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The aim of our study is to evaluate the effectiveness and safety of a sutureless off-clamp robot-assisted partial nephrectomy (sl-oc RAPN), particularly its impact on renal function. A multicenter study was conducted from April 2021 to June 2022. Patients diagnosed with a renal mass of >2 cm and a PADUA score of ≤6 consecutively underwent an sl-oc RAPN procedure. Tumor features, patients characteristics, and intraoperative outcomes were assessed. An evaluation of renal function was performed preoperatively, and again at 1 and 3 months after surgery by measuring the creatinine and blood urea nitrogen levels. The renal function of the two separate kidneys was assessed by a sequential renal scintigraphy performed before and at least 30 days after surgery. A total of 21 patients underwent an sl-oc RAPN. The median age was 64 years (IQR 52/70), the median tumor diameter was 40 mm (IQR 29/45), and the median PADUA score was 4 (3.5/5). The intraoperative outcomes included operative time (OT), 90 (IQR 74/100) min; estimated blood loss (EBL), 150 (IQR 50/300) mL; and perioperative complications, CD > 3 1(5%); only two patients presented positive surgical margins in their final histology (2/21, 10%). Compared to the preoperative value, a decrease in renal function was highlighted with a statistically significant median decrease of 10 mL/min (p < 0.01). The renal scintigraphy showed an overall decrease in renal function compared to the preoperative value, with a range in the operated kidney that varied from 0 to 15 mL/s and from 0% to 40%, with a median value of 4 mL/s and 12%. sl-oc RAPN is a safe procedure, with a minimal impact on kidney function alteration. This technique has proven effective in preserving renal function and maintaining optimal oncological outcomes with limited complications.
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BACKGROUND: The aim of this study was to evaluate whether the sequential use of Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) is superior to BCG alone in reducing the risk of disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC) with high risk of progression. METHODS: Prospective randomized trial was conducted from March 2021 to March 2023 and included 72 patients with high risk NMIBC. Trial registration number: NCT03790384; EUDRACT Number: 2017-004540-37. Thirty-one patients underwent to BCG alone and forty-one to MMC plus BCG during the induction course. The BCG schedule comprised six weekly instillation of 81 mg Connaught strain BCG as the induction course, followed by a further three-monthly instillation at three, six and twelve months, as the maintenance course. Forty mg of MMC were administered the day prior to each weekly BCG instillation in BCG plus MMC arm. A planned interim analysis was carried out in June 2023, at the end of the 12mo follow-up period. RESULTS: Six out of thirteen 6/31(19.3%) and 10/41 (24.4%) patients experienced recurrence in BCG and BCG plus MMC group (P=0.611), respectively. BCG plus MMC did not improve Disease Free Interval (HR: 1.23 95% CI:0.46-3.50; P=0.640). Patients receiving sequential treatment experienced similar AEs (P>0.05) and more urinary symptoms (P<0.05). CONCLUSIONS: This interim pre-planned analysis suggested absence of clinical advantages in terms of disease recurrence rate when MMC is administered one day prior to BCG during induction course.
