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Author: Eli Lilly Nederland B.V.


Long information

What is it?

Byetta is a solution for injection that contains the active substance exenatide. It is available as prefilled injection pens that provide either 5 or 10 micrograms of exenatide in each dose.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Byetta is used to treat type 2 diabetes. It is used together with other antidiabetes medicines in patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines. It can be used with metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, or metformin and a thiazolidinedione.

The medicine can only be obtained with a prescription.

How is it used?

Byetta is given by injection under the skin of the thigh, the abdomen (tummy) or the upper arm, using the injection pen. The pen has a user manual.

Treatment with Byetta should start at a dose of 5 micrograms twice a day for at least a month. The dose can then be increased to 10 micrograms twice a day. A dose higher than 10 micrograms twice a day is not recommended. The first dose of the day is administered within the one hour before the morning meal, and the second dose within the one hour before the evening meal. Byetta should never be given after a meal. When adding Byetta to a sulphonylurea, the doctor may need to reduce the dose of the sulphonylurea because there is a risk of hypoglycaemia (low blood sugar levels). Adding Byetta to metformin or a thiazolidinedione is not associated with this risk.

Patients being treated with Byetta should continue to follow their diet and exercise plans.

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How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Byetta, exenatide, is an ?incretin mimetic?. This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food. This helps with the control of blood glucose levels.

How has it been studied?

Byetta has been studied in seven main studies involving a total of almost 3,000 patients whose blood glucose was not adequately controlled with other antidiabetes medicines.

In five of the studies, Byetta was compared with placebo (a dummy treatment), as an add-on to metformin (336 patients), sulphonylureas with or without metformin (1,110 patients) or thiazolidinediones with or without metformin (398 patients).

The other two studies compared adding Byetta or an insulin to metformin and sulphonylureas. In one study, Byetta was compared with insulin glargine in 456 patients and in the other study it was compared with biphasic insulin in 483 patients.

In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. At the start of the studies, the patients? HbA1c levels were around 8.4%.

What benefits has it shown during the studies?

Byetta was more effective than placebo in reducing the levels of HbA1c when used in combination with other antidiabetes medicines. When it was added to metformin and/or sulphonylureas, the 5-microgram dose of Byetta decreased HbA1c levels by an average of 0.59% after 30 weeks, and the 10-microgram dose decreased them by an average of 0.89%. When added to thiazolidinediones with or without metformin, the 10-microgram dose of Byetta reduced HbA1c levels by an average of 0.74% after 16 weeks and 0.84% after 26 weeks. Little or no effect was seen with placebo.

Byetta was as effective as injected insulin. The 10-microgram dose of Byetta decreased HbA1c by an average of 1.13% after 26 weeks, compared with an average of 1.10% with insulin glargine. In the final study, the 10-microgram dose of Byetta decreased HbA1c by an average of 1.01% after 52 weeks, compared with an average of 0.86% with biphasic insulin.

What is the risk associated?

In studies, the most common side effects with Byetta (seen in more than 1 patient in 10) were nausea (feeling sick), vomiting and diarrhoea. For the full list of all side effects reported with Byetta, see the package leaflet.

Byetta should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.

Why has it been approved?

The CHMP decided that Byetta?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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