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.

Abstract licence: CC BY-NC

The goal of combination therapy for moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH) is to ease both the dynamic and static symptoms by using agents that have complementary mechanisms of action. Similar to prescribing other drugs, LUTS/BPH combination therapy has been affected by multiple factors. Previous qualitative research discussed the individual perspectives that influenced combination therapy administration. Yet, until recently, there has been limited interest in clinical reasons that physicians have to consider before prescribing LUTS/BPH combination treatment. This systematic review aimed to identify the clinical considerations that influence the decision to prescribe combination therapy of tamsulosin 0.4 mg + dutasteride 0.5 mg for Asian men with LUTS/BPH. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A systematic search was performed in databases Medline, CINAHL, the Cochrane Library, and Embase from inception until January 2024 using Medical Subject Headings (MeSH) terms and keywords with truncation for alternative acronyms. A citation search was performed to gather works of literature on LUTS/BPH combination treatment in addition to the "PICO" framework for search terms. Five English-language primary randomized controlled trials (RCTs) were included in the narrative analysis using the Critical Appraisal Skills Program (CASP) checklist after critical appraisal. Several dosages of tamsulosin (0.2 mg and 0.4 mg) have been administered in LUTS/BPH combination treatment over the last few decades despite 0.2 mg tamsulosin being standardized as an effective regime in Asian countries. A remarkable correlation between prostate volume (PV) and prostate-specific antigen (PSA) was found in Asian men, which requires higher PSA secretion to enlarge each prostate unit and causes an increased risk of moderate-to-severe LUTS. Additionally, BPH baseline variables may lead to a different response to combination therapy, especially the PV and PSA differences. In conclusion, compared with Caucasian men, a significantly higher risk of moderate-to-severe LUTS was found in Asian men. Initiation of combination therapy, especially dutasteride, depends on a larger PV (≥ 30 mL); it is possible, therefore, that earlier PV and PSA examinations and baseline variables assessments ought to be performed by physicians before the combination therapy prescription. Alternative treatment options may be considered for a patient who prefers an active pattern of sexual activity during their BPH combined pharmacotherapy. These clinical considerations may influence the prescription of tamsulosin 0.4 mg + dutasteride 0.5 mg combination therapy for Asian men with moderate-to-severe LUTS/BPH. This study was registered on PROSPERO (CRD42024575528).

Abstract licence: CC BY-NC 4.0

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.

Abstract licence: CC BY-NC

BACKGROUND: We performed a meta-analysis to confirm the efficacy and safety of the combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia (BPH) during a treatment cycle of at least 1 year. METHODS: Randomized controlled trials were searched by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The data was evaluated and statistically analyzed by using RevMan version 5.3.0. RESULTS: Five studies including 4348 patients were studied. The analysis found that the combination group was significantly greater effect in international prostate symptom score (mean difference [MD], - 1.43; 95% confidence interval [CI], - 2.20 to - 0.66; P = 0.0003), prostate volume (MD, - 10.13; 95% CI, - 12.38 to - 7.88; P < 0.00001), transitional zone volume (MD, - 3.18; 95% CI, - 3.57 to - 2.79; P<0.0001), maximum urine flow rate (MD, 1.05; 95% CI, 0.82 to 1.29; P < 0.00001), prostate specific antigen (MD, - 0.54; 95% CI, - 0.80 to - 0.29; P < 0.0001) and post-void residual volume (MD, - 3.85; 95% CI, - 4.95 to - 2.76; P < 0.00001) compared with the tamsulosin group. In terms of safety, including adverse events (odds ratio [OR], 2.06; 95% CI, 1.34 to 3.17; P = 0.001), erectile dysfunction (OR, 2.24; 95% CI, 1.73 to 2.92; P < 0.00001), ejaculation disorder (OR, 3.37; 95% CI, 1.97 to 5.79; P < 0.0001), retrograde ejaculation (OR, 2.30; 95% CI, 1.08 to 4.93; P = 0.03), decreased libido (OR, 2.25; 95% CI, 1.53 to 3.31; P < 0.0001) and loss of libido (OR, 3.38; 95% CI, 1.94 to 5.88; P<0.0001), the combination group showed poor tolerance than the tamsulosin group with the exception of dizziness (OR, 1.16; 95% CI, 0.75 to 1.80; P = 0.50). The combination group significantly reduced the risk of clinical progression than the tamsulosin group especially in incidence of BPH-related symptom progression (OR, 0.56; 95% CI, 0.46 to 0.67; P < 0.00001) and acute urinary retention (OR, 0.61; 95% CI, 0.38 to 0.98; P = 0.04). CONCLUSION: The combination of tamsulosin plus dutasteride provides a preferable therapeutic effect for BPH with a higher incidence of sexual side effects, but combination-therapy can markedly reduce risk of BPH-related symptom progression and acute urinary retention relative to tamsulosin monotherapy.

Abstract licence: CC BY 4.0

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.

Abstract licence: CC BY-NC-ND

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.

Abstract licence: CC BY-NC-ND