Thursday, May 1, 2008

Diovan(R) (valsartan) Trial To Lower C-Reactive Protein, An Important Marker Of Inflammation




Diovan lower the horizontal of the inflammatory pointer high-ranking inflammation C-reactive protein (hsCRP), alone of its settled efficacy within lower blood stiffness, according to findings presented at the American Society of Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition (ASH 2006) and published online in Hypertension subsequent today. The belief poll also provide verification that Diovan and Diovan HCT assist a celebrated digit of hard-to-treat patients beside a tricky figure of high blood pressure -- name "stage 2" -- swiftly bring about blood pressure goal.



"Increased hsCRP level be prevalently found in those patients at increased hazard in desire of cardiovascular suit," said Paul Ridker, MD, MPH, Eugene Braunwald Professor of Medicine, Brigham and Women's Hospital and Harvard Medical School, and head investigator of the Val-MARC trial (Valsartan-Managing blood pressure Aggressively and weigh against Reductions in hsCRP). "Until very in a while, statins be among with the sole purpose a few medicine programme to subjugate hsCRP. This study showed that treat high blood pressure with valsartan can also chop spinal column sullen levels of this significant inflammatory marker." The exotic findings are from a significant, randomized clinical trial called Val-MARC in 1,668 high blood pressure patients. Val-MARC be the largest study to study whether blood pressure medication, freeway Diovan or Diovan HCT, can lower hsCRP in build-up to effectively treating produce 2 hypertension. Val-MARC be conduct in 384 former keeping clinic across the U.S.



in a different capacity of hard-to-treat high blood pressure patients, plus African Americans, Hispanics, those with diabetes and the elderly.



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



Val-MARC also demonstrated that Diovan HCT, including two new intricate strengths not protracted approved with the FDA, produced double-digit blood pressure reduction all-embracing awake to 27 mmHg in systolic and 14 mmHg in diastolic blood pressure (p0.0001 from baseline). These reductions are consistent with other facts at ASH 2006 that formed the cause of the recent FDA esteem.



"There is a striking have need of to commence more vigorous coverage option to help empire with high blood pressure elatedly control their clause," said Marjorie Gatlin, MD, Vice President, US Clinical Development and Medical Affairs for the Cardiovascular and Metabolic Diseases Therapeutic Area, Novartis Pharmaceuticals Corporation. "Val-MARC, the up-to-the-minute accomplishment from our robust clinical trial program for Diovan, provide perspicacity into the efficacy of this high blood pressure agent in helping patients achieve in good health blood pressure levels." Val-MARC is one of the study in the Diovan clinical trial program, which represent a large-scale research commitment across the cardiovascular continuum. The grades of Val-MARC will be further reconnoitre in the MADE-ITT trial, which will reason the effects of Diovan, Diovan HCT and hydrochlorothiazide alone on insulin sensitivity and a range of inflammatory marker, including hsCRP. Other ongoing trials list NAVIGATOR, the pilot and largest study designed to understand the addition and defeat of diabetes and cardiovascular virus. Completed Diovan trials include VALUE in high blood pressure patients at high risk for cardiovascular events, VALIANT in post-heart salvo patients and Val-HeFT in heart undo patients.



With the new strengths nearly new in Val-MARC, Diovan HCT now provides physician the widest range of dose options in its lecture to help them address the continuing municipal heart disaster of high blood pressure. One third of American adults -- beyond 65 million -- wallow in high blood pressure, and a significant numeral have the more severe stage 2 form of the disease. In reality, the risk of cardiovascular disease twin with both increase of 20/10 mmHg above a on extreme form blood pressure of 115/75 mmHg.



Study Details A prospective, randomized, blinded-endpoint, open-label, community-based study, Val-MARC compare 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) using initial psychiatric therapy for 1,668 patients with stage 2 hypertension (defined as systolic blood pressure linking 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 connected to or elected 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 any arm, physicians were allowed to prescribe an added 12.5 mg hydrochlorothiazide if a patient's blood pressure was unmoving uncontrolled.



The median evolution in hsCRP from baseline after six weeks in the Diovan sect was -0.12 mg/L compared to 0.05 mg/L in the Diovan HCT group, representing a incongruity between the treatment group of 13.3% (p0.001). No analogy 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.



Baseline blood pressure levels in Val-MARC were 164/101 mmHg and 165/101 mmHg in the Diovan and Diovan HCT artillery respectively. At six weeks, the systolic and diastolic blood pressure of the participant in the Diovan group plunge a median of 18 mmHg and 9 mmHg (p0.0001 from baseline), respectively. Blood pressure was further reduced from baseline by a median of 22 mmHg and 12 mmHg (p0.0001) at 12 weeks after physicians were allowed to prescribe the identical of the new higher strength of Diovan HCT. Blood pressure of patients in the Diovan HCT arm was reduced by 25 mmHg and 14 mmHg (systolic and diastolic, respectively, p0.0001) at six weeks, and at 12 weeks was further reduced from baseline by a median of 27 mmHg and 14 mmHg (p0.0001), respectively, when physicians could prescribe the equivalent of the not long approved high point dose of Diovan HCT. The blood pressure comeback was consistent across all tolerant populations studied.



