Reaffirmation of Istin's Therapeutic Benefits to Patients After Initial Results Of Large Hypertension Study, Pfizer Says

Main Category: Hypertension
Article Date: 09 Mar 2005 - 10:00 PST

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Landmark Hypertension Study Stopped Earlier Than Expected Due to Reductions in Cardiovascular Death and All Cause Mortality -

Preliminary results of a large UK and Scandinavian hypertension clinical trial showed that patients receiving treatment based on the calcium channel blocker Istin (amlodipine besylate, Pfizer) experienced significant reductions in cardiovascular mortality and all cause mortality, and also had significantly fewer heart attacks and strokes compared to patients receiving a beta-blocker based regimen (one of the current mainstays of UK treatment). These initial data reaffirm the cardiovascular benefits of Istin, and were presented today at the annual American College of Cardiology meeting in Orlando, Florida.

Involving nearly 20,000 patients with high blood pressure, the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was designed to compare the effects of a Istin-based regimen versus a standard beta-blocker based regimen in reducing cardiac events in patients with hypertension and multiple cardiovascular risk factors. The trial was stopped early because preliminary data showed that patients receiving the Istin- based regimen demonstrated a 25 percent reduction in cardiovascular death and a 15 percent reduction in total mortality. These patients experienced a reduction in the primary endpoint (fatal coronary heart disease and non-fatal heart attack) of 10 percent, which did not reach statistical significance. In addition, they showed significant reductions in stroke, coronary events and they were also less likely to develop diabetes compared to patients taking the beta-blocker based regimen.

In the Istin based regimen, patients received the ACE-inhibitor perindopril and the alpha-blocker Cardura XL (doxazosin GITS) as add-on therapy if additional blood pressure control was needed. Patients receiving the beta-blocker based regimen atenolol, received a diuretic and Cardura XL (doxazosin GITS), if needed.

Funded by Pfizer, ASCOT is an investigator-initiated trial coordinated by an independent steering committee. The study began in 1998 and enrolled patients in the United Kingdom, Ireland, Sweden, Norway, Denmark, Finland and Iceland. In December 2004, the independent ASCOT steering committee endorsed the recommendation to stop the trial early due to favorable benefits demonstrated by patients in the Norvasc-based regimen.

"It is clear, based on these preliminary ASCOT results as well as previous studies that an Istin based blood-pressure lowering treatment regimen results in cardiovascular benefits for patients with high blood pressure" said Dr. Joseph Feczko, chief medical officer at Pfizer. "We look forward to seeing the final study results."

Gareth Field
Account Executive
35-41 Folgate Street
London
E1 6BX
Tel: 020 7611 3668

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