Statin arm of ASCOT study stopped early

Laurent Castellucci

October 10, 2002

Thu, 10 Oct 2002 21:50:00

New York, NY - The International Steering Committee of the independent Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) has announced that it formally stopped the atorvastatin (Lipitor® - Pfizer) portion of the trial on October 1 at the recommendation of the ASCOT Data Safety Monitoring Board because the patients on atorvastatin "suffered significantly fewer heart attacks and strokes compared with those receiving the placebo treatment."

"It is too early to quantify the precise size of the effect, but we expect to see a reduction in heart attacks of about one third among those taking a statin," according to ASCOT study cochairs Björn Dahlöf (Sahlgrenska University Hospital, Sweden) and Peter Sever (Imperial College, UK).

The rest of the trial, which compares the strategy of the calcium channel blocker amlodipine (with the ACE inhibitor perindopril) with the beta blocker atenolol (with the diuretic bendrofluazide) for treating hypertension, will continue unchanged.

Only the patients with cholesterol levels of 6.5 mmol/L (250 mg/dL) or less were eligible for the atorvastatin part of the study, which investigated the effect of the statin on a hypertensive population with only slightly elevated or normal cholesterol levels. These 10297 patients received either 10 mg of atorvastatin or placebo in the trial.

All patients will be examined again in the coming weeks and are being encouraged to continue on their medications.

Data collection relating to the atorvastatin portion of the trial is expected to continue until the end of December 2002. Further announcements about the results of the atorvastatin part of the trial will be made in 2003, with final results of the whole ASCOT study expected in 2004.

ASCOT is primarily funded by Pfizer and jointly coordinated by the Imperial College London (Cardiovascular Studies Unit, Department of Clinical Pharmacology, St Mary's Hospital, London) and Göteborg University (Scandinavian CRI), Sweden. The trial began in 1998 and enrolled 19342 patients from the UK, Ireland, and across Scandinavia, making it the largest European-based prospective randomized hypertension trial ever conducted. Entry criteria are high blood pressure and the presence of at least 3 other prespecified cardiovascular risk factors. Patients in the trial are between 40 and 79 years old.

The primary end point of the trial is death or nonfatal MI. A large number of other cardiovascular events, including stroke, are identified as secondary end points in the study.



Related links

1. [HeartWire >News; Dec 17, 2001]

2. [HeartWire >News; Sep 1, 2000]

3. [HeartWire >News; Apr 19, 2000]


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