EAST HANOVER, N.J., March 26, 2007 /PRNewswire/ -- Results from a new study have shown patients taking two Novartis cardiovascular medicines -- the recently U.S.-approved drug Tekturna(R) (aliskiren) and the leading therapy Diovan(R) (valsartan) -- experienced greater reductions in blood pressure levels than those using either agent alone.
The study also found more patients receiving both Tekturna, which received U.S. approval in March and represents the first type of new high blood pressure medicine in a decade, and Diovan reached their treatment goal compared to either drug alone (ACC presentation #405).
Data from this trial involving 1,800 patients -- the first large-scale study to assess the potential benefits of combining these medicines -- were presented for the first time at the of Cardiology 56th Scientific Session in New Orleans.
Half of the patients in the eight-week trial taking both Tekturna and Diovan saw a reduction in blood pressure to the target of 140/90 mmHg (systolic/diastolic pressure), higher levels than seen in patients taking either of the medicines alone.
Tekturna and Diovan work in different ways to target the renin angiotensin system, one of the body's key regulators of blood pressure. Tekturna targets renin, an enzyme responsible for triggering a process that can lead to high blood pressure. Diovan, an angiotensin receptor blocker (ARB) and one of the world's most-prescribed cardiovascular medicines, works later in this system by blocking the action of angiotensin II, which causes narrowing of blood vessels.
"These study results are exciting because they suggest the value of different mechanisms of action when Tekturna and Diovan are used together," said Suzanne Oparil, MD, Director of the Vascular B iology and Hypertension Program and Professor of Medicine at the University of Alabama at Birmingham in Alabama. "In addition to important blood pressure lowering, the combination of Tekturna and Diovan maintained a tolerability profile similar to that seen with either agent alone," said Dr. Oparil.
Tekturna received U.S. regulatory approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. In an extensive clinical trial program involving more than 6,400 patients, Tekturna provided significant blood pressure reductions for a full 24 hours. This once-daily oral therapy is expected to be available by the end of March in U.S. pharmacies as 150 mg and 300 mg tablets.
A second study presented at the meeting compared Tekturna (150 mg or 300 mg alone or 300 mg in combination with HCTZ) to ramipril (5 mg or 10 mg alone or 10 mg in combination with HCTZ), another high blood pressure medicine in a class known as angiotensin converting enzyme (ACE) inhibitors (ACC presentation #1014). Results showed 61.4% of patients treated with the Tekturna-based therapy reached their blood pressure goal vs. 53.1% of patients treated with the ramipril-based therapy.
Tekturna and Diovan should be discontinued as soon as pregnancy is detected as they may harm an unborn baby, causing injury and even death. Women who plan to become pregnant should talk to their doctor about other treatment options before taking Tekturna or Diovan.
The need for new high blood pressure medicines is urgent given that this condition affects one in three adults in the U.S. and nearly 70% of these patients remain uncontrolled. In fact, many require two or more medications to reach their target blood pressure goal. Uncontrolled high blood pressure can increase the risk of cardiovascular disease, the world's leading cause of death.
"We are very encouraged by these results since they show Tekturna and Diovan are effective w hen used together," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Through our portfolio of high blood pressure medications, Novartis is committed to providing physicians with a wide range of tools to help patients lower their blood pressure."
Tekturna received FDA approval in March 2007 for the treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. The use of Tekturna with maximal doses of ACE inhibitors has not been adequately studied. Tekturna was developed in collaboration with Speedel.
In clinical trials, the approved doses of Tekturna were generally well tolerated and the most common side effect experienced by more patients taking Tekturna than patients taking a sugar pill was diarrhea. Other less common reactions to Tekturna include cough and rash.
Angioedema has been rarely reported in patients taking Tekturna.
Novartis remains at the forefront of cardiovascular medicine through development of innovative products like DIOVAN, the most-prescribed member of the ARB class (angiotensin receptor blocker) in the world today. DIOVAN is available for the treatment of high blood pressure in more than 100 countries, for the treatment of heart attack survivors in more than 70 countries and in more than 90 countries for the treatment of people with heart failure.
DIOVAN is contraindicated in patients who are hypersensitive to any component of this product.
Volume and or salt depletion should be corrected in patients prior to administering DIOVAN or symptomatic hypotension may occur.
Care should be exercised with dosing of DIOVAN in patients with severe renal impairment. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be observed in susceptible individuals (e.g. patients with renal artery stenosis or severe heart failure).
No significant differences b etween adverse events, DIOVAN and placebo. AEs more frequent with DIOVAN than placebo: viral infection (3% vs 2%), fatigue (2% vs 1%), abdominal pain (2% vs 1%); the most common AEs: headache and dizziness. An increase in dizziness was observed with the 320 mg (8%) vs 10 mg to 160 mg (2% to 4%).
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "provides," "can," "effective," "is expected," or similar expressions, or by express or implied discussions regarding potential future regulatory filings, approvals or future sales of Tekturna, or potential future sales of Diovan. Such statements reflect the current views of the Novartis group of companies with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that Tekturna will be approved for sale in any other market, or that Tekturna or Diovan will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Tekturna or Diovan could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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