Tamsulosin 400microgram / Dutasteride 500microgram capsules

PURPOSE: Alpha-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. METHODS: Following 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. RESULTS: Five 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. CONCLUSION: This 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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Objective To 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 Methods A 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. Results The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Q max ; 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 < 0.001), incomplete emptying ( P = 0.002), total IPSS ( P = 0.032), Q max ( P = 0.006) and quality of life ( P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group. Conclusion Prostate 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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Abstract Background Based on our observations at the largest outpatient urology clinic in Iran, patients for whom finasteride is prescribed as a secondary drug to tamsulosin tend to experience earlier and more severe sexual side effects without any difference in the amelioration of symptoms. This study aimed to compare the time lag, efficacy, and side effects of combination therapy with varying doses of dutasteride or finasteride added to tamsulosin for benign prostatic hyperplasia (BPH) treatment. Methods In this study 165 were randomized into 5 groups (each N = 33); receiving tamsulosin 0.4mg plus either of A: finasteride 3mg, B: placebo, C: dutasteride 0.25mg, D: finasteride 5mg or E: dutasteride 0.5mg. During the 6-month period of the study, International Prostate Symptom Score (IPSS), post-void residual urine (PVR), International Index of Erectile Function (IIEF-5), prostate volume (PV), prostate specific antigen (PSA) and maximum urinary flow rate (Qmax) were evaluated at baseline and at the 1st, 3rd and 6th month. The differences between each time point and baseline were then compared between groups. Results At 3-month follow-up, group E exhibited a higher decrease in PSA but a greater increase in Qmax compared to group A ( p = 0.047 and 0.006, respectively). Group C showed higher Qmax increase compared to group A at 3 and 6 months ( p = 0.003 and 0.014) and concurrently a more pronounced PV decrease at 1 and 3 months ( p = 0.047 and 0.003, respectively). Group D had a significantly more decrease in their IIEF-5 compared to group A at one-month visit ( p = 0.006). Conclusions In summary, at the sixth-month follow-up, dutasteride demonstrated superiority over finasteride solely in enhancing Qmax. Therefore, dutasteride may be marginally more beneficial as a secondary component of combination therapy in BPH. Trial registration IRCT, IRCT20120516009772N2. Registered 18 January 2021 Retrospectively registered, https://irct.behdasht.gov.ir/search/result?query=IRCT20120516009772N2 .

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Objective: This study assessed the impact of a fixed-dose combination 5α-reductase inhibitor (5-ARI) dutasteride 0.5 mg and the α-blocker (AB) tamsulosin 0.4 mg on erectile dysfunction (ED) using The International Index of Erectile Function-5 (IIEF-5) score and Erectile Hard Score (EHS) in patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Material & Methods: This was an analytical cross-sectional with consecutive sampling. We reviewed the medical records of the symptomatic BPH patients. Then we interviewed The International Prostate Symptom Score (IPSS), Quality of Life (QOL), IIEF-5, and EHS scores after administered combination therapy. The data were analyzed with SPSS IBM 21.0 using univariate and then bivariate analysis. Results: Forty (40) patients fulfilled inclusion criteria. The results showed that the frequency of patients at most in the age range of 50-59 years (40%), most of IPSS after therapy showed mild grade 45%, and moderate grade 55%. The QOL average score is 2.08, most of the patients felt pleased (35%). IIEF-5 average score after treatment is 11.6 (moderate ED) and the EHS is 2.48 (grade 2: tumescence with minimal rigidity). The Spearman test showed that there was no correlation between IPSS and IIEF-5, the score is -0.658. Then, the Spearman correlation score between BPH grade after combination treatment and ED grade is 0.739 and had a statistically significant 0.000 (p<0.001). Conclusion: This research shows that there is a correlation of the impact of tamsulosin/ dutasteride combination therapy on ED in BPH with secondary LUTS.
 Keywords: BPH, erectile dysfunction, tamsulosin/dutasteride combination.

