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Journal of Clinical and Diagnostic... Jun 2015To evaluate the efficacy/safety of 'tamsulosin and darifenacin' (TD) vs. 'tamsulosin and placebo' (TP) for patients with symptomatic benign prostrate hyperplasia (BPH)...
PURPOSE
To evaluate the efficacy/safety of 'tamsulosin and darifenacin' (TD) vs. 'tamsulosin and placebo' (TP) for patients with symptomatic benign prostrate hyperplasia (BPH) with accompanying overactive bladder (OAB) symptoms.
MATERIALS AND METHODS
This study included symptomatic patients of BPH with one or more of the following OAB symptoms; micturition frequency >8, nocturnal frequency > 2, urgency > 1 per 24 hour between November 2012 and February 2014. After protocol approval by ethics committee and obtaining informed consent, patients were randomly assigned to receive tamsulosin 0.4mg plus placebo (TP) (n=30) or tamsulosin 0.4 mg plus darifenacin 7.5 mg (TD) (n=30) for 8 weeks. The mean change from baseline in urinary frequency and incontinence episodes/24 hour (primary end points), and nocturnal frequency; mean change in PVR and changes in IPSS (secondary end points) were compared between groups at 0/eight week using voiding diary and ultrasonography.
RESULTS
The mean change in frequency, incontinence, nocturnal frequency/24 hour and IPSS (International prostrate symptom score) were (-4.83 vs. -3.93, p=0.023), (-1.50 vs. 1.08, p=0.001), (-2.20 vs. -1.87, p<0.001) and (-7.90 vs. -6.27, p<0.001) in the TD/TP group respectively (significant). Apart from some minor side effects (12 vs. 9) all interventions appeared to be safe and well tolerated. The mean change in the PVR (Postvoid residual) was marginal (+10.84ml and -16.93) and the incidence of urinary retention was 13% and 3% in the TD and TP groups respectively (p=0.35).
CONCLUSION
Treatment with tamsulosin and darifenacin for 8 weeks is an effective and safe treatment modality in select patients of BPH with accompanying OAB symptoms.
PubMed: 26266159
DOI: 10.7860/JCDR/2015/12526.6019 -
Surgery Nov 2018Tamsulosin, an α-adrenergic receptor inhibitor, is prescribed to treat benign prostatic hyperplasia in men >60 years of age, the same demographic most susceptible to...
BACKGROUND
Tamsulosin, an α-adrenergic receptor inhibitor, is prescribed to treat benign prostatic hyperplasia in men >60 years of age, the same demographic most susceptible to abdominal aortic aneurysm. The goal of this study was to investigate the effect of tamsulosin on abdominal aortic aneurysm pathogenesis.
METHODS
Abdominal aortic aneurysms were induced in WT C57BL/6 male mice (n = 9-18/group), using an established topical elastase abdominal aortic aneurysm model. Osmotic pumps were implanted in mice 5 days before operation to create the model, administering either low dose (0.125 µg/day tamsulosin), high dose (0.250µg/day tamsulosin), or vehicle treatments with and without topical application of elastase. Blood pressures were measured preoperatively and on postoperative days 0, 3, 7, and 14. On postoperative day 14, aortic diameter was measured before harvest. Sample aortas were prepared for histology and cytokine analysis.
RESULTS
Measurements of systolic blood pressure did not differ between groups. Mice treated with the low dose of tamsulosin and with the high dose of tamsulosin showed decreased aortic diameter compared with vehicle-treated control (93% ± 24 versus 94% ± 30 versus 132% ± 24, respectively; P = .0003, P = .0003). Cytokine analysis demonstrated downregulation of pro-inflammatory cytokines in both treatment groups compared with the control (P < .05). Histology exhibited preservation of elastin in both low- and high-dose tamsulosin-treated groups (P = .0041 and P = .0018, respectively).
