Study: Therapy addition reduces risk of stroke and other cardiovascular events

Sep 17 2009

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,>

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)