[ASCOT results]
>>STOCKHOLM, Sweden, Sept. 4 /PRNewswire-FirstCall/ -- CV Therapeutics (Nasdaq: CVTX - News) announced today that patients in ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) receiving a treatment regimen of the calcium channel blocker amlodipine plus or minus the angiotensin converting enzyme (ACE) inhibitor perindopril experienced a significant reduction in major cardiovascular endpoints and in all-cause mortality compared to patients receiving a regimen of the beta blocker atenolol plus or minus the diuretic bendroflumethiazide, according to data presented today at the European Society of Cardiology Congress 2005 in Stockholm, Sweden, and published concurrently in The Lancet.
ASCOT had been stopped early by the study's steering committee due to the benefits observed from the combination of the newer blood pressure lowering drugs, amlodipine and perindopril. All cause mortality was reduced by 11 percent (p=0.025) with this regimen. In the amlodipine and perindopril based treatment regimen, nearly two-thirds of patients were receiving perindopril at the end of the study.
In addition, ASCOT showed that the amlodipine and perindopril based regimen reduced total cardiovascular events and procedures by 16 percent (p<0.0001), the risk of fatal and non-fatal stroke by 23 percent (p=0.0003), and also new cases of diabetes by 30 percent (p<0.0001) compared with the standard treatment of the atenolol and diuretic based regimen.
Patients in the amlodipine and perindopril based regimen of the study experienced a 10 percent reduction in the primary endpoint of nonfatal myocardial infarction and fatal coronary heart disease. This difference did not reach statistical significance.
"As a result of the ASCOT data, the investigators believe that recommendations for managing high blood pressure may need to be reviewed to account for the benefits observed with the treatment regimen of amlodipine and perindopril," said Peter Sever, M.D., co-chairman of the ASCOT steering committee and professor of clinical pharmacology and therapeutics at the International Centre for Circulatory Health, Imperial College, London.
ACEON® (perindopril erbumine) Tablets is indicated to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction in patients with stable coronary artery disease and also is indicated for the treatment of patients with essential hypertension.
The 19,000 patient ASCOT study compared the ability of these two different treatment regimens to reduce a composite endpoint of nonfatal myocardial infarction and fatal coronary heart disease in hypertensive patients.
The final results of the blood pressure lowering arm of ASCOT, and potential explanations for the observed benefits, are reviewed in separate papers published today in The Lancet and available online (http://www.thelancet.com/journals/eop). Further information on ASCOT can be obtained at ascotstudy.org.
In the United States, perindopril, an ACE inhibitor with tissue activity, is marketed under the brand name ACEON® and is approved to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction in patients with stable coronary artery disease and also is indicated for the treatment of patients with essential hypertension.
Solvay Pharmaceuticals, Inc. and CV Therapeutics co-promote ACEON® in the United States. In other parts of the world such as Europe, Canada and Australia, perindopril is marketed under several brand names, including Coversyl®. Perindopril is one of the leading ACE inhibitors in Europe.
The ASCOT study was neither funded nor sponsored by CV Therapeutics, Inc. or Solvay Pharmaceuticals. Solvay Pharmaceuticals is the holder of the ACEON® Tablets IND and NDA in the United States.<<
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Cheers, Tuck |