CONCLUSION
Tamsulosin attenuates abdominal aortic aneurysm formation with increased preservation of elastin and decreased production of pro-inflammatory cytokines. Further studies are necessary to elucidate the mechanism by which tamsulosin attenuates abdominal aortic aneurysm pathogenesis.
Topics: Adrenergic alpha-1 Receptor Antagonists; Animals; Aorta, Abdominal; Aortic Aneurysm, Abdominal; Blood Pressure; Cytokines; Disease Models, Animal; Down-Regulation; Drug Evaluation, Preclinical; Elastin; Humans; Male; Mice; Mice, Inbred C57BL; Pancreatic Elastase; Tamsulosin; Treatment Outcome
PubMed: 30174141
DOI: 10.1016/j.surg.2018.06.036 -
Turkish Journal of Pharmaceutical... Aug 2018The present study was undertaken with the objective to develop and validate a simple spectrofluorimetric method for the simultaneous quantification of tamsulosin...
OBJECTIVES
The present study was undertaken with the objective to develop and validate a simple spectrofluorimetric method for the simultaneous quantification of tamsulosin hydrochloride and solifenacin succinate.
MATERIALS AND METHODS
First-derivative synchronous spectrofluorimetry was attempted for the simultaneous quantification of the analytes. Tamsulosin hydrochloride was quantified at a wavelength of 322 nm (zero-crossing wavelength point of solifenacin succinate) and solifenacin succinate was measured at 570 nm (zero-crossing wavelength point of tamsulosin hydrochloride).
RESULTS
Calibration plots were constructed over the concentration range of 2-10 µg/mL for tamsulosin hydrochloride and 30-150 µg/mL for solifenacin succinate. The method gave satisfactory results when it is validated for linearity, specificity, accuracy, precision, LOD and LOQ as per the ICH guidelines. The assay values in the commercial formulation were found to be in the percentage range of 95.0 for tamsulosin hydrochloride and 103.5 for solifenacin succinate by the proposed method. These results were well in agreement with their label claim.
CONCLUSION
The proposed synchronous analytical method can be employed for routine quality control analysis of tamsulosin hydrochloride/solifenacin succinate in tablet dose forms.
PubMed: 32454654
DOI: 10.4274/tjps.72692 -
Journal of Endourology Case Reports 2020Tamsulosin in a widely used drug in urology practice in treating lower urinary tract symptoms of benign prostatic hyperplasia, distal ureteral stones, and ureteral...
Tamsulosin in a widely used drug in urology practice in treating lower urinary tract symptoms of benign prostatic hyperplasia, distal ureteral stones, and ureteral stent-related symptoms. Ischemic priapism is a rare but serious adverse effect of tamsulosin. We report two cases of tamsulosin-induced priapism and reviewed available literature citing priapism as a complication of tamsulosin. We also reviewed the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to identify reported cases of tamsulosin-induced priapism. First patient was a 61-year-old African American male with paraplegia of 30-year duration. He developed priapism after taking first dose of tamsulosin for lower urinary tract symptoms. He presented with 18 hours of painful erection and was treated with aspiration and irrigation, followed by phenylephrine injection. The patient maintained potency after treatment. The second patient was a 24-year-old male who received tamsulosin in the emergency department as medical expulsive therapy for 11 mm distal ureteral stone. Since he had intractable pain, he underwent emergency primary ureteroscopy with laser lithotripsy as definitive treatment of his ureteral calculus. He developed intraoperative priapism that subsided postoperatively. However, he was discharged with tamsulosin to reduce stent-related urinary symptoms. He returned back to the emergency department after 3 days with persistent priapism for 3 days and needed penoscrotal corporeal decompression to treat his priapism. At 6 weeks follow-up visit, the patient has lost his potency. Although there were only 4 case reports on review of the literature, we were able to identify 46 cases reported in the U.S. FAERS database. Priapism can be an adverse reaction to tamsulosin. Providers and patients should be aware about this complication to ensure early seeking of management to avoid devastating outcomes, particularly in young patients when tamsulosin is given as medical expulsive therapy for ureteral stone and stent-related symptoms.
