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How has Forxiga been studied? The effects of Forxiga were first tested in experimental models before being studied in humans. Forxiga on its own has been compared with placebo (a dummy treatment) in two studies in 840 patients. A third study compared Forxiga with a sulphonylurea (glipizide), both taken in combination with metformin in 814 patients. Four other studies compared Forxiga with placebo, when used as an add-on to either metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients.
In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. What benefit has Forxiga shown during the studies? Forxiga was more effective than placebo at reducing the levels of HbA1c when used alone and in combination with other antidiabetes medicines. When Forxiga was used on its own at a dose of 10 mg, it decreased HbA1c levels by 0.66% more than placebo after 24 weeks. When Forxiga was added to other antidiabetes medicines, Forxiga 10 mg decreased HbA1c levels by 0.54-0.68% more than placebo after 24 weeks. When compared with a sulphonylurea, Forxiga was at least as effective and both medicines reduced HbA1c levels by 0.52% after 52 weeks.
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The most common side effects are hypoglycemia, thrush, urinary tract infections, increased need to visit the toilet, pain when urinating, changes in levels of blood fats, lowering of blood pressure. Check with your doctor as soon as possible if any of the following side effects occur: redness or rash of the penis or foreskin (yeast infection), signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion), signs of vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching), symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision), symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain, strong odour). Stop taking the medication and seek immediate medical attention if any of the following occur: fainting or lightheadedness when standing, severe dehydration (e.g., confusion, sweating stops, heart palpitations), severe hypoglycemia (low blood sugar; disorientation, loss of consciousness, seizure), signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat).
