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Minerva Urology and Nephrology Aug 2023Patients on alpha-blockers (ABs) treatment may have an increased risk of adverse events (AEs). Aim of our study was to compare real-life data on neuro-vascular and...
BACKGROUND
Patients on alpha-blockers (ABs) treatment may have an increased risk of adverse events (AEs). Aim of our study was to compare real-life data on neuro-vascular and sexual AEs associated with ABs based on Eudra-Vigilance reported AEs.
METHODS
Eudra-Vigilance (EV) database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of sexual and neuro-vascular AEs for tamsulosin, alfuzosin, silodosin, prazosin and doxazosin per category and severity until July 30, 2022. Pooled Relative Risk (PRR) was used to compare data between drugs.
RESULTS
Overall the number of AEs were 2842 for Alfuzosin, 11,086 for tamsulosin, 792 for terazosin, 572 for prazosin and 4641 for doxazosin. Different percentages of AEs were obtained for each drug and in different age groups according to EV sub-groups (≤65, 65-85, ≥85). On PRR analysis, the risk of ejaculatory disorders for Silodosin (11%) is 18.5 times higher (PRR 18.5 95%CI; 10.7-31.8; P<0.05) when compared to alfuzosin and the risk of orthostatic hypotension is 2 times lower (PRR=1,84 95%CI 1.32-2.57; P<0.05).
CONCLUSIONS
Real life data is consistent with registry studies regarding side effects related to alpha-blockers. Alfuzosin is safer in terms of ejaculatory disorders while silodosin and tamsulosin in terms of orthostatic hypotension. Clinicians should consider these data when prescribing ABs especially in younger and older patients.
Topics: Humans; Doxazosin; Tamsulosin; Hypotension, Orthostatic; Adrenergic alpha-Antagonists; Prazosin; Urogenital Diseases
PubMed: 37067186
DOI: 10.23736/S2724-6051.23.05225-4 -
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 -
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 -
Pharmaceuticals (Basel, Switzerland) Oct 2023Overactive bladder (OAB) is characterized by urinary urgency and increased urinary frequency, substantially affecting quality of life. Tamsulosin and mirabegron...
Overactive bladder (OAB) is characterized by urinary urgency and increased urinary frequency, substantially affecting quality of life. Tamsulosin and mirabegron combination therapy has been studied as a safe and effective treatment option for patients with OAB. This study evaluated the effects of combining these two drugs on their pharmacokinetics and safety profiles in healthy Korean males. In this open-label, fixed-sequence, three-period, drug-drug interaction phase 1 study, a total of 36 male participants were administered multiple doses of tamsulosin alone (0.2 mg once daily), mirabegron alone (50 mg once daily), or a combination of both drugs. The results showed that the combination of tamsulosin and mirabegron increased tamsulosin exposure in the plasma by approximately 40%. In contrast, the maximum plasma concentration of mirabegron was reduced by approximately 17% when administered with tamsulosin. No clinically significant changes in the safety profiles, vital signs, or clinical laboratory test results were observed in this study. In conclusion, there were no clinically relevant drug-drug interactions between tamsulosin and mirabegron in terms of pharmacokinetics, safety, and tolerability, suggesting that their combination could be a promising treatment option for patients with OAB.
PubMed: 37895930
DOI: 10.3390/ph16101457 -
International Journal of Applied &... 2023Overactive bladder (OAB) is a common condition in elderly men with coexisting benign prostatic enlargement (BPE), and it significantly impairs their quality of life...
Comparison of Efficacy and Safety of a Combination of Tamsulosin and Mirabegron versus Tamsulosin Alone in the Management of Overactive Bladder in Males with Lower Urinary Tract Symptoms - TAME-Overactive Bladder: An Open-labeled Randomized Controlled Trial.
BACKGROUND
Overactive bladder (OAB) is a common condition in elderly men with coexisting benign prostatic enlargement (BPE), and it significantly impairs their quality of life (QoL).
AIM
This study aimed to assess the safety and efficacy of adding beta-3 adrenergic receptor agonist (mirabegron 50 mg) to tamsulosin 0.4 mg for symptomatic men with BPE and OAB symptoms (OABS).
MATERIALS AND METHODS
It was an open-labeled randomized controlled trial. Ninety men with BPE and International Prostate Symptom Score (IPSS) of more than seven with predominant OABS were enrolled for the study. A detailed history, uroflowmetry, and baseline scores, including IPSS, OABS score (OABSS), and QoL assessment, were done for each patient. After written informed consent, patients were randomized into two groups of 45 each. Group-1 received tamsulosin 0.4 mg and placebo, and Group-2 received a combination of tamsulosin 0.4 mg plus mirabegron 50 mg once daily at bedtime. Follow-up of patients was done at 2, 4, and 8 weeks. Efficacy at 8 weeks was assessed using repeat history for symptoms, uroflowmetry, IPSS, OABSS, and QoL score.
