Rhode Island Hospital Joins National Clinical Trial to Test New Drug Therapy For ACE Inhibitor-Induced Angioedema

September 9, 2014

Angioedema leading cause of emergency department visits in the US

Rhode Island Hospital has joined a national clinical trial to test the safety and efficacy of a new medication for the treatment of Angiotensin-Converting Enzyme Inhibitor (ACE-I)-induced angioedema in adults, and is currently recruiting patients. Angioedema is the swelling of the deeper layers of skin, caused by a buildup of fluid. It can affect any part of the body, but swelling usually affects the eyes, lips, hands or feet. The clinical trial was first launched at Henry Ford Hospital in Detroit, Michigan, and now includes numerous hospitals throughout the U.S. and the world.

ACE inhibitors are widely prescribed for patients with hypertension, myocardial infarction, heart failure with systolic dysfunction, diabetes and chronic kidney disease. Nearly 40 million people in the U.S. have been prescribed an ACE inhibitor, which is the leading cause of drug-induced angioedema in the U.S. Angioedema – ACE inhibitor-induced, allergic reactions and idiopathic angioedema – results in more than 100,000 emergency department visits annually in the U.S., according to the National Institutes of Health.

The clinical trial will test the efficacy and safety of the investigational drug Icatibant as compared to a placebo in reducing swelling and other symptoms of angioedema. Symptoms of ACE inhibitor-induced angioedema may include a prickling sensation in the affected area before swelling is visible, a hot or painful sensation in the swollen area, and swelling of the face and lips, as well as inside of the throat, windpipe and tongue, which make breathing difficult.

Participants in the clinical trial must be age 18 or older, must be currently treated with an ACE inhibitor, and must meet additional criteria. For more information on the study, please visit http://clinicaltrials.gov (Identifier: NCT01919801).

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