Percutaneous nephrolithotomy use in the United States has increased and females are now the majority gender. Although mortality remains low, rates of sepsis and overall complications have increased. Broad use of percutaneous nephrolithotomy, especially in older and more ill patients, may account for these changes.
ImportanceThere is ongoing controversy about the adverse events of finasteride, a drug used in the management of alopecia and benign prostatic hyperplasia (BPH). In 2012, reports started emerging on men who had used finasteride and either attempted or completed suicide.ObjectiveTo investigate the association of suicidality (ideation, attempt, and completed suicide) and psychological adverse events (depression and anxiety) with finasteride use.Design, Setting, and ParticipantsThis pharmacovigilance case-noncase study used disproportionality analysis (case-noncase design) to detect signals of adverse reaction of interest reported with finasteride in VigiBase, the World Health Organization’s global database of individual case safety reports. To explore the strength of association, the reporting odds ratio (ROR), a surrogate measure of association used in disproportionality analysis, was used. Extensive sensitivity analyses included stratifying by indication (BPH and alopecia) and age (≤45 and >45 years); comparing finasteride signals with those of drugs with different mechanisms but used for similar indications (minoxidil for alopecia and tamsulosin hydrochloride for BPH); comparing finasteride with a drug with a similar mechanism of action and adverse event profile (dutasteride); and comparing reports of suicidality before and after 2012. Data were obtained in June 2019 and analyzed from January 25 to February 28, 2020.ExposuresReported finasteride use.Main Outcomes and MeasuresSuicidality and psychological adverse events.ResultsVigiBase contained 356 reports of suicidality and 2926 reports of psychological adverse events (total of 3282 adverse events of interest) in finasteride users (3206 male [98.9%]; 615 of 868 [70.9%] with data available aged 18-44 years). A significant disproportionality signal for suicidality (ROR, 1.63; 95% CI, 1.47-1.81) and psychological adverse events (ROR, 4.33; 95% CI, 4.17-4.49) in finasteride was identified. In sensitivity analyses, younger patients (ROR, 3.47; 95% CI, 2.90-4.15) and those with alopecia (ROR, 2.06; 95% CI, 1.81-2.34) had significant disproportionality signals for increased suicidality; such signals were not detected in older patients with BPH. Sensitivity analyses also showed that the reports of these adverse events significantly increased after 2012 (ROR, 2.13; 95% CI, 1.91-2.39).Conclusions and RelevanceIn this pharmacovigilance case-noncase study, significant RORs of suicidality and psychological adverse events were associated with finasteride use in patients younger than 45 years who used finasteride for alopecia. The sensitivity analyses suggest that these disproportional signals of adverse events may be due to stimulated reporting and/or younger patients being more vulnerable to finasteride’s adverse effects.
Other than slight prolongation of duration of bladder irrigation and hospital stay, the intermittent or continuous use of anticoagulant therapy did not adversely affect outcomes of HoLEP, suggesting that this approach is an attractive approach for such patients, especially when the prostate is extremely large.
Objective: To determine the incidence of prostate cancer identified on holmium enucleation of the prostate (HoLEP) specimens and evaluate variables associated with prostate cancer identification.Methods: All patients undergoing HoLEP between 1998 and 2013 were identified.Patients with a known history of prostate cancer were excluded. Multivariable logistic regression assessed variables associated with identification of prostate cancer on HoLEP specimens and Gleason 7 or higher prostate cancer among the malignant cases.Gleason grade was used as a proxy for disease severity. Each of the models was adjusted for age, preoperative PSA, and HoLEP specimen weight.
Results:The cohort was comprised of 1272 patients of whom 103 (8.1%) had prostate cancer identified. Prostate cancer cases had higher pre-HoLEP PSA (p=0.06) but lower HoLEP specimen weight (p=0.01). On multivariate logistic regression, age and preoperative PSA were associated with increased odds of prostate cancer being present (p<0.01 each) while increasing HoLEP specimen weight was associated with decreased odds of prostate cancer (p<0.001). Men older than 80 had 20% predicted probability of being diagnosed with prostate cancer. Seventy-eight percent of prostate cancer cases were Gleason 6 or less. Pre-HoLEP PSA was associated with increased adjusted odds of intermediate or high grade prostate cancer.
Conclusion:Prostate cancer identified by HoLEP is not uncommon but is generally low risk disease. Older patients with smaller prostate glands have the highest odds of prostate cancer identification.
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