What is Rasilez?
Rasilez is a medicine that contains the active substance aliskiren. It is available as tablets (pink round: 150 mg; red oval: 300 mg).
What is Rasilez used for?
Rasilez is used to treat essential hypertension (high blood pressure). The term 'essential' means that hypertension has no obvious cause.
The medicine can only be obtained with a prescription.
How is Rasilez used?
The recommended dose of Rasilez is 150 mg once a day, given alone or in combination with other antihypertensive drugs. The medicine should be taken with a light meal, preferably at the same time each day. Rasilez must not be taken together with grapefruit juice. In patients whose blood pressure is not adequately controlled, the dose of Rasilez can be increased to 300 mg once a day. Rasilez is not recommended for use in patients below 18 years of age due to a lack of information on safety and efficacy in this age group.
How does Rasilez work?
The active substance in Rasilez, aliskiren, is a renin inhibitor. It blocks the activity of a human enzyme called renin, which participates in the production of a substance called angiotensin I in the body. Angiotensin I is converted to the hormone angiotensin II, which is a potent vasoconstrictor (a substance that causes blood vessels to narrow). When angiotensin I production is blocked, angiotensin I and angiotensin II levels decrease. As a result, the vessels dilate (vasodilation) and blood pressure drops. This can reduce the risk associated with hypertension, such as heart attack.
How has Rasilez been studied?
Before being studied in humans, the effects of Rasilez were tested in experimental models.
Rasilez has been studied in 14 main studies involving more than 10,000 patients with essential hypertension. Thirteen of these studies involved subjects with mild to moderate hypertension, while one was performed in patients with severe hypertension. In five of these studies, the effects of Rasilez taken alone (alone) were compared with those of placebo (a dummy treatment). Rasilez taken alone or in combination with other medicines was also compared with other antihypertensive medicines. The combination therapy studies looked at the effectiveness of Rasilez in combination with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor antagonist (valsartan), a beta blocker (atenolol), a blocker of calcium channel or calcium channel blocker (amlodipine) and a diuretic (hydrochlorothiazide). The duration of the studies ranged from 6 to 52 weeks and the main measure of effectiveness was the change in blood pressure during the resting phase of the heartbeat (diastolic pressure) or during the contraction phase of the heart ventricles (systolic pressure). ) Blood pressure was measured in "millimeters of mercury" (mmHg).
What benefit has Rasilez shown during the studies?
Rasilez alone was more effective than placebo and as effective as comparator therapies in lowering blood pressure. The cumulative analysis of the results of the five studies comparing Rasilez monotherapy with placebo shows that, after 8 weeks of therapy with Rasilez 150 mg, an average reduction in diastolic blood pressure of 9 was observed in patients under the age of 65, 0 mmHg compared to a mean value of 99.4 mmHg measured at the start of the study. This figure should be compared with the reduction of 5.8 mmHg (compared to the initial value of 99.3 mmHg) recorded in patients treated with placebo.
Greater reductions were seen in patients aged 65 years or older and in subjects receiving higher doses of Rasilez. Rasilez also helped lower blood pressure in diabetic and overweight patients. In two of the studies, the drug's effects lasted for up to a year.
Studies have also shown that Rasilez, when taken in combination with other medicines (especially hydrochlorothiazide), can induce further reductions in blood pressure than the reductions induced by these same medicines taken without Rasilez.
What is the risk associated with Rasilez?
The most common side effect reported with Rasilez (seen in 1 to 10 patients in 100) is diarrhea. For the full list of side effects reported with Rasilez, see the package leaflet.
Rasilez must not be used in people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients. It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren or in women who have been pregnant for more than three months. The use of the medicine during the first three months of pregnancy and in women planning to become pregnant is not recommended. Furthermore, Rasilez should not be taken together with cyclosporine (a medicine that reduces the activity of the immune system), quinidine (used for treatment of irregular heartbeat) or verapamil (used to treat heart problems).
Why has Rasilez been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rasilez's benefits are greater than its risks in the treatment of essential hypertension. The Committee therefore recommended that Rasilez be given a marketing authorization.
More information about Rasilez
On 22 August 2007, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Rasilez, valid throughout the European Union.
For the full version of Rasilez's EPAR, click here.
Last update of this summary: 04-2009.
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