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Middle East African Journal of... 2021Tamsulosin is an antagonist of a subtype-specific alpha-1A- and alpha-1D-adrenoceptor (AR) that is expressed in the prostate gland, urethra, and bladder. Several reports... (Review)
Review
Tamsulosin is an antagonist of a subtype-specific alpha-1A- and alpha-1D-adrenoceptor (AR) that is expressed in the prostate gland, urethra, and bladder. Several reports have shown a possible relationship between ophthalmologic adverse effects and the use of alpha-1-receptor medicines, including tamsulosin. This descriptive review evaluates the intraoperative floppy iris syndrome (IFIS) associated with tamsulosin. A search of the Medline and PubMed databases was conducted to identify control trials, case reports, and observational examinations published in English. The publication dates were restricted (January 1, 2000, to January 1, 2020). Keywords (tamsulosin, alpha-blocker, ocular, eye, adverse reaction, and IFIS) were used in the searches. The searches identified 66 studies including or studies, trials, and observational studies. Twenty-two (33.33%) studies were articles citing tamsulosin and IFIS as having confirmed potential risk to ocular safety. The results of this review, including a comprehensive summary of published research on tamsulosin use in different populations, have identified several articles showing associations between tamsulosin and IFIS that merit further investigation. Suspending of potential causative pharmacological treatment of IFIS before ocular surgery including tamsulosin, proper identification of at-risk patients, preoperative prophylaxis treatments, and surgical technique modifications clearly can mitigate the anticipated risk of IFIS induced by tamsulosin.
Topics: Adrenergic alpha-1 Receptor Antagonists; Humans; Intraoperative Complications; Iris; Iris Diseases; Risk Factors; Sulfonamides; Tamsulosin
PubMed: 34321822
DOI: 10.4103/meajo.MEAJO_561_20 -
International Braz J Urol : Official... 2021To describe the otorhinolaryngological adverse effects of the main drugs used in urological practice. (Review)
Review
PURPOSE
To describe the otorhinolaryngological adverse effects of the main drugs used in urological practice.
MATERIALS AND METHODS
A review of the scientific literature was performed using a combination of specific descriptors (side effect, adverse effect, scopolamine, sildenafil, tadalafil, vardenafil, oxybutynin, tolterodine, spironolactone, furosemide, hydrochlorothiazide, doxazosin, alfuzosin, terazosin, prazosin, tamsulosin, desmopressin) contained in publications until April 2020. Manuscripts written in English, Portuguese, and Spanish were manually selected from the title and abstract. The main drugs used in Urology were divided into five groups to describe their possible adverse effects: alpha-blockers, anticholinergics, diuretics, hormones, and phosphodiesterase inhibitors.
RESULTS
The main drugs used in Urology may cause several otorhinolaryngological adverse effects. Dizziness was most common, but dry mouth, rhinitis, nasal congestion, epistaxis, hearing loss, tinnitus, and rhinorrhea were also reported and varies among drug classes.
CONCLUSIONS
Most of the drugs used in urological practice have otorhinolaryngological adverse effects. Dizziness was most common, but dry mouth, rhinitis, nasal congestion, epistaxis, hearing loss, tinnitus, and rhinorrhea were also reported. Therefore, doctors must be aware of these adverse effects to improve adherence to the treatment and to minimize damage to the health of patients.
Topics: Adrenergic alpha-Antagonists; Doxazosin; Humans; Male; Pharmaceutical Preparations; Prazosin; Prostatic Hyperplasia; Tadalafil; Tamsulosin
PubMed: 33566468
DOI: 10.1590/S1677-5538.IBJU.2021.99.06 -
Pharmacology Research & Perspectives Apr 2022Tamsulosin hydrochloride, a selective alpha-adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if...
Tamsulosin hydrochloride, a selective alpha-adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC = 4.1; PRR = 19.9; ROR = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a 'sole suspect,' and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha-adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off-label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism.
Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Aged; Databases, Factual; Humans; Male; Middle Aged; Off-Label Use; Pharmacovigilance; Priapism; Risk; Tamsulosin; Young Adult
PubMed: 35170870
DOI: 10.1002/prp2.934 -
Pharmacoepidemiology and Drug Safety Oct 2022Tamsulosin has been associated with dementia, but the results have been inconsistent. Concerns have been raised about using exposure assessment time too close to the...