PubMed: 33102720
DOI: 10.1089/cren.2019.0157 -
Nature Communications Jun 2023The αadrenergic receptor (αAR) belongs to the family of G protein-coupled receptors that respond to adrenaline and noradrenaline. αAR is involved in smooth muscle...
The αadrenergic receptor (αAR) belongs to the family of G protein-coupled receptors that respond to adrenaline and noradrenaline. αAR is involved in smooth muscle contraction and cognitive function. Here, we present three cryo-electron microscopy structures of human αAR bound to the endogenous agonist noradrenaline, its selective agonist oxymetazoline, and the antagonist tamsulosin, with resolutions range from 2.9 Å to 3.5 Å. Our active and inactive αAR structures reveal the activation mechanism and distinct ligand binding modes for noradrenaline compared with other adrenergic receptor subtypes. In addition, we identified a nanobody that preferentially binds to the extracellular vestibule of αAR when bound to the selective agonist oxymetazoline. These results should facilitate the design of more selective therapeutic drugs targeting both orthosteric and allosteric sites in this receptor family.
Topics: Humans; Oxymetazoline; Cryoelectron Microscopy; Receptors, Adrenergic, alpha-1; Norepinephrine; Tamsulosin
PubMed: 37339967
DOI: 10.1038/s41467-023-39310-x -
Therapeutic Advances in Urology Feb 2016Despite their multifactorial etiology, male lower urinary tract symptoms (LUTS) have been traditionally associated with benign prostatic enlargement (BPE) because of... (Review)
Review
Despite their multifactorial etiology, male lower urinary tract symptoms (LUTS) have been traditionally associated with benign prostatic enlargement (BPE) because of benign prostatic hyperplasia (BPH). Several pharmaceutical therapies have been used to manage LUTS, with α1-adrenergic receptor antagonists (α1-blockers) and inhibitors of 5α-reductase (5α-RIs) representing the most commonly prescribed agents currently in use for LUTS treatment. Due to their different modes of action, combined use of α1-blockers and 5α-RIs has been proven to offer more optimal control of symptoms and better associated quality of life, even though higher rates of adverse events have been shown. Following previous studies on the separate administration of dutasteride and tamsulosin, a fixed-dose combination capsule of tamsulosin 0.4 mg and dutasteride 0.5 mg has been approved and released for clinical use in men with BPH. The present review aims to discuss the rationale behind the combined use of tamsulosin and dutasteride for treating male LUTS, and to present the available data on the role of combination therapy in the management of BPH-related symptoms in terms of efficacy and safety. Special attention is given to the impact of combination treatment on the prevention of clinical progression of BPH. Cost-effectiveness of fixed-dose combination and patients' adherence to treatment are also discussed.
PubMed: 26834837
DOI: 10.1177/1756287215607419 -
American Journal of Men's Health 2020Studies reported that was effective in relieving lower urinary tract symptoms (LUTS). This article carried out a systematic review and meta-analysis to compare with... (Meta-Analysis)
Meta-Analysis
Studies reported that was effective in relieving lower urinary tract symptoms (LUTS). This article carried out a systematic review and meta-analysis to compare with tamsulosin in the treatment of benign prostatic hyperplasia (BPH) after at least 6-month treatment cycle. Four studies involving 1,080 patients (543 in the group and 537 in the tamsulosin group) were included in the meta-analysis. The results were as follows: compared with tamsulosin, had a same effect in treating BPH in terms of International Prostate Symptom Score (IPSS) (mean difference [MD] 0.63, 95% confidence interval [CI] [-0.33, 1.59], = 0.20), quality of life (QoL) (MD 1.51, 95% CI [-1.51, 4.52], = 0.33), maximum flow rate (Qmax) (MD 0.27, 95% CI [-0.15, 0.68], = 0.21), postvoid residual volume (PVR) (MD -4.23, 95% CI [-22.97, 14.44], = 0.65), prostate-specific antigen (PSA) (MD 0.46, 95% CI [-0.06, 0.97], = 0.08) with the exception of prostate volume (PV) (MD -0.29, 95% CI [-0.41, -0.17], < 0.00001). For side effects, was well tolerated compared with tamsulosin especially in ejaculation disorders (odds ratio [OR] = 12.56, 95% CI [3.83, 41.18], < 0.0001) and decreased libido (OR = 5.40; 95% CI [1.17, 24.87]; = 0.03). This study indicated that had the same effect in treating BPH compared with tamsulosin in terms of IPSS, QoL, and PVR after at least 6-month treatment cycle, however, the latter had a greater improvement in PV compared with the former. And did not increase the risk of adverse events especially with respect to ejaculation disorders and libido decrease.
