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 |
Title: Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and Multimorbidity. Project Number: 5K08AG055670 PI: Elisabetta Patorno Aims: To create and implement a novel approach for the near-real-time monitoring of the comparative safety and effectiveness of new diabetes drugs in older patients as treated in routine care. https://reporter.nih.gov/search/diQcB47KYEyuHTLOz41DOA/project-details/10066296 Funded by: The National Institute of Aging (NIA) |
Title: Comparative Safety of Non-Insulin Agents in Pregnant Women with Pregestational Diabetes Project Number: 5R01HD097778 PI: Sonia Hernandez-Diaz Aims: To quantify the risk of maternal and fetal adverse events associated with specific non-insulin medications for pre-gestational type 2 diabetes during pregnancy. https://reporter.nih.gov/search/8ONv8E3MQkuodKakAxcagw/project-details/10428610 Funded by: The Eunice Kennedy Shriver National Institute of Child Health and Human (NICHD) |
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) |
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Division of Pharmacoepidemiology & Pharmacoeconomics
Department of Medicine Brigham & Women's Hospital and Harvard Medical School 1620 Tremont Street Suite 3030 Boston, MA 02120 |
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