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Blood pressure pill gains European approval


Rasitrio®, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill, has received approval from the European Commission (EC) for the treatment of high blood pressure.

Rasitrio combines the first and only approved direct renin inhibitor (DRI), Rasilez, with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide.

Rasitrio has been approved as substitution therapy for patients with high blood pressure that are adequately controlled by the combination of the three components at the same dose.

The approval of Rasitrio is based on pivotal phase III data involving more than 1,181 high blood pressure patients.

The study showed that Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300mg/10mg, aliskiren/HCTZ 300mg/25mg and amlodipine/HCTZ 10mg/25mg.

The effect of Rasitrio was observed as early as one week after initiation of therapy and was maintained over the entire 24-hour dose interval.

Up to 85% of high blood pressure patients may need several medications to help them reach their goal. However, the management of multiple drugs can lead to compliance concerns, a major challenge for primary care physicians.

“Simplification of treatment for high blood pressure patients on three or more therapies is key to improving patient compliance and outcomes,” said Professor Josep Redon, M.D., 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.”

The single pill combination Rasitrio works to lower blood pressure in three ways.

The Rasilez component directly binds to and inhibits renin, an enzyme produced by the kidneys that starts a process that can make blood vessels narrow and lead to high blood pressure.

The calcium channel blocker amlodipine lowers blood pressure by relaxing the blood vessel walls, and the diuretic hydrochlorothiazide increases the excretion of sodium chloride and water.

All three complementary medicines enable blood to flow more easily, therefore lowering blood pressure.

It is estimated that about one billion people globally have high blood pressure, with many remaining uncontrolled despite treatment. High blood pressure alone can cause damage to the vital organs of the body, including the heart, brain and kidneys.

It is also linked with other conditions such as diabetes, where high blood pressure is estimated to cause up to 75% of diabetic cardiovascular complications.

However, if high blood pressure is properly controlled, the incidence of stroke and heart failure can be reduced by almost half and heart attacks by one quarter.

European Commission

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