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Vacina BCG , Mitomicina , Invasividade Neoplásica , Neoplasias da Bexiga Urinária , Humanos , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/patologia , Mitomicina/administração & dosagem , Mitomicina/uso terapêutico , Mitomicina/efeitos adversos , Vacina BCG/uso terapêutico , Vacina BCG/administração & dosagem , Masculino , Feminino , Estudos Prospectivos , Idoso , Pessoa de Meia-Idade , Adjuvantes Imunológicos/uso terapêutico , Adjuvantes Imunológicos/administração & dosagem , Quimioterapia Adjuvante , Antibióticos Antineoplásicos/uso terapêutico , Antibióticos Antineoplásicos/administração & dosagem , Quimioterapia Combinada , Recidiva Local de Neoplasia/prevenção & controle , Recidiva Local de Neoplasia/patologia , Resultado do Tratamento , Administração IntravesicalRESUMO
Objectives: To compare perioperative outcomes of patients treated with sutureless off-clamp robotic partial nephrectomy (sl-oc RAPN) by either a novice or an expert robotic surgeon at two different institutions. Methods: Data concerning two continuous series of patients with cT1-2N0M0 renal tumors treated with sl-oc RAPN either by a novice or an expert surgeon were extracted from prospectively populated institutional databases over the last 4 years. Perioperative outcomes as well as the baseline characteristics of patients and tumors were compared by using χ2 and Mann-Whitney tests for categorical and continuous variables, respectively. A 1:1 propensity match score analysis (PMSa) generated two homogeneous cohorts. Logistic regression analysis was performed to assess predictors of trifecta outcomes, defined as negative surgical margins, no Clavien-Dindo ⧠3 grade complications, and no ⧠30% postoperative eGFR reduction. Results: Overall, 328 patients were treated by an expert surgeon, while 40 were treated by a novice surgeon. After PMSa analysis, two cohorts of 23 patients each were generated, homogeneous for all baseline variables (p ≥ 0.07). Hospital stay was the only significantly different outcome observed between the two groups (5 days vs. 2 days; p < 0.001). No statistically significant differences were recorded when comparing trifecta outcomes (expert: 100% vs. novice: 87%; p = 0.07). In the logistic regression analysis, no statistically significant predictors of trifecta outcomes were recorded. Conclusions: sl-oc RAPN is a feasible and safe nephron sparing technique, even when performed by a novice robotic surgeon.
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The purpose of this study was to assess the importance of the post-void residual (PVR) ratio (PVR ratio) in achieving a favorable trifecta outcome for patients suffering from lower urinary tract symptoms and benign prostatic enlargement (LUTS-BPE) who undergo transurethral resection of the prostate (TURP). Starting from 2015, a series of patients with LUTS-BPE who underwent TURP were included in a forward-looking study. These patients were assessed using the international prostate symptom score (IPSS) screening tool, uroflowmetry, and a transrectal ultrasound to measure prostate volume (TRUS). Both the PVR urine volume and the PVR ratio (PVR-R), which is the PVR as a percentage of total bladder volume (voided volume + PVR), were measured. The assessment of outcomes was based on the trifecta favorable outcome, defined as meeting all of the following criteria: (1) absence of perioperative complications, (2) a postoperative IPSS of less than eight, and (3) a postoperative maximum urinary flow rate (Qmax) greater than 15 mL/s. A total of 143 patients were included, with a median age of 70 years (interquartile range 65-73). Of these, 58% (83/143) achieved a positive trifecta outcome. Upon conducting a multivariate analysis, both IPSS and Qmax were identified as predictors of a positive trifecta outcome, whereas the PVR-R did not prove to be an independent predictor. In summary, it was found that preoperative IPSS and Qmax are indicative of a trifecta outcome following TURP, whereas PVR-R is not.
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BACKGROUND: Phosphodiesterase 5 inhibitors (PDE5i) are the standard medical treatment for erectile dysfunction. Aim of our study was to evaluate the rate of major adverse cardiovascular events (MACE) reported during PDE5i treatment based on Eudra-Vigilance (EV) reports. METHODS: EV database is the system for managing and analyzing data on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area. MACE are defined as non-fatal stroke, non-fatal myocardial infarction, non-fatal congestive heart failure, revascularization after aorto-coronary graft bypass and cardiovascular death. We recorded the number of MACE for sildenafil, tadalafil, vardenafil, avanafil per category and severity until 1st July 2023. Pooled Relative Risk (PRR) was used to compare data between drugs. RESULTS: Overall, 951 MACE events were reported. Most of them were observed in younger patients <65 years old (452/951 events, 48%). Overall, 377/8939 (4%) MACE events were observed for sildenafil, 221/5213 (4%) for tadalafil, 50/1029 (4%) for vardenafil and no events for avanafil. No significative differences were reported comparing sildenafil and tadalafil (PRR 0.71-0.99, IQR 0.61-1.35, P>0.05), neither sildenafil vs. vardenafil (PRR 0.68-0.79, IQR 0.43-1.55, P>0.05), neither tadalafil vs. vardenafil (PRR 0.77-0.95, IQR 0.64-1.30. P>0.05) even when compared for age. Comparison between different classes of age showed MACE were more frequent in patients younger than 65 years old taking sildenafil and tadalafil when compared to patients older than 85 years old (PRR 0.02-0.11. IQR 0.01-0.40. P<0.01) and when compared to patients in 65-85 class of age (PRR 0.02-0.12, IQR 0.01-0.95, P<0.01). CONCLUSIONS: Real life data is consistent with MACE related to PDE5i. PDE5is are infrequently (<5%) associated with MACE. However, risk seems higher in younger patients, particularly for sildenafil (452/951 events, 48%). Clinicians should consider these data when prescribing PDE5i especially in young patients.
