Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients

Aug 21, 2020Postgraduate medicine

Oral semaglutide use in type 2 diabetes patients with heart, kidney, other health issues, or older age

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Abstract

Oral semaglutide showed a significant reduction in glycated hemoglobin by 0.8% compared to placebo over 26 weeks in patients with type 2 diabetes.

PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide with a hazard ratio of 0.79, indicating no increased cardiovascular risk.
In PIONEER 5, oral semaglutide significantly decreased body weight by 2.5 kg compared to placebo.
Renal function remained unchanged in both the oral semaglutide and placebo treatment groups.
Age did not impact the effectiveness of oral semaglutide in lowering blood sugar levels.
The presence of upper gastrointestinal disease or liver impairment did not alter the pharmacokinetics of oral semaglutide.
Gastrointestinal adverse events were the most commonly reported side effects, consistent with the safety profile of GLP-1 receptor agonists.

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Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years. There are many therapies for the treatment of T2D but not all are suitable for patients with comorbidities. Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA) and was recently approved for the treatment of T2D, representing an oral alternative to injectable GLP-1RAs. This article reviews data from: PIONEER 6, a phase 3a cardiovascular outcomes trial in patients at high cardiovascular risk; PIONEER 5, a phase 3a trial in patients with moderate renal impairment; a post-hoc analysis of PIONEER data by age; and pharmacokinetic trials investigating the effects of renal impairment, gastrointestinal disease, and hepatic impairment on the exposure of oral semaglutide. PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide compared with placebo (hazard ratio: 0.79; 95% confidence interval [CI]: 0.57, 1.11; p < 0.001 for noninferiority), ruling out excess cardiovascular risk. In PIONEER 5, oral semaglutide was superior to placebo in decreasing glycated hemoglobin over 26 weeks (estimated treatment difference [ETD]: -0.8%; 95% CI: -1.0, -0.6; p < 0.0001) and body weight (ETD: -2.5 kg; 95% CI: -3.2, -1.8; p < 0.0001), and renal function was unchanged in both treatment groups. There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide. Across the trials, the safety profile of oral semaglutide was as expected for a GLP-1RA, with gastrointestinal adverse events most commonly reported. As such, oral semaglutide provides an effective oral GLP-1RA treatment option in older patients and/or those with comorbidities, with no requirements for dose adjustment.

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Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients

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