What is Zomarist?
Zomarist is a medicine that contains the active substances vildagliptin and metformin hydrochloride. It is available as oval tablets (light yellow: 50 mg of vildagliptin and 850 mg of metformin hydrochloride; dark yellow: 50 mg of vildagliptin and 1 000 mg of metformin hydrochloride).
This medicine is identical to Eucreas, already authorized in the European Union (EU). The company that makes Eucreas has agreed that its scientific data will be used for Zomarist.
What is Zomarist used for?
Zomarist is used to treat type 2 diabetes (non-insulin-dependent diabetes). It is used in patients whose disease is not sufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.
The medicine can only be obtained with a prescription.
How is Zomarist used?
The recommended dose of Zomarist is one tablet twice a day, one tablet in the morning and one in the evening. The choice of the initial dose depends on the dose of metformin currently taken by the patient, but the recommended dose is 50 mg of vildagliptin and 1 000 mg of metformin twice a day. Patients already taking vildagliptin and metformin should switch to Zomarist tablets containing the same doses of each active ingredient. Doses of vildagliptin greater than 100 mg are not recommended. Taking Zomarist during or immediately after meals may reduce stomach problems caused by metformin.
Zomarist should not be used by patients with moderate or severe kidney problems or liver disorders. In elderly patients taking Zomarist, renal function should be monitored regularly. The use of Zomarist is not recommended in patients over 75 years of age.
How does Zomarist work?
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose (sugar) in the blood or where the body is unable to use insulin effectively. Zomarist contains two active ingredients, each with a different mechanism of action. Vildagliptin, a dipeptidyl-peptidase 4 (DPP-4) inhibitor, works by inhibiting the breakdown of 'incretin' hormones in the body. These hormones, which are released into the blood after a meal, stimulate the pancreas to produce insulin. By increasing the level of incretin in the blood, vildagliptin stimulates the pancreas to produce more insulin when the glycemic rate is high. Vildagliptin does not work if blood glucose concentration is low. Vildagliptin also reduces the amount of glucose produced by the liver by increasing insulin levels and reducing the levels of the glucagon hormone. Metformin basically inhibits glucose production and reduces its absorption in the intestine. The result of the combined action of the two active ingredients consists in a reduction of the glucose present in the blood, which helps to control type 2 diabetes.
What studies have been carried out on Zomarist?
Vildagliptin alone was approved by the European Union in September 2007 under the name Galvus, while metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in patients with type 2 diabetes, whose disease is not sufficiently controlled with metformin alone. Studies on Galvus in addition to metformin have been used to support the use of Zomarist for the same indication. In these studies, the concentration in the blood of a substance called glycosylated hemoglobin (HbA1c) was measured, which gives an indication of the effectiveness of blood glucose control.
The applicant also presented the results of two studies showing that the active ingredients in the two dosages of Zomarist were absorbed by the body in the same way as when they were taken in separate tablets.
What benefit has Zomarist shown during the studies?
Vildagliptin was more effective than placebo (a dummy treatment) in reducing HbA1c levels when added to metformin. Patients who added vildagliptin reported a decrease in HbA1c levels of 0.88% after 24 weeks, with an initial level of 8.38%. Instead, the patients who added the placebo recorded smaller changes in HbA1c levels, with an increase of 0.23%, starting from an initial level of 8.30%.
What is the risk associated with Zomarist?
The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea, vomiting, diarrhea, abdominal pain and loss of appetite. For the full list of all side effects reported with Zomarist, see the Package Leaflet.
Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients. It must not be used in patients who present with diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic precoma, kidney or liver problems, conditions that may affect the kidneys or diseases that cause a reduction in the oxygen supply to the tissues such as heart or lung failure or a recent heart attack. Furthermore, it should not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, nor during breastfeeding. For the full list of usage restrictions, see the package leaflet.
Why has Zomarist been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that vildagliptin taken with metformin reduces blood glucose levels and that the combination of the two active ingredients in one tablet can help patients to stick to the treatment. The Committee therefore decided that Zomarist's benefits are greater than its risks in the treatment of patients with type 2 diabetes mellitus, who cannot achieve sufficient glycemic control at their maximum tolerated dose of oral metformin alone or who are already in therapy with the combination of vildagliptin and metformin as separate tablets. The committee recommended the granting of the marketing authorization for Zomarist.
More information on Zomarist:
On 1 December 2008, the European Commission granted a marketing authorization valid for Zomarist, valid throughout the European Union, to Novartis Europharm Limited.
For the full EPAR of Zomarist, click here.
Last update of this summary: 10-2008.