What is Dafiro?
Dafiro is a medicine that contains two active substances, amlodipine and valsartan. The medicine is available as tablets (dark yellow and round: 5 mg amlodipine and 80 mg valsartan; dark yellow and oval: 5 mg amlodipine and 160 mg valsartan; pale yellow and oval: 10 mg amlodipine and 160 mg valsartan).
What is Dafiro used for?
Dafiro is used in patients with essential hypertension (high blood pressure) that is not adequately controlled with amlodipine or valsartan given alone. The term "essential" indicates that hypertension has no obvious cause. Dafiro is not recommended for patients under 18 years of age because there is no information on safety and efficacy for this age group.
The medicine can only be obtained with a prescription.
How is Dafiro used?
Dafiro is taken by mouth, in the quantity of one tablet once a day, with a little water, with or without food. The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking previously. The patient may need to take separate tablets or capsules before switching to the combination tablet. Dafiro should be used with caution in patients with liver problems or biliary obstruction disorders (problems with eliminating bile).
How does Dafiro work?
Dafiro contains two active substances, amlodipine and valsartan. These are two antihypertensive agents available separately in the European Union (EU) since the mid-1990s, which act in a similar way in lowering blood pressure, ie by relaxing the blood vessels. As blood pressure decreases, the associated risks decrease. high blood pressure, such as having a stroke.
Amlodipine is a calcium channel blocker, meaning it blocks particular channels on the cell surface, called calcium channels, which normally allow calcium ions to enter cells. When calcium ions penetrate the muscle cells of the vascular walls , cause a contraction. By reducing the flow of calcium into the cells, amlodipine inhibits the contraction of the cells, promoting relaxation of the vessels.
Valsartan is an angiotensin II receptor antagonist, that is, it blocks the action of a hormone present in the body called angiotensin II, Angiotensin II is a powerful vasoconstrictor (a substance that constricts blood vessels). binds angiotensin II, valsartan blocks the effect of the hormone, allowing blood vessels to dilate.
How has Dafiro been studied?
As amlodipine and valsartan have been used for many years, the company presented data on the two substances from previous studies and the scientific literature, as well as new studies relating to the use of the two substances in combination.
Five main studies were conducted involving a total of approximately 5,200 patients, mostly with mild to moderate hypertension. Two of these (totaling nearly 3,200 patients) compared the effectiveness of amlodipine, valsartan or the combination of the two substances with that of placebo (a dummy treatment). Two other studies (1,891 patients) compared the effects of this combination in patients whose hypertension was not adequately controlled with amlodipine 10 mg or valsartan 160 mg. The fifth, smaller study compared efficacy. of the combination compared to lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (measured blood pressure). between two heartbeats). Blood pressure was measured in "millimeters of mercury" (mmHg).
The company also presented data showing that the blood levels of amlodipine and valsartan were the same in patients treated with Dafiro and in patients treated with the two drugs separately.
What benefit has Dafiro shown during the studies?
In lowering blood pressure, the combination of amlodipine and valsartan was more effective than placebo and valsartan or amlodipine taken alone. Studies comparing the efficacy of the combination in patients already taking amlodipine or valsartan alone showed that in patients taking valsartan alone, blood pressure dropped by 6.6 mmHg after eight weeks, while in patients who were combined with valsartan 5 or 10 mg of amlodipine the reduction was 9.6 and 11, respectively In patients treated with amlodipine alone the reduction was 10.0 mmHg, while in patients in whom 160 mg of valsartan was combined with amlodipine the reduction was 11.8 mmHg.
What is the risk associated with Dafiro?
The most frequent side effects associated with taking Dafiro (seen in 1 to 10 patients out of 100 treated) are headache, nasopharyngitis (inflammation of the nose and throat), flu, various types of edema (swelling), fatigue (tiredness) , redness, asthenia (weakness) and hot flashes For the full list of side effects reported with Dafiro, see the package leaflet.
Dafiro should not be used in patients who may be hypersensitive (allergic) to "amlodipine or other medicines of the" dihydropyridine derivatives "class, to valsartan or to any of the other ingredients. It should not be used in women who are pregnant for longer. three months. Use during the first three months of pregnancy is not recommended. Dafiro must not be used in patients with severe liver, kidney or bile problems, as well as in patients undergoing dialysis (a blood clearance technique).
Why has Dafiro been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Dafiro's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine monotherapy or valsartan The committee recommended that Dafiro be given marketing authorization.
Other information about Dafiro:
On January 16, 2007, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Dafiro, valid throughout the EU.
For the complete version of the Dafiro EPAR, click here.
Last update of this summary: 03-2009.
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