Background Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used in patients diagnosed with type-2 diabetes, either alone or in combination with other anti-diabetic drugs. Recently, the Spanish Agency of Medicine and Health Products published several informative notes warning of serious adverse events caused by these drugs. Furthermore, they are more expensive than the alternatives and the efficacy seems to be lower, so it becomes especially important to clarify the risks associated with their use.
Purpose To evaluate the safety of the treatment with inhibitors of the co-transporter 2 in patients with type-2 diabetes.
Material and methods A retrospective and observational study was performed in a university hospital. Between January 2017 and August 2018, patients who had active treatment with canagliflozina, empagliflocina or dapagliflozina in their discharge reports were selected.
Data collected and obtained from medical history records, were: sex, age, drugs’ reactions, time in treatment, total number of drugs and which service prescribed the drug. Later, the Karch–Lasagna modified algorithm was applied in order to analyse the relationship between treatment and the occurrence of adverse effects.
Results One-hundred and ten patients were selected, out of which 25 (22.7%) had 30 adverse events, which were: 15 infections of the urinary tract, nine gastrointestinal symptoms, three non-traumatic amputation of the lower limbs, two dry mucous membranes and one ulceration.
The median age of the patients with drugs’ reactions was 75 years, the majority being women. The median of the total drugs that patients had was 10. The Karch–Lasagna modified algorithm was applied and all gastrointestinal symptoms, ulcers and dryness of mucous membranes obtained a conditional category. On the other hand, urinary tract infections were conditional in 11 patients and possible in four. Regarding amputation, one was conditional and two possible.
Nine of the patients suspended treatments after adverse events, however, 16 continued. The drugs were prescribed mostly by the internal medicine and cardiology department.
Conclusion There was a high percentage of patients with adverse drug reactions (22.7%). Urinary tract infections and non-traumatic amputation of the lower limbs were adverse events with greater accountability, which coincided with the informative notes published. Therefore, the risk-benefit relationship should be closely valued before using SGLT2 inhibitors.
References and/or acknowledgements No conflict of interest.
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