Real-world observations of using compounded GLP-1 ± GIP agonists within a clinical pharmacist-managed cardiometabolic clinic

Abstract

Introduction

The long-acting glucagon-like peptide-1 (GLP-1) agonist semaglutide and the GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide have demonstrated efficacy in reducing cardiometabolic risk factors in individuals with diabetes and obesity. Popularity of these agents has led to increased demand, even among patients with cardiometabolic risk factors beyond type 2 diabetes mellitus (T2DM). The growing demand and supply chain disruptions have resulted in a shortage of therapies. As a direct consequence, patients are exploring alternative options including compounded GLP-1 ± GIP formulations.

Objective

This study reports real-world observations on the safety and efficacy of compounded semaglutide and tirzepatide within a clinical pharmacist-managed cardiometabolic clinic.

Methods

This retrospective cohort included 50 patients with cardiometabolic risk who had received a prescription for compounded GLP-1 ± GIP therapy between July 2022 and July 2023. Observations were reported for this cohort with changes from baseline to 12 weeks and out to 24 weeks. Primary outcomes were changes in weight/body mass index (BMI) and hemoglobin A1c (HbA1c). Secondary outcomes included changes in waist circumference, blood pressure, triglyceride levels, inflammatory markers, medication adherence, and the incidence of adverse events and/or dropout rates.

Results

Fifty patients (18 males and 32 females) completed the 12-week follow-up, with an additional subset of patients (n = 40) continuing to 24 weeks of therapy. The average weight loss observed at 12 weeks was 16.06 ± 7.6 pounds (p = 0.001) and 38.82 ± 11.4 pounds at 24 weeks. HbA1c decreased on average from 5.5 ± 0.3 at baseline to 5.3 ± 0.3 at 12 weeks (p < 0.0001) and to 5.2 ± 0.027 (p < 0.001) at 24 weeks. All secondary cardiometabolic outcomes improved significantly throughout the study.

Conclusion

This study demonstrates a significant positive impact on cardiometabolic outcomes from utilizing compounded GLP-1 ± GIP agonists when branded products could not be obtained. These observations also support the use of compounded GLP-1 ± GIP agonists under pharmacist supervision as an alternative during drug shortages.