Can Hypertension Be Delayed Or Prevented? Ground-breaking Trophy Study To Examine Whether Medication Can Prevent High Blood Pressure

WAYNE, Pa., Jul 8, 1999 /PRNewswire via COMTEX/ -- In an innovative approach to investigating the feasibility of preventing the development of high blood pressure, researchers have commenced an unprecedented study known as the Trial of Preventing Hypertension (TROPHY) to stop blood pressure from rising in patients at risk. By starting treatment early with ATACAND(R) (candesartan cilexetil) in patients with "high normal" blood pressure -- in the range of 130-139/85-89 mmHg -- TROPHY investigators hope to delay or prevent the onset of hypertension, thereby delaying or averting its consequences.

Hypertension, defined as a blood pressure of 140/90 mmHg or higher, isa relatively frequent condition affecting approximately 40 million Americans. It is called the "silent killer" because it usually causes no symptoms. However, hypertension is a major risk factor for death and disability related to coronary heart disease, heart attacks, heart failure, strokes, kidney disease and vascular complications. Commonly accepted guidelines call for a physician to initially recommend appropriate lifestyle changes to lower blood pressure in these patients unless they have a coexisting disease such as diabetes, in which case patients with even lower levels are treated with medication. But, in time, most patients with high normal blood pressure levels will rise to 140/90 mmHg or higher -- classified as Stage I hypertension -- when physicians usually start treating them with medication.

The prevention of hypertension has been identified as the next largearea for intervention by the World Health Organization and the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, sponsored by the National Heart, Lung and Blood Institute.

TROPHY is a new four-year study of 1,000 people at 100 clinical centers around the United States. During the treatment phase of the study, participants will receive a placebo or once-daily treatment with ATACAND, an angiotensin receptor blocker (ARB) introduced in the U.S. by AstraZeneca LP last October for the treatment of hypertension. Neither the patient nor the treating physician will know which patients are receiving whichtreatment. The primary endpoint is whether the patient develops blood pressure of at least 140mmHg systolic and/or 90 mmHg diastolic at any three subsequent visits or a blood pressure reading of at least 160 mmHg systolic and/or 100 mmHg diastolic at any one visit. Any patient whose blood pressure reaches these levels will be prescribed either the AstraZeneca LP beta-blocker TOPROL-XL(R) (metoprolol succinate) extended release tablets or the diuretic hydrochlorothiazide as once-a-day add-on therapy.

"An obstacle to effective treatment is that often the drugs make a patient feel worse than the untreated disease," noted lead TROPHY investigator Stevo Julius, MD, ScD, Professor of Medicine and Physiology at the University of Michigan Medical Center. "Because we are studying people with high normal blood pressure, we have to use a medication that will not have side effects that dissuade them from taking their medications regularly. ATACAND, a member of the newest class of approved antihypertensive agents called ARBs, hasfew side effects and a safety profile comparable to a placebo."

Most frequent adverse events with ATACAND are headache, upper respiratory tract infections and back pain. While the overall incidence of adverse events has been similar to placebo in controlled clinical trials, some adverse events that occurred in at least one percent of patients treated with ATACAND were higher than placebo, including back pain, dizziness, upper respiratory tract infection, pharyngitis and rhinitis. As with other drugs that act directly on the renin-angiotensin system, ATACAND should not be used by pregnant women and should be discontinued if pregnancy is detected.

ATACAND is marketed in the United States by AstraZeneca LP. The TROPHY Study has been underwritten by AstraZeneca PLC. AstraZeneca PLC is one ofthe top five pharmaceutical companies in the world based on sales and is a therapeutic leader in gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. Based in the United Kingdom, AstraZeneca PLC (NYSE: AZN) is a major $15.8 billion international bioscience business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and agricultural products, and the supply of healthcare services. The U.S. operations of AstraZeneca include AstraZeneca, a business unit of Zeneca Inc., AstraZeneca LP, Zeneca Ag Products and Salick Health Care. In the United States, AstraZeneca is a $7.2 billion bioscience business with approximately 10, 000 employees.