RESULTS
After 8 weeks of therapy, collected data were compared to baseline parameters in both groups. Significant improvement with respect to OABSS ( = 0.046), IPSS ( = 0.006), and QoL ( = 0.038) was observed with combination therapy versus tamsulosin alone. There were mild adverse effects, which were self-limiting.
CONCLUSIONS
A combination of tamsulosin with mirabegron is effective and safe in improving the OABSS, IPSS, and QoL in men with BPE who have predominant OABS.
PubMed: 38229731
DOI: 10.4103/ijabmr.ijabmr_331_23 -
International Braz J Urol : Official... 2023Medical expulsive therapy (MET) is recommended for distal ureteral stones from 5 to 10 mm. The best drug for MET is still uncertain. In this review, we aim to compare... (Meta-Analysis)
Meta-Analysis
PURPOSE
Medical expulsive therapy (MET) is recommended for distal ureteral stones from 5 to 10 mm. The best drug for MET is still uncertain. In this review, we aim to compare the effectiveness of tadalafil and tamsulosin for distal ureteral stones from 5 to 10 mm in terms of stone expulsion rate (SER), stone expulsion time (SET) and the side effect profile.
MATERIALS AND METHODS
A comprehensive literature search was conducted on MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Scopus and Web of Science, from inception until April 2023. Only randomized controlled trials were included in the analysis.
RESULTS
Eleven publications with 1,330 patients were included. We observed that tadalafil has a higher SER (OR 0.55, CI 95% 0.38;0.80, p=0.02, I2=52%) and the same efficacy in SET (MD 1.07, CI 95% -0.25; 2.39, p=0.11, I2=84%). No differences were found when comparing side effects as headache, backache, dizziness, and orthostatic hypotension.
CONCLUSION
Tadalafil has a higher stone expulsion rate than tamsulosin as a medical expulsive therapy for patients with distal stones from 5 to 10 mm without differences in side effects.
Topics: Humans; Sulfonamides; Tadalafil; Tamsulosin; Treatment Outcome; Ureteral Calculi; Urological Agents
PubMed: 37903004
DOI: 10.1590/S1677-5538.IBJU.2023.0345 -
The Lancet Regional Health. Europe Aug 2023Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms...
Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.
BACKGROUND
Prostatic 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.
METHODS
A 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.
FINDINGS
Ninety 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.
INTERPRETATION
In 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.
FUNDING
French Ministry of Health and a complementary grant from Merit Medical.
PubMed: 37415648
DOI: 10.1016/j.lanepe.2023.100672 -
Cureus Oct 2023Medical expulsive therapy (MET) is an established treatment option for distal ureteric stones. Tamsulosin, a selective alpha-1 blocker, has been used for MET with good...
INTRODUCTION
Medical expulsive therapy (MET) is an established treatment option for distal ureteric stones. Tamsulosin, a selective alpha-1 blocker, has been used for MET with good results, while silodosin, a more selective alpha-1a blocker, is more effective than tamsulosin for MET. Thus, this study aimed to compare the efficacy of silodosin with tamsulosin.
METHODS
This prospective randomized study was conducted at the Department of Urology, Government Chengalpattu Medical College Hospital, Tamil Nadu, India. Eighty patients who presented with ureteric colic and were radiologically diagnosed with distal ureteric calculus of size <10mm were included. Participants in the silodosin group received tablet silodosin 8mg OD until the passage of the stone, not more than two weeks, and analgesics as per demand. And participants in the tamsulosin group received tablet tamsulosin 0.4mg OD until the passage of the stone, not more than two weeks, and analgesics as per demand.
RESULTS
A total of 80 patients were included in the study. Forty patients in the silodosin group and forty patients in the tamsulosin group were included. In the silodosin group, out of 40 patients, 38 expelled the calculus. In the tamsulosin group, out of 40 patients, 28 expelled the calculus. The silodosin group had a significantly higher rate of expulsion, with a p-value of 0.003. Stone expulsion time was shorter in the silodosin group when compared with the tamsulosin group (10.15 vs. 13.4 days). Analgesic usage during medical expulsive therapy was lower in the silodosin group (5.68 vs. 8.4). We observed significant differences in comparing the outcome, stone expulsion time, and analgesic requirement between the silodosin and tamsulosin groups. We observed no significant difference between the groups for age-wise and gender-wise comparisons. Furthermore, non-expulsion of calculus in four patients and pain in eight patients were the reasons for intervention in the tamsulosin group. The reason for intervention in the silodosin group was the non-expulsion of calculus in two patients.