Topics: Aged; Aged, 80 and over; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Plant Extracts; Prostatic Hyperplasia; Serenoa; Tamsulosin; Urological Agents
PubMed: 32274957
DOI: 10.1177/1557988320905407 -
Journal of Fluorescence Jul 2022Sensitive and green spectrofluorimetric methods were utilized for Tamsulosin Hydrochloride (TAM) and Tadalafil (TDL) assessment in bulk and their newly available...
Green & Sensitive pH-dependent Spectrofluorimetric Assay of Tamsulosin Hydrochloride and Tadalafil in their New Combined Formulation for Benign Prostatic Hyperplasia: Application to Spiked Human Plasma.
Sensitive and green spectrofluorimetric methods were utilized for Tamsulosin Hydrochloride (TAM) and Tadalafil (TDL) assessment in bulk and their newly available combined mixture for benign prostatic hyperplasia and erectile dysfunction. The technique relies on measuring native fluorescence of TAM in 0.1 N HCl at 324 nm and TDL in 0.1 N NaOH at 348 nm due to their different fluorimetric behavior in acidic and basic media where TAM has no fluorescence in basic medium and vice versa. To achieve better regression, the spectra were derivatized allowing determination of TAM at 314 nm and TDL at 320 and 380 nm (peak to peak) by applying third and first derivative, respectively. In addition, pH-dependent "constant-wavelength synchronous" spectrofluorimetry was applied where TAM and TDL were determined at 218 nm in acidic medium and at 268 nm in basic medium, respectively. Finally, derivatizing the latter emission spectra allowed determination of TAM and TDL at 232 nm and at 262 and 278 nm (peak to peak), respectively. Acidic and basic emission spectra where scanned at λ = 225 nm (for TAM assay) and at λ = 247 nm (for TDL assay), respectively. Fluorescence-concentration plots were linear and the proposed methods were used for analysis of TAM and TDL combined laboratory prepared formulation. These procedures are green, sensitive and of low cost which make them suitable for quality control analysis of the two drugs. In addition, the high selectivity of the proposed methods was tested by successfully applying them for TAM and TDL assay in plasma samples.
Topics: Humans; Hydrogen-Ion Concentration; Male; Prostatic Hyperplasia; Spectrometry, Fluorescence; Tadalafil; Tamsulosin
PubMed: 35576092
DOI: 10.1007/s10895-022-02938-x -
BMC Urology Dec 2021To assess the use and safety of free combination therapy (dutasteride and tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign...
Free combination of dutasteride plus tamsulosin for the treatment of benign prostatic hyperplasia in South Korea: analysis of drug utilization and adverse events using the National Health Insurance Review and Assessment Service database.
OBJECTIVE
To assess the use and safety of free combination therapy (dutasteride and tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign prostatic hyperplasia (BPH).
