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Background <p>Oral semaglutide, a glucagon-like peptide-1 receptor agonist, improves glycemic control and reduces body weight in patients with type 2 diabetes. Although proton pump inhibitors (PPIs) have been reported to slightly increase the absorption of oral semaglutide, the impact of 24-week co-administration of PPIs on clinical efficacy and safety remains unclear.</p> Methods <p>This retrospective study included patients with type 2 diabetes who initiated treatment with oral semaglutide between March 2021 and August 2024. The primary outcome was the change in the HbA1c at week 24. The secondary outcomes included the change in body weight and discontinuation of oral semaglutide due to gastrointestinal adverse events at week 24. Patients were divided into two groups according to PPI co-administration. Propensity score matching was performed to balance the baseline characteristics between the groups. Changes in HbA1c and body weight were analyzed using a linear mixed-effects model, and discontinuation rates were compared using Fisher’s exact test.</p> Results <p>Among the 114 eligible patients, 30 received concomitant PPIs. After propensity score matching, 27 patients were included in each group. At week 24, the estimated mean change in HbA1c and body weight (95% confidence interval) was − 1.0% (-1.3 to -0.6) and − 1.4&#xa0;kg (-2.6 to -0.3) in the PPI group and − 0.6% (-0.8 to -0.3) and − 1.8&#xa0;kg (-2.5 to -1.0) in the non-PPI group. There were no statistically significant group-by-time interactions for HbA1c and body weight (<i>P</i> for interaction = 0.097 and 0.431, respectively). Discontinuation due to gastrointestinal adverse events did not differ significantly between the groups (25.9% vs. 18.5%).</p> Conclusions <p>24-week co-administration of PPIs may not significantly affect the glycemic efficacy, weight reduction, or gastrointestinal tolerability of oral semaglutide. These findings suggest that the co-administration of PPIs is unlikely to meaningfully impact the clinical efficacy or tolerability of oral semaglutide in routine practice.</p>

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Impact of co-administration of proton pump inhibitors on efficacy and safety of oral semaglutide in patients with type 2 diabetes: a single-center retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月5日

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  • Tasuku Yokoyama,
  • Tomonobu Uchino,
  • Yasuharu Yazawa,
  • Shohei Ueno,
  • Daiki Tsuji

摘要

Background

Oral semaglutide, a glucagon-like peptide-1 receptor agonist, improves glycemic control and reduces body weight in patients with type 2 diabetes. Although proton pump inhibitors (PPIs) have been reported to slightly increase the absorption of oral semaglutide, the impact of 24-week co-administration of PPIs on clinical efficacy and safety remains unclear.

Methods

This retrospective study included patients with type 2 diabetes who initiated treatment with oral semaglutide between March 2021 and August 2024. The primary outcome was the change in the HbA1c at week 24. The secondary outcomes included the change in body weight and discontinuation of oral semaglutide due to gastrointestinal adverse events at week 24. Patients were divided into two groups according to PPI co-administration. Propensity score matching was performed to balance the baseline characteristics between the groups. Changes in HbA1c and body weight were analyzed using a linear mixed-effects model, and discontinuation rates were compared using Fisher’s exact test.

Results

Among the 114 eligible patients, 30 received concomitant PPIs. After propensity score matching, 27 patients were included in each group. At week 24, the estimated mean change in HbA1c and body weight (95% confidence interval) was − 1.0% (-1.3 to -0.6) and − 1.4 kg (-2.6 to -0.3) in the PPI group and − 0.6% (-0.8 to -0.3) and − 1.8 kg (-2.5 to -1.0) in the non-PPI group. There were no statistically significant group-by-time interactions for HbA1c and body weight (P for interaction = 0.097 and 0.431, respectively). Discontinuation due to gastrointestinal adverse events did not differ significantly between the groups (25.9% vs. 18.5%).

Conclusions

24-week co-administration of PPIs may not significantly affect the glycemic efficacy, weight reduction, or gastrointestinal tolerability of oral semaglutide. These findings suggest that the co-administration of PPIs is unlikely to meaningfully impact the clinical efficacy or tolerability of oral semaglutide in routine practice.