Title: Novel approaches to improve comparative effectiveness research of medical and surgical weight reduction strategies in clinical practice Project Number: R01DK138036 PI: Elisabetta Patorno Aims: While several medical and surgical weight reduction strategies are available, with newer, transformative medications recently approved, little is known about their safety and effectiveness in clinical practice. This proposal’s goal is to develop, implement, and test approaches to produce large scale, high-quality evidence on the comparative safety and effectiveness of medical and surgical weight loss strategies in clinical practice. This work will develop more accurate, methodologically rigorous approaches to conduct real-world evidence studies of medical and surgical weight reduction strategies using large scale, real-world data and will create an invaluable infrastructure to conduct future studies on the comparative safety and effectiveness of various cardiometabolic treatments. https://reporter.nih.gov/search/3c7uO7hlM0uVSQEX6mV8QA/project-details/10778493 Funded by: National Institute of Diabetes and Digestive and Kidney Diseases |
Title: Enhancing evidence generation by linking randomized clinical trials (RCTs) to real world data (RWD) Project Number: 5U01FD007213 PI: Elisabetta Patorno Aims: The overarching objective of this project is to use linked RCT-RWD to develop and validate methods that can enrich both randomized and non-randomized comparative effectiveness studies. We will use linked RCT-RWD to accomplish the following specific aims: Aim 1. To enhance RCT findings using long-term, validated, RWD-based outcome measures. Aim 2. To develop methods for using RWD to replace or impute missing RCT data. Aim 3. To generalize RCT results to broader patient populations in real-world setting. Aim 4: To develop methods to identify sources of discrepant results between RCTs and RWD-based studies. We will be working with linked RCT-RWD leveraging data from two RCTs. The first RCT, INVESTED, is a Phase 4 study in which high-risk cardiovascular patients are randomized to high-dose or standard-dose influenza vaccine and their cardiopulmonary outcomes are compared. The second RCT, DELIVER, is a Phase 3 study in which patients with heart failure are randomized to receive dapagliflozin or placebo, with the goal of comparing their cardiovascular outcomes. https://reporter.nih.gov/search/diQcB47KYEyuHTLOz41DOA/project-details/10250390 Funded by: Food & Drug Administration (FDA) |
Title: Optimizing the Safety of the Newer Diabetes Medications in Patients with Diabetes and Kidney Disease Project Number: R01DK135706 PI: Julie Paik Aims: While the newer classes of diabetes medications have shown clinical benefits in patients with diabetic kidney disease (DKD) in randomized controlled trials, one of the major prescribing barriers is the lack of safety data in real-world patients with DKD, a complex, older population with multimorbidity and polypharmacy, who are at greater risk for adverse events and drug-drug interactions. This proposal’s goal is to develop a framework to optimize the safety of newer diabetes medications in real-world patients with DKD. This proposal will advance our understanding of these drugs’ safety and thus, will help overcome barriers to prescribing in patients with DKD who may largely benefit from them, greatly advancing the clinical care of patients with DKD. https://reporter.nih.gov/search/95dCPpZRsE2whvQAkrD_Gg/project-details/10799382 Funded by: National Institute of Diabetes and Digestive and Kidney Diseases |
Title: The comparative effectiveness and safety of four second-line pharmacological strategies in type 2 diabetes study (The CER-4-T2D study) Project number: DB-2020C2-20326 PI: Elisabetta Patorno Aims: To answer the question that most patients and their healthcare providers face when metformin is insufficient to manage hyperglycemia: “Which glucose-lowering medications should patients with type 2 diabetes with moderate cardiovascular disease and their providers add, to best balance tradeoffs in benefits and risks?” https://www.pcori.org/research-results/2021/comparing-effect-four-diabetes-medicines-risk-heart-disease-among-patients-type-2-diabetes-cer-4-t2d-study#project_summary Funded by: Patient-Centered Outcomes Research Institute (PCORI) |
Title: The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study PI: Elisabetta Patorno Aims: 1. To compare selected CV effectiveness outcomes in patients with T2DM initiating empagliflozin compared to propensity score (PS) matched patients with T2DM initiating a Dipeptidyl peptidase-4 (DPP-4) inhibitor in sequential analyses within periodically updated cohorts in the U.S.; secondary objectives include other effectiveness outcomes, safety outcomes, and healthcare utilization and cost outcomes. 2. To compare selected effectiveness, healthcare utilization and cost outcomes in patients with T2DM initiating empagliflozin compared to PS matched patients with GLP-1 receptor agonist (GLP1-RA) in sequential analyses within periodically updated cohorts in the U.S. https://onlinelibrary.wiley.com/doi/epdf/10.1002/edm2.103 Funded by an investigator initiated grant to the Brigham and Women's Hospital from Boehringer-Ingelheim |