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Valsartan Lowers C-reactive Protein Levels; Combination Doesn't: Presented at ASH

By Ed Susman

NEW YORK, N.Y. -- May 19, 2006 -- Treating patients with uncontrolled high blood pressure and high levels of the cardiovascular risk marker C-reactive protein lowers both blood pressure and the inflammatory disease indicator, researchers said here at the 21^st annual scientific meeting and exposition of the American Society of Hypertension (ASH).

Paradoxically, adding a diuretic to valsartan (Diovan) allows even more patients to reach blood pressure goals -- but appears to raise levels of C-reactive protein, Paul Ridker, MD, Eugene Braunwald professor of medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, reported here on May 19^th in a late-breaker oral presentation.

The results of the Valsartan-Managing Blood Pressure Aggressively and Evaluating Reductions in hsCRP (Val-MARC) trial were reported simultaneously at the ASH meeting and in the electronic version of the journal Hypertension.

"We thought that C-reactive protein levels world track with blood pressure change," Dr. Ridker said. "It appears that it is not as simple as that."

The investigator-initiated study enrolled 1668 participants. Subjects were randomized into 1 group of 836 subjects who received valsartan 160 mg and another group of 832 subjects who received valsartan 160 mg plus hydrochlorothiazide 12.5 mg.

At week 2, researchers titrated the valsartan dose in 807 patients to 320 mg; in the combination group, the doses were titrated to 320 mg of valsartan and 12.5 mg of hydrochlorothiazide through 6 weeks.

Study endpoints were effects on levels of C-reactive protein and on blood pressure. The researchers analyzed the data to determine whether the effects on levels of C-reactive protein were dependent or independent of effects on blood pressure.

The effect on blood pressure of the combination regimen was clearly superior to monotherapy, Dr. Ridker said. Systolic blood pressure was reduced by 25 mm Hg in the total group on the combination, and was lowered 18 mm Hg in the monotherapy group (P <.001). Similar statistical differences were seen in men, women, blacks and whites, he said.

In addition, 48% of the combination cohort reached their blood pressure goals, compared to 32% of those on monotherapy (P <.0001). That difference held when the researchers analyzed the groups by race and sex.

But while valsartan monotherapy resulted in a statistically significant (P <.001) 13.3% net difference in C-reactive protein when compared with the combination, the monotherapy patients achieved an 8.9% reduction while the combination patients experienced a 4.4% increase.

Dr. Ridker noted that while reductions in blood pressure have been found to improve outcomes in stroke and heart disease and kidney disease, treatment to decrease levels of C-reactive protein have not yet demonstrated independent confirmation of beneficial outcomes.

The study was supported by Novartis.


[Presentation title: Valsartan, Blood Pressure Reduction, and C-Reactive Protein: Primary Report of the Val-MARC Trial. Late breaker presentation.]

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