Tekturna new hypertension drug - first in a decade

Mar 7 2007

The Food and Drug Administration (FDA) in the United States has given it's approval for the use of a new drug to treat hypertension.

Hypertension or high blood pressure affects an estimated 25 percent of Americans and 1 billion people worldwide and is uncontrolled in 70% of patients.

Many patients need a combination of drugs to control their hypertension.

Left untreated the condition can cause stroke, heart attack, kidney failure, heart failure and death.

Hypertension is a leading contributor to the world's top killer, cardiovascular disease and is called "the silent killer" because it usually has no symptoms until it causes major damage to the body organs.

The new drug Tekturna (aliskiren) comes in tablet form and works by inhibiting the kidney enzyme renin which is linked to the regulation of blood pressure.

Tekturna is a new molecular entity (NME), and is the first high blood pressure drug approved by FDA that inhibits renin which is a trigger in the blood pressure regulation process.

Tekturna is the first new drug in over a decade for treating hypertension.

Currently available high blood pressure medications act at later stages whereas Tekturna acts at the start of the regulation process.

Dr. Douglas C. Throckmorton, the Deputy Director of the FDA's Center for Drug Evaluation and Research, says the approval adds a new safe and effective treatment option for people who need help to control their blood pressure.

In an extensive clinical trial involving over 6,400 patients Tekturna was seen to be effective in lowering blood pressure.

In six eight-week clinical trials, which studied more than 2,000 patients with mild to moderate hypertension where a placebo was used as the control, Tekturna was effective across all demographic subgroups and the benefit was maintained for up to one year.

African American patients had smaller reductions in blood pressure than Caucasians and Asians, which is apparently common for drugs that affect the renin-angiotensin system.

When Tekturna was used in combination with hydrochlorothiazide, a diuretic, further reductions in blood pressure were achieved.

The most common side effect was diarrhea which was reported by approximately 2 percent of patients on the higher of the two approved doses but these were usually mild and brief.

Tekturna is available in 150mg and 300mg tablets.

Patients taking Tekturna rarely developed an allergic reaction but the drug is unsuitable for pregnant women as it can cause injury and even death to the developing fetus.

Dr. Marc Pfeffer, a professor of Medicine at Harvard and a cardiologist at Brigham & Womens Hospital, says renin-angiotensin system activity contributes to many of the complications associated with high blood pressure and Tekturna offers an exciting new therapeutic option for treating hypertension.

Tekturna is manufactured by Novartis Pharmaceuticals which will conduct a large outcome trial in order to evaluate the long-term effects of Tekturna and renin inhibition.

Last September the European Medicines Agency was approached for Tekturna to be reviewed for use in the European Union.