PURPOSE
Tamsulosin has been associated with dementia, but the results have been inconsistent. Concerns have been raised about using exposure assessment time too close to the outcome. We investigated the association between use of α1-adrenoceptor antagonists indicated for benign prostate hyperplasia and risk of Alzheimer's disease (AD) using different exposure windows.
METHODS
The study (24 602 cases and 98 397 matched controls) included men from the Finnish nationwide nested case-control study on Medication and Alzheimer's disease (MEDALZ). Cases received clinically verified AD diagnosis during 2005-2011 and were community-dwelling at the time of diagnosis. Use of tamsulosin and alfuzosin in 1995-2011 was identified from the Prescription Register and categorized based on whether it had occurred within 3 years before AD diagnosis (lag time) or before that. Dose-response analysis using defined daily doses of drug (DDDs) was conducted. Associations were investigated with conditional logistic regression, adjusted for confounders and mediators.
RESULTS
The use of α1-adrenoceptor antagonists before lag time associated with an increased risk of AD (OR 1.24 [1.20-1.27]). After adjustment for comorbidities and concomitant drug use throughout the assessment time (confounders) and healthcare contacts within the lag period (mediators), the association weakened (aOR 1.10 [1.06-1.14]). We found no evidence of dose-response-relationship when comparing the users of higher than median DDDs to the users of lower than median DDDs.
CONCLUSION
Our findings, especially the lack of dose-response-relationship and attenuation after mediator adjustment, do not provide strong support for the previous hypothesis on α1-adrenoceptor antagonists as a risk factor for dementia.
Topics: Adrenergic alpha-Antagonists; Alzheimer Disease; Case-Control Studies; Humans; Male; Quinazolines; Receptors, Adrenergic; Sulfonamides; Tamsulosin
PubMed: 35751619
DOI: 10.1002/pds.5503 -
Tamsulosin facilitates depressive-like behaviors in mice: Involvement of endogenous glucocorticoids.Brain Research Bulletin Jan 2022The benign prostatic hyperplasia (BPH) is the main source of lower urinary tract symptoms. The BPH is a common age-dependent disease and tamsulosin is an α-adrenoceptor...
The benign prostatic hyperplasia (BPH) is the main source of lower urinary tract symptoms. The BPH is a common age-dependent disease and tamsulosin is an α-adrenoceptor blocker widely prescribed for BPH. Beyond the common adverse effects of tamsulosin, increased diagnosis of dementia after prescription was observed. Importantly, a clinical study suggested that tamsulosin may exert antidepressant effects in BPH patients. Considering the expression of α-adrenoceptors in the brain, this study aimed to investigate the effects of tamsulosin in the forced swimming and open field tests in mice. For this, tamsulosin (0.001-1 mg/kg) was orally administered subacutely (1, 5 and 23 hr) and acutely (60 min) before tests. Mifepristone (10 mg/kg), a glucocorticoid receptor antagonist, and aminoglutethimide (10 mg/kg), a streoidogenesis inhibitor, were intraperitoneally injected before tamsulosin to investigate the role of the hypothalamic-pituitary-adrenal axis in the mediation of tamsulosin-induced effects. Subacute and acute administrations of tamsulosin increased the immobility time in the first exposition to an inescapable stressful situation. In the re-exposition to the swim task, controls displayed a natural increase in the immobility time, and the treatment with tamsulosin further increased this behavioral parameter. Tamsuslosin did not affect spontaneous locomotion neither in naïve nor in stressed mice. Our findings also showed that mifepristone and aminoglutethimide prevented the tamsulosin-induced increase in the immobility time in the first and second swimming sessions, respectively. In conclusion, tamsulosin may contribute to increased susceptibility to depressive-like behaviors, by facilitating the acquisition of a passive stress-copying strategy. These effects seem to be dependent on endogenous glucocorticoids.
Topics: Adaptation, Psychological; Adrenergic alpha-1 Receptor Antagonists; Aminoglutethimide; Animals; Aromatase Inhibitors; Behavior, Animal; Depression; Disease Models, Animal; Hormone Antagonists; Hypothalamo-Hypophyseal System; Mice; Mifepristone; Receptors, Glucocorticoid; Tamsulosin
PubMed: 34798218
DOI: 10.1016/j.brainresbull.2021.11.005 -
International Braz J Urol : Official... 2023To evaluate the penile morphology after the isolated and combined administration of dutasteride and tamsulosin in a rodent model.
