New data on post-MI benefits of valsartan
Sep 7, 2005, 07:26, Reviewed by: Dr.
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One of the largest megatrials confirms that Diovan � the most prescribed angiotensin receptor blocker � protects a broad range of people with heart disease
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By Novartis,
Diovan� (valsartan) is the first drug of its class (angiotensin receptor blocker or ARB) shown to reduce the chance of cardiovascular events that may be caused by clogged arteries (atherosclerosis) in people who have had a recent heart attack, according to data presented at the European Society of Cardiology Congress (ESC 2005).
The need for new treatments after a heart attack remains significant. More than three million people from the EU and 1.2 million people in the US suffer a heart attack every year. Additionally, one in three people die within one year after their first recognized heart attack.
The data presented at ESC further reinforce the protective effects of Diovan, which is already the No. 1 prescribed ARB worldwide. These findings follow recent marketing authorizations throughout the world for the cardioprotective use of Diovan as a potentially lifesaving treatment for high-risk patients who have had a recent heart attack or people with heart failure. Diovan is the only ARB with both of these indications.
A new analysis of the VALIANT (VALsartan In Acute myocardial iNfarcTion) megatrial confirmed that Diovan is as effective as the ACE inhibitor captopril, a commonly used treatment, in reducing atherosclerotic events, such as heart attacks.
"Until now, the nature of ARB trials have made it difficult to determine whether this class of drugs is effective in preventing atherosclerotic events. We now have further evidence that valsartan is as effective as an ACE inhibitor in preventing atherosclerotic events," said John McMurray, MD, Professor of Medical Cardiology and Honorary Consultant Cardiologist, Clinical Research Initiative in Heart Failure, University of Glasgow, Western Infirmary in the United Kingdom and co-principal investigator in VALIANT, in explaining the benefits of these findings for heart attack survivors.
High blood pressure is a major risk factor for cardiovascular diseases such as heart attack and heart failure. While progress has been made in treating heart attacks, people who survive the acute phase are at greatly increased risk for repeat attacks and other events that can result from clogged arteries, also called atherosclerosis. This condition is the leading cause of morbidity and mortality from cardiovascular disease and can result in heart attacks or stroke. For example, nearly half of all heart attacks are repeat attacks, and one in 12 men and one in nine women will have a stroke within six years of a heart attack.
The new retrospective analysis presented at ESC 2005 demonstrated similar beneficial effects of Diovan, captopril, and their combination on a composite endpoint of events that may be caused by atherosclerosis in the 14,703 patients randomized in the VALIANT trial. There was no significant difference between the effects of Diovan or captopril on the composite endpoint of cardiovascular death, heart attack, angina, revascularization, or stroke (2,175 in the Diovan group, 2,228 in the captopril group, and 2,197 in the combination group; Diovan vs. captopril p=0.286).
VALIANT demonstrated that Diovan is the only cardiovascular agent ever shown by a head-to-head trial to be at least as effective as an ACE inhibitor in these patients. This finding can translate into a 25% reduction by Diovan in premature death in patients at high risk following a heart attack. VALIANT also showed that Diovan is well-tolerated in post-heart attack patients. The percentage of permanent discontinuations due to adverse events was statistically higher in the captopril-treated (7.7%) patients than in the valsartan-treated (5.8%) patients [p less than 0.05].
Recent regulatory approvals for Diovan in people who have had a heart attack are based on the positive results of VALIANT, one of the largest long-term studies ever conducted in people who have survived a heart attack.
- European Society of Cardiology Congress (ESC 2005)
www.novartis.com
Diovan megatrials
A new analysis of Val-HeFT examining the protective benefits of Diovan for people with heart failure is also being presented today. Anand IS et al. Addition of an angiotensin receptor blocker to standard heart failure therapy reduces morbidity in patients with reduced renal function; abstract presented at ESC 2005 Further protective effects of Diovan have also been shown in the VALUE trial, where Diovan prevented the development of new onset diabetes compared to amlodipine. This data will be discussed at the ESC 2005 Abstract session on September 7 at 11.30 am. Kjeldsen S E. Valsartan prevents new onset diabetes compared to amlodipine in the VALUE trial; abstract presented at ESC 2005.
In order to explore this benefit of Diovan and the CV event reduction, Novartis is conducting NAVIGATOR, the largest outcomes trial ever conducted on the delay or prevention of cardiovascular events and type II diabetes in patients with impaired glucose tolerance.
Novartis is committed to improving research, especially in cardiovascular and metabolism care. The Diovan clinical trial program represents one part of this commitment, involving more than 50,000 patients across the cardiovascular continuum. Recently completed Diovan megatrials include VALUE in hypertension patients at high-risk for cardiovascular complications, VALIANT in post-heart attack patients and Val-HeFT in heart failure patients.
About Diovan
Novartis remains on the forefront of cardiovascular medicine, through development of innovative products like Diovan, the number one prescribed ARB in the world today. Diovan is available as a powerful first-line treatment for high blood pressure in more than 90 countries, for the treatment of heart attack survivors in 51 countries and in 71 countries for the treatment of people with heart failure. Additional marketing authorization applications are pending for the treatment of post-heart attack and heart failure.
For high-risk heart attack patients, Diovan recently completed the EU Mutual Recognition Procedure (MRP) in 14 countries for the treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent myocardial infarction.
For heart failure, Diovan also completed an EU type II variation application in 14 countries for the treatment of people with symptomatic heart failure when ACE inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers can not be used.
The foregoing release contains forward-looking statements that can be identified by terminology such as "potentially," "are pending" or similar expressions, or by express or implied discussions regarding potential new indications or labeling and marketing approvals for Diovan or regarding potential 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 be approved for any additional indications or labeling in any other market. Nor can there be any guarantee regarding potential future sales of Diovan. In particular, management's expectations regarding commercialization of Diovan or 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; industry, government, and general public pricing pressures; and other risks and factors referred to in Novartis AG'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. 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
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the businesses of the Novartis Group 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 83,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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