ABSTRACT
OBJECTIVE: To analyse the adverse drug reactions (ADRs) caused by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) notified in Spain since they have been on the market. MATERIAL AND METHODS: An analysis was made of all the notifications registered in the Spanish Pharmacovigilance System of drugs for human use, arising from the use of SGLT2i. RESULTS: A total of 311 notifications were recorded, of which 169 (54.34%) were related to dapagliflozin, 81 (26.05%) to empagliflozin, and 61 (19.61%) to canagliflozin. There was a ratio of 52.1% women to 47.9% men. The mean age was 62.07±12.17years. There were 167 (53.7%) notifications were classified as non-serious and 144 (46.3%) as serious. A total of 534 ADRs were notified, with the most common being urinary tract infections in 37 (6.9%) cases, diabetic ketoacidosis in 30 (5.6%), balanoposthitis in 24 (4.5%), ketoacidosis in 16 (3%), vulvovaginal candidiasis in 16 (3%), dizzy spells in 11 (2.1%), and 10 (1.9%) with dysuria, Candida balanitis, and vulvovaginal pruritus. As regards the outcomes of the 534 ADRs, 55.6% recovered with no sequelae, with 14% still recovering, 4.9% not recovered, fatal in 1.1%, and unknown in 24.3%. CONCLUSIONS: The majority of the ADRs notified are infections of the urogenital tract, ketoacidosis, and kidney damage. Although the majority of the former were not serious, the ketoacidosis and kidney damage were, leading to hospital admission and being life threatening in some patients. For these reasons, it is recommended that they are, prescribed with caution, the warnings published by the health authorities consulted, as well as notify any ADR that is suspected in this therapeutic group, in order to improve and provide us with further knowledge.
Subject(s)
Adverse Drug Reaction Reporting Systems , Hypoglycemic Agents/adverse effects , Sodium-Glucose Transporter 2 Inhibitors , Aged , Databases, Factual , Diabetes Mellitus, Type 2/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Hypoglycemic Agents/administration & dosage , Male , Middle Aged , Pharmacovigilance , Sodium-Glucose Transporter 2 , Spain/epidemiologySubject(s)
Fluoxetine/adverse effects , Long QT Syndrome/chemically induced , Selective Serotonin Reuptake Inhibitors/adverse effects , Aged, 80 and over , Electrocardiography , Female , Fluoxetine/administration & dosage , Humans , Long QT Syndrome/diagnosis , Selective Serotonin Reuptake Inhibitors/administration & dosageABSTRACT
OBJECTIVE: To assess whether there are differences between atrial fibrillation (AF) patients initiating new direct-acting oral anticoagulants (DOAC) therapy and vitamin K antagonist (VKA) therapy in an emergency service. METHODS: Descriptive, observational, prospective study. We enrolled patients with AF who were visited in a hospital emergency service over one year. RESULTS: This study included 492 patients with AF, and 189 subjects received anticoagulant therapy, 104 with VKA (55%), and 85 with DOAC (45%). The VKA group: mean age 76.1 years, male 50.9% and female 49.1%, CHA2DS2-VASc mean 3.2±1.3 points, and a HAS-BLED mean of 1.9±0.8 points. The DOAC group: mean age 73.4 years, male 37.6% and female 63.3%, CHA2DS2-VASc mean 3.1±1.6 points, and a HAS-BLED mean of 1.7±0.8 points. On analysing the medical history, 17.3% of patients in the VKA group had a previous stroke, and 13.5% significant valve disease, as well as 7.1 and 1.2% of patients, respectively, in the DOAC group. In the analysis of the DOAC types, 24.2% of patients in the dabigatran group had a previous stroke, 22.7% in the rivaroxaban group had ischaemic heart disease. CONCLUSIONS: Patients with AF who start on treatment in emergency services with VKA or with DOAC show a similar profile of age, gender, CHA2DS2-VASc score, and HAS-BLED score. The patients with a history of valvular or ischaemic heart disease received more VKA than DOAC. When the patient has a history of stroke, the DOAC more used is dabigatran, and in patients with ischaemic heart disease it is preferred to give rivaroxaban.