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.
Topics: Humans; Male; Rats; Animals; Dutasteride; Tamsulosin; 5-alpha Reductase Inhibitors; Prostatic Hyperplasia; Rodentia; Cross-Sectional Studies; Drug Therapy, Combination
PubMed: 37115177
DOI: 10.1590/S1677-5538.IBJU.2022.0583 -
International Journal of Clinical... Jan 2020To evaluate real-world persistence and adherence in patients with benign prostate hyperplasia (BPH) receiving a fixed-dose combination of dutasteride plus tamsulosin... (Observational Study)
Observational Study
Persistence and adherence to dutasteride/tamsulosin fixed-dose versus free-combination alpha blocker/5ARI therapy in patients with benign prostate hyperplasia in Germany .
OBJECTIVE
To evaluate real-world persistence and adherence in patients with benign prostate hyperplasia (BPH) receiving a fixed-dose combination of dutasteride plus tamsulosin (DUT-TAM FDC) versus α-blocker plus 5-α reductase inhibitor (AB/5ARI) free-combination therapy.
MATERIALS AND METHODS
This retrospective, observational cohort study utilized the German IMS LRx (IQVIA) database. Patients ≥ 45 years old with BPH receiving DUT-TAM FDC or AB/5ARI free-combination therapy from July 1, 2011 to November 30, 2017 were included. Data were analyzed for 48 months from index date (date of first prescription). Persistence, measured as time to discontinuation (defined as a 90-day gap in therapy), was evaluated using Kaplan-Meier curves (log-rank tests). Adherence, measured as medication possession ratio (MPR), was based on a comparison of mean prescribing duration and expected treatment duration.
RESULTS
A total of 141,667 patients were included (DUT-TAM FDC, n = 86,057; free AB/5ARI: n = 55,610). Small differences in persistence were observed between treatment arms. At month 12, 41.8% of DUT-TAM FDC-treated and 41.0% of AB/5ARI free-combination therapy-treated patients were persistent; at month 24, 28.2% and 27.1% were persistent, respectively. A higher proportion of DUT-TAM FDC-treated patients had MPR ≥ 0.80, ≥ 0.75 and ≥ 0.70 compared with AB/5ARI free-combination therapy (p < 0.0001).
CONCLUSION
Small differences observed in persistence between treatment arms may not translate to meaningful clinical relevance. Adherence was significantly better in the FDC arm, which may be clinically relevant as improved adherence is associated with better outcomes. Persistence and adherence to BPH therapy in Germany is low; further studies exploring the reasons behind this are required.
Topics: 5-alpha Reductase Inhibitors; Drug Therapy, Combination; Dutasteride; Germany; Humans; Male; Medication Adherence; Middle Aged; Prostatic Hyperplasia; Retrospective Studies; Tamsulosin
PubMed: 31670653
DOI: 10.5414/CP203549 -
Annals of Medicine and Surgery (2012) Aug 2022To date, no study evaluates the effect of atherosclerosis risk level on the efficacy of BPH drug therapies. Therefore, the present study aimed to assess the effect of...
INTRODUCTION
To date, no study evaluates the effect of atherosclerosis risk level on the efficacy of BPH drug therapies. Therefore, the present study aimed to assess the effect of atherosclerosis risk levels on the effectiveness of Tamsulosin and Tadalafil in LUTS treatment.
METHODS
The present study was a randomized clinical trial that assessed men with LUTS symptoms (at least six months). The inclusion criteria were being older than 50 years, international prostate symptom score (IPSS) ≥ 13, and maximum urinary flow rate (Qmax) between 4 and 15 ml/s. Framingham Risk Score was used to measure atherosclerosis risk. The patients were classified into four groups, including group 1: Patients with low risk and treated with Tamsulosin (0.4 mg/day), group 2: Patients with low risk and treated with Tadalafil (5 mg/day), group 3: Patients with high risk and treated with Tamsulosin (0.4 mg/day), group 4: Patients with high risk and treated with Tadalafil (5 mg/day).
RESULTS
The study included 44 and 38 