Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations.
Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations.
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DOI：
10.7326/0003-4819-154-9-201105030-00336
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发表时间：
2011-05-03
影响因子：
39.2
通讯作者：
Bolen S
中科院分区：
文献类型：
--
作者：
Bennett WL;Maruthur NM;Singh S;Segal JB;Wilson LM;Chatterjee R;Marinopoulos SS;Puhan MA;Ranasinghe P;Block L;Nicholson WK;Hutfless S;Bass EB;Bolen S
鉴于2型糖尿病药物的增加，临床医生和患者需要有关其有效性和安全性的信息，以便做出明智的选择。总结二甲双胍、第二代磺脲类、噻唑烷二酮类、氯茴苯酸类、二肽基肽酶-4（DPP-4）抑制剂和胰高血糖素样肽-1受体激动剂单药治疗和联合治疗成人2型糖尿病的获益和危害。检索MEDLINE、EMBASE和科克伦对照试验中心注册中心（Central Register of Controlled Trials），从开始到2010年4月，检索英文观察性研究和试验。MEDLINE检索更新至2010年12月，以获得长期临床结局。两名评审员独立筛选了报告，并确定了140项试验和26项观察性研究，这些研究报告了中期或长期临床结局或危害。两名审查员按照标准化方案连续提取数据，评估适用性，并独立评估研究质量。长期临床结局（全因死亡率、心血管疾病、肾病和神经病变）的证据强度低或不足。大多数药物降低血红蛋白A1 c水平约1个百分点，大多数2种药物组合产生类似的降低。二甲双胍比DPP-4抑制剂更有效，与噻唑烷二酮类或磺脲类药物相比，体重的平均差异约为-2.5 kg。与吡格列酮、磺脲类药物和DPP-4抑制剂相比，二甲双胍可降低低密度脂蛋白胆固醇水平。磺酰脲类药物发生轻度或中度低血糖的风险比二甲双胍单药高4倍，与二甲双胍联合用药的风险比二甲双胍加噻唑烷二酮类药物高5倍以上。与磺脲类药物相比，噻唑烷二酮类药物可增加充血性心力衰竭的风险，与二甲双胍相比，可增加骨折的风险。二甲双胍组腹泻发生率高于噻唑烷二酮类。仅审查了英文出版物。一些研究可能选择性地报告了结果。许多研究规模较小，持续时间较短，评估临床重要危害和获益的能力有限。有证据支持二甲双胍作为治疗2型糖尿病的一线药物。大多数2种药物的组合同样降低血红蛋白A1 c水平，但有些增加了低血糖和其他不良事件的风险。医疗保健研究和质量机构。
Given the increase in medications for type 2 diabetes mellitus, clinicians and patients need information about their effectiveness and safety to make informed choices. To summarize the benefits and harms of metformin, second-generation sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 receptor agonists, as monotherapy and in combination, to treat adults with type 2 diabetes. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception through April 2010 for English-language observational studies and trials. The MEDLINE search was updated to December 2010 for long-term clinical outcomes. Two reviewers independently screened reports and identified 140 trials and 26 observational studies of head-to-head comparisons of monotherapy or combination therapy that reported intermediate or long-term clinical outcomes or harms. Two reviewers following standardized protocols serially extracted data, assessed applicability, and independently evaluated study quality. Evidence on long-term clinical outcomes (all-cause mortality, cardiovascular disease, nephropathy, and neuropathy) was of low strength or insufficient. Most medications decreased the hemoglobin A1c level by about 1 percentage point and most 2-drug combinations produced similar reductions. Metformin was more efficacious than the DPP-4 inhibitors, and compared with thiazolidinediones or sulfonylureas, the mean differences in body weight were about −2.5 kg. Metformin decreased low-density lipoprotein cholesterol levels compared with pioglitazone, sulfonylureas, and DPP-4 inhibitors. Sulfonylureas had a 4-fold higher risk for mild or moderate hypoglycemia than metformin alone and, in combination with metformin, had more than a 5-fold increased risk compared with metformin plus thiazolidinediones. Thiazolidinediones increased risk for congestive heart failure compared with sulfonylureas and increased risk for bone fractures compared with metformin. Diarrhea occurred more often with metformin than with thiazolidinediones. Only English-language publications were reviewed. Some studies may have selectively reported outcomes. Many studies were small, were of short duration, and had limited ability to assess clinically important harms and benefits. Evidence supports metformin as a first-line agent to treat type 2 diabetes. Most 2-drug combinations similarly reduce hemoglobin A1c levels, but some increased risk for hypoglycemia and other adverse events. Agency for Healthcare Research and Quality.
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