July 28, 2008

Dr. Flack addresses NMA on new blood pressure medication study

John Flack, M.D., M.P.H., Chair of the Department of Internal Medicine for the Wayne State University School of Medicine, presented to the National Medical Association his findings as lead investigator for a treatment that showed the largest blood pressure drops recorded in a clinical trial for the drug combination.

Dr. Flack spoke July 26 on a clinical trial for the combination of amlodipine and valsartan. The study showed large decreases in high blood pressure for patients of African heritage.

"In the Ex-STAND Study involving almost 500 blacks, mostly from the U.S., including 17 percent of Hispanic origin, we showed in a randomized trial that the combination of amlodipine/valsartan lowered blood pressure more effectively than amlodipine monotherapy both before and after the optional addition of the diuretic hydrochlorothiazide," said. Dr. Flack. "This is an important trial for black populations given that many will need combination therapy to attain blood pressure control and frequently a blocker of the renin angiotensin system (angiotensin converting enzyme inhibitor or angiotensin receptor blocker) will be needed in persons with diabetes and/or chronic kidney disease.

"The long available combination of calcium blockers with angiotensin converting enzyme inhibitors have been less well tolerated in this population because of the greater incidence of angioedema and cough to the ACE inhibitor component. However, there is no cough and no angioedema with ARBs. This is the first large-scale clinical trial in blacks of the combination of a calcium blocker and an ARB."

The study showed that black patients treated with the drug combination experienced a significantly higher reduction in systolic blood pressure than those on amlodipine alone. This marked the "most significant" blood pressure drop seen to date in such clinical studies, said the drug manufacturer, Novartis.

"The large blood pressure reductions seen in this trial were experienced by severe patients who have the most difficulty getting their blood pressure to healthy levels," said Dr. Flack. "These data may have a real impact on helping patients who are most at risk."

African-Americans have a higher risk of developing high blood pressure than other ethnic groups. High blood pressure is a leading risk factor for cardiovascular disease.

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