PDF(Pubmed)
Abstract：
BACKGROUND: Real-world data provide insight into how medications perform in clinical practice. The PIONEER REAL Switzerland study aimed to understand clinical outcomes with oral semaglutide in adults with type 2 diabetes (T2D).
METHODS: PIONEER REAL Switzerland was a 34-44-week, multicentre, prospective, non-interventional, single-arm study of adults with T2D naïve to injectable glucose-lowering medication who were initiated on oral semaglutide in routine clinical practice. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS); secondary endpoints included change in body weight (BW) from BL to EOS and the proportion of participants achieving HbA1c < 7.0% and the composite endpoints HbA1c reduction ≥ 1%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.
RESULTS: Of the 185 participants (female/male, n = 67/118) initiating oral semaglutide, 168 (90.8%) completed the study and 143 (77.3%) remained on treatment with oral semaglutide at EOS. At BL, participants had a mean age of 62 years, diabetes duration of 6.4 years, HbA1c of 7.7%, BW of 95.6 kg and body mass index of 33.2 kg/m2; 56.2% of participants were receiving glucose-lowering medications. Significant reductions were observed for HbA1c (estimated change - 0.91%; 95% confidence interval [CI] - 1.10, - 0.71; p < 0.0001) and BW (estimated change - 4.85%; 95% CI - 5.70, - 4.00; p < 0.0001). In total, 139 adverse events (AEs) were reported in 65 (35.1%) participants; most were mild or moderate. The most frequent AEs were gastrointestinal disorders (27.0%); 31 AEs in 20 (10.8%) participants led to discontinuation of oral semaglutide. Six serious AEs were reported; all were considered unlikely to be related to oral semaglutide.
CONCLUSIONS: People living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA1c and BW, with no new safety signals.
BACKGROUND: ClinicalTrials.gov: NCT04537624. A graphical abstract is available for this article.
METHODS: PIONEER REAL Switzerland was a 34-44-week, multicentre, prospective, non-interventional, single-arm study of adults with T2D naïve to injectable glucose-lowering medication who were initiated on oral semaglutide in routine clinical practice. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS); secondary endpoints included change in body weight (BW) from BL to EOS and the proportion of participants achieving HbA1c < 7.0% and the composite endpoints HbA1c reduction ≥ 1%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.
RESULTS: Of the 185 participants (female/male, n = 67/118) initiating oral semaglutide, 168 (90.8%) completed the study and 143 (77.3%) remained on treatment with oral semaglutide at EOS. At BL, participants had a mean age of 62 years, diabetes duration of 6.4 years, HbA1c of 7.7%, BW of 95.6 kg and body mass index of 33.2 kg/m2; 56.2% of participants were receiving glucose-lowering medications. Significant reductions were observed for HbA1c (estimated change - 0.91%; 95% confidence interval [CI] - 1.10, - 0.71; p < 0.0001) and BW (estimated change - 4.85%; 95% CI - 5.70, - 4.00; p < 0.0001). In total, 139 adverse events (AEs) were reported in 65 (35.1%) participants; most were mild or moderate. The most frequent AEs were gastrointestinal disorders (27.0%); 31 AEs in 20 (10.8%) participants led to discontinuation of oral semaglutide. Six serious AEs were reported; all were considered unlikely to be related to oral semaglutide.
CONCLUSIONS: People living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA1c and BW, with no new safety signals.
BACKGROUND: ClinicalTrials.gov: NCT04537624. A graphical abstract is available for this article.
摘要：
背景：真实世界的数据提供了关于药物在临床实践中如何发挥作用的见解。PioneerREALSwitzerland研究旨在了解口服司马鲁肽治疗成人2型糖尿病（T2D）的临床结果。
方法：Pioneer真正的瑞士是一个34-44周，多中心,prospective,非干预性，在常规临床实践中开始口服司马鲁肽的T2D未接受可注射降糖药的成人的单臂研究。主要终点是糖化血红蛋白（HbA1c）从基线（BL）到研究结束（EOS）的变化；次要终点包括从BL到EOS的体重（BW）变化以及达到HbA1c<7.0％和复合终点HbA1c降低≥1％-点，BW降低≥3％或≥5％EOS。在接受≥1剂口服司马鲁肽的参与者中评估安全性。
结果：在185名参与者中（女性/男性，n=67/118)开始口服司马鲁肽，168人（90.8％）完成了研究，143人（77.3％）仍在EOS口服司马鲁肽治疗。在BL,参与者的平均年龄为62岁，糖尿病病程6.4年，HbA1c为7.7%，体重为95.6kg，体重指数为33.2kg/m2；56.2％的参与者正在接受降糖药物。HbA1c（估计变化-0.91%；95%置信区间[CI]-1.10，-0.71；p<0.0001）和BW（估计变化-4.85%；95%CI-5.70，-4.00；p<0.0001）显著下降。总的来说,65名（35.1%）参与者报告了139起不良事件（AE）；大多数为轻度或中度。最常见的不良事件是胃肠道疾病（27.0％）；20名（10.8％）参与者中的31种不良事件导致口服司马鲁肽停药。报告了6种严重的不良事件；所有不良事件均被认为不太可能与口服司马鲁肽有关。
结论：在瑞士口服司美鲁肽治疗的患有T2D的人在临床上实现了HbA1c和BW的显著降低，没有新的安全信号.
背景：ClinicalTrials.gov：NCT04537624。本文提供了图形摘要。
方法：Pioneer真正的瑞士是一个34-44周，多中心,prospective,非干预性，在常规临床实践中开始口服司马鲁肽的T2D未接受可注射降糖药的成人的单臂研究。主要终点是糖化血红蛋白（HbA1c）从基线（BL）到研究结束（EOS）的变化；次要终点包括从BL到EOS的体重（BW）变化以及达到HbA1c<7.0％和复合终点HbA1c降低≥1％-点，BW降低≥3％或≥5％EOS。在接受≥1剂口服司马鲁肽的参与者中评估安全性。
结果：在185名参与者中（女性/男性，n=67/118)开始口服司马鲁肽，168人（90.8％）完成了研究，143人（77.3％）仍在EOS口服司马鲁肽治疗。在BL,参与者的平均年龄为62岁，糖尿病病程6.4年，HbA1c为7.7%，体重为95.6kg，体重指数为33.2kg/m2；56.2％的参与者正在接受降糖药物。HbA1c（估计变化-0.91%；95%置信区间[CI]-1.10，-0.71；p<0.0001）和BW（估计变化-4.85%；95%CI-5.70，-4.00；p<0.0001）显著下降。总的来说,65名（35.1%）参与者报告了139起不良事件（AE）；大多数为轻度或中度。最常见的不良事件是胃肠道疾病（27.0％）；20名（10.8％）参与者中的31种不良事件导致口服司马鲁肽停药。报告了6种严重的不良事件；所有不良事件均被认为不太可能与口服司马鲁肽有关。
结论：在瑞士口服司美鲁肽治疗的患有T2D的人在临床上实现了HbA1c和BW的显著降低，没有新的安全信号.
背景：ClinicalTrials.gov：NCT04537624。本文提供了图形摘要。
