Tamsulosin 400microgram / Dutasteride 500microgram capsules

Alpha-1 adrenergic receptor (α1-AR) antagonists are commonly used for management of benign prostatic hyperplasia or hypertension. Some studies have shown a potential link between α1-AR antagonist use and cognitive impairment. Given the conflicting data surrounding α1-AR antagonists association with cognitive dysfunction, we aim to systematically review the association of cognitive dysfunction with α1-AR antagonist use to aid clinician decision both with medication initiation and continuation. A systematic review was performed following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We searched Ovid Cochrane, Ovid Embase, Ovid MEDLINE, Scopus, and Web of Science on March 7, 2023, with an update run on January 22, 2024. The primary outcome was cognitive dysfunction. We used Cochrane risk of bias for randomized controlled trials (RCTs) and MINORS (Methodological Index for Non-Randomized Studies) criteria for non-RCTs to evaluate study quality. This study was registered with PROSPERO (CRD42024505751). We identified 7 studies for our systematic review (3 RCTs, 4 non-RCTs). Tamsulosin was the most studied medication (6 of 7 studies). Tamsulosin was associated with no cognitive dysfunction in 2 RCTs, increased risk for dementia in 2 non-RCTs, no change in cognition in 1 non-RCT, and decreased risk for dementia in 1 non-RCT. Among 3 non-RCTs analyzing alfuzosin, it was associated with decreased risk of or no association with dementia in 2 studies and increased risk for dementia in 1 study. Doxazosin, prazosin, and terazosin were neutral or showed a negative risk for dementia. Our systematic review did not show a convincing causal association between α1-AR antagonists, including tamsulosin, and cognitive dysfunction. Considering the existing literature, it is appropriate to use α1-AR antagonists without concern for cognitive dysfunction. Future research, through robust study designs considering the multifactorial nature of cognitive dysfunction, is required to further evaluate this association.

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PurposeAlpha-blockers and 5-alpha reductase inhibitors (5ARIs) are well-established treatments for symptoms of benign prostatic hyperplasia (BPH). Despite their therapeutic benefits, concerns have been raised regarding a potential association between these medications and an increased risk of dementia. However, current evidence remains inconsistent, highlighting the need for further evaluation. This study aims to assess the potential dementia risk among patients receiving alpha-blockers and 5ARIs.MethodsFollowing PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines (PROSPERO CRD42025643431), 7 databases were systematically searched through December 2024 for studies examining the association between alpha-blockers or 5ARIs and dementia risk in patients with BPH. Risk of bias was assessed using the ROBINS-I (Risk of Bias in Non-randomized Studies of Interventions) tool. A Bayesian network meta-analysis was performed to estimate risk ratios with 95% credible intervals and to generate surface under the cumulative ranking curve (SUCRA) values.ResultsFive multicenter studies involving 3,650,434 patients (mean age, 71.1 years) and demonstrating an overall low risk of bias were included. The network analysis indicated that neither alpha-blockers nor 5ARIs were significantly associated with an increased risk of dementia compared with no treatment. However, SUCRA values suggested a relatively higher probability of dementia risk for 5ARIs (finasteride and dutasteride), followed by tamsulosin, doxazosin, terazosin, and alfuzosin.ConclusionThis study found no significant association between the use of alpha-blockers or 5ARIs and increased dementia risk. These findings may assist clinicians in making more informed prescribing decisions, particularly for older male patients with BPH. Further large-scale research with extended follow-up periods is needed to strengthen the evidence across all BPH medications.

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PURPOSE: Doxazosin and tamsulosin are the most frequently used α1-blockers for the treatment of male lower urinary tract symptoms. Clinical practice guidelines state that all α1-blockers have a similar clinical efficacy but differ in tolerability when used in appropriate doses. We compared the efficacy and tolerability of different doses/formulations of doxazosin (immediate release 2, 4 or 8mg; gastrointestinal therapeutic system [GITS] 4 or 8mg) versus tamsulosin (modified release 0.2, 0.4 or 0.8mg; oral controlled absorption system [OCAS] 0.4mg). METHODS: PubMed, EMBASE and Cochrane databases were systematically searched until December 2024 to identify RCTs with doxazosin and/or tamsulosin. Bayesian random-effects models estimated efficacy and tolerability outcomes, including all International Prostate Symptom Score (IPSS) variations, QoL, overall adverse events (AE) and discontinuation. Tests for heterogeneity, similarity, and consistency ensured robust estimates. RESULTS: In total, 1,866 abstracts were identified, of which we included 40 publications with 12,201 participants. Doxazosin GITS 4mg had the largest mean (95% credible interval) improvement from baseline in total IPSS (-10.07 [-11.96, -8.25]), IPSS-QoL (-1.82 [-2.07, -1.60]) and IPSS storage-subscore (-4.26 [-4.29, -3.40]), and was statistically superior compared to most tamsulosin doses. No significant differences between different doses or formulations for the two drugs were seen for the IPSS voiding-subscore, maximum urine flow or post-void residuals. Only doxazosin GITS 4mg had significantly lower odds of discontinuation due to AE compared to tamsulosin OCAS 0.4mg. CONCLUSIONS: This network meta-analysis found a statistically significantly greater clinical efficacy (IPSS-T, IPSS-S, QoL improvement) for doxazosin GITS 4mg versus most tamsulosin formulations and a similar overall tolerability profile.

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BackgroundProstatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment.MethodsA randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971.FindingsNinety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively.InterpretationIn patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months.FundingFrench Ministry of Health and a complementary grant from Merit Medical.

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ObjectiveTo compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first-line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment-naïve patients in the 'Prostate Embolisation AS first-line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial' (P-EASY ADVANCE).Patients and methodsA total of 39 men with enlarged prostates, moderate-severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow-up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short- to medium-term intervals following interventions and compared to baseline.ResultsThe medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P max (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group.ConclusionProstate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment-naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.

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