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Examining the REWIND cardiovascular outcomes study for Trulicity (dulaglutide) with a BiostatisticianTicker(s): LLY
Name: Dr Michael Kattan - PhD
Institution: Cleveland Clinic | Case Western
- Chairman, Department of Quantitative Health Sciences, at Cleveland Clinic & Professor of Medicine and Professor, Department of Epidemiology and Biostatistics, School of Medicine, Case Western Reserve University.
- Fellow of the American Statistical Association and has held several posts with the Society for Medical Decision Making.
- Research is primarily focused on the development, validation, and use of prediction models; has coauthored over 600 articles in peer-reviewed journals.
Based on the powering of the study, what is the minimum CV risk reduction that would need to be seen for the study to be statistically significant?Added By: c_admin
Can you quantify how the long duration for this study (duration of treatment of ~5.6 years vs. 2.1-3.5 years in the other GLP1 CV outcome studies) impacts the probability of success?
Are there any unique features of the statistical analysis method being used in the Rewind study (compared to the Leader and Sustain 6 studies) that would likely impact the probability of success?
One analysis that was conducted suggesting the risk reduction would need to be 11% to statistically significant. What are your thoughts on this?
If we assume that 50% of the events in the study are coming from patients with established CV disease, and those patients get a 20% CV risk reduction from dulaglutide. And then the remaining 50% of the events come from patients with no previous CV disease, and those patients experience no CV risk reduction from treatment with dulaglutide, does that simply translate into a 10% risk reduction in the overall study? If yes, what is the probability that the study would be successful with an overall 10% risk reduction?
It would be helpful to know how a range of overall risk reduction from 10-20% with dulaglutide would impact the probability of success in the study.
- If the overall risk reduction in the study is 10%, what is the probability that the study is statistically significant? (Same for 11-20% overall risk reduction)
In the Leader publication,, patients with established CV disease and treated with liraglutide had a 17% reduction in CV risk. Those patients had an average duration of treatment of 3.5 years. What risk reduction would have likely been seen if those patients were treated for 5.5 years?Added By: c_admin
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