The Reagan Udall Foundation (RUF) recently awarded the Harvard Pilgrim Health Care Institute Department of Population Medicine (HPHCI PI: J Brown) a contract to continue implementation of a study titled: “Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycemic agents (AHA)” (EU PAS Register number: EUPAS31378). The goal of the study is to compare the risk of diabetic ketoacidosis (DKA) with use of ertugliflozin compared to the risk of DKA in other antihyperglycemic agents.
The research activities will be a collaborative effort between Merck, the Innovation in Medical Evidence Development and Surveillance (IMEDS) Operations Center at RUF, the IMEDS Analytic Center at HPHCI, and participating IMEDS Network Partners.
The Reagan Udall Foundation (RUF) recently awarded the Harvard Pilgrim Health Care Institute Department of Population Medicine (HPHCI PI: Jeffrey Brown) a contract to conduct the final analyses for a study titled: Database cohort study to assess the risk of serious angioedema in association with LCZ696 (sacubitril/valsartan; Entresto) use in Black patients with heart failure in the United States. The study will use data sources from the Innovation in Medical Evidence Development and Surveillance (IMEDS) and the Center for Medicare and Medicaid (CMS). The goal of the study is to provide real-world estimates of the incidence of angioedema among HF patients initiating Entresto (sacubitril/valsartan) and HF patients initiating an ACE inhibitor, with a primary focus on Black patients. The research activities will be a collaborative effort between Novartis, the IMEDS Operations Center at RUF, the IMEDS Analytic Center at HPHCI, and participating IMEDS Network Partners.
Developing a Program to Educate Sensitize Caregivers to Reduce the Inappropriate prescription Burden In Elderly with Alzheimer's Disease study (D-PRESCRIBE-AD, NIA R61AG069794 ) is a pragmatic trial of a planned 22,500 individuals with Alzheimer's disease or related dementias in the community. It examines the effect of a provider and patient/caregiver-centered educational intervention on inappropriate prescribing, which includes the use of medications that may no longer be necessary or that may increase the risk of harm. PI: Jerry Gurwitz; HPHCI PI: Rich Platt. Funded on 9/30/2020, with potential for an additional 4 years of funding if approved for an R33 phase.
The Harvard Pilgrim Health Care Institute Department of Population Medicine (PI: Jeffrey Brown) was recently awarded a 22 month contract with GlaxoSmithKline to study the use of selected medications during pregnancy. This multi-site study uses health plan claims data and claims data linked to electronic health record data to identify and characterize women exposed to Nucala (mepolizumab) and Benlysta (belimumab) during pregnancy specifically, and more generally among women of child-bearing years. The project will also evaluate the potential of these data for conducting comparative studies between women who were exposed and women who were not exposed to these products during pregnancy.
Dr. Jeffrey Brown was awarded a three-month contract with GlaxoSmithKline (GSK) titled, Shingrix Pregnancy Exposure Study (Preparatory Activities) in June 2020. The goal of this contract is to provide GSK with recommendations for the design and conduct of their planned monitoring study.
Dr. Julia Marcus presented on March 6, 2019 at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019) in Seattle, WA. Her presentation titled "Using EHR Data to Identify Potential PrEP Candidates in a Large Health Care System" described a prediction model to identify patients at risk of HIV acquisition in Kaiser Permanente Northern California.