Galvus
Active Substance: vildagliptin
Common Name: vildagliptin
ATC Code: A10BH02
Marketing Authorisation Holder: Novartis Europharm Limited
Active Substance: vildagliptin
Status: Authorised
Authorisation Date: 2007-09-26
Therapeutic Area: Diabetes Mellitus, Type 2
Pharmacotherapeutic Group: Drugs used in diabetes
Therapeutic Indication
Vildagliptin is indicated in the treatment of
type-2 diabetes mellitus in adults:
as monotherapy:
in patients inadequately controlled
by diet and exercise alone and for whom metformin is inappropriate due to
contraindications or intolerance;
as dual oral therapy in combination with:
metformin, in patients with
insufficient glycaemic control despite maximal tolerated dose of
monotherapy with metformin;a sulphonylurea, in patients with
insufficient glycaemic control despite maximal tolerated dose of a
sulphonylurea and for whom metformin is inappropriate due to
contraindications or intolerance;a thiazolidinedione, in patients
with insufficient glycaemic control and for whom the use of a
thiazolidinedione is appropriate;
as triple oral therapy in combination with:
a sulphonylurea and metformin when
diet and exercise plus dual therapy with these medicinal products do not
provide adequate glycaemic control.
Vildagliptin is also indicated for use in
combination with insulin (with or without metformin) when diet and exercise
plus a stable dose of insulin do not provide adequate glycaemic control.
What is Galvus?
Galvus is a medicine that contains the active
substance vildagliptin. It is available as tablets (50 mg).
What is Galvus used for?
Galvus is used to treat type-2 diabetes mellitus.
It can be used in the following ways:
on its own (monotherapy) in
patients whose diabetes is not sufficiently controlled by diet and
exercise and who cannot take metformin;together with metformin, a
thiazolidinedione or a sulphonylurea (dual therapy) when the patient’s
diabetes is insufficiently controlled by this other medicine taken alone,
but it is only used in combination with a sulphonylurea in patients who
cannot take metformin;together with a sulphonylurea and
metformin (triple therapy) in patients whose diabetes is not sufficiently
controlled by these medicines plus diet and exercise;together with insulin (with or
without metformin) in patients whose diabetes is not sufficiently
controlled by diet and exercise plus a stable dose of insulin.
The medicine can only be obtained with a
prescription.
How is Galvus used?
In adults, the recommended dose of Galvus is:
one tablet in the morning and
another in the evening (100 mg per day), when used alone, with metformin,
with a thiazolidinedione, with metformin plus a sulphonylurea, or with
insulin (with or without metformin);one tablet in the morning (50 mg
per day) when taken with a sulphonylurea. A lower dose of the sulphonylurea
may also be considered to reduce the risk of hypoglycaemia (low blood
glucose levels).
The daily dose should not exceed two tablets (100
mg). In patients with moderate or severe kidney problems, the recommended dose
is 50 mg once daily.
How does Galvus work?
Type-2 diabetes is a disease in which the pancreas
does not make enough insulin to control the level of glucose (sugar) in the
blood or when the body is unable to use insulin effectively. The active
substance in Galvus, vildagliptin, is a dipeptidyl-peptidase-4 (DPP-4)
inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the
body. These hormones are released after a meal and stimulate the pancreas to
produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin
stimulates the pancreas to produce more insulin when blood glucose levels are
high. Vildagliptin does not work when the blood glucose is low. Vildagliptin
also reduces the amount of glucose made by the liver, by increasing insulin
levels and decreasing the levels of the hormone glucagon. Together, these
processes reduce blood glucose levels and help to control type-2 diabetes.
How has Galvus been studied?
Galvus has been studied in eleven main studies
involving a total of over 5,000 patients with type-2 diabetes and insufficient
control of blood glucose levels.
Five of these studies looked at the effects of
Galvus taken alone in a total of 3,644 patients, comparing it with placebo (a
dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide
(a sulphonylurea).
Four studies compared the effects of Galvus, taken
at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used
as an add-on to existing treatment with metformin (544 patients), pioglitazone
(a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515
patients) or insulin (296 patients).
A further study compared Galvus with placebo as an
add-on treatment in 318 patients who were already taking metformin and
glimepiride.
A further study compared Galvus with placebo as an
add-on treatment in 449 patients who were already taking a stable dose of
long-acting insulin. Some of the patients were also taking metformin.
In all studies, the main measure of effectiveness
was the change in blood levels of a substance called glycosylated haemoglobin
(HbA1c), which gives an indication of how well blood glucose is controlled.
What benefit has Galvus shown during
the studies?
Galvus used on its own was effective at reducing
levels of HbA1c, but was less effective than the comparator medicines. In the
study comparing Galvus with metformin, significantly better results were seen
with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks
compared with a reduction of around 1 percentage point in patients treated with
Galvus.
When used as an add-on to existing treatment for
type-2 diabetes, Galvus was more effective than placebo in reducing HbA1c
levels. With metformin and with pioglitazone, the 100 mg daily dose was more
effective than the 50 mg daily dose, with a reduction in HbA1c levels of
between 0.8 and 1.0 percentage points. In combination with glimepiride, both 50
mg and 100 mg daily doses caused a reduction of around 0.6 percentage points.
In contrast, patients adding placebo to their existing treatment showed smaller
changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage
points.
In combination with metformin and glimepiride, 50
mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point,
compared with a reduction of 0.3 percentage points in patients taking placebo.
In the study involving 296 patients taking insulin,
adding Galvus caused a greater reduction in HbA1c levels than adding placebo,
but the size of this effect was small possibly due to the fact that the study
included long-term patients who were less likely to show improvement. However,
in another study involving 449 patients taking insulin, the size of this effect
was significant. Patients taking Galvus in addition to insulin, with or without
metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared
with 0.05 percentage points in patients taking placebo in addition to insulin.
What is the risk associated with
Galvus?
The most common side effect with Galvus (seen in
between 1 and 10 patients in 100) is dizziness. For the full list of all side
effects reported with Galvus, including side effects occurring when Galvus is
taken with other antidiabetes medicines, see the package leaflet.
Galvus must not be used in people who are
hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Because vildagliptin has been associated with liver
problems, patients should have tests to check their liver function before
treatment with Galvus and at regular intervals during treatment.
Why has Galvus been approved?
The CHMP noted that Galvus was effective as an
add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a
sulphonylurea and metformin (triple therapy) or insulin with or without
metformin, and concluded that the benefits of the add-on treatment outweigh the
risks.
The CHMP also considered the use of Galvus on its
own and concluded that it was effective in reducing blood glucose but less so
than metformin. Galvus should therefore be used only in patients for whom
metformin is inappropriate either because of side effects occurring with
metformin or because they have a condition that makes metformin unsuitable for
them.
Other information about Galvus
The European Commission granted a marketing
authorisation valid throughout the European Union for Galvus on 26 September
2007.
For more information about treatment with Galvus,
read the package leaflet (also part of the EPAR) or contact your doctor or
pharmacist.
Source: European Medicines Agency
