Tan Jixue, Wang Yang, Liu Song, Shi Qingyang, Zhou Xu, Zhou Yiling, Yang Xiaoling, Chen Pingshan, Li Sheyu
The Second School of Clinical Medicine, Nanchang University, Nanchang, China.
Department of Science and Technology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Front Pharmacol. 2021 May 17;12:669814. doi: 10.3389/fphar.2021.669814. eCollection 2021.
Metformin, a commonly used antidiabetic medication, is available in both an immediate-release (IR) formulation and a long-acting formulation (metformin extended-release; XR). We performed a systematic review to compare the effectiveness, safety, and patient compliance and satisfaction between the metformin IR and XR formulations. We searched for randomized control trials (RCTs) and observational studies comparing the effectiveness, safety, or patient compliance and satisfaction of metformin XR with metformin IR using the MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases. Following report screening, data collection, and risk of bias assessment, we separately pooled data from RCTs and observational studies using the Grading of Recommendation Assessment, Development, and Evaluation approach to rate the quality of evidence. We included five RCTs, comprising a total of 1,662 patients, and one observational study, comprising 10,909 patients. In the meta-analyses, no differences were identified in outcomes of effectiveness and safety between the two forms of metformin (including change in HbA1c: mean difference (MD), 0.04%, 95% confidence interval [CI], -0.05-0.13%, fasting blood glucose: MD, -0.03 mmol/L, 95% CI, -0.22-0.15 mmol/L, postprandial blood glucose: MD, 0.50 mmol/L, 95% CI, -0.71-1.72 mmol/L, adverse events of abdominal pain: relative risk (RR), 1.15, 95% CI, 0.57-2.33, all-cause death (RR, 3.02, 95% CI 0.12-73.85), any adverse events (RR, 1.14, 95% CI 0.97-1.34), any adverse events leading to treatment discontinuation: RR, 1.51, 95% CI, 0.82-2.8, any gastrointestinal adverse events: RR, 1.09, 95% CI, 0.93-1.29, diarrhea: RR, 0.82, 95% CI, 0.53-1.27, flatulence: RR, 0.43, 95% CI, 0.15-1.23, nausea: RR, 0.97, 95% CI, 0.64-1.47, severe adverse events: RR, 0.64, 95% CI, 0.28-1.42, and vomiting: RR, 1.46, 95% CI, 0.6-3.56). Data from both the RCTs and the observational study indicate mildly superior patient compliance with metformin XR use compared with metformin IR use; this result was attributable to the preference for once-daily administration with metformin XR. Our systematic review indicates that metformin XR and IR formulations have similar effectiveness and safety, but that metformin XR is associated with improved compliance to treatment.
二甲双胍是一种常用的抗糖尿病药物，有速释（IR）制剂和长效制剂（二甲双胍缓释片；XR）两种剂型。我们进行了一项系统评价，以比较二甲双胍IR和XR剂型在有效性、安全性、患者依从性和满意度方面的差异。我们使用MEDLINE、Embase和Cochrane对照试验中央注册库数据库，检索了比较二甲双胍XR与二甲双胍IR在有效性、安全性或患者依从性和满意度方面的随机对照试验（RCT）和观察性研究。在报告筛选、数据收集和偏倚风险评估之后，我们使用推荐分级评估、制定和评价方法分别汇总RCT和观察性研究的数据，以评估证据质量。我们纳入了5项RCT（共1662例患者）和1项观察性研究（10909例患者）。在荟萃分析中，两种二甲双胍剂型在有效性和安全性结果方面未发现差异（包括糖化血红蛋白变化：平均差（MD）为0.04%，95%置信区间[CI]为-0.05-0.13%；空腹血糖：MD为-0.03 mmol/L，95%CI为-0.22-0.15 mmol/L；餐后血糖：MD为0.50 mmol/L，95%CI为-0.71-1.72 mmol/L；腹痛不良事件：相对风险（RR）为1.15，95%CI为0.57-2.33；全因死亡（RR为3.02，95%CI为0.12-73.85）；任何不良事件（RR为1.14，95%CI为0.97-1.34）；任何导致治疗中断的不良事件：RR为1.51，95%CI为0.82-2.8；任何胃肠道不良事件：RR为1.09，95%CI为0.93-1.29；腹泻：RR为0.82，95%CI为0.53-1.27；胃肠胀气：RR为0.43，95%CI为0.15-1.23；恶心：RR为0.97，95%CI为0.64-1.47；严重不良事件：RR为0.64，95%CI为0.28-1.42；呕吐：RR为1.46，95%CI为0.6-3.56）。RCT和观察性研究的数据均表明，与使用二甲双胍IR相比，患者使用二甲双胍XR的依从性略高；这一结果归因于患者更倾向于每日一次服用二甲双胍XR。我们的系统评价表明，二甲双胍XR和IR剂型具有相似的有效性和安全性，但二甲双胍XR与更好的治疗依从性相关。
