More people survive heart attacks than ever before, only to remain at great risk of another heart attack, heart failure, stroke or sudden death.

An international research team led by investigators from Brigham and Women's Hospital (BWH), University of Glasgow and Duke Clinical Research Institute has proven that a newer type of high blood pressure medication, valsartan, also saves lives and prevents recurrent heart attacks and hospitalisations for heart failure after heart attack as effectively as an ACE inhibitor, today's standard treatment.

VALIANT (the VALsartan In Acute myocardial iNfarction Trial) has been the largest long-term study ever conducted in people who have survived a heart attack (myocardial infarction or MI) and its findings are expected to lead to a change in current treatment guidelines.

The results were announced today during a late-breaking presentation at the American Heart Association Scientific Sessions 2003 by Marc Pfeffer, MD, PhD, the VALIANT lead investigator and senior cardiologist at BWH.

"The findings of VALIANT show that valsartan preserved all the life-saving benefits of the ACE inhibitor (99.6%). Because VALIANT compared valsartan to an active treatment with proven benefits vs. placebo, we can impute the placebo effect of valsartan and conclude it translates into a 25% reduction in all-cause mortality", said Professor John McMurray (Professor of Medical Cardiology at the University of Glasgow and Honorary Consultant Cardiologist, Western Infirmary, Glasgow), co-chair of VALIANT. He added,"VALIANT has identified valsartan as an important new therapy for these high risk patients".

More than eighty thousand people in Scotland are alive today following a heart attack. Each year, more than fourteen thousand people in Scotland have a heart attack ﾖ nearly half of which are repeat attacks. Despite significant advances in cardiac care, people who survive a heart attack have a risk of illness and death that is up to 15 times higher than the general population.

"VALIANT tells us that valsartan is as effective as ACE inhibitors in reducing death and other cardiovascular events in these patients", said Dr. Pfeffer, who is also a professor of medicine at Harvard Medical School. "This is an important discovery, because it gives physicians a new option for treating these high-risk patients."

This is especially true for patients with a "VALIANT MI" ﾖ a heart attack complicated by heart failure and/or left ventricular systolic dysfunction (impaired pump function of the heart muscle).

VALIANT was a prospective, double blind, randomised active-controlled study conducted with 14,703 patients from 931 centres in 24 countries. The study was designed to investigate the effects of valsartan on all-cause mortality in comparison to, and in combination with, the ACE inhibitor captopril. A rigorous head-to-head comparison, the study was designed with adequate statistical power to determine if valsartan was comparable to captopril, a proven treatment.

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The design, patient population and dosing regimens in VALIANT were modelled after earlier studies that established the benefits of ACE inhibitors in post-MI treatment so that direct comparisons of the findings could be made. Men and women aged 18 and older were enrolled in the study between 12 hours and 10 days after their heart attack and randomised into one of the three treatment groups.

Patients underwent reperfusion with angioplasty and thrombolytics as determined by their physicians and also received other medical treatments including aspirin, cholesterol-lowering agents (statins), and beta-blockers.

The study also demonstrated that valsartan was at least as effective as the ACE inhibitor in reducing cardiovascular complications including repeat heart attacks, hospitalisation for heart failure, stroke, and cardiac arrest. No additional reduction in mortality was observed in patients taking valsartan and captopril combined.

The findings of VALIANT were consistent across all endpoints and patient subgroups. In VALIANT, treatment was generally well tolerated and few patients discontinued study medication due to side effects. Discontinuations due to drug related adverse events were lowest in the valsartan group and highest in the combination group. Hypotension and renal side effects were most common in the group that received both medications together than in either group receiving valsartan or captopril alone.

The rate of hypotension and renal dysfunction was slightly higher in the valsartan group than in the captopril group. Reducing the dose of study drug allowed a majority of patients who experienced hypotension and renal dysfunction to continue on study medication, and thus remain on life-saving therapy. Overall, there was a statistically significant higher rate of patient discontinuation of study medication for adverse events in the captopril group where more treatment-limiting side effects occurred, including cough, rash and taste disturbance, compared to the valsartan group.

Data co-ordination and analysis for VALIANT were conducted at Duke Clinical Research Institute, Durham, North Carolina, under the direction of Robert M. Califf, MD, Director of the Institute and Associate Vice Chancellor for Clinical Research, Duke University Medical Centre. This research was funded by Novartis Pharma AG.

For further information please contact Judith or Kate in the University Press office Tel: 0141 330 3683 or to organise an interview with Prof McMurray contact Janene Ferrara at CCA PR Tel: +1 407 235 7282.

First published: 10 November 2003