CONCLUSION
Using silodosin for MET of distal ureteric calculus, we found to have a better stone expulsion rate, early expulsion time, and reduced analgesic requirement.
PubMed: 37841986
DOI: 10.7759/cureus.47008 -
American Journal of Translational... 2023To analyze the effects of transcutaneous electrical nerve stimulation (TENS) combined with levofloxacin (0.1 g, twice daily) and tamsulosin (0.2 mg, once daily) on...
Transcutaneous electrical nerve stimulation combined with levofloxacin and tamsulosin for patients with chronic prostatitis: clinical efficacy and changes in serum factors.
OBJECTIVE
To analyze the effects of transcutaneous electrical nerve stimulation (TENS) combined with levofloxacin (0.1 g, twice daily) and tamsulosin (0.2 mg, once daily) on clinical efficacy and serum factors in patients with chronic prostatitis (CP).
METHODS
A retrospective analysis was conducted on 105 patients with CP who received treatment at Hangzhou Lin'an District Hospital of Traditional Chinese Medicine from February 2020 to December 2022. Among them, 47 patients received levofloxacin and tamsulosin were included in a drug group (DG), and 58 patients received additional TENS therapy (frequency: 1/4/1 Hz+80/120/80 Hz; pulse width: 270/230/270 μs+120/80/120 μs; waveform: square and continuous waveforms) were included in a joint group (JG). The changes in the National Institutes of Health chronic prostatitis symptom index (NIH-CPSI), international prostate symptom score (IPSS), and the levels of inflammatory and pain-causing factors were compared between the two groups before and after treatment. The clinical efficacy was compared between the two groups after treatment. Moreover, the incidence of adverse reactions was compared between the two groups.
RESULTS
After treatment, the scores of NIH-CPSI and IPSS, and the levels of IL-6, CRP, TNF-α, IL-1β, 5-hydroxytryptamine, substance P, and dynorphin in the JG were obviously lower than those in the DG (P<0.001). The clinical response rate in the DG was obviously lower than that in the JG (P=0.006, Table 2). There was no difference in total incidence of adverse reactions between the two groups (P=0.801).
CONCLUSION
Compared to medication alone (levofloxacin and tamsulosin), the combination of TENS with levofloxacin and tamsulosin can reduce the levels of inflammatory and pain-causing factors in patients, and improve the efficacy. Importantly, it has been observed that this combination therapy does not lead to an increase in adverse reactions and is considered to be safe for patients.
PubMed: 37692965
DOI: No ID Found -
World Journal of Urology Feb 2024To evaluate the effect of semirigid ureteroscopy and tamsulosin therapy as dilatation methods before flexible ureteroscopy advancement to the renal collecting system. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To evaluate the effect of semirigid ureteroscopy and tamsulosin therapy as dilatation methods before flexible ureteroscopy advancement to the renal collecting system.
PATIENTS AND METHODS
This prospective study included patients with renal stones less than 2 cm who underwent retrograde flexible ureteroscopy and laser lithotripsy. The patients were randomized into two groups: group A patients were given a placebo for 1 week before flexible ureteroscopy, and group B patients were administered 0.4 mg of tamsulosin once daily for 1 week before surgery and underwent active dilatation using semirigid ureteroscopy before flexible ureteroscopy. The ability of the flexible ureteroscope to reach the collecting system in both groups during the same operative session was assessed. Operative outcomes and complications were collected and analyzed in both groups.
RESULTS
A total of 170 patients were included in our study, with each group comprising 85 patients. In group B, the flexible ureteroscope successfully accessed the kidney in 61 patients, while in group A, the flexible ureteroscope was successful only in 28 cases (71.4% versus 32.9%). In group A, 33 (38.8%) patients had lower urinary tract symptoms compared to 17 (20.2%) patients in group B (P = 0.013).
CONCLUSION
Using tamsulosin therapy and semirigid ureteroscopy as dilatation methods before flexible ureteroscopy increased the success of primary flexible ureteroscopy advancement to renal collecting system.
Topics: Humans; Ureteroscopy; Ureteroscopes; Tamsulosin; Dilatation; Prospective Studies; Kidney Calculi
PubMed: 38329579
DOI: 10.1007/s00345-023-04696-2