~ Significant Reductions Seen in Heart Failure Morbidity and Hospitalisations ~
DORVAL, Quebec (December 6, 2001) -- Results of the landmark Valsartan Heart Failure Trial (Val-HeFT) study published in the December 6th issue of the New England Journal of Medicine (NEJM) show that Diovan® (valsartan), an angiotensin II receptor blocker (ARB), reduces morbidity in heart failure patients by 13.2% (p=0.009).
Diovan® is the first ARB shown to offer incremental benefits on morbidity in a large-scale trial of heart failure patients receiving standard care. The rate of all-cause mortality was similarly low in both the Diovan® group and the control group. Sub-group analysis showed that Diovan® did not appear to benefit patients taking Diovan® in combination with both a beta blocker and an ACE inhibitor. Benefits were much stronger, however, in patients not receiving other neurohormonal inhibitor therapy.
In Val-HeFT, a statistically significant 13.2% (p = 0.009) reduction of morbidity was achieved. Also, there was an overall reduction in the incidence of heart failure hospitalisations of 27.5% (p < 0.001) and significant improvement of patients' quality of life (p = 0.005).
Diovan® achieved a 44% (p=0.003) reduction of morbidity in the sub-group of 366 patients not taking an ACE inhibitor.
"Diovan® was able to reduce morbidity and hospitalisations through a highly selective blockade of angiotensin II at the AT1 receptor," says Dr. Peter Liu, a cardiologist at Toronto General Hospital University Health Network. "Data from Val-HeFT and previous studies show Diovan® to be a valuable option for the treatment of high blood pressure and heart failure," adds Dr. Liu.
"Val-HeFT was unprecedented because it evaluated the effects of Diovan® in patients who were already receiving existing heart failure therapy," said Professor Jay Cohn, Lead Investigator of Val-HeFT, Cardiovascular Division, University of Minnesota Medical School. "The robustness of the data and the consistency of its findings across primary and secondary endpoints support an important clinical role for Diovan® in this devastating disease."
Based on Val-HeFT results, Novartis recently received an "approvable" letter from the US Food and Drug Administration (FDA) for Diovan® to be used in the treatment of heart failure in patients not taking an ACE inhibitor. Final approval is contingent on further analysis of existing data and possibly the submission of additional data. If approved, Diovan® will be the only ARB indicated for the treatment of heart failure in the US. In Canada, Novartis has filed an application for a heart failure indication with Health Canada.
Heart failure is the fastest growing cardiovascular disease and one of the most challenging heart conditions to treat. An estimated 300,000 Canadians suffer from heart failure and approximately four million Canadians have high blood pressure, a major risk factor for heart failure.
Val-HeFT was a double-blind, randomised clinical trial involving 5010 patients at 300 centres in 16 countries that compared Diovan® to placebo in heart failure patients who were also taking usual therapy, including ACE inhibitors, beta blockers, diuretics, and digoxin. Study patients received either a maximum dose of 320 mg of Diovan® (160 mg twice daily) or placebo, in addition to their usual individualised heart failure therapy prescribed by their doctors. Unlike other recent heart failure trials, the study population included many earlier stage heart failure patients and was consistent with the real-world heart failure population.
Heart failure, or progressive weakening of the heart muscle, is the fastest growing cardiovascular disease in the world and has reached epidemic proportions in industrialised nations. Twenty million people worldwide have heart failure and the condition is the most common reason why patients aged 65 or older are hospitalised. High blood pressure is a common risk factor for heart failure. About 75 % of patients have hypertension before they progress to heart failure.
Diovan® is a well established, effective treatment for hypertension, and belongs to the ARB class of medicines already recommended by the World Health Organization (WHO) for first-line treatment of this condition. Diovan® has been approved in Canada for the treatment of hypertension since 1997.
This release contains certain "forward-looking statements", relating to the business of Novartis, which can be identified by the use of forward-looking terminology such as "is contingent upon", "has filed an application", "approvable", "if approved" or similar expressions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned approvable letter or application for a heart failure indication in Canada will result in increased sales of Diovan®. Any such commercialisation can be affected by, amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed,estimated or expected.
About Novartis (NYSE:NVS)
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2000, the Company invested close to $34 million in research and development. Novartis Pharmaceuticals Canada Inc. employs over 600 people in Canada and its headquarters are located in Dorval, Quebec.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation) and CIBA Vision Canada Inc. Worldwide in 2000, the Novartis Group's ongoing businesses achieved sales of $25.5 billion and a net income of $5.7 billion. The Group invested approximately $3.5 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000 people and operates in over 140 countries around the world.
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