News Release

Many high risk patients do not receive cholesterol-lowering therapies

Research also shows effective antihypertensive agent reduces side effects

Peer-Reviewed Publication

American College of Cardiology

ATLANTA, GA (March 14, 2006) -- New insights into medical treatment of high blood pressure, including a review of the extent of care for patients in need and the potential value of newer therapies, are among the topics of studies presented today at the American College of Cardiology's 55th Annual Scientific Session. ACC.06 is the premier cardiovascular medical meeting, bringing together over 30,000 cardiologists to further breakthroughs in cardiovascular medicine.

Are High-Risk Hypertensive Patients Prescribed Concomitant Statin Therapy? Prescription Patterns in Patients Initiating Antihypertensive Therapy in the United States (Abstract 1021-251)

Studies show that patients with high blood pressure and other cardiac risk factors, including high cholesterol, heart disease and diabetes, can benefit from cholesterol-lowering statin drugs. However, it is believed that many of these high-risk patients do not receive these potentially life-saving drugs. Researchers at ValueMedics Research in Virginia examined how frequently high-risk patients were prescribed statins during the first year of treatment for high blood pressure in a U.S. managed care setting.

PharMetrics' Patient-Centric Database, a proprietary, anonymous database which contains medical and pharmaceutical claims from members in more than 75 health plans across the United States, was used to identify patients aged 25 years or older who began treatment for high blood pressure between September 2001 and February 2004. Within this group of newly treated hypertensive patients, statin use was evaluated in patients with high cholesterol, established heart disease and diabetes, as well as in patients with no heart disease but three or more risk factors for heart disease, such as being greater than 55 years old or a history of stroke.

A total of 142,389 patients meeting these criteria were included in the study. About 30 percent (43,825 pts) had been diagnosed with high cholesterol, but less than one-fifth (17.3 percent) were already on statin therapy when they started treatment for high blood pressure and only a third (29.4 percent) began taking statins in the first year. More than half of these patients – 53.3 percent – received no statin therapy at all during the first year after starting hypertension medication.

In the group of patients who had high blood pressure and established heart disease (14,647 patients), just 11.5 percent were on statin therapy already, with an additional 30.9 percent starting during the first year. Yet again, more than half (57.6 percent) of this group did not receive a statin. Similarly, for the study populations with diabetes (17,567 patients) and with 3 or more heart disease risk factors (15,701 patients), the majority did not receive a statin in the first year (61 percent and 53.7 percent, respectively).

"While research demonstrates that statin therapy could benefit hypertension patients who have other cardiac risk factors, the majority of these patients were not receiving cholesterol-lowering statin drugs," said Richard H. Chapman, Ph.D., of ValueMedics Research and lead author of the study. "Statins are the standard of care for this group of patients, and they should be prescribed along with antihypertensive therapy. Failing to do so may restrict patients' access to potentially life-saving treatment."

Aliskiren, an Oral Renin Inhibitor, Provides Dose-Dependent Efficacy, and Placebo-Like Tolerability in Patients with Hypertension (Abstract 1027-191)

Physicians who treat people with hypertension continually seek better treatment options with fewer side effects for their patients. Aliskiren is the first in a new class of orally-administered renin inhibitors, and is under investigation for the treatment of hypertension, or high blood pressure. Renin is an enzyme produced in the kidneys that helps create angiotensin I and II, a hormone which constricts the arteries, raising blood pressure as a result.

In a randomized, double-blind, multi-center, placebo-controlled study led by the Seoul National University College of Medicine in South Korea, 672 patients were randomized to 150, 300 or 600 mg of aliskiren or placebo, once daily for eight weeks. All patients had mild to moderate hypertension [resting diastolic blood pressure (DBP) of 95 to less than 110 mmHg]. "Normal" blood pressure is lower than 120/80 mmHg (systolic over diastolic).

Aliskiren significantly lowered the DBP and resting systolic blood pressure (SBP) dose-dependently overall, in all patients, compared to placebo. The proportion of treatment responders (those who experienced a greater than 10 mmHg reduction in DBP and/or DBP less than 90 mmHg at endpoint) was significantly higher in patients receiving aliskiren –150 mg (59%), 300 mg (63%) or 600 mg (69%) – versus placebo (36%). The drug remained effective over the 24-hour dosing period, and demonstrated the same side effects as placebo up to the 300 mg dose. At the 600 mg dose, patients experienced a greater incidence of diarrhea, but there were no serious side effects in any of the dosage groups or the placebo group.

"Aliskiren is an effective antihypertensive drug for patients with mild-to-moderate hypertension, without serious side effects," said Byung-Hee Oh, M.D., F.A.C.C., of Seoul National University College of Medicine and lead author of the study. "The drug offers another option for patients seeking to control high blood pressure and prevent further cardiovascular diseases."

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The American College of Cardiology (www.acc.org) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.06 and the ACC inaugural i2 Summit, the first-ever meeting for interventional cardiologists, will bring together more than 30,000 cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.


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