L., Fernndez-Hernando, C., and Lamas, S
So theres definitely been the evolution of science that weve seen
Randomized clinical trials (RCTs) 7,8 Evaluate the safety and efficacy of a treatment in specific populations under controlled conditions Prospective designs with prespecified, well-defined inclusion/exclusion criteria, outcomes, and end points Patients are randomly assigned to treatment or comparator Limitations: Tightly controlled conditions and inclusion/exclusion criteria of RCTs may limit generalizability to real-world conditions or clinical populations Can be expensive and time-consuming Randomized clinical trials are designed to show causality 7,8 Real-world evidence (RWE) 8,9 Use data from routine clinical practice Capture outcomes across broad patient populations Offer insight into how treatments perform outside of a controlled clinical trial setting Should be viewed as complementary to clinical trial data Limitations: Susceptible to bias and confounding due to factors such as lack of randomization, missing or duplicative data, coding inaccuracies, and data variability reflecting routine clinical practice Real-world studies evaluate associations and cannot determine causality 8,9 SCORE: The largest real-world CV outcomes study assessing the effectiveness of Wegovy in adults with established CVD and overweight or obesity 10 Patient population 10 27,963 patients Baseline period: 12 months prior to index date 11 Key Inclusion Criteria 10 Adults: 45 years Overweight or obesity (BMI: 27 kg/m 2 ) Established CVD: Prior MI Ischemic stroke PAD No prior history of diabetes Treatment arms 10 End point assessed 10 MACE-3 CV Death** Non-Fatal MI Non-Fatal Stroke Patients were followed until the earliest instance of 10 : The earliest instance of the end of continuous enrollment or of data availability The initiation of a (non-semaglutide) GLP-1 or GLP-1/GIP receptor agonist A bariatric surgical procedure Death This study used the Komodo research database, which includes administrative medical and pharmacy claims linked with clinical and laboratory measurements for patients in the US during January 1, 2016-December 31, 2023
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