Adverse events related to alpha-blockers: analysis of real-life data from Eudra-Vigilance.

BACKGROUND: Patients on alpha-blockers (ABs) treatment may have an increased risk of adverse events (AEs). Aim of our study was to compare real-life data on neuro-vascular and sexual AEs associated with ABs based on Eudra-Vigilance reported AEs. METHODS: Eudra-Vigilance (EV) database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of sexual and neuro-vascular AEs for tamsulosin, alfuzosin, silodosin, prazosin and doxazosin per category and severity until July 30th, 2022. Pooled Relative Risk (PRR) was used to compare data between drugs. RESULTS: Overall the number of AEs were 2842 for Alfuzosin, 11,086 for tamsulosin, 792 for terazosin, 572 for prazosin and 4641 for doxazosin. Different percentages of AEs were obtained for each drug and in different age groups according to EV sub-groups (≤65, 65-85, ≥85). On PRR analysis, the risk of ejaculatory disorders for Silodosin (11%) is 18.5 times higher (PRR 18.5 95%CI; 10.7-31.8; P<0.05) when compared to alfuzosin and the risk of orthostatic hypotension is 2 times lower (PRR=1,84 95%CI 1.32-2.57; P<0.05). CONCLUSIONS: Real life data is consistent with registry studies regarding side effects related to alpha-blockers. Alfuzosin is safer in terms of ejaculatory disorders while silodosin and tamsulosin in terms of orthostatic hypotension. Clinicians should consider these data when prescribing ABs especially in younger and older patients.

External validation of Imamura nomogram as a tool to predict preoperatively laser semi-rigid ureterolithotripsy outcomes.

BACKGROUND: We aimed to validate Imamura nomogram for prediction of stone free rate in patients undergoing ureterolithotripsy (ULT). METHODS: From January 2013 to June 2016, patients undergoing laser semi-rigid ULT were prospectively enrolled at our center. All patients were preoperatively assessed with clinical history, blood samples, uranalysis and non-contrast enhanced computed tomography (CT). Treatment efficacy was assessed 1 month later by non-contrast enhanced CT. ROC curve was used to evaluate the performance characteristics of Imamura nomogram. RESULTS: Overall, we enrolled 275 patients. Median age was 55 years (IQR: 46/64), median length of stone was 9.8 mm (IQR: 7.5/12). Pyuria was detected in 6/275 (2.1%) patients. Stones were located at ureteropelvic junction in 55/275 (19%) patients, proximal ureter in 74/275 (26%) patients, middle and distal ureter in 66/275 (24%) patients and 82/275 (30%) patients, respectively. At 1-month follow-up, 209/275 (76%) patients were stone free. Imamura nomogram presented an AUC of 0.67 (95% CI: 0.580-0.761) for the prediction of stone free rate. At the best cut-off value of 75%, sensitivity was 76%, specificity was 55%, positive predictive value (PPV) was 83% and negative predictive value was 45%. CONCLUSIONS: We firstly validated Imamura nomogram in a European cohort study. It proved a reasonable accuracy (area under curve: 0.67) and a good PPV (83%). Further studies should confirm our results to support the routine clinical use of Imamura nomogram as a tool to predict ULT outcomes.