Food and Drug Administration boxed warning for metformin will increase its use in persons with historical contraindications or precautions. Prescribers must understand the clinical outcomes of metformin use in these populations.
To synthesize data addressing outcomes of metformin use in populations with type 2 diabetes and moderate to severe chronic kidney disease (CKD), congestive heart failure (CHF), or chronic liver disease (CLD) with hepatic impairment.
MEDLINE (via PubMed) from January 1994 to September 2016, and Cochrane Library, EMBASE, and International Pharmaceutical Abstracts from January 1994 to November 2015.
English-language studies that: 1) examined adults with type 2 diabetes and CKD (with estimated glomerular filtration rate less than 60 mL/min/1.73 m2), CHF, or CLD with hepatic impairment; 2) compared diabetes regimens that included metformin with those that did not; and 3) reported all-cause mortality, major adverse cardiovascular events, and other outcomes of interest.
2 reviewers abstracted data and independently rated study quality and strength of evidence.
On the basis of quantitative and qualitative syntheses involving 17 observational studies, metformin use is associated with reduced all-cause mortality in patients with CKD, CHF, or CLD with hepatic impairment, and with fewer heart failure readmissions in patients with CKD or CHF.
Strength of evidence was low, and data on multiple outcomes of interest were sparse. Available studies were observational and varied in follow-up duration.
Metformin use in patients with moderate CKD, CHF, or CLD with hepatic impairment is associated with improvements in key clinical outcomes. Our findings support the recent changes in metformin labeling.
U.S. Department of Veterans Affairs. (PROSPERO: CRD42016027708).
美国食品药品监督管理局对二甲双胍黑框警告的近期变更将增加其在有既往禁忌证或注意事项人群中的使用。开处方者必须了解二甲双胍在这些人群中的临床结局。
综合有关二甲双胍在2型糖尿病合并中度至重度慢性肾脏病（CKD）、充血性心力衰竭（CHF）或有肝损伤的慢性肝病（CLD）人群中使用结局的数据。
1994年1月至2016年9月的MEDLINE（通过PubMed），以及1994年1月至2015年11月的Cochrane图书馆、EMBASE和国际药学文摘。
英文研究，其满足以下条件：1）研究2型糖尿病合并CKD（估计肾小球滤过率低于60 mL/min/1.73 m²）、CHF或有肝损伤的CLD的成年人；2）比较包含二甲双胍的糖尿病治疗方案与不包含二甲双胍的方案；3）报告全因死亡率、主要不良心血管事件及其他感兴趣的结局。
两名审阅者提取数据并独立评估研究质量和证据强度。
基于涉及17项观察性研究的定量和定性综合分析，二甲双胍的使用与CKD、CHF或有肝损伤的CLD患者的全因死亡率降低相关，且与CKD或CHF患者较少的心力衰竭再入院相关。
证据强度低，且关于多个感兴趣结局的数据稀少。现有研究为观察性研究，随访时间各异。
在中度CKD、CHF或有肝损伤的CLD患者中使用二甲双胍与关键临床结局的改善相关。我们的研究结果支持了二甲双胍标签的近期变更。
美国退伍军人事务部。（国际前瞻性系统评价注册库：CRD42016027708）
