Significant blood pressure reductions seen with Exforge across difficult-to-treat groups

Novartis AGNew data show that Exforge, a single-pill combination of the world's leading high blood pressure medicines Diovan® (valsartan) and amlodipine, gets nearly twice as many patients with high baseline blood pressure to a healthier blood pressure goal compared to amlodipine alone[1].

Results of a study in patients with systolic baseline blood pressure >=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 alone1. Systolic blood pressure, measured when the heart contracts and pumps, is an important indicator of a person's risk of cardiovascular events[3].

"The blood pressure drops achieved with Exforge are important since systolic blood pressure continues to increase with age. Therefore as population demographics shift towards older age, the cardiovascular disease burden could almost be entirely attributable to systolic blood pressure," said Dr. Maurizio Destro, lead investigator from the Azienda Ospedaliera di Pavia in Italy. "Furthermore, 65% of people with high blood pressure do not achieve their blood pressure goal, and most require two or more medicines. Patients are more likely to keep taking a single pill a day rather than multiple medications, so Exforge is clearly an important and effective therapy option."

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[1].

In the same study, patients with systolic blood pressure >=180 mmHg treated with Exforge experienced significant systolic blood pressure reduction of up to 40.1 mmHg, compared with 31.7 mmHg for those treated with amlodipine alone[1].

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[1].

Treatment guidelines recommend that patients with high blood pressure >=160/100 mmHg should be considered for a combination of two medicines from different drug classes[4].

"To lower the risk of complications from uncontrolled high blood pressure, it is vital to treat patients early and effectively," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "Exforge consistently demonstrates large blood pressure drops across all stages of high blood pressure and has been shown to get as many as nine out of 10 patients without diabetes to goal."

High blood pressure is a leading cause of cardiovascular disease, the world's number one cause of death[2]. Controlling high blood pressure can reduce complications such as heart attack, heart failure, stroke, kidney failure and premature death[3].

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[1].

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[1].

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, a single pill combining two leading high blood pressure medicines, and a novel DPP-4 inhibitor. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.

About Novartis
Novartis AG 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 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References
[1] Destro et al. Efficacy and Safety of Amlodipine/Valsartan Compared with Amlodipine Monotherapy in Patients with Stage 2 Hypertension: A Randomized, Double-blind, Multicenter Study: The EX-EFFeCTS Study. The Journal of the American Society of Hypertension. On-line publication doi:10.1016/j.jash.2008.01.004
[2] Kearney et al. Global burden of hypertension: analysis of worldwide data. The Lancet. 2005;265:217-23
[3] Chobanian et al. Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003;42:12006-1251.
[4] Mancia G et al. The 2007 ESH/ESC Guidelines for the management of arterial hypertension. J Hypertens 2007;26(4):825-6.

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