Landmark study shows therapy addition almost halves risk of stroke and
other cardiovascular events
DORVAL, QC, Sept. 14 /CNW/ - Data from the independent KYOTO HEART study, presented recently at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, and published online in the European Heart Journal demonstrated the addition of the angiotensin receptor blocker (ARB) Diovan* (valsartan) to a non-ARB-based treatment regimen for high blood pressure provided a significant 45% relative risk reduction in cardiovascular events(1) including stroke, compared to conventional non-ARB treatment regimen.(1)
A total of 3,031 Japanese patients with uncontrolled high blood pressure either with no treatment or on a previous non-ARB-based regimen and with one or more pre-defined cardiovascular risk factors (e.g. existing diabetes, obesity, smokers, or a history of cardiovascular disease) took part in the study.
"These findings are useful to Canadian physicians who are working with their patients to prevent long-term complications of high blood pressure, such as stroke" said Peter Lin, MD, CCFP, Primary Care Physician, Toronto, Ontario. "This study followed high risk patients commonly seen in clinical practice and while the results reinforce that getting blood pressure down is important, choosing the right treatment to get there is vital because some medicines have additional protective benefits."
"The KYOTO HEART study confirms that valsartan can significantly reduce the incidence of the composite of heart, brain and vascular complications in patients at high risk of cardiovascular events, independent of its blood pressure-lowering efficacy," said Hiroaki Matsubara, MD, PhD, Professor of Cardiovascular Medicine at the Kyoto Prefectural University of Medicine, Kyoto, Japan and Principal Investigator of the KYOTO HEART study. "In addition, the study also confirms that the numerous benefits of blockade of the renin angiotensin system extend to East Asian patients."
While the cardiovascular risk profile of Japanese patients has historically been different to that of Caucasians and African-Americans, general changes in lifestyle throughout East Asia in recent years have resulted in the Japanese risk profile becoming more similar to that of western populations. "KYOTO HEART enrolled patients with high rates of metabolic syndrome and obesity, and numerous smokers," said Professor Gordon T McInnes, Clinical Pharmacology, University Division of Cardiovascular and Medical Sciences, Western Infirmary, Glasgow. "For this reason, the results of this study may not only be relevant to patients with high blood pressure in Japan, but also other populations where such risk factors are highly prevalent."
More details on the study
The study participants were randomized to receive either Diovan* add-on therapy or a non-ARB-based regimen, with dose increases and add-on therapies allowed in both arms to achieve optimal blood pressure-lowering efficacy. The primary study endpoint was a composite of defined cardio- and cerebrovascular events including stroke, myocardial infarction, and hospitalization for heart failure or angina.(2)
Significant, double-digit blood pressure reductions were observed in both treatment arms (133/76 mmHg in both arms at study end). However, compared to the non-ARB-based therapy group, significantly fewer individuals in the Diovan* add-on group experienced a primary endpoint, Hazard Ratio (HR) =0.55, p=0.00001). The reduction in the composite primary endpoint was largely due to a 45% reduction observed in the risk of stroke (HR=0.55, p=0.0149) and a 49% reduction in the risk of angina (HR=0.51, p=0.0106).(1) Importantly, the number of adverse events was low overall, and there was no significant difference in tolerability between the two treatment groups.(1)
The KYOTO HEART study was conceived designed and conducted by an independent steering committee, representing the Kyoto Prefectural University School of Medicine, and was funded by the Kyoto Foundation for the Promotion of Medical Science. Novartis Pharmaceuticals Canada Inc. had no role in the study's conception or design, or in carrying out the study, including data collection, data analysis, data planning or data interpretation, or in the writing of the study report.
Novartis Pharma K.K. Japan has already made several research grants to the Kyoto Prefectural University School of Medicine.
Cardiovascular disease and stroke in Canada
Cardiovascular disease accounts for the death of more Canadians than any other disease. In 2005 (the latest year for which Statistics Canada has data), cardiovascular disease accounted for more than 71,000 Canadian deaths: 54% of all cardiovascular deaths are due to ischemic heart disease; 20% to stroke and 24% to heart attack.(3)
In Canada, stroke is the third most common cause of death. More than 50,000 Canadians suffer from a stroke each year, resulting in approximately 14,000 deaths. Of these sufferers, 40% are left with a moderate to severe impairment, while 10% are so severely disabled they require long-term care.(3)
According to Statistics Canada, Canadians of Asian ancestry comprise the largest visible minority in the country, at 11% of the population, and is the fastest growing. Most Asian Canadians are concentrated in urban areas of southern Ontario, the Greater Vancouver area, Montreal, and other large Canadian cities.(4)
More details on Diovan*
The results from KYOTO HEART extend the existing wealth of evidence from multiple studies and patient populations of the clinical value of Diovan*, which remains the only ARB indicated in Canada for post-myocardial infarction and heart failure patients, in addition to its proven powerful blood pressure-lowering efficacy. An additional, large-scale outcomes study - NAVIGATOR - is currently ongoing which will assess whether Diovan* or the oral antidiabetic nateglinide can reduce the incidence of cardiovascular events and reduce and delay the progression to clinical diabetes in patients with impaired glucose tolerance or 'pre-diabetes' at high risk of cardiovascular events.(5)
Approved in Canada in 1997, Diovan* (valsartan) is a selective ARB, and is indicated for the treatment of mild to moderate essential hypertension. Diovan* may be administered alone, or in combination with thiazide diuretics or as a fixed dose combination called Diovan*-HCT. Diovan* is also approved to reduce cardiovascular mortality in clinically stable patients with signs and 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 also approved for use in patients with chronic heart failure who have been shown to be intolerant to an angiotensin converting enzyme inhibitor. There is no evidence that Diovan* provides added benefits when it is used with ACE inhibitors. Diovan* is not approved to reduce the risk of stroke or angina pectoris.
The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "may allow," "offers a real potential to" or implied statements regarding potential future revenues from Diovan.* Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results 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 submitted or approved for any additional indications or labeling. There can be no guarantee that Diovan* will reach any particular sales levels. In particular, management's expectation regarding the commercial success of Diovan* could be affected by among 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 Form 20F filed with the 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 described herein 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 Pharmaceuticals 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 Inc. conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, oncology, diabetes, cancer, ophthalmology and organ transplantation. In 2007, the Company invested close to $86 million in research and development. Novartis Pharmaceuticals Canada Inc. employs more than 800 people in Canada and its headquarters are located in Dorval, Québec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit www.novartis.com.
*Diovan is a registered trademark
1 Matsubara H. Effects of Valsartan on morbidity and mortality in
uncontrolled hypertensive patients with high risk of cardiovascular
events (KYOTO HEART Study). Data presented at ESC Congress 2009,
Barcelona, Spain. Abstract No: 3582.
2 Sawada T, et al. Rationale and design of the KYOTO HEART study:
effects of valsartan on morbidity and mortality in uncontrolled
hypertensive patients with high risk of cardiovascular events. J Hum
3 Statistics. The Heart & Stroke Foundation Web Site. Available at:
Accessed September 4, 2009.
4 Statistics Canada, 2006 Census, as reported on Wikipedia.org
5 Califf RM, et al. Prevention of diabetes and cardiovascular disease
in patients with impaired glucose Tolerance: rationale and design of
the Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes
Research (NAVIGATOR) Trial. Am Heart J 2008;156(4):623-32
SOURCE Novartis Pharmaceuticals Canada Inc.
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