To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: New Treatment Option for Patients With High Blood Pressure URL: http://www.pslgroup.com/dg/3CD16.htm Doctor's Guide October 7, 1997
PRINCETON, NJ. -- October 7, 1997 -- The U.S. Food and Drug Administration has granted marketing clearance for Bristol-Myers Squibb Company and Sanofi S.A.'s Avapro (irbesartan) -- the newest member of a class of drugs known as angiotensin II receptor blockers (ARBs) -- for use as a first-line treatment of hypertension. The decision provides the more than 60 million patients with high blood pressure in the U.S. a new effective, once-a-day treatment option that has been shown in clinical studies to have an excellent side effect profile. It is estimated only 21 percent of treated hypertensive patients are currently controlling their blood pressure. In fact, up to 70 percent of treated patients with high blood pressure discontinue their medication within the first nine months of starting treatment. Side effects and inconvenient dosing schedules are some of the reasons given why patients do not consistently take their antihypertensive medication and fail to achieve blood pressure control. "In individual cases, achieving control of blood pressure can require a wide dosing range of medication," said Randall M. Zusman, M.D., director of the division of hypertension and vascular medicine, Massachusetts General Hospital. "This need for an increase in medication often results in a greater incidence of side effects, such as fatigue, depression, impotence, sleeplessness and cough. In clinical studies, the incidence of these common side effects was no different with Avapro than with placebo." In short-term trials (six to eight weeks), Avapro therapy produced satisfactory blood pressure response in up to 67 percent of patients. In a one-year open label study, 91 percent of patients taking an Avapro-based regimen responded with satisfactory blood pressure readings. Over 75 percent of these patients were taking Avapro alone. In addition, Avapro monotherapy provides increased control of hypertension when doses are titrated from 150 to 300 mg once daily, while maintaining an excellent safety profile at every dose. Avapro should not be used in women who are pregnant or by people who are allergic to any component of the medication. In placebo-controlled clinical trials, the adverse event experiences that occurred in at least one percent of patients treated with Avapro and at a higher incidence versus placebo included: diarrhea (three percent versus two percent), dyspepsia/heartburn (two percent versus one percent), musculoskeletal trauma (two percent versus one percent), fatigue (four percent versus three percent) and upper respiratory infection (nine percent versus six percent). None of these differences were significant. More information on: Bristol-Myers Squibb Company, Sanofi S.A. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.