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Doenças Cardiovasculares , Bases de Dados Factuais , Inibidores da Fosfodiesterase 5 , Humanos , Inibidores da Fosfodiesterase 5/efeitos adversos , Inibidores da Fosfodiesterase 5/uso terapêutico , Masculino , Pessoa de Meia-Idade , Idoso , Doenças Cardiovasculares/induzido quimicamente , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Disfunção Erétil/induzido quimicamente , Disfunção Erétil/tratamento farmacológico , Disfunção Erétil/epidemiologia , Tadalafila/uso terapêutico , Tadalafila/efeitos adversos , Citrato de Sildenafila/efeitos adversos , Citrato de Sildenafila/uso terapêuticoRESUMO
Bladder cancer is considered a global health concern characterized by significant morbidity and mortality rates. The complex relationship between diet and bladder cancer is examined, with a specific focus on the role of diet in risk, outcomes, and treatment efficacy. Attention is drawn to the burgeoning field of immunotherapy in bladder cancer treatment, and the possible influence of diet on its outcomes is explored. While evidence remains limited, prior studies in other cancer types have suggested a potential connection between diet and immunotherapy response. To address this knowledge gap, the ongoing BLOSSOM study is presented, which aims to investigate the link between dietary factors, lifestyle, and the effectiveness of immunotherapy in patients with non-muscle-invasive bladder cancer. Ongoing efforts to decipher the intricate relationship between diet and bladder cancer care are highlighted, emphasizing the quest to unravel the dietary puzzle for the improvement of bladder cancer management.
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The aim of our study was to compare the performance of residents vs. consultants in transrectal fusion prostate biopsies (FUS-PBs), as well as patient-reported comfort. Between January 2021 and October 2022, a consecutive series of patients undergoing FUS-PBs were randomized into two groups: (A) FUS-PBs performed by a consultant; (B) FUS-PBs performed by trained residents (>50 procedures). All patients underwent FUS-PBs with 12 systematic cores and 3/6 target cores. The detection rate and number of positive cores in the target lesion were compared between groups, and the patient's discomfort after the procedure was evaluated using the VAS scale. Overall, 140 patients with a median age of 72 years were enrolled. Overall, 69/140 (49.3%) presented prostate cancer and 53/69 (76.8%) presented a clinically significant cancer (Grade Group ≥ 2). Consultants presented a detection rate of 37/70 (52.9%) and residents a detection rate of 32/70 (45.7%) (p > 0.2); the mean number of positive cores in the index lesion was similar in both groups (1.5 vs. 1.1; p > 0.10). In terms of the patients' experiences, the procedure was well tolerated, with a median VAS score of 2 in both groups, with no statistically significant differences. Residents showed satisfactory outcomes in terms of detection rate, procedural time, and patient comfort when performing prostate biopsies. Residents, after adequate training, can safely perform prostate biopsies.
