Early potential safety signals for gliptins and gliflozins using real-world pharmacy data compared to spontaneous reporting
Abstract
BACKGROUND: Dipeptidyl peptidase 4 inhibitors (DPP4i, gliptins) and sodium-glucose co-transporter 2 inhibitors (SGLT2i, gliflozins) are two oral antidiabetic drug classes that have been widely used in recent decades. Their pharmacological actions have led to the identification of new adverse drug reactions and contraindications. In this context, ambulatory real-world data (RWD) analysis has the potential to detect early signals of suspected adverse drug reactions (ADR) that complement or anticipate risk events.
METHODS: We conducted an exploratory pharmacovigilance study based on a multicentre observational cross-sectional survey with retrospective 6-month recall in community pharmacies among patients treated with DPP4i or SGLT2i, using metformin as a control. Candidate drug-event signals identified in the pharmacy dataset collected in 2021 were compared with spontaneous reporting data from the Spanish Agency of Medicines and Medical Devices repository in 2022 and 2024. A validated adaptation of the Bayesian Confidence Propagation Neural Network (BCPNN) methodology was applied in all analyses.
RESULTS: Exploratory signals identified in the community pharmacy dataset included sitagliptin-dry mouth (FDR 0.059), empagliflozin-asthenia (0.067), linagliptin-bone fracture (0.077), linagliptin-renal impairment (0.082), dapagliflozin-hyperglycemia (0.088), canagliflozin-pruritus (0.092), dapagliflozin-urinary tract infection (0.096), and alogliptin-exanthematic eruptions (0.100).…
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Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause.
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