From HealthNewsDigest.com
Tekturna®, First Approved Direct Renin Inhibitor, Effectively Lowers High Blood Pressure in Elderly Patients
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Nov 11, 2008 - 11:10:49 AM
·AGELESS is part of the landmark ASPIRE HIGHER clinical program, which includes more than 35,000 patients
(HealthNewsDigest.com) - East Hanover, NJ, — 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 older. In the AGELESS study, Tekturna lowered systolic blood pressure by an 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) Scientific Sessions 2008.
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. Even adults who do not have high blood pressure by age 55 face a 90 percent chance of developing it in their lifetime.
“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).
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.
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