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Próstata , Neoplasias da Próstata , Idoso , Humanos , Masculino , Consultores , Biópsia Guiada por Imagem/métodos , Estudos Prospectivos , Próstata/cirurgia , Próstata/patologia , Neoplasias da Próstata/diagnóstico , Internato e ResidênciaRESUMO
OBJECTIVE: To identify which medications are mostly associated with ejaculatory disorders through a disproportionality analysis. METHODS: The Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) and the Eudra-Vigilance (EV) database were queried to identify medications more commonly associated to ejaculatory disorders from September 10, 2012 to June 1, 2023. Proportional Reported Ratios (PRRs) were computed for all the selected drugs. RESULTS: Overall, 7404 reports of ejaculatory disorders reports were identified, and of these, 6854 cases (92.6%) were attributed to ten specific medications. On FDA-FAERS and EV databases, Paroxetine and Tamsulosin were the main responsible of delayed ejaculation (103/448 events, 23.0%) and retrograde ejaculation (366/1033 events, 35.4%), respectively. Finasteride was mostly related to painful ejaculation and ejaculation failure, with 150 events (7.8%) and 735 events (38.4%) respectively. Within the group of high-risk medications, Sildenafil presented higher risk of ejaculatory disorders than Tadalafil (PRR=5.85 (95%CI 5.09-6.78), P < .01). CONCLUSION: Ten drugs were recognized to display significant reporting levels of ejaculatory disorders. Among them, Finasteride and Sildenafil were responsible for the most reports in FDA-FAERS and in EV databases, respectively. Physicians should thoroughly counsel patients treated with these drugs about the risk of ejaculatory disorders. Further integration into clinical trials is needed to enhance the applicability and significance of these results.
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Finasterida , Farmacovigilância , Masculino , Estados Unidos , Humanos , Finasterida/efeitos adversos , Citrato de Sildenafila , United States Food and Drug Administration , Tansulosina , Bases de Dados FactuaisRESUMO
Chat-GPT, a natural language processing (NLP) tool created by Open-AI, can potentially be used as a quick source for obtaining information related to prostate cancer. This study aims to analyze the quality and appropriateness of Chat-GPT's responses to inquiries related to prostate cancer compared to those of the European Urology Association's (EAU) 2023 prostate cancer guidelines. Overall, 195 questions were prepared according to the recommendations gathered in the prostate cancer section of the EAU 2023 Guideline. All questions were systematically presented to Chat-GPT's August 3 Version, and two expert urologists independently assessed and assigned scores ranging from 1 to 4 to each response (1: completely correct, 2: correct but inadequate, 3: a mix of correct and misleading information, and 4: completely incorrect). Sub-analysis per chapter and per grade of recommendation were performed. Overall, 195 recommendations were evaluated. Overall, 50/195 (26%) were completely correct, 51/195 (26%) correct but inadequate, 47/195 (24%) a mix of correct and misleading and 47/195 (24%) incorrect. When looking at different chapters Open AI was particularly accurate in answering questions on follow-up and QoL. Worst performance was recorded for the diagnosis and treatment chapters with respectively 19% and 30% of the answers completely incorrect. When looking at the strength of recommendation, no differences in terms of accuracy were recorded when comparing weak and strong recommendations (p > 0,05). Chat-GPT has a poor accuracy when answering questions on the PCa EAU guidelines recommendations. Future studies should assess its performance after adequate training.
