Details
Protocol-based one-time assessment of the risk of angioedema associated with new use of drugs that act on the renin-angiotensin-aldosterone system (RAAS), including angiotensin converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), and aliskiren. The assessment concerned individuals aged ≥18 years who initiated oral ACEIs, ARBs, aliskiren or beta-blockers. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.
Additional Information
Contributors
Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Sean Hennessy PhD, PharmD; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Marsha E. Reichman PhD; Monika Houstoun PharmD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Xiao Ding PhD; Mark Levenson PhD; Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Adrian Hernandez MD; Division of Cardiology, Duke University School of Medicine, Durham, NC
Lingling Li PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Carolyn McCloskey MD, MPH; Eileen Wu PharmD; Gwen Zornberg MD, ScD, MS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Azadeh Shoaibi MS, MHS; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Mary Ross Southworth PharmD; Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD