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Abstract：
BACKGROUND: No meta-analysis has holistically analyzed and summarized the therapeutic efficacy and safety of albiglutide in type 2 diabetes (T2D). This meta-analysis addresses this knowledge gap.
METHODS: Randomized controlled trials involving patients with T2D receiving albiglutide in the intervention arm and either a placebo or an active comparator in the control arm were searched through electronic databases. The primary outcome was the change from baseline (CFB) in glycated hemoglobin (HbA1c); secondary outcomes included CFB in fasting plasma glucose, body weight, and adverse events (AE).
RESULTS: From 443 initially screened articles, data from 12 randomized controlled trials involving 6423 subjects were analyzed. Albiglutide, at both doses, outperformed placebo in terms of HbA1c reductions (for albiglutide 30 mg: mean differences -1.04%, 95% confidence interval [CI] [-1.37--0.72], P < .00001, I2 = 89%; and for albiglutide 50 mg: mean differences -1.10%, 95% CI [-1.45--0.75], P < .00001, I2 = 90%). Higher proportions of subjects achieved HbA1c < 7% in the albiglutide arm than in placebo (for albiglutide 30 mg: odds ratio 6.26, 95% CI [2.50-15.70], P < .0001, I2 = 82%; and for albiglutide 50 mg: odds ratio 5.57, 95% CI [2.25-13.80], P = .0002, I2 = 84%). Albiglutide had glycemic efficacy comparable to other glucose-lowering drugs. CFB in body weight was similar with albiglutide and placebo. AE profile, including gastrointestinal AE, was identical with albiglutide and placebo, except for higher drug-related AE and injection-site reaction with albiglutide.
CONCLUSIONS: Albiglutide provides reassuring data on good glycemic efficacy, tolerability, and safety over an extended period of clinical use in patients with T2D. Albiglutide 30 mg has comparable efficacy and safety profiles to albiglutide 50 mg.
METHODS: Randomized controlled trials involving patients with T2D receiving albiglutide in the intervention arm and either a placebo or an active comparator in the control arm were searched through electronic databases. The primary outcome was the change from baseline (CFB) in glycated hemoglobin (HbA1c); secondary outcomes included CFB in fasting plasma glucose, body weight, and adverse events (AE).
RESULTS: From 443 initially screened articles, data from 12 randomized controlled trials involving 6423 subjects were analyzed. Albiglutide, at both doses, outperformed placebo in terms of HbA1c reductions (for albiglutide 30 mg: mean differences -1.04%, 95% confidence interval [CI] [-1.37--0.72], P < .00001, I2 = 89%; and for albiglutide 50 mg: mean differences -1.10%, 95% CI [-1.45--0.75], P < .00001, I2 = 90%). Higher proportions of subjects achieved HbA1c < 7% in the albiglutide arm than in placebo (for albiglutide 30 mg: odds ratio 6.26, 95% CI [2.50-15.70], P < .0001, I2 = 82%; and for albiglutide 50 mg: odds ratio 5.57, 95% CI [2.25-13.80], P = .0002, I2 = 84%). Albiglutide had glycemic efficacy comparable to other glucose-lowering drugs. CFB in body weight was similar with albiglutide and placebo. AE profile, including gastrointestinal AE, was identical with albiglutide and placebo, except for higher drug-related AE and injection-site reaction with albiglutide.
CONCLUSIONS: Albiglutide provides reassuring data on good glycemic efficacy, tolerability, and safety over an extended period of clinical use in patients with T2D. Albiglutide 30 mg has comparable efficacy and safety profiles to albiglutide 50 mg.
摘要：
背景：尚无荟萃分析对阿比鲁肽治疗2型糖尿病（T2D）的疗效和安全性进行全面分析和总结。这项荟萃分析解决了这一知识差距。
方法：通过电子数据库搜索涉及T2D患者的随机对照试验，这些患者在干预组中接受阿必鲁肽，在对照组中接受安慰剂或活性比较。主要结局是糖化血红蛋白（HbA1c）相对于基线（CFB）的变化；次要结局包括空腹血糖的CFB，体重,和不良事件（AE）。
结果：从443篇最初筛选的文章中，我们分析了12项随机对照试验的数据,包括6423名受试者.Albiglutide,在两种剂量下，在HbA1c降低方面优于安慰剂（对于albiglutide30mg：平均差异-1.04%，95%置信区间[CI][-1.37--0.72]，P<.00001，I2=89%；对于50毫克阿必鲁肽：平均差异-1.10%，95%CI[-1.45--0.75]，P<.00001，I2=90%)。与安慰剂组相比，阿必鲁肽组达到HbA1c<7%的受试者比例更高(阿必鲁肽30mg:比值比6.26,95%CI[2.50-15.70],P<.0001，I2=82%；对于阿必鲁肽50mg：比值比5.57，95%CI[2.25-13.80]，P=.0002，I2=84%）。阿比鲁肽的血糖功效与其他降糖药物相当。体重的CFB与阿必鲁肽和安慰剂相似。AE简介，包括胃肠道AE，与阿比鲁肽和安慰剂相同，除了与药物相关的较高的AE和与阿必鲁肽的注射部位反应。
结论：Albiglutide提供了关于良好血糖疗效的可靠数据，耐受性,以及在T2D患者的长期临床使用中的安全性。阿比鲁肽30mg与阿比鲁肽50mg具有相当的疗效和安全性。
方法：通过电子数据库搜索涉及T2D患者的随机对照试验，这些患者在干预组中接受阿必鲁肽，在对照组中接受安慰剂或活性比较。主要结局是糖化血红蛋白（HbA1c）相对于基线（CFB）的变化；次要结局包括空腹血糖的CFB，体重,和不良事件（AE）。
结果：从443篇最初筛选的文章中，我们分析了12项随机对照试验的数据,包括6423名受试者.Albiglutide,在两种剂量下，在HbA1c降低方面优于安慰剂（对于albiglutide30mg：平均差异-1.04%，95%置信区间[CI][-1.37--0.72]，P<.00001，I2=89%；对于50毫克阿必鲁肽：平均差异-1.10%，95%CI[-1.45--0.75]，P<.00001，I2=90%)。与安慰剂组相比，阿必鲁肽组达到HbA1c<7%的受试者比例更高(阿必鲁肽30mg:比值比6.26,95%CI[2.50-15.70],P<.0001，I2=82%；对于阿必鲁肽50mg：比值比5.57，95%CI[2.25-13.80]，P=.0002，I2=84%）。阿比鲁肽的血糖功效与其他降糖药物相当。体重的CFB与阿必鲁肽和安慰剂相似。AE简介，包括胃肠道AE，与阿比鲁肽和安慰剂相同，除了与药物相关的较高的AE和与阿必鲁肽的注射部位反应。
结论：Albiglutide提供了关于良好血糖疗效的可靠数据，耐受性,以及在T2D患者的长期临床使用中的安全性。阿比鲁肽30mg与阿比鲁肽50mg具有相当的疗效和安全性。