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Background: Following the c In the management of BPH, Tamsulosin is an example of a-adrenergic receptor blocker drug that is usually used. In addition, dutasteride is also a BPH drug that works as a group of 5 a reductase inhibitor. However, the weakness of long-term administration of a1-adrenergic receptor antagonists can result in upregulation of prostate smooth muscle cell contractility and expression of a-adrenergic mRNA receptors, resulting in hyperactivity and supersensitivity to a-agonists. Objective: Our study aimed to determine the effect of long-term administration of tamsulosin, dutasteride and tamsulosin-dutasteride combination on the contractility of prostate smooth muscle cells in BPH model rats. Methods: This study was designed using an experimental post test only method, control group design. It measured the contractility of prostate smooth muscle cells from samples obtained from the prostatic stroma of experimental animals adult male Rattus norvegicus Wistar strain induced BPH and administered tamsulosin 1 mg/kg/day, dutasteride 0.5 mg/kg/day, and a combination of continuous administration for 1, 6 and 12 consecutive days. Data were analyzed using one way ANOVA if the data distribution was normal or Kruskall Walis if the data distribution was abnormal. Result: The effect of tamsulosin, dutasteride and the combination of tamsulosin with dutasteride on prostate smooth muscle cell contractility in experimental animals Rattus norvegicus Wistar strain showed that tamsulosin administration for six days, twelve days, and the combination of tamsulosin dutasteride for one day got statistically significant different result (p=0.016; p=0.006; p=0.029) compared to the negative control group. In addition, there was a difference between the tamsulosin and dutasteride combination group for 12 days compared to tamsulosin monotherapy for 6 days and 12 days (p=0.160; p=0.010). Conclusion: Continuous administration of monotherapy tamsulosin has an upregulation effect on the sixth to twelfth day. Decreased contractility of prostate smooth muscle cells occurs on the first day but will increase on the sixth to twelfth day. On the other hand, the results of our study also showed that the combination of tamsulosin and dutasteride gave the effect of reducing contractility and was most effective on day 12.

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PURPOSE: To study the effects of benign prostatic hyperplasia treatments, namely: alpha-adrenergic receptor blockers, 5-alpha-reductase inhibitors and phosphodiesterase-5 inhibitors on the risk of Parkinson's disease, Alzheimer's disease and mortality. MATERIALS AND METHODS: All male Medicare enrollees aged 65 or above who were diagnosed with benign prostatic hyperplasia and received one of the study drugs between 2007-2020 were followed-up for the three outcomes. We used Cox regression analysis to assess the relative risk of each of the outcomes for each study drug compared to the most prescribed drug, tamsulosin, while controlling for demographic, socioeconomic and comorbidity factors. RESULTS AND CONCLUSIONS: The study analyzed 1.1 million patients for a mean follow-up period of 3.1 years from being prescribed one of the study drugs. For all outcomes, patients on tamsulosin were used as the reference for comparison. For mortality, alfuzosin was associated with 27% risk reduction (HR 0.73, 95%CI 0.68-0.78), and doxazosin with 6% risk reduction (HR 0.94, 95%CI 0.91-0.97). For Parkinson's disease, terazosin was associated with 26% risk reduction (HR 0.74, 95%CI 0.66-0.83), and doxazosin with 21% risk reduction (HR 0.79, 95%CI 0.72-0.88). For Alzheimer's disease, terazosin was associated with 27% risk reduction (HR 0.73, 95%CI 0.65-0.82), and doxazosin with 16% risk reduction (HR 0.84, 95%CI 0.76-0.92). Tadalafil was associated with risk reduction (27-40%) in all 3 outcomes. More research is needed to elucidate the underlying mechanisms of these observations. Given the availability of safer alternatives for treating benign prostatic hyperplasia, caution should be exercised when using tamsulosin in elderly patients, especially those with an increased risk of developing neurodegenerative diseases.

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PURPOSE: To evaluate the penile morphology after the isolated and combined administration of dutasteride and tamsulosin in a rodent model. MATERIALS AND METHODS: Forty male rats were assigned into the following groups: Control group (C, receiving distilled water, n=10); Dutasteride group (D, receiving 0.5 mg/Kg/day of dutasteride, n=10); Tamsulosin group (T, receiving 0.4 mg/Kg/day of tamsulosin, n=10); and Dutasteride associated with Tamsulosin group (DT, receiving both drugs n = 10). All drugs were administered via oral gavage. After 40 days, the animals were submitted to euthanasia and their penises were collected for histomorphometric analyses. Data were compared using one-way ANOVA followed by Bonferroni's post-test, considering p<0.05 as significant. RESULTS: The sinusoidal space and smooth muscle fiber surface densities (Sv), and the cross-sectional penile areas of rats in groups D, T and DT were reduced in comparison to controls with the most notable reductions in the combined therapy group. The connective tissue and elastic system fibers Sv were augmented in groups D, T and DT in comparison with the control group, again with the most pronounced changes observed in animals receiving the combined therapy. CONCLUSION: Both treatments with dutasteride or tamsulosin promoted penile morphometric modifications in a rodent model. The combination therapy resulted in more notable modifications. The results of this study may help to explain the erectile dysfunction observed in some men using these drugs.

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