Importantly, after the stage 2 patients in Val-MARC were gratification with only two weeks of the initial starting dose of Diovan 160 mg or Diovan HCT 160/12.5 mg, 22% and 37%, respectively, achieve a blood pressure dream of 140/90 mmHg. At six weeks, goal rates increased to 32% and 48% and at 12 weeks further increased to 42% and 52% of these difficult-to-treat patients in the Diovan and Diovan HCT groups, respectively.



In Val-MARC, both Diovan and Diovan HCT were in good health accept with a at a low level rate of loin effects. As can be anticipated with a more powerful blood pressure-reducing regimen, patients treated with Diovan HCT first have higher rates of unsteadiness compared to those in the monotherapy group (8.5% compared to 4.7%, respectively, p0.002). No other significant difference in adverse piece rates were observed between the treatment groups.



About Diovan and Diovan HCT Diovan and Diovan HCT should be discontinue as soon as pregnancy is detect because it may inflict hurt or even demise to the unborn teenager. If you receive expectant or stratagem to get pregnant, call your doctor of prescription at once. Do not cart Diovan or Diovan HCT if you are allergic to any of the ingredient in these products.



Do not take Diovan HCT if you have a times of yore of reduced urine yield, or have allergic flinch to consistent drugs known as sulfonamides. If you're taking Diovan HCT, tell your doctor going on for all your medical requisites and medicines you take, including: liver or kidney teething troubles, lupus or if you take lithium.



In clinical studies with Diovan and Diovan HCT, side effects have collectively be nice. The peak bookish side effects with both Diovan and Diovan HCT are low blood pressure (hypotension) and kidney problems, and additionally with Diovan HCT, peelings unwary.



High blood pressure medications approaching Diovan, that affect the renin- angiotensin association, have generally been found to be smaller number impressive in patients with low renin -- a condition more constant among African Americans.



Diovan HCT is not for the initial treatment of high blood pressure. Diovan HCT may be the permission medication for you if Diovan or certain other blood pressure medicines alone have not work.



Diovan and Diovan HCT are approved to treat high blood pressure, and are not approved to preclude death, heart attack, pat, kidney disease, or eye intolerance resultant from high blood pressure.



For more intelligence or arranged prescribe information for Diovan or Diovan HCT, run to "Prescribing Info/Quick Download" at The foregoing liberate contain forward-looking letter that can be identified by argot such as "will be further explored," "will examine," "designed to understand," or by pondering about eventual new indication or labelling for Diovan and/or Diovan HCT. Such forward-looking statements necessitate known and unknown risk, uncertainties and other factor that may cause actual results with Diovan and/or Diovan HCT to be materially like chalk and cheese from any approaching results, ceremonial or achievement expressed or implied by such statements. There can be no back that Diovan and/or Diovan HCT will be approved for any additional indications or labelling in any marketplace. In easier said than done to enchant, management's expectations regarding Diovan and/or Diovan HCT could be wooden by, among other things, surprising clinical trial results, including new clinical data and additional analysis of surviving clinical data; unexpected regulatory activities or adjournment or political affairs ruling generally; the company's capacity to get your appendage on or state officer symbols or other proprietary brainy assets padding; enmity generally; increased government price pressure, and other risks and factors referred to in the Company's customary Form 20-F on database with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying thought prove wide of the red mark, actual results may ebb and passage materially from those anticipated, believed, ballpark or looked-for. Novartis is providing the information here wring release beginning this date and do not operation with any mission to update any forward-looking statements contained in this press release as a effect of new information, future events or otherwise.



About Novartis Novartis Pharmaceuticals Corporation research, develop, manufacture and market chief rebel prescription drugs used to treat a quantity of disease and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, middle agitated system, dermatological, gastrointestinal and respiratory spread. The company's pursuit is to modernize people's have your home by pioneering fresh healthcare solution.



Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world perspective in offering medicines to connected health, treat disease and improve well-being. Our goal is to unearth, refine and successfully market innovative products to treat patients, allay incapacitated and enhance the component of energy. Novartis is the only joint venture with admin position in both patented and generic pharmaceuticals. We are increase our medicine-based portfolio, which is resolute on strategic lump platform in innovation-driven pharmaceuticals, first-class and low-cost generics, human vaccines and leading self-medication OTC brand. In 2005, the Group's firm achieve trellis public sale of USD 32.2 billion and net rush back of USD 6.1 billion. Approximately USD 4.8 billion was put into in R&D. Headquartered in Basel, Switzerland, Novartis Group company conscript generally 96,000 people and operate in complete 140 country in discus the world. For more information, please look in Novartis US Pharma




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