Study Shows Tekturna, the First and Only Approved Direct Renin Inhibitor, Reduces a Key Marker of Heart Failure Severity
• Treatment with Tekturna, when added to standard therapy, led to 35% reduction in B-type natriuretic peptide (BNP), a hormone increasingly accepted as an indicator of heart failure severity
• Heart failure, when the heart’s pumping power is weaker than normal, is a major cause of hospitalization
EAST HANOVER, NJ, November 6, 2007 – Tekturna® (aliskiren), the first and only approved type of high blood pressure medicine called a direct renin inhibitor, showed significant reductions in B-type natiuretic peptide (BNP), a hormone produced by the heart and a marker of heart failure severity when added to standard therapy.
Heart failure may develop slowly over years, and occurs when the heart’s ability to pump blood is weaker than normal. This progressive condition, when associated with high blood pressure, contributes to hospitalization.
The ALOFT (ALiskiren Observation of Heart Failure Treatment) study results were presented at the American Heart Association Scientific Sessions in Orlando, FL (presentation #2491; Bertram Pitt, MD).
Tekturna was approved for the treatment of high blood pressure in the US in March 2007 and received European Union approval in August under the trade name Rasilez®.
In the 12-week trial, Tekturna 150 mg was added to existing standard therapies for heart failure such as ACE inhibitors, angiotensin receptor blockers, beta-blockers or aldosterone antagonists which are other types of blood pressure medicines. Tekturna achieved its primary endpoint and demonstrated an acceptable safety and tolerability profile in these hard-to-treat patients. A slightly higher, but non-significant, number of patients receiving Tekturna experienced hyperkalemia (elevated potassium levels) compared to those taking placebo added to standard therapy. Potassium levels in these patients returned to baseline when treatment with Tekturna was discontinued.
Results also showed that treatment with Tekturna, when added to standard therapy, resulted in a 35% reduction in BNP (B-type natriuretic peptide), compared to placebo.
The level of BNP in the blood increases when heart failure worsens, and decreases when heart failure stabilizes. The reductions in BNP seen with Tekturna were nearly five times greater than the reductions seen in patients treated with the standard heart failure therapies (ACE inhibitors, angiotensin receptor blockers, beta-blockers or aldosterone antagonists) that patients in ALOFT also received (-61 pg/mL vs -12.2 pg/mL, respectively).
"It is encouraging to see that adding Tekturna to standard therapy such as an angiotensin converting enzyme inhibitor and a beta adrenergic receptor blocker further reduces BNP. These study results build on existing knowledge of the effects of other medicines indicated for heart failure treatment that act within the renin angiotensin aldosterone system (RAAS)," said Bertram Pitt, MD, F.A.C.C., Professor of Medicine Emeritus at the University of Michigan School of Medicine Division of Cardiology in Ann Arbor, Michigan. "Further research will tell us whether this reduction in BNP might be associated with improvements in clinical outcomes."
Tekturna, which acts by directly inhibiting renin, an enzyme that triggers a process that can lead to high blood pressure, has demonstrated significant reductions in blood pressure when used alone or in combination with other medicines. Tekturna has not been studied in combination with the maximum doses of a class of medications called ACE inhibitors. It is not indicated for heart failure, and additional long-term studies are needed to assess its potential effects on these patients.
"Tekturna demonstrated effective blood pressure lowering in clinical trials enrolling over 6,400 patients," said Marjorie Gatlin, MD, Vice President of the Cardiovascular and Metabolic Therapeutic Area with US Medical at Novartis Pharmaceuticals Corporation. "The ALOFT study is one in a series of trials in ASPIRE HIGHER, an extensive ongoing clinical trials program investigating the effects of Tekturna on markers of heart and kidney damage, indicators of disease progression."
IMPORTANT WARNING: If you get pregnant, stop taking Tekturna and call your doctor right away. Tekturna may harm an unborn baby, causing injury and even death. If you plan to become pregnant, talk to your doctor about other treatment options before taking Tekturna.
If you develop an allergic reaction involving swelling of the face, lips, throat and/or tongue which may cause difficulty in breathing and swallowing, stop taking Tekturna and contact your doctor immediately.
Tell you doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.
In clinical studies, 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.
Disclaimer
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "encouraging," "will," "might," "can," "may," or similar expressions, or by express or implied discussions regarding the long-term effects of
Tekturna and direct renin inhibition, potential future approvals of Tekturna, or potential future sales of Tekturna. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee regarding the long-term effects of a patient's use of Tekturna and direct renin inhibition. Nor can there be any guarantees that Tekturna will be approved for sale in any additional markets, or that it will reach any particular sales levels. In particular, management's expectations regarding Tekturna 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; competition in general; increased government, industry, and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; 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.
About Novartis
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 (NYSE: NVS), a world leader in offering medicines to protect health, cure 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. 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. Novartis is the only company with leadership positions in these areas. 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 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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Posted: November 2007
