Health Canada Approves Diovan (valsartan) to reduce cardiovascular death after heart failure

Main Category: Cardiovascular / Cardiology
Article Date: 26 Sep 2005 - 0:00 PDT

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Novartis Pharmaceuticals Canada Inc. announced today that Health Canada has approved PrDiovan* (valsartan) for a new indication to reduce cardiovascular death in patients at high risk (with heart failure or left ventricular dysfunction) following a heart attack. Diovan* is the world's most prescribed angiotensin-receptor blocker (ARB) for mild-to-moderate hypertension.

Currently, one in three patients who survives a heart attack will die within one year.1 "Medications like valsartan are an important tool in our therapeutic strategy to reduce morbidity and mortality in this patient group who often can't or won't take their medications due to side effects," said Kenneth R. Melvin, MD, FRCPC, a Toronto cardiologist.

"Valsartan is proven to be more tolerable than some of the first line therapies used to treat heart attack survivors, so while offering excellent blood pressure control it supports better compliance," continued Dr. Melvin.

High blood pressure, a disease which affects about one in five Canadians2, greatly increases the risk of suffering a heart attack, as does smoking, obesity, high cholesterol and diabetes. There are 70,000 heart attacks in Canada each year2, and these patients are at greater risk of repeat attacks or death. In fact, approximately half of all heart attacks are repeat attacks.1

Heart attack survival

Within six years after a heart attack:

1 in 15 will die suddenly
1 in 12 men and 1 in 9 women will have a stroke
1 in 5 men and 2 in 5 women will be disabled by heart failure (progressive heart disease)
4 in 10 people who suffer a heart attack develop heart failure
People who develop these complications are four times more likely to die.1

Every 7 minutes someone in Canada suffers a heart attack3

"While we've made great strides in terms of saving people when they have their first heart attack, death due to a second event remains too high," said Jean-Lucien Rouleau, MD, FRCPC, of the Montreal Heart Institute, dean of the Université de Montréal Faculty of Medicine, and a lead investigator of VALIANT (VALsartan In Acute myocardial iNfarcTion), the study that led to Health Canada's approval. "VALIANT was a tremendous scientific undertaking involving more than 14,000 patients in 24 countries including over 1,000 Canadians at 67 centres coast-to-coast.3 We are proud it has resulted in the approval of a new treatment to reduce cardiovascular death following a heart attack."

New approval based on landmark VALIANT trial4

The Health Canada approval of Diovan* to reduce cardiovascular death in high-risk heart attack survivors is based on the results of VALIANT, one of the largest, long-term studies ever conducted in people who have suffered a heart attack. VALIANT was a rigorous comparison of Diovan* vs. captopril, an angiotensin converting enzyme (ACE) inhibitor, vs. the combination of both in 14,703 patients at high risk for death following a heart attack. In the VALIANT trial Diovan* was reported to improve survival and reduce cardiovascular events including recurrent heart attack and hospitalizations for heart failure in these patients.

There were no differences observed in overall mortality among the treatment groups. The results of VALIANT were published in the peer-reviewed journal, the New England Journal of Medicine, and presented at the American Heart Association Scientific Sessions in November, 2003.

A demonstrated commitment to improving patient care

Novartis Pharma AG is focused on improving the care of patients with high blood pressure and heart disease through world-class research and unprecedented public health initiatives. The Diovan* clinical trial program represents an impressive research commitment across the cardiovascular continuum, which involves more than 55,000 patients. Recently completed Diovan* trials include VALUE in high blood pressure patients; VALIANT in post-heart attack patients; and Val-HeFT in heart failure patients. Ongoing studies include the NAVIGATOR trial, examining whether long-term treatment with Diovan* delays or prevents the progression to type 2 diabetes and/or cardiovascular events in 9,524 people with impaired glucose tolerance, and Val-MARC, a study of the effects of Diovan* on C-reactive protein, an inflammatory marker for heart disease.

About Diovan*

The most prescribed ARB (angiotensin receptor blocker) in world5, Diovan* is indicated for the first-line treatment of mild-to-moderate essential hypertension and may be used over a dose range of 80 mg to 160 mg daily, administered once-a-day.

In clinically stable patients with signs or symptoms of left ventricular dysfunction in conjunction with acute myocardial infarction when the use of an angiotensin-converting enzyme inhibitor (ACEI) is not appropriate, Diovan* is indicated to reduce cardiovascular mortality. The recommended starting dose for post-MI therapy is 20 mg twice daily (1/2 40 mg scored tablet) initiated as early as 12 hours after a myocardial infarction, followed by up titration within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction. Diovan* should be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin and statins, as indicated.

Forward looking statement

The foregoing release contains forward-looking statements that can be identified by terminology such as "significant," "added benefit," "tremendous," or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or future sales of Diovan*. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan* to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Diovan* will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. In particular, management's expectations regarding commercialization of Diovan* could be affected by, among other things, additional analysis of Diovan* clinical data, new clinical data, unexpected clinical trial results, unexpected regulatory actions or delays or government regulation generally, the company's ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, increased government, industry, and general public pricing pressures, and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. The purpose of this media document is for information only, and is not meant to promote or encourage a use of this medication outside the approved Product Monograph in Canada. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Canada

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 2004, the Company invested over $55 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 860 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 Gerber [Canada] Inc.) and CIBA Vision Canada Inc. For further information about Novartis Canada, please consult http://www.novartis.ca.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

*Diovan is a registered trademark.

References
1 American Heart Association. Heart Disease and Stroke Statistics - 2003 Update. (NOTE: 25% of men and 38% of women averaged to obtain 31.5%, or one in three dies within a year of a first heart attack)
2 Heart and Stroke Foundation of Canada Annual Report Card on the Health of Canadians, 2001
3 Heart and Stroke Foundation of Canada (1999). The Changing Face of Heart Disease and Stroke in Canada 2000.
4 Pfeffer, M.A., et al. Valsartan, Captopril, or both in Myocardial Infarction Complication by Heart Failure, Left Ventricular Dysfunction or Both. New England Journal of Medicine.2003; 349:20 (1893-1906)
5 data on file

Novartis Pharmaceuticals Canada Inc. 385 Bouchard Boulevard Dorval, Quebec H9S 1A9
http://www.novartis.ca

Jason Jacobs
Director, Communications
Tel 514-633-7872
Jason.jacobs@novartis.com

View drug information on Captopril and hydrochlorotiazide.