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BACKGROUND: Drugs may have a direct causative role in triggering hematuria. The range of medications which may be responsible for hematuria is wide, but little is known on those which are most frequently involved. The aim of our study was to identify and compare drugs mostly related with hematuria. METHODS: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and the EudraVigilance (EV) database were queried to identify the drugs which were associated the most with hematuria individual reports till 30 September 2021. Rivaroxaban, aspirin, warfarin sodium, clopidogrel bisulfate, dabigatran etexilate mesylate, apixaban, warfarin, cyclophosphamide, lansoprazole, enoxaparin sodium, and ibuprofen were analyzed. Analysis per gender, age and severity was performed. Disproportional analysis was performed to compare drugs. RESULTS: Overall, 15,687 reports of hematuria were recorded in the FDA database and 15 007 in the EV database. Rivaroxaban and Warfarin appear to be the most dangerous medications in terms of hematuria when compared to the other medications (PRR>1, P<0.05) while apixaban is the safest one (PRR<1, P<0.05) when compared to the other medications. In terms of severity only 162/15 007 (1.08%) were fatal. Between the drugs analyzed cyclophosphamide 7.2%, enoxaparin (3%) and dabigatran (2.5%) presented a higher number of fatal hematuria episodes when compared to the other drugs (<1%). CONCLUSIONS: Anticoagulants and antiplatelets are more frequently related to hematuria episodes however some differences exist between them. Particularly warfarin and rivaroxaban should be prescribed with caution in patients at increased risk of hematuria. Prescribers should inform those treated with these medications about the risk of hematuria and its sequelae.
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Hematúria , Rivaroxabana , Estados Unidos/epidemiologia , Humanos , Hematúria/induzido quimicamente , Hematúria/epidemiologia , Farmacovigilância , United States Food and Drug Administration , Varfarina , Ciclofosfamida , DabigatranaRESUMO
CONTEXT: The optimum use of brachytherapy (BT) combined with external beam radiotherapy (EBRT) for localised/locally advanced prostate cancer (PCa) remains uncertain. OBJECTIVE: To perform a systematic review to determine the benefits and harms of EBRT-BT. EVIDENCE ACQUISITION: Ovid MEDLINE, Embase, and EBM Reviews-Cochrane Central Register of Controlled Trials databases were systematically searched for studies published between January 1, 2000 and June 7, 2022, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Eligible studies compared low- or high-dose-rate EBRT-BT against EBRT ± androgen deprivation therapy (ADT) and/or radical prostatectomy (RP) ± postoperative radiotherapy (RP ± EBRT). The main outcomes were biochemical progression-free survival (bPFS), severe late genitourinary (GU)/gastrointestinal toxicity, metastasis-free survival (MFS), cancer-specific survival (CSS), and overall survival (OS), at/beyond 5 yr. Risk of bias was assessed and confounding assessment was performed. A meta-analysis was performed for randomised controlled trials (RCTs). EVIDENCE SYNTHESIS: Seventy-three studies were included (two RCTs, seven prospective studies, and 64 retrospective studies). Most studies included participants with intermediate-or high-risk PCa. Most studies, including both RCTs, used ADT with EBRT-BT. Generally, EBRT-BT was associated with improved bPFS compared with EBRT, but similar MFS, CSS, and OS. A meta-analysis of the two RCTs showed superior bPFS with EBRT-BT (estimated fixed-effect hazard ratio [HR] 0.54 [95% confidence interval {CI} 0.40-0.72], p < 0.001), with absolute improvements in bPFS at 5-6 yr of 4.9-16%. However, no difference was seen for MFS (HR 0.84 [95% CI 0.53-1.28], p = 0.4) or OS (HR 0.87 [95% CI 0.63-1.19], p = 0.4). Fewer studies examined RP ± EBRT. There is an increased risk of severe late GU toxicity, especially with low-dose-rate EBRT-BT, with some evidence of increased prevalence of severe GU toxicity at 5-6 yr of 6.4-7% across the two RCTs. CONCLUSIONS: EBRT-BT can be considered for unfavourable intermediate/high-risk localised/locally advanced PCa in patients with good urinary function, although the strength of this recommendation based on the European Association of Urology guideline methodology is weak given that it is based on improvements in biochemical control. PATIENT SUMMARY: We found good evidence that radiotherapy combined with brachytherapy keeps prostate cancer controlled for longer, but it could lead to worse urinary side effects than radiotherapy without brachytherapy, and its impact on cancer spread and patient survival is less clear.
