PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Enviage?
Enviage is a medicine that contains the active substance aliskiren. It is available as tablets (pink round: 150 mg; red ovals: 300 mg).
What is Enviage used for?
Enviage 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 Enviage used?
The recommended dose of Enviage 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. Enviage should not be taken together with grapefruit juice. In patients whose blood pressure is not adequately controlled, the dose of Enviage can be increased to 300 mg once a day. The use of Enviage is not recommended in patients under the age of 18 due to the lack of information on safety and efficacy in this age group.
How does Enviage work?
The active substance in Enviage, 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 carried out on Enviage?
Before being studied in humans, the effects of Enviage were analyzed in experimental models.
Enviage 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 Enviage taken alone (alone) were compared with those of a placebo (a dummy treatment). Enviage 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 Enviage in combination with an angiotensin-converting enzyme inhibitor (ramipril), 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 Enviage shown during the studies?
Enviage monotherapy was more effective than placebo and as effective as comparative therapies in reducing blood pressure. From the cumulative analysis of the results of the five studies comparing Enviage in monotherapy and placebo, it emerges that, after 8 weeks of therapy with Enviage 150 mg, an average reduction in diastolic blood 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 Enviage. Enviage has also helped to 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 Enviage, 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 Enviage.
What is the risk associated with Enviage?
The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhea. For the full list of all side effects reported with Enviage, see the Package Leaflet.
Enviage 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, Enviage 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 Enviage been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage outweigh its risks in the treatment of essential hypertension. The Committee therefore recommended that Enviage be given marketing authorization.
More information on Enviage
On 22 August 2007, the European Commission issued a marketing authorization valid for Enviage, valid throughout the European Union, to Novartis Europharm Limited.
For the full EPAR for Enviage, click here.
Last update of this summary: 04-2009.
