Saxenda® (liraglutide) injection
This is a summary of the European public assessment report (EPAR) for Saxenda. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Saxenda.
For practical information about using Saxenda, patients should read the package leaflet or contact their doctor or pharmacist.
Description
WHAT IS SAXENDA AND WHAT IS IT USED FOR?
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Saxenda is a medicine used along with diet and exercise to help manage weight in adults:
- who are obese (have a body-mass index – BMI – of 30 or more);
- who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep).
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Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment). Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise. Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo. Patients treated with Saxenda had a continuous decrease in body weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained. Weight loss was more pronounced in women than in men. When the figures for the main studies were re-analysed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted.
Description
WHAT IS SAXENDA AND WHAT IS IT USED FOR?
-
Saxenda is a medicine used along with diet and exercise to help manage weight in adults:
- who are obese (have a body-mass index – BMI – of 30 or more);
- who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep).
-
Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment). Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise. Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo. Patients treated with Saxenda had a continuous decrease in body weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained. Weight loss was more pronounced in women than in men. When the figures for the main studies were re-analysed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted.