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What have we learnt from "real world" data, observational studies and meta-analyses
Sudesna Chatterjee1, Melanie J Davies1, Kamlesh Khunti1
1Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.
Diabetes, Obesity & Metabolism
|January 25, 2018
Summary
Incretin therapies like GLP-1 RAs and DPP-IV inhibitors are effective for type 2 diabetes. Real-world evidence confirms their safety and cardiovascular benefits, reassuringly showing low risks of pancreatitis.
Area of Science:
- Endocrinology
- Pharmacology
- Diabetes Management
Background:
- Incretin-based therapies, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-IV (DPP-IV) inhibitors, are established treatments for type 2 diabetes.
- Evidence from randomized clinical trials (RCTs) and observational studies over the past decade supports their efficacy and safety.
Purpose of the Study:
- To review the established role and evidence base for incretin therapies in type 2 diabetes management.
- To evaluate cardiovascular outcomes and real-world safety data, including concerns regarding pancreatitis and pancreatic cancer.
Main Methods:
- Analysis of data from large multicentre randomized clinical trials (RCTs).
- Review of observational studies and post-marketing surveillance data for real-world evidence.
- Evaluation of cardiovascular outcome trials for specific agents like liraglutide and semaglutide.
Main Results:
- GLP-1 RAs and DPP-IV inhibitors are effective as second/third-line therapies and in combination with insulin.
- Cardiovascular outcome trials show non-inferiority to placebo, with liraglutide and semaglutide demonstrating superiority in reducing major adverse cardiovascular events.
- Real-world evidence suggests that risks of pancreatitis and pancreatic cancer are not significant concerns in large patient populations.
Conclusions:
- Incretin therapies, particularly GLP-1 RAs, offer significant benefits for type 2 diabetes management, including cardiovascular protection.
- Real-world data complements RCTs, providing reassurance on the safety profile of these agents.
- Continued development of data and methodologies is crucial for addressing clinical questions regarding incretin therapy use.