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Braquiterapia , Neoplasias da Próstata , Humanos , Masculino , Neoplasias da Próstata/radioterapia , Neoplasias da Próstata/patologia , Braquiterapia/métodos , Resultado do TratamentoRESUMO
Recently, researchers have proposed perilesional sampling during prostate biopsies to avoid systematic biopsies of patients at risk of prostate cancer. The aim of our study is to evaluate the role of perilesional sampling to avoid systematic biopsies of patients undergoing fusion biopsies. A prospective cohort of patients undergoing transrectal MRI transrectal fusion biopsies were consecutively enrolled. All the patients underwent systematic biopsies (SB), targeted biopsies (TB) and perilesional biopsies within 10 mm from the lesion (PB). The detection rates of different strategies were determined. A total of 262 patients were enrolled. The median age of those enrolled was 70 years. The mean BMI was 27 kg/m2, and the mean and prostate volume was 52 mL. A PIRADS score ≥ 4 was recorded in 163/262 (40%) patients. Overall, the detection rates of cancer were 43.5% (114/262) and 35% (92/262) for csPCa. The use of the target + peri-target strategy resulted in a detection of 32.8% (86/262) of cancer cases and of 29% (76/262) of csPCa cases (Grade Group > 2). Using the target plus peri-target approach resulted in us missing 18/262 (7%) of the csPCa cases, avoiding the diagnosis of 8/262 (3%) of nsPCa cases. A biopsy strategy including lesional and perilesional sampling could avoid unnecessary prostate biopsies. However, the risk of missing significant cancers is present. Future studies should assess the cost-benefit relationship of different strategies.
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BACKGROUND: Aim of our study was to analyze adverse events (AEs) associated with darolutamide using real life data from Eudra-Vigilance (EV) and the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) databases. METHODS: EV database in European Economic Area (EEA) and the FDA FAERS database were queried to identify darolutamide AEs occurred from 30th July 2019 to May 2022. AEs were recorded in according to category and severity. Real-life data was compared to Aramis registry study. RESULTS: The total number of AEs including data from both databases was 409 reported by FDA-FAERS and 253 reported by EV databases. On registry study, 794 AEs were reported, with serious AEs occurring in 24.8% of patients in the darolutamide group and with 1 death related to trial regimen. The most frequently reported AEs from both database were general disorders (33% and 26%), investigations (19% and 22%), gastrointestinal (15% and 11%), renal and urinary (9%), gastrointestinal (6%) and musculoskeletal disorder (5%). CONCLUSIONS: According to our results darolutamide is safe in a real-life scenario and the most frequent side effect is fatigue. Although up to now there are few reports in both real-life databases, these data are encouraging for clinicians using darolutamide in every day clinical practice.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Estados Unidos/epidemiologia , Humanos , United States Food and Drug Administration , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , PirazóisRESUMO
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.
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Hipotensão Ortostática , Doenças Urogenitais , Humanos , Doxazossina/uso terapêutico , Tansulosina/uso terapêutico , Hipotensão Ortostática/induzido quimicamente , Hipotensão Ortostática/epidemiologia , Hipotensão Ortostática/tratamento farmacológico , Antagonistas Adrenérgicos alfa/efeitos adversos , Prazosina/efeitos adversosRESUMO
BACKGROUND: On March 11th 2019, European Medicines Agency (EMA) issues a warning after a review of serious, disabling and potentially permanent adverse events (AEs), particularly on musculoskeletal and nervous system, with quinolone (QN) and fluoroquinolone (FQ) antibiotics. Aim of this study was to evaluate the effect of the EMA warning on the rate of AEs after QN and FQ treatments, reported in the EudraVigilance (EV) database. METHODS: EV database is the system for managing and analyzing information on suspected AEs to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We retrospectively explored the effect of FQs and QNs on musculoskeletal and nervous system from the EMA warning up to now (21 months) and compared these results with the 21 months before the EMA warning. RESULTS: Main part of AEs in EV database were reported for ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin. Ciprofloxacin total AEs before 21 months till 12 months of EMA warning were 2763. 12 months before EMA Warning they were 2935. Twelve months after EMA Warning they were 3419. Between 12 months till 21 months they were 3174. Musculoskeletal disorders were respectively 574 (21% of the total) 21 months before, 558 (19%) 12 months before, 1048 (31%) after 12 months, 540 (17%) after 21 months of EMA Warning. Nervous system disorders were respectively 606 (22% of the total) 21 months before, 517 (18%) 12 months before, 680 (20%) after 12 months, 560 (18%) after 21 months of EMA Warning (respectively OR 1,16 95%CI 1,10 -1,22, P 0,12 ; OR 0,76 95%CI 0,69-0,83, P 0,27 ; OR 1,01 95%CI 0,96-1,06 P 0,05). CONCLUSIONS: Our analysis clearly showed no significant differences before and after EMA warning, opening new insights in the role of the EMA warning in clinical practice.
