What is Jardiance - empagliflozin and what is it used for?
Jardiance is a diabetes medicine that contains the active substance empagliflozin. It is used in adults with type 2 diabetes to control the level of glucose (sugar) in the blood. Jardiance can only be used in patients with type 2 diabetes whose blood glucose levels are not satisfactorily controlled with diet and exercise alone and who cannot take metformin (another medicine for diabetes) Jardiance can also be used as an 'add-on' to other diabetes medicines, including insulin, when these medicines, along with exercise and diet, do not provide adequate control of diabetes.
How is Jardiance used - empagliflozin?
Jardiance is available in tablet form (10 and 25 mg) and can only be obtained with a prescription. The recommended starting dose is 10 mg once daily, which may be increased to 25 mg daily if needed in suitable patients. If Jardiance is used in combination with insulin or medicines that stimulate the body's production of insulin, the dose may need to be reduced to limit the risk of hypoglycaemia (low blood sugar levels). As the effect of Jardiance depends on the functioning of the kidneys, treatment with this medicine is not recommended in some patients, for example those over 85 years of age or with moderate or severe renal impairment. For more information, see leaflet. illustrative.
How does Jardiance - empagliflozin work?
Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood, or in which the body is unable to use insulin effectively. This causes high levels of blood glucose. blood glucose. The active substance in Jardiance, empagliflozin, works by blocking a protein in the kidneys called sodium-glucose cotransporter 2 (SGLT2). SGLT2 is a protein that reabsorbs glucose from urine into the bloodstream as the blood filters kidneys. By blocking the action of SGLT2, Jardiance causes more glucose to be eliminated through the urine, thereby lowering blood glucose levels.
What benefit has Jardiance - empagliflozin shown during the studies?
A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients. Jardiance 10 or 25 mg once daily was compared with placebo (a dummy treatment), either used alone or as an adjunct to treatment with other medicines for diabetes (metformin, pioglitazone, or metformin plus pioglitazone or another type of diabetes medicine called sulphonylurea). The main measure of effectiveness was the change in the blood level of a substance called glycosylated hemoglobin (HbA1c), which provides an indication of how well the blood glucose is controlled after 24 weeks of treatment. All studies have shown a modest, but clinically significant, improvement in HbA1c with Jardiance compared to placebo: in the study investigating the use of Jardiance without other medicines, the reduction in HbA1c was 0.74% greater than placebo at the dose 10 mg, and 0.85% higher than placebo, with the 25 mg dose. Modest, but clinically significant, reductions in HbA1c were also observed when Jardiance was added to other medicines. Furthermore, the results indicate that treatment with Jardiance was associated with a beneficial reduction in body weight and blood pressure. support was provided by six other studies, some of which were a continuation of the main studies, which indicated that the medicine's benefits continue with prolonged therapy. There was also supportive evidence suggesting a benefit when the medicine was combined. all "insulin.
What is the risk associated with Jardiance - empagliflozin?
The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar), when the medicine is taken with a sulfonylurea or insulin. For the full list of side effects reported with Jardiance and their limitations, see the package leaflet.
Why has Jardiance - empagliflozin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Jardiance's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Jardiance has been shown to be effective in "to lower blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action."In addition, beneficial reductions in weight and blood pressure have been observed in patients treated with Jardiance. However, the medicine's benefits are reduced in patients with renal insufficiency and the CHMP recommended not to use the medicine in some patients, based on their kidney function. Regarding safety, overall side effects were considered manageable.
What measures are being taken to ensure the safe and effective use of Jardiance - empagliflozin?
A risk management plan has been developed to ensure that Jardiance is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Jardiance, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information about Jardiance - empagliflozin
On 22 May 2014, the European Commission issued a "Marketing Authorization" for Jardiance, valid throughout the European Union. For more information on Jardiance therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 05-2014.
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