METHODS
This non-interventional retrospective cohort study used claims data from the Korea Health Insurance Review and Assessment-National Patient Sample database. Patients with BPH ≥ 40 years of age receiving combination therapy (dutasteride 0.5 mg and tamsulosin 0.4 mg daily) or dutasteride 0.5 mg, or tamsulosin 0.4 mg daily dose between 2012 and 2017 were included. The frequency, duration of treatment and risk of any adverse event (AE) or serious AE (SAE) was compared for combination therapy versus each monotherapy using non-inferiority testing.
RESULTS
Of 14,755 eligible patients, 1529 (10.4%) received combination therapy, 6660 (45.1%) dutasteride monotherapy, and 6566 (44.5%) tamsulosin monotherapy. The proportion of patients treated with combination therapy exceeded the pre-specified 3% threshold for 'frequent' use. Safety results indicated a similar risk of any AE and SAE irrespective of treatment group. The adjusted relative risk for any AE over the treatment observation period comparing combination therapy with dutasteride monotherapy was 1.07 (95% confidence interval [CI] 1.03, 1.12), and with tamsulosin monotherapy was 0.98 (95% CI 0.95, 1.02) demonstrating non-inferiority. The adjusted relative risk for any SAE was 1.07 (95% CI 0.66, 1.74) and 0.90 (95% CI 0.56, 1.45), compared with dutasteride and tamsulosin monotherapy, respectively. Although the SAE results did not statistically demonstrate non-inferiority of combination therapy based on pre-specified margins, the 95% CI for the risk ratio estimates included the null with a lower limit below the non-inferiority margins, indicating no meaningful differences in SAE risk between groups. Absolute SAE risks were low.
CONCLUSION
Combination therapy with dutasteride and tamsulosin is frequently used in real-world practice in South Korea for treatment of BPH and demonstrates a safety profile similar to either monotherapy.
Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adult; Aged; Databases, Factual; Drug Therapy, Combination; Dutasteride; Humans; Male; Middle Aged; Prostatic Hyperplasia; Republic of Korea; Retrospective Studies; Tamsulosin
PubMed: 34933674
DOI: 10.1186/s12894-021-00941-1 -
Frontiers in Cellular and Infection... 2023Disordered gut microbiota (GM) structure and function may contribute to osteoporosis (OP). This study explores how traditional Chinese medicine (TCM) intervention... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Disordered gut microbiota (GM) structure and function may contribute to osteoporosis (OP). This study explores how traditional Chinese medicine (TCM) intervention affects the structure and function of the GM in patients with OP.
METHOD
In a 3-month clinical study, 43 patients were randomly divided into two groups receiving conventional treatment and combined TCM (Yigu decoction, YGD) treatment. The correlation between the intestinal flora and its metabolites was analyzed using 16S rDNA and untargeted metabolomics and the combination of the two.
RESULTS
After three months of treatment, patients in the treatment group had better bone mineral density (BMD) than those in the control group ( < 0.05). Patients in the treatment group had obvious abundance changes in GM microbes, such as Bacteroides, Escherichia-Shigella, Faecalibacterium, Megamonas, Blautia, Klebsiella, Romboutsia, Akkermansia, and Prevotella_9. The functional changes observed in the GM mainly involved changes in metabolic function, genetic information processing and cellular processes. The metabolites for which major changes were observed were capsazepine, Phe-Tyr, dichlorprop, D-pyroglutamic acid and tamsulosin. These metabolites may act through metabolic pathways, the citrate cycle (TCA cycle) and beta alanine metabolism. Combined analysis showed that the main acting metabolites were dichlorprop, capsazepine, D-pyroglutamic acid and tamsulosin.
CONCLUSION
This study showed that TCM influenced the structure and function of the GM in patients with OP, which may be one mechanism by which TCM promotes the rehabilitation of patients with OP through the GM.
Topics: Humans; Gastrointestinal Microbiome; Pyrrolidonecarboxylic Acid; Tamsulosin; RNA, Ribosomal, 16S
PubMed: 37475958
DOI: 10.3389/fcimb.2023.1091083