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Rasitrio Approved to Treat Essential Hypertension

Rasitrio is a medicine that contains the active substances aliskiren, amlodipine and hydrochlorothiazide. It is available as tablets in the following strengths: 150 /5/12.5 mg; 300/5/12.5 mg; 300/5/25 mg; 300/10/12.5 mg; and 300/10/25 mg.

Rasitrio is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose. 'Essential' means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

The patient should take one tablet once a day with a light meal, preferably at the same time each day. The tablet should be swallowed whole with water. It should not be taken together with grapefruit juice.
The strength of the Rasitrio tablet that the patient takes depends on the doses of aliskiren, amlodipine and hydrochlorothiazide that they received previously. Patients should be switched to the fixed combination tablet of Rasitrio that contains the same component doses as previously used individually.

Rasitrio contains three active substances, aliskiren, amlodipine, and hydrochlorothiazide.

Aliskiren is a renin inhibitor. It blocks the activity of an enzyme called renin, which is involved in the production of a substance called angiotensin I in the body. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the activity of renin, levels of both, angiotensin I and angiotensin II, fall. This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure.

Hydrochlorothiazide is a diuretic. It works by increasing urine production, reducing the volume of fluid in the blood and lowering the blood pressure.
The combination of these three active substances reduces blood pressure more than either medicine acting alone.

In a main study in 1,191 patients with moderate or severe hypertension, Rasitrio combinations containing the three active substances were compared with combinations containing only two active substances: aliskiren plus amlodipine, amlodipine plus hydrochlorothiazide, and aliskiren plus hydrochlorothiazide. The patients were treated for eight weeks. The main measure of effectiveness was the reduction in the average systolic blood pressure (blood pressure when the heart is contracting) measured when the patients were seated.

The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.

The Rasitrio combination was more effective than the double combinations at reducing systolic blood pressure. After eight weeks, patients treated with Rasitrio had an average reduction in sitting systolic blood pressure of 37.4 mmHg. Reductions of 28.2 mmHg, 30.6 mmHg and 30.8 mmHg were seen for aliskiren plus hydrochlorothiazide, aliskiren plus amlodipine and amlodipine plus hydrochlorothiazide respectively.

The most frequent adverse reactions for Rasitrio are hypotension, peripheral oedema and dizziness.
Rasitrio must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, or hydrochlorothiazide, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine) or sulphonamide (includes hydrochlorothiazide). It must not be used in patients who have had angioedema (swelling under the skin), who have severe kidney or liver problems, or whose blood potassium levels are too low or blood calcium levels are too high. It must not be taken with ciclosporin or itraconazole (medicine that reduces the activity of the immune system) or medicines that may slow down the breakdown of aliskiren in the body such as quinidine (used to correct irregular heartbeat). It must not be used in people with very low blood pressure, suffering from shock, with a narrowing of the aortic heart valve, or with heart failure after an acute heart attack. It must not be used in women who are more than three months pregnant or breast-feeding. Its use during the first three months of pregnancy is not recommended.

The main study showed a greater reduction in blood pressure with Rasitrio than with combinations of two active substances. Studies also showed that the active substances in Rasitrio are absorbed in the body in the same way as the active substances when given as separate tablets. The CHMP noted that taking the three active substances in one tablet, as opposed to taking separate tablets, may lead to better compliance with treatment.

The Committee therefore decided that Rasitrio‘s benefits are greater than its risks and recommended that it be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Rasitrio on 22 November 2011.

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Prepared by: Houssam Nahhas

Source :

European Medicines Agency

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