The European Commission (EC) has approved Novartis’ triple combination drug Rasitrio as a treatment for high blood pressure.

Rasitrio, the first combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill, has been shown to reduce blood pressure more effectively than dual combinations of any of its components.

The combination drug is based on Novartis’ direct renin inhibitor Rasilez (aliskiren), a successful regulator of high blood pressure.

The growing need for multiple medications to treat high blood pressure (estimated to be up to 85% of patients) is driving the market for combination drugs, which improve patient compliance.

Rasitrio lowers blood pressure in three ways:

• Aliskiren binds to and inhibits renin, an enzyme produced by the kidneys that can make blood vessels narrower.

• Amlopidine, a calcium channel blocker, relaxes the blood vessel walls.

• HCT, a diuretic, increases excretion of water and salt.

All three components also improve blood flow.

Hypertension affects as many as one billion people worldwide. Effective control can reduce the incidence of stroke and heart failure by half and heart attacks by one quarter.

The EC approval of Rasitrio is based on phase III data involving 1,181 patients, showing that the combination drug reduced blood pressure more effectively than dual combinations of any of its three components.

“Simplification of treatment for high blood pressure patients on three or more therapies is key to improving patient compliance and outcomes,” said Prof. Josep Redon, Hospital Clinico, University of Valencia, Spain.

“This innovative triple combination therapy, which has demonstrated significant reductions in blood pressure during clinical trials, offers patients a new and convenient treatment option.”

Daiichi Sankyo UK has launched the first 3-in-1 combination drug available in the UK for the management of hypertension.

Sevikar HCT combines olmesartan medoxomil, amlodipine and hydrochlorothiazide (HCT) in a single pill to help improve patient compliance and manage hypertension more effectively.

It is indicated for patients who are already taking these three drugs in the form of Olmesartan Plus and amlodipine, and is available in five different fixed doses to meet varied patient needs.

Research has shown that up to 80% of the 2 million UK patients who are prescribed three or more anti-hypertensive drugs are not compliant with their treatment, putting many of them at risk of stroke or heart disease.

Strokes resulting from hypertension cost the NHS an estimated £2.8 billion per year, and are a major cause of disability.

Clinical studies have shown that replacing multiple prescriptions with a single-pill combination can improve compliance rates and hence improve blood pressure control.

“A simplified treatment regimen for those patients taking three or more tablets makes eminent sense for hypertension and could lead to improved compliance rates”, said Professor Tony Heagerty, Head of the Cardiovascular Research Group at Manchester University.

“After lifestyle advice, medication is the most powerful way of managing high blood pressure, but only when it is taken correctly.”

The Daiichi Sankyo Group aims to develop pharmaceutical products to target diversified and unmet patient needs.

The CHMP has adopted a positive opinion for Novartis’ Rasitrio, recommended as replacement therapy for patients with high blood pressure.

The single-pill treatment combines calcium channel blocker amlodipine with the diuretic hydrochlorothiazide (HCT) and Rasilez, the only approved direct renin inhibitor in the world.

Professor Roland E. Schmieder at the University Hospital of the University Erlangen-Nuremberg, Germany, commented that the drug will provide patients with a “comprehensive and convenient high blood pressure treatment in one pill”.

The CHMP positive opinion of Rasitrio is based on a Phase III clinical trial involving more than 1,181 patients with high blood pressure. Data showed that Rasitrio significantly reduced blood pressure compared to dual combinations of each of its individual components.

David Epstein, Division Head of Novartis Pharmaceuticals, said: “This positive CHMP opinion is an important step towards approval and making this new triple combination therapy available for patients whose blood pressure is not under control and who may require multiple medications.”

Approximately 1 billion people have high blood pressure worldwide, with many remaining uncontrolled despite treatment, with up to 85% of patients requiring multiple medications to help control their blood pressure.

High blood pressure can cause damage to the heart, brain and kidneys and is also linked with other conditions such as diabetes.