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DAR No 5: Empagliflozin. Jardiance® for Type 2 Diabetes Mellitus
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Sweet look, uncertain benefits
The EMPA-REG OUTC OME trial was designed to assess the safety of empagliflozin. Its results apparently showed that empagliflozin may reduce cardiovascular death, though this can be challenged due to methodological limitations of the trial.
- Its main adverse events include: risk of genital infections, syncope, hypotension and renal damage. Due to reported severe cases of ketoacidosis, the AEMPS has issued a safety communication reminding physicians of the need to monitor the occurrence of this adverse effect.
- Empagliflozin can be used as an alternative add-on therapy in patients with a glomerular filtration rate >60 ml/min, with special caution in older patients, when first-choice antidiabetics are contraindicated or not tolerated (metformine, sulfonylurea and/ or insulin).
