Tekturna First New Type of High Blood Pressure Medicine

New study results show more patients receiving both Tekturna and Diovan reached target blood pressure goal compared to those taking either agent alone

• Tekturna approved in the U.S. as first direct renin inhibitor, works by directly targeting an enzyme which triggers a process that can lead to high blood pressure

• Tekturna provides significant blood pressure reductions for a full 24 hours and is generally well tolerated

• Urgent need for new therapies like Tekturna since nearly 70% of patients with high blood pressure still not achieving treatment goals

Results from a new study have shown patients taking two Novartis cardiovascular medicines -- the recently U.S.-approved drug Tekturna(R) (aliskiren) and the leading therapy Diovan(R) (valsartan) -- experienced greater reductions in blood pressure levels than those using either agent alone.

The study also found more patients receiving both Tekturna, which received U.S. 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 (ACC presentation #405).

Data from this trial involving 1,800 patients -- the first large-scale study to assess the potential 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.

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, works later in this system by blocking the action of angiotensin II, which causes narrowing of blood vessels.

"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," said Dr. Oparil.

Tekturna received U.S. 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 U.S. pharmacies as 150 mg and 300 mg tablets.

A second study presented at the meeting compared Tekturna (150 mg or 300 mg alone or 300 mg in combination with HCTZ) to ramipril (5 mg or 10 mg alone or 10 mg in combination with HCTZ), another high blood pressure medicine in a class known as angiotensin converting enzyme (ACE) inhibitors (ACC presentation #1014). Results showed 61.4% of patients treated with the Tekturna-based therapy reached their blood pressure goal vs. 53.1% of patients treated with the ramipril-based therapy.

Tekturna and Diovan should be discontinued as soon as pregnancy is detected as they may harm an unborn baby, causing injury and even death. Women who plan to become pregnant should talk to their doctor about other treatment options before taking Tekturna or Diovan.

The need for new high blood pressure medicines is urgent given that this condition affects one in three adults in the U.S. and nearly 70% of these patients remain uncontrolled. In fact, many require two or more medications to reach their target blood pressure goal. Uncontrolled high blood pressure can increase the risk of cardiovascular disease, the world's leading cause of death.

"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."

Tekturna received FDA approval in March 2007 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. Tekturna was developed in collaboration with Speedel.