Results from a new study have shown patients taking two Novartis cardiovascular medicines - the recently US-approved drug Tekturna® (aliskiren) and the leading therapy Diovan® (valsartan) - experienced greater reductions in blood pressure levels than those using either agent alone[1].
The study also found more patients receiving both Tekturna, which received US approval in March and represents the first type of new high blood pressure medicine in a decade, and Diovan reached their treatment goal compared to either drug alone[1].
Data from this trial involving 1,800 patients - the first large-scale study to assess the benefits of combining these medicines - were presented for the first time at the American College of Cardiology 56th Scientific Session in New Orleans.
Half of the patients in the eight-week trial taking both Tekturna and Diovan saw a reduction in blood pressure to the target of 140/90 mmHg (systolic/diastolic pressure), higher levels than seen in patients taking either of the medicines alone. Failure to properly control high blood pressure, also called hypertension, can increase the risk of heart attacks and strokes.
Tekturna and Diovan work in different ways to target the Renin Angiotensin System, one of the body's key regulators of blood pressure. Tekturna targets renin, an enzyme responsible for triggering a process that can lead to high blood pressure. Diovan, an angiotensin receptor blocker (ARB) and one of the world's most-prescribed cardiovascular medicines, blocks a hormone later in this system that causes narrowing of blood vessels[3].
"These study results are exciting because they suggest the value of different mechanisms of action when Tekturna and Diovan are used together," said Suzanne Oparil, MD, Director of the Vascular Biology and Hypertension Program and Professor of Medicine at the University of Alabama at Birmingham in Alabama.
"In addition to important blood pressure lowering, the combination of Tekturna and Diovan maintained a tolerability profile similar to that seen with either agent alone," Dr. Oparil said.
Tekturna received US regulatory approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. In an extensive clinical trial program involving more than 6,400 patients, Tekturna provided significant blood pressure reductions for a full 24 hours. This once-daily oral therapy is expected to be available by the end of March in US pharmacies as 150 mg and 300 mg tablets.
A second study presented at the meeting compared Tekturna to ramipril, another high blood pressure medicine in a class known as ACE inhibitors. Results showed more patients treated with the Tekturna-based therapy reached their blood pressure goal than patients treated with the ramipril-based therapy (61.4% vs. 53.1% respectively)[4].
The need for new high blood pressure medicines is urgent given that this condition affects one in four adults globally and more than 70% of these patients remain uncontrolled[5]. In fact, many require two or more medications to reach their target blood pressure goal[2,6]. Uncontrolled high blood pressure can increase the risk of cardiovascular disease, the world's leading cause of death[6,7].
"We are very encouraged by these results since they show Tekturna and Diovan are effective when used together," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Through our portfolio of high blood pressure medications, Novartis is committed to providing physicians with a wide range of tools to help patients lower their blood pressure."
About Tekturna
Tekturna received approval in March 2007 from the US Food and Drug Administration (FDA) for the treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. The use of Tekturna with maximal doses of ACE inhibitors has not been adequately studied. In September 2006, Tekturna - known as Rasilez® outside the US - was submitted to the European Medicines Agency (EMEA) for review in the European Union. In clinical trials, the approved doses of Tekturna were generally well tolerated. Tekturna was developed in collaboration with Speedel.
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