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Fluoroquinolonas , Quinolonas , Fluoroquinolonas/efeitos adversos , Estudos Retrospectivos , Ciprofloxacina/efeitos adversos , LevofloxacinoRESUMO
The aim of our study is to review the current available knowledge regarding preferences and expectations of patients with overactive bladder (OAB). The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement guidelines were followed for this manuscript's preparation. Three online databases were searched: PubMed/Medline, Embase, and Scopus, while a combination of the following keywords was used: detrusor overactivity, overactive bladder, urinary incontinence, perspectives, expectations, and preferences. Overall, 1349 studies were retrieved and screened while only 10 studies appeared to be relevant for the scope of this review. Most of the studies were related to preferences about OAB medications (i.e., antimuscarinics); four of them reported patients' inclinations to alternative treatments in the case of medication therapy failure (i.e., neuromodulation, Botox). No data were found about diagnosis or other aspects of disease management (i.e., surgery, follow-up). Based on these findings, from the patient's point of view, the ideal medication should be cheap, without risk of cognitive function impairment, and able to reduce daytime urinary frequency and incontinence episodes.
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INTRODUCTION AND OBJECTIVES: GnRH agonists and GnRH antagonists are two of the mainstays of hormonal therapy (HT) for prostate cancer (PCa). These drugs are at increased risk of cardiovascular (CV) adverse events (AEs). Aim of our study was to compare real-life data on AEs associated with GnRH agonists and GnRH antagonists based on Eudra-Vigilance (EV) and Food and Drug Administration (FDA) reported AEs. MATERIALS AND METHODS: EV and FDA databases were queried and the number of CV adverse events (AEs) for degarelix, buserelin, goserelin, leuprorelin, triptorelin until September 2021 were recorded. Specific CV AEs were recorded and data were analyzed per age and severity. pooled relative risk (PRR) was used to compare data between drugs. RESULTS: CV events were reported in 315/5128 (6%) for Degarelix, in 55/628 for Buserelin (9%), in 843/12,145 (7%) for Goserelin, in 3395/71,160 (5%) for Leuprorelin and in 214/4969 (5%) for Triptorelin. In terms of specific CV disorders, Degarelix presented lower risk of hypertension (PRR 0.60 (95% CI 0.37-0.98), p = 0.04), of myocardial infarction (PRR 0.05 (95% CI 0.01-0.39), p < 0.01) and thrombosis (PRR 0.14 (0.02-1.07), p = 0.06) when compared to GnRH agonists. Overall, younger patients (<65 years) presented a very low risk of CV AEs. Side effects were classified as serious in 90-96% of the cases. Fatal AEs were 5-20% over the CV AEs and 0.2-1% over the total AEs. CONCLUSIONS: Real-life data are consistent with registry studies regarding side effects related to HT. Real-life data suggest GnRH agonists are associated with higher CV AEs when compared to GnRH antagonists. Clinicians should consider these data when prescribing HT especially in patients with CV comorbidities.