EAST HANOVER, N.J., July 28 /PRNewswire/ -- New data show Exforge(R) (amlodipine and valsartan), a single-pill combination of the world’s leading high blood pressure medicines Diovan(R) (valsartan) and amlodipine, gets nearly twice as many patients with high baseline blood pressure to a healthier blood pressure goal compared to amlodipine alone.
Results of a study in patients with baseline systolic blood pressure greater than or equal to 160 mmHg published in The Journal of the American Society of Hypertension, showed that 51.8% of patients on Exforge achieved systolic blood pressure control, defined as <140 mmHg at week four, compared to 27.7% of those on amlodipine alone. Systolic blood pressure, measured when the heart contracts and pumps, is an important indicator of a person’s risk of cardiovascular events.
The primary endpoint of the study was the change from baseline Mean Sitting Systolic Blood Pressure (MSSBP) at week four. Results showed that on average, patients on Exforge experienced a significant 30.1 mmHg reduction in systolic blood pressure compared to a 23.5 mmHg reduction in patients on amlodipine alone.
In the same study, patients with systolic blood pressure greater than or equal to 180 mmHg treated with Exforge experienced significant systolic blood pressure reductions of up to 40.1 mmHg, compared with 31.7 mmHg for those treated with amlodipine alone. High blood pressure is estimated to affect one in three adults in the US -- approximately 73 million adults.
“All patients who received Exforge achieved significant blood pressure drops, with the bigger blood pressure drops of up to 40 mmHg being seen in those patients with a higher baseline level,” said Maurizio Destro, MD, the lead investigator from the Azienda Ospedaliera di Pavia in Italy. “In addition, Exforge was well tolerated which is important for patients in managing their blood pressure.”
Treatment guidelines recommend that patients with high blood pressure greater than or equal to 160/100 mmHg should be considered for a combination of two medicines from different drug classes.
Exforge also demonstrated significantly better blood pressure-lowering efficacy than amlodipine alone across certain difficult-to-treat patient groups, including the elderly (over 65 years), obese people and those with diabetes.
“Exforge has shown significant benefit in difficult-to-treat patients with high blood pressure,” said Marjorie Gatlin, MD, Vice President and Head of Cardiovascular and Metabolism Medical Franchise, US Medical and Drug Regulatory Affairs at Novartis Pharmaceuticals Corporation. “This is important as high blood pressure remains a highly prevalent condition and underlying cause of cardiovascular disease.”
The study was designed to investigate and compare the efficacy and safety of Exforge with amlodipine in patients with stage 2 high blood pressure (a more severe stage of the disease, with systolic blood pressure between 160 and 200 mmHg). It was a randomized, double-blind, multi-center parallel-group study carried out in 75 centers across Europe and the US. In total, 646 patients were randomized to receive treatment with Exforge 5-10/160 mg (n=322) or amlodipine 5-10 mg (n=324). Demographic and high blood pressure baseline characteristics were similar for both groups.
Overall blood pressure measurements consist of two values, both expressed in millimeters of mercury (mmHg). The first is the systolic blood pressure when the heart beats and the second is the diastolic pressure when the heart relaxes between beats. In this study, overall blood pressure control rates (<140/90 mmHg) were higher at all assessment points for patients treated with Exforge than for those receiving amlodipine alone. In this study both medications were well tolerated.
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.
The core of the Novartis portfolio is its cardiovascular medications for the treatment of high blood pressure and diabetes. These include the world’s most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, and a single pill combining two leading high blood pressure medicines. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.
About Diovan, Tekturna(R) (aliskiren), and Exforge
Diovan, Tekturna, and Exforge are prescription medications for adults used to treat high blood pressure. They can be used alone or in combination with other high blood pressure medications. It is not known whether additional blood pressure reductions are present when Tekturna is used in combination with ACE inhibitors or beta blockers.
Important Considerations:
IMPORTANT WARNING: Taking Diovan, Tekturna or Exforge during pregnancy can cause injury and even death to your unborn baby. If you get pregnant, stop taking Diovan, Tekturna or Exforge and call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
Do not take Diovan, Tekturna or Exforge if you are allergic to any of the ingredients in the product you are taking. Additionally, do not take Tekturna if you take cyclosporine. If you take Tekturna or Exforge, tell your doctor if you have kidney problems.
If you take Tekturna and have 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.
The most serious side effect with Diovan, Tekturna and Exforge is low blood pressure, and additionally with Diovan kidney problems.
In clinical studies, diarrhea was experienced by more patients taking Tekturna than patients taking a sugar pill. Other less common reactions to Tekturna include cough and rash. Side effects that occur more frequently with Exforge than placebo are swelling of the hands, ankles, or feet; nasal congestion or sore throat; head or chest cold; and dizziness.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “will,” “may,” “potential,” “could,” or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Exforge or regarding potential future revenues from Exforge. 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 Exforge to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Exforge will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Exforge will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Exforge 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, 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, 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 growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and 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 98,000 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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