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| |  Milestone in the Treatment of Hypertensive Patients STOCKHOLM/TORONTO -- August 27, 1997 -- Results of the first prospective, randomized, double-blind, placebo-controlled, outcome clinical trial in hypertensive patients were presented to the medical community today in Stockholm, Sweden at the 19th Congress of the European Society of Cardiology. The results showed very positive outcomes for patients with high blood pressure after treatment with a dihydropyridine calcium channel blocker (CCB). The Systolic Hypertension in Europe (SYST-EUR) study found that treatment with Bayer's CCB nitrendipine reduced stroke by 42 per cent and cardiac endpoints such as heart failure, heart attack and sudden death by 26 per cent. Patients treated with nitrendipine benefited so dramatically that the trial's Ethics Committee felt it necessary to halt the clinical trial early so that hypertensive patients could start benefiting from the medication. The Systolic Hypertension in Europe (SYST-EUR) trial included 4,695 elderly patients. According to the study coordinators Professor Jan Staessen and Professor Robert Fagard from the University of Leuven in Belgium's Cardiovascular and Hypertension Unit, treating 1,000 elderly patients with isolated systolic hypertension for five years would prevent 29 strokes or 53 major cardiovascular events. “The SYST-EUR trial represents a milestone for older patients with high blood pressure being treated with a calcium channel blocker,'' said Dr.Timothy Shannon, Vice-President of Medical and Scientific Affairs for Bayer Inc. (in Canada). “SYST-EUR - which started in 1989 - is the first major study to provide definitive data that dihydropyridine CCBs reduce cardiovascular morbidity and mortality and dramatically improve prognosis among the hypertensive population, in addition to reducing high blood pressure. It is the proof we've been waiting for.'' According to Dr. Shannon, SYST-EUR is the first prospective, randomized, double-blind study to show a reduction in clinical events with an antihypertensive drug other than a diuretic or beta-blocker. SYST-EUR is a prospective, randomized, double blind, placebo-controlled study, which included patients 60 years old and over with isolated systolic hypertension randomized to either stepwise antihypertensive treatment starting with nitrendipine, with the possible additions of enalapril and/or hydrochlorothiazide or to placebo. Nitrendipine reduced stroke by 42 per cent Active treatment reduced the total stroke rate from 13.7 to 7.9 events per 1,000 patient-years (a highly significant decrease of 42 per cent). In the active treatment group, all fatal and non-fatal cardiac endpoints, including heart failure, heart attack, and sudden death, declined by 26 per cent. A similar trend was observed for non-fatal heart failure (a decrease of 29 per cent), and for fatal and non-fatal heart attack (a decrease of 30 per cent). Positive Outcomes with CCBs The SYST-EUR trial confirms the findings of another study involving 1,600 patients, which showed positive outcomes with a calcium channel blocker. The Shanghai Trial of Nifedipine in the Elderly (STONE) found that patients treated with the long-acting calcium channel blocker nifedipine had a 62 per cent reduction in risk of all cardiovascular events (such as heart failure, heart attacks, etc.). In addition, the study demonstrated that nifedipine significantly reduces stroke and severe arrhythmia in elderly hypertensives. Bayer's Cardiovascular Leadership Bayer has long been a leader in cardiovascular research and development, beginning with the discovery of nifedipine, the prototype dihydropyridine calcium channel blocker (Ca-antagonist), which was first marketed in Europe in 1975. Nifedipine (Adalat(R)) is the most widely used calcium channel blocker in the world. The SYST-EUR trial was carried out in consultation with the World Health Organization, the International Society of Hypertension, the European Society of Hypertension and the World Hypertension League, and was sponsored by Bayer AG. Bayer Inc., the Canadian subsidiary of the international chemical and health care company, Bayer AG (Germany) is research-based with major businesses in health care, rubber, chemicals and imaging technologies. In the area of health care, Bayer offers leadership in a wide range of fields including: pharmaceuticals, self care products, diagnostics, medical imaging and biologics. Bayer is deeply committed to the health and well-being of Canadians and to helping Canada move toward a better health care system.
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