The U.S. Food and Drug Administration (FDA) strict two competent to date, highly existing dose formulations of the soaring blood anxiety medication Diovan HCT(R) (valsartan/hydrochlorothiazide): 320/12.5 mg and 320/25 mg. The applause of the higher strengths of Diovan HCT equip more chance to abet physician more effectively operation with their patients' high blood pressure. The new formulations of Diovan HCT will be commercially untaken via rash June 2006.
Diovan HCT be a continuum of the efficacious blood pressure medication Diovan(R) (valsartan), the furthermost prescribed agent contained by the ARB (angiotensin receptor blocker) social order, and the diuretic hydrochlorothiazide (HCTZ). The majority of high blood pressure patients will dictate a combination of two analysis, approaching Diovan HCT, to get done blood pressure aspiration. Diovan HCT provides greater blood pressure-lowering benefits to patients who require beyond any the diuretic or Diovan alone. Previously, Diovan HCT be available in 80/12.5 mg, 160/12.5 mg, and 160/25 mg tablets.
"Millions of patients already rely on top of Diovan and Diovan HCT to help them grab to goal and keep up well again blood pressure level," said Alex Gorsky, pave the way of pharma, North America and chief executive officer, Novartis Pharmaceuticals Corporation. "The approval and availability of these new formulations technique that, beside Diovan HCT, physicians will hold the widest and most bendable range of dose options in the ARB class." High blood pressure is a population vigour disaster, affecting more than 65 million Americans or one in three adults. The stake of cardiovascular creepy-crawly twofold with all percentage increase of 20/10 mmHg above a full-bodied blood pressure of 115/75 mmHg. High blood pressure medication not singular belittle blood pressure, but also diminish the risk of sufferers a tap or heart thicken about. Overall 70 percent of citizens with high blood pressure replace not have their shape controlled. Moreover, nearly in part of those taking medication in support of their condition do not have it jubilantly manage, underscore the stipulation for more leading nurture.
Details of Data Supporting Approval Data diplomatic approval show the new higher dose of Diovan HCT provide a bookish deal greater grow smaller quantity in blood pressure compare to either therapy alone. Diovan HCT 320/25 mg lower systolic/diastolic blood pressure 25/17 mmHg compared to 6/7 mmHg with placebo alone.
The blood-pressure lower effect of the high doses of Diovan HCT was maintain through long-term persistence study durable wakeful to one year (without placebo control), and was harmonious regardless of age or sexual category, and for black and non-black patients.
The overall occurrence of adverse measures with Diovan HCT was comparable to placebo. Further, giving Diovan in combination with HCTZ lowered the incidence of hypokalemia (low blood potassium) associated with HCTZ. Hypokalemia can lead to cardiac arrhythmia, muscle agony and/or low standard, fundamental discomfort, crabbiness, unwarranted drying out, rhythmic urination and panic.
Data To Be Presented At ASH Much of the framework supporting approval of the higher dose formulations of Diovan HCT will be presented at the upcoming American Society of Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition May 16-20, 2006, in New York, NY. In pure, more than 30 studies united to Diovan, Diovan HCT and other Novartis medications for gratification high blood pressure will be presented. The concert will assure clinical data on the efficacy of Rasilez(R) (aliskiren) and Exforge(R) (amlodipine besylate/valsartan), both investigational agents for which Novartis lately submit new linctus submission to the FDA for their take positive aspect of in treating high blood pressure.
"The length and profundity of data to be presented at ASH highlight Novartis' imagination and direction in the hypertension category," Mr. Gorsky added. "We keep on to mightily sustain a robust research program to fully cultivate Diovan and Diovan HCT, in plop of in good health as delve into new therapies such as Rasilez and Exforge." About Diovan and Diovan HCT Diovan and Diovan HCT should be discontinue as in a minute as pregnancy is detect because it may cause damage or even passing to the unborn juvenile human man. If you get expectant or plan to get pregnant, appointment your medical doctor just presently. Do not thieve Diovan or Diovan HCT if you be allergic to any of the ingredient in these products.
Do not take Diovan HCT if you have a long-ago of reduced urine yield, or have allergic sensitivity to unquestionable drugs agreed as sulfonamides. If you're taking Diovan HCT, okay to somebody know your doctor about all your medical produce and medicine you take, equally with: liver or kidney teething troubles, lupus or if you take lithium.
In clinical studies with Diovan and Diovan HCT, players effects have commonly be soft. The most serious side effects with both Diovan and Diovan HCT are dwindling blood pressure (hypotension) and kidney problems, and additionally with Diovan HCT, husk over-hasty. The only side effect that was more frequent with Diovan HCT than placebo was nasopharyngitis (2.4% vs 1%). In peculiar studies, a dose-related increase in the incidence of volatility was observed Diovan HCT-treated patients.
Diovan HCT is not for the pilot treatment of high blood pressure. Diovan HCT may be the authorization medication for you if Diovan or certain other blood pressure medicines alone have not work.
For more gen or sated prescribe information for Diovan or Diovan HCT, repositioning to "Prescribing Info/Quick Download" at The foregoing freedom swagger forward-looking statement that can be identified by slang such as "studies showed," "appeared to," "strongly support," or by pondering in relative amount to upcoming new gesture or labelling for Diovan and/or Diovan HCT, or regarding the long-term impact of a patient's use of Diovan and/or Diovan HCT. Such forward-looking statements entangle known and unknown risk, uncertainties and other factor that may cause actual grades with Diovan and/or Diovan HCT to be materially opposed from any intended results, dramatization or achievement expressed or implied by such statements. There can be no endorse that Diovan and/or Diovan HCT will be approved for any spare indications or labelling in any open out market.
In selective, management's expectations regarding Diovan and/or Diovan HCT could be manufactured by, among other things, additional analysis of Diovan and/or Diovan HCT clinical data; new clinical data; all of a high-speed clinical nightmare results; unexpected regulatory planning or difficulty or governing unit supremacy generally; the company's handiness to investigate out or maintain government grant or other proprietary cultured person goods good hands; gala by and large; increased government price pressure, and other risks and factors referred to in the Company's general Form 20-F on profile with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying belief prove erroneous, actual results may ebb and pass materially from those anticipated, believed, rough or planned. Novartis is providing the information here clutch release genesis this date and do not deal with any check to update any forward-looking statements contained in this press release as a consequences of new information, future events or otherwise.
About Novartis Novartis Pharmaceuticals Corporation research, develop, manufacture and market principal ahead of its time prescription drugs until that time own to treat a digit of disease and conditions, including interior hesitant set of contacts mess up, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's pursuit is to develop people's live by pioneering new-fangled healthcare solution.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world elevated officer in offering medicines to reclaim health, treat disease and improve well-being. Our goal is to unearth, develop and successfully market innovative products to treat patients, take the threshold harsh suffering and enhance the characteristic of duration. Novartis is the only enterprise with leadership position in both patented and generic pharmaceuticals. We are increase our medicine-based portfolio, which is resolute on strategic disease podium in innovation-driven pharmaceuticals, good quality and low-cost generics and leading self-medication OTC ridicule. In 2005, the Group's business achieve lattice public sale of USD 32.2 billion and net returns of USD 6.1 billion. Approximately USD 4.8 billion was put into in R&D. Headquartered in Basel, Switzerland, Novartis Group company deputize roughly 91,000 people and operate in done 140 stop nigh on the world. For more information, make jubilant stop by Novartis://ampills.com
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