What is Rasilez?
Rasilez is a medicine that contains the active substance aliskiren. It is available as tablets (pink round: 150 mg; red ovals: 300 mg).
What is Rasilez used for?
Rasilez is indicated for the treatment of essential hypertension (high blood pressure). The term "essential" indicates 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 should 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. The use of Rasilez is not recommended in patients under the age of 18 due to the lack of safety and efficacy information 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, present in the body. Angiotensin I is converted to the hormone angiotensin II, which is a powerful vasoconstrictor (substance that causes narrowing of blood vessels). 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 attacks.
What studies have been performed on Rasilez?
The effects of Rasilez were first tested in experimental models before being studied in humans.
Rasilez has been studied in 14 main studies involving over 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 to those of a placebo (a dummy treatment). Rasilez taken as monotherapy or in combination with other medicines has also been compared with other antihypertensive drugs. Combination therapy studies have examined the efficacy of Rasilez in combination with an angiotensin-converting enzyme (ramipril) inhibitor, an angiotensin receptor antagonist (valsartan), a beta blocker (atenolol), a blocker of calcium channels or calcium channel blocker (amlodipine) and a diuretic (hydrochlorothiazide). The duration of the studies varied between 6 and 52 weeks and the main indicator of effectiveness was the change in blood pressure during the resting phase of the heartbeat (diastolic pressure) or during the contraction phase of the cardiac ventricles (systolic pressure ). Blood pressure was measured in "millimeters of mercury" (mmHg).
What benefit has Rasilez shown during the studies?
Rasilez monotherapy was more effective than placebo and as effective as comparator therapies in reducing blood pressure. From the cumulative analysis of the results of the five comparison studies between Rasilez in monotherapy and placebo it emerges that, after 8 weeks of therapy with Rasilez 150 mg, an average reduction in diastolic pressure of 9 was observed in patients under the age of 65 years 0 mmHg compared to a mean value of 99.4 mmHg measured at the beginning of the study. This data 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.
Major reductions were observed in patients 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 effects of the medicine lasted up to a maximum of one year.
Studies have also shown that Rasilez, when taken in combination with other drugs (especially with hydrochlorothiazide), can induce further reductions in blood pressure compared to reductions induced by these same drugs taken without Rasilez.
What is the risk associated with Rasilez?
The most common side effect with Rasilez (seen in between 1 and 10 patients in 100) is diarrhea. For the full list of all side effects reported with Rasilez, see the Package Leaflet.
Rasilez should not be used in people who may be hypersensitive (allergic) to aliskiren or any of the other components. It must not be used in patients who have had angioedema (subcutaneous swelling) with aliskiren or even 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 pregnancy is not recommended. Furthermore, Rasilez should not be taken together with ciclosporin (a drug that reduces the activity of the immune system), quinidine (used to treat 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 for the treatment of essential hypertension. The Committee therefore recommended that Rasilez be given marketing authorization.
More information on Rasilez
On 22 August 2007, the European Commission issued a marketing authorization valid throughout the European Union for Rasilez to Novartis Europharm Limited.
For the full EPAR of Rasilez, click here.
Last update of this summary: 04-2009.
