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11-Nov-2008

Tekturna®, first approved direct renin inhibitor, effectively lowers high blood pressure in elderly patients

• New AGELESS data show Tekturna lowers systolic blood pressure by additional 2.3 mmHg in patients aged 65 and over compared to ACE inhibitor ramipril¹
   
• Almost 70% of people over age 60 have high blood pressure² - a condition that becomes increasingly prevalent and challenging to treat with age³
   
• AGELESS is part of the landmark ASPIRE HIGHER clinical program, which includes more than 35,000 patients

East Hanover, NJ, November 11, 2008 - New clinical data presented today show the first approved direct renin inhibitor Tekturna® (aliskiren) provides effective blood pressure reductions in patients with high blood pressure aged 65 and older¹. In the AGELESS study, Tekturna lowered systolic blood pressure by additional 2.3 mmHg in patients aged 65 and over, compared to the ACE inhibitor ramipril. Results from the AGELESS study were presented at the American Heart Association (AHA) 2008 scientific sessions.

Almost seventy percent of people over age 60 have high blood pressure and it remains uncontrolled in more than 60 percent of hypertensive adults over age 60^2,4. Even adults who do not have high blood pressure by age 55 face a 90 percent chance of developing it in their lifetime⁵.

"High blood pressure becomes more prevalent and challenging to treat with age," said Professor Daniel Duprez, lead author of the AGELESS study and Director of Research at the Rasmussen Center for Cardiovascular Disease Prevention, University of Minnesota. "The elderly population is expected to more than double over the next thirty years. Therefore, it is important to have effective therapies such as aliskiren to treat a range of patients, including the elderly."

The AGELESS study, conducted in 900 patients with systolic hypertension aged 65 and older, showed that Tekturna (150 mg daily increased to 300 mg daily if uncontrolled) lowered systolic blood pressure by 13.6 mmHg, versus a reduction of 11.3 mmHg in patients taking ramipril (5 mg daily increased to 10 mg daily if uncontrolled) after 12 weeks of treatment. A reduction of diastolic blood pressure (pressure between heart beats) was also achieved after 12 weeks of treatment with Tekturna versus ramipril (-4.8 mmHg vs. -3.5 mmHg, respectively)¹.

The efficacy and safety in this study was generally similar to that with younger patients in other Tekturna studies.

AGELESS is part of the landmark ASPIRE HIGHER program, the largest ongoing cardio-renal development program worldwide involving more than 35,000 patients. In addition to 35 hypertension studies in specific patient populations, the ASPIRE HIGHER program involves four outcome studies and six surrogate markers trials (trials studying key markers of disease progression) evaluating the effects of Tekturna-based therapy in a wide range of patient types.

"AGELESS, one study which is part of the ASPIRE HIGHER clinical program,  is the first US trial that was conducted solely in an elderly patient population taking Tekturna and adds to the growing body of evidence of the effectiveness of Tekturna in hypertensive patients," said Marjorie Gatlin, M.D., Vice President, Cardiovascular and Metabolic Therapeutic Area Head, US Medical. "Through the ASPIRE HIGHER program we hope to further explore the effects of Tekturna on blood pressure lowering in special populations, as well as surrogate markers and outcomes."

Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues.

About Tekturna
Tekturna, approved in the US in March 2007, is a prescription medication for adults, used to treat high blood pressure. It can be used alone or in combination with other high blood pressure medications. Tekturna has not been adequately studied in combination with the maximum doses of a type of medication called ACE inhibitors.

Important Considerations:

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.

Do not take Tekturna if you are allergic to any of its ingredients.

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.

Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel dizzy or faint. Call your doctor right away.

Tell your doctor about all your medical conditions, including whether you are pregnant or plan to become pregnant, are breast-feeding, or have kidney problems.

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.

For more information about Tekturna go to www.tekturna.com.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "expected," "hope," or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Tekturna or regarding potential future revenues from Tekturna. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Tekturna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Tekturna will be submitted or approved for any additional indications or labelling in any market. Nor can there be any guarantee that Tekturna will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Tekturna could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the effect that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; 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 Pharmaceuticals Corporation
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, GI 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 which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

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Media Contact

Heather Rose
Novartis Pharmaceuticals Corporation
862-778-1414 (direct)
917-859-4086 (mobile)
heather.rose@novartis.com

References
1. Duprez DA et al. The AGELESS Study: The Effect of Aliskiren vs Ramipril Alone or in Combination with Hydrochlorothiazide and Amlodipine in Patients = 65 Years of Age with Systolic Hypertension. Oral Presentation at the American Heart Association 2008 Scientific Sessions.
2. Fagard RH. Epidemiology of Hypertension in the Elderly. Am J Geriatr Cardiol 2002;11:23-28.
3. Ostchega Y, Dillon CF, Hughes JP, et al. Trends in Hypertension Prevalence, Awareness, Treatment, and Control in Older U.S. Adults: Data from the National Health and Nutrition Examination Survey 1988 to 2004. J Am Geriatr Soc 2007;55:1056-1065.
4. Ong KL, Cheung BMY, Man YB, et al. Prevalence, awareness, treatment, and control of hypertension among United States adults 1999-2004. Hypertension. 2007; 49:69-75.
5. Chobanian AV, Bakris GL, Black HR, et al. and the National High Blood Pressure Education Program Coordinating Committee. The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003; 42:1206-1252.

 

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