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Commonly seen side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary-tract infection (infection of the structures that carry urine), and are considered to be manageable. A small but higher number of bladder-, breast- and prostate-cancer cases were seen in patients who took Forxiga compared with patients who took placebo. However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Forxiga did not show this risk. 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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