Study has important implications for African Americans who suffer from high blood pressure

May 20 2004

A new study has important implications for the millions of African Americans who suffer from high blood pressure. The study, AADVANCE, shows Diovan HCT(R) (valsartan and hydrochlorothiazide) lowers blood pressure in African Americans to aggressive recommended target blood pressure goals as effectively as amlodipine.

AADVANCE was among 15 new studies underscoring the blood pressure efficacy of Diovan(R) (valsartan) and Diovan HCT presented this week during the American Society of Hypertension 19th Annual Scientific Meeting and Exposition in New York.

High blood pressure is a national health crisis. Nearly 60 million Americans -- one in four adults -- suffer from high blood pressure, and an alarming 70 percent of those who are treated do not have the condition under control. Blacks develop high blood pressure earlier in life and have higher average blood pressures than whites, placing them at substantially increased risk for its consequences, which include stroke, heart disease, death and end-stage kidney disease.

As many as 30 percent of all deaths in black men and 20 percent of all deaths in black women with high blood pressure may be linked to this condition. Because of genetic and other factors, high blood pressure is often difficult to treat in African Americans, particularly in those who also have diabetes.

According to new treatment guidelines, most hypertensive patients need more than one type of high blood pressure treatment to achieve healthy blood pressure levels. A leading fixed-dose combination of two effective high blood pressure medicines, Diovan HCT combines a diuretic (water pill) and Diovan in a convenient once-a-day tablet. Diovan, the most-prescribed angiotensin II receptor blocker (ARB) on the market, blocks the renin- angiotensin system (RAS), a hormonal system that regulates blood pressure.

A newer type of RAS inhibitor, Diovan not only powerfully lowers blood pressure, but is known to have additional positive effects beyond lowering blood pressure. Despite proven cardiovascular benefits, RAS inhibitors are underused in African Americans because of perceptions about their efficacy in lowering blood pressure. "Although African Americans suffer disproportionately from high blood pressure, they are less likely to receive treatments that not only control blood pressure, but provide added protection against vascular damage," said Kenneth A. Jamerson, M.D., the primary investigator of AADVANCE and associate professor, Department of Internal Medicine, University of Michigan Cardiovascular Center, Ann Arbor, Michigan. "AADVANCE has important clinical implications because it identifies an effective way to overturn this disparity in care." AADVANCE was a prospective, double-blind, randomized, head-to-head comparison of Diovan HCT and amlodipine, a calcium channel blocker, in 482 African Americans with mild to moderate high blood pressure.

After a 2-3 week placebo run-in, patients were randomized to Diovan 160 mg monotherapy or amlodipine 5 mg for 2 weeks, and then force-titrated to Diovan HCT 160/12.5 mg or amlodipine 10 mg for an additional 10 weeks. AADVANCE showed Diovan HCT reduced blood pressure as effectively as amlodipine (mean reduction in 24-hr ABPM diastolic BP -10.2 +/- 8.6 mmHg vs. -9.1 +/- 8.3 mmHg respectively; p<0.0001) but was significantly less likely to cause peripheral edema (1.7% vs. 5.8% respectively; p=0.0309) or joint swelling (0% vs. 2.9% respectively; p=0.0082). VALUE (Valsartan Antihypertensive Long-term Use Evaluation Trial) is also exploring the differential effects of Diovan-based therapy vs. amlodipine- based therapy in 15,314 high blood pressure patients at high-risk for cardiovascular events because of at least one other co-existing disease or risk factor (e.g., diabetes, history of stroke, high cholesterol, angina).

VALUE is designed to discover whether, in high-risk patients with the same level of blood pressure control, Diovan-based therapy has additional effects on cardiovascular outcomes such as heart attack, heart failure and stroke.

The findings of VALUE will be reported at the 14th European Meeting on Hypertension in Paris on June 14. AADVANCE and VALUE are part of the Diovan clinical trial program, one of the world's largest cardiovascular research programs. The program involves more than 50,000 patients, including more than 9,500 patients with diabetes, in major trials investigating potential new applications for Diovan within the cardiovascular disease continuum.

Recently completed Diovan trials include Val-HeFT in heart failure patients and VALIANT in post-heart attack patients. Ongoing trials include NAVIGATOR in pre-diabetes patients at risk for cardiovascular disease and Val-MARC, a study of the effects of Diovan on C-reactive protein, an inflammatory marker for heart disease. World-class research is only one way Novartis works to address the public health crisis of high blood pressure and heart disease. The company recently launched an unprecedented national initiative called Take Action for Healthy Blood Pressure, which will unite health care professionals and patients in the fight against uncontrolled high blood pressure.

For more information about this program visit http://www.HealthyBP.com.

Diovan is a first-line treatment for high blood pressure. Diovan HCT is indicated for the treatment of patients who need additional blood pressure control beyond that provided with Diovan or the diuretic hydrochlorothiazide alone.

Diovan HCT is not indicated for the initial treatment of high blood pressure. Diovan and Diovan HCT should be discontinued as soon as pregnancy is detected because they may cause harm or even death to the unborn child. Side effects have generally been mild. The most common side effects with Diovan and Diovan HCT are headache, dizziness and fatigue. Diovan and Diovan HCT are contraindicated for patients who are allergic to any of the ingredients of the products.

Because of the hydrochlorothiazide component, Diovan HCT should not be taken by patients who have a history of reduced urine output or have had allergic reactions to drugs in the sulfonamide class. Diovan is also indicated for the treatment of heart failure in patients who cannot tolerate ACE inhibitors.

The most common side effects in heart failure patients with Diovan were dizziness, hypotension and diarrhea. In patients with heart failure, concomitant use of Diovan, an ACE inhibitor and a beta blocker is not recommended. In Val-HeFT, this triple combination was associated with an unfavorable heart failure outcome. Because of the risk of hypotension, caution should be observed when initiating therapy in heart failure patients. Evaluation of heart failure patients should always include assessment of renal function.

For more information or for full prescribing information for Diovan and Diovan HCT go to http://www.pharma.us.novartis.com or call Kim Fox at 862-778-7692.