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Diovan lowered the level of the inflammatory
marker high sensitivity C-reactive protein (hsCRP), independently of its
established efficacy in lowering blood pressure, according to findings
presented at the American Society of Hypertension, Inc. (ASH) Annual
Scientific Meeting and Exposition (ASH 2006) and published online in
Hypertension later today. The study also showed that Diovan and Diovan HCT
helped a significant number of hard-to-treat patients with a severe form of
high blood pressure — called “stage 2″ — quickly achieve blood pressure
goals.

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“Increased hsCRP levels are commonly found in those patients at increased
risk for cardiovascular events,” said Paul Ridker, MD, MPH, Eugene
Braunwald Professor of Medicine, Brigham and Women’s Hospital and Harvard
Medical School, and lead investigator of the Val-MARC trial
(Valsartan-Managing blood pressure Aggressively and evaluating Reductions
in hsCRP). “Until now, statins were among only a few medicines known to
lower hsCRP. This study showed that treating high blood pressure with
valsartan can also reduce levels of this important inflammatory marker.”

The new findings are from a large, randomized clinical trial called
Val-MARC in 1,668 high blood pressure patients. Val-MARC is the largest
study to investigate whether blood pressure medications, specifically
Diovan or Diovan HCT, can lower hsCRP in addition to effectively treating
stage 2 hypertension. Val-MARC was conducted in 384 primary care clinics
across the U.S. in a diverse range of hard-to-treat high blood pressure
patients, including African Americans, Hispanics, those with diabetes and
the elderly.

In Val-MARC, the reduction observed with Diovan on hsCRP levels was
preserved in all subgroups in the trial, including those patients who were
taking statins. There was no consistent effect observed with Diovan HCT on
levels of hsCRP.

Val-MARC also demonstrated that Diovan HCT, including two new higher
strengths recently approved by the FDA, produced double-digit blood
pressure reductions up to 27 mmHg in systolic and 14 mmHg in diastolic
blood pressure (p < 0.0001 from baseline). These reductions are consistent
with other data at ASH 2006 that formed the basis of the recent FDA
approval.

“There is a clear need to provide more powerful treatment options to help
people with high blood pressure successfully manage their condition,” said
Marjorie Gatlin, MD, Vice President, U.S. Clinical Development and Medical
Affairs for the Cardiovascular and Metabolic Diseases Therapeutic Area,
Novartis Pharmaceuticals Corporation. “Val-MARC, the latest achievement
from our robust clinical trial program for Diovan, provides insight into
the efficacy of this high blood pressure agent in helping patients achieve
healthier blood pressure levels.”

Val-MARC is one of the studies in the Diovan clinical trials program, which
represents a large-scale research commitment across the cardiovascular
continuum. The results of Val-MARC will be further explored in the
MADE-ITT trial, which will examine the effects of Diovan, Diovan HCT and
hydrochlorothiazide alone on insulin sensitivity and a range of
inflammatory markers, including hsCRP. Other ongoing trials include
NAVIGATOR, the first and largest study designed to understand the
progression and prevention of diabetes and cardiovascular disease.
Completed Diovan trials include VALUE in high blood pressure patients at
high risk for cardiovascular events, VALIANT in post-heart attack patients
and Val-HeFT in heart failure patients.

With the new strengths used in Val-MARC, Diovan HCT now provides physicians
the widest range of dosing options in its class to help them address the
continuing public health crisis of high blood pressure. One third of
American adults — more than 65 million — have high blood pressure, and a
significant number have the more severe stage 2 form of the disease. In
fact, the risk of cardiovascular disease doubles with every increase of
20/10 mmHg above a healthy blood pressure of 115/75 mmHg.

Study Details

A prospective, randomized, blinded-endpoint, open-label, community-based
study, Val-MARC compared the efficacy of Diovan alone (160 mg
force-titrated to 320 mg at week two) versus Diovan HCT (160/12.5 mg
force-titrated to 320/12.5 mg at week two) as initial therapy for 1,668
patients with stage 2 hypertension (defined as systolic blood pressure
between 160-185 mmHg and/or diastolic blood pressure of 100-109 mmHg). The
trial was designed to examine the effect of Diovan on hsCRP levels and
whether this effect was related to or independent of Diovan’s established
blood pressure-lowering efficacy. The primary blood pressure and
inflammation endpoints were measured at the six-week timepoint. After six
weeks of therapy in either arm, physicians were allowed to prescribe an
additional 12.5 mg hydrochlorothiazide if a patient’s blood pressure was
still uncontrolled.

The median change in hsCRP from baseline after six weeks in the Diovan
group was
-0.12 mg/L compared to 0.05 mg/L in the Diovan HCT group, representing a
difference between the treatment groups of 13.3% (p < 0.001). No
relationship was observed between the change in hsCRP levels and blood
pressure reductions, suggesting the hsCRP-lowering effect of Diovan is
independent of the agent’s blood pressure efficacy.