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Semaglutide for the Treatment of Type 2 Diabetes Mellitus.

ABSTRACT: Objective: To detail studies investigating the efficacy/safety of semaglutide as a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the treatment of type 2 diabetes mellitus. Data Sources: A literature search in MEDLINE and ClinicalTrials.gov (January 2013 to May 2018) using the terms semaglutide, SUSTAIN, oral, and PIONEER resulted in 10 published articles and 14 ongoing/unpublished articles. Study Selection and Data Extraction: All English language phase 2 and 3 clinical trials evaluating efficacy/safety of semaglutide were included. Data Synthesis: In 9 phase 3, multicenter SUSTAIN trials, the efficacy and safety of semaglutide have been compared with placebo and other pharmacologic therapy for diabetes (PTD). In these trials, semaglutide resulted in lower hemoglobin A1c (HbA1c; approximately -1.5%) and weight reductions (approximately -4.5 kg) as comparable with dulaglutide for HbA1c lowering (approximately -1.5%). Semaglutide also has cardiovascular (CV) outcomes data that show significant reduction in risk of death from CV causes, nonfatal myocardial infarction, or nonfatal stroke (hazard ratio = 0.74; 95% confidence interval = 0.58-0.95). A safety finding that emerged from the CV outcomes trial was an association of semaglutide treatment with an increased risk of retinopathy complications in patients with preexisting diabetic retinopathy. Phase 3 trial data assessing semaglutide oral formulation have shown similar HbA1c (approximately -1.5% for 14 mg dose) and body weight (approximately -4.1 kg for 14 mg dose) reductions as compared with placebo. Across these studies, semaglutide was generally well tolerated with the most common adverse event reported as gastrointestinal side effects as seen in all GLP-1 RAs. Conclusions: These results suggest that semaglutide may have a place in therapy as a GLP-1 RA add-on therapy with higher weight loss as compared with other GLP-1 RAs and PTD and CV benefit.

SUBMITTER: Miles KE

PROVIDER: S-EPMC6231279 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundType 2 Diabetes Mellitus (T2DM) is a highly prevalent disease worldwide and in Colombia, representing one of the main causes of death and placing a considerable burden on healthcare systems. 13 classes of drugs are approved for the treatment of T2DM, with Glucagon-like Peptide-1 (GLP-1) receptor agonists being a first-line treatment option for patients with or at high risk of certain cardiovascular diseases and chronic kidney disease. The objective of this study is to conduct a short-term cost-effectiveness analysis of once-weekly semaglutide versus once-weekly dulaglutide in Colombian adults with T2DM, from a third-party payer perspective.MethodsNumbers needed to treat were calculated for different single and composite endpoints of the SUSTAIN 7 trial, annual costs for once weekly semaglutide 1.0 mg and dulaglutide 1.5 mg were extracted from the public SISMED database. With these inputs a cost of control model was developed, to obtain the annual cost of bringing one T2DM patient to relevant clinical outcomes by using semaglutide or dulaglutide.ResultsSemaglutide was considered cost-effective compared to dulaglutide across all pre-specified endpoints, even in the different scenarios evaluated in the sensitivity analyses, and in a particularly pronounced manner for weight loss outcomes. Semaglutide at a dose of 1.0 mg once-weekly was cost-effective compared to dulaglutide 1.5 mg across all outcomes in the short-term, making it an appropriate first-line choice in the treatment of T2DM when deciding between these two GLP-1 receptor agonists.ConclusionsThis is the first short-term cost-effectiveness study of semaglutide and dulaglutide in T2DM Colombian patients. Our modeled results suggest that once-weekly semaglutide represents a cost-effective option for treating individuals with T2DM in Colombia who are not achieving glycaemia control with metformin, and it would be expected to improve HbA1C, promote greater weight loss and reduce costs from a third-payer perspective compared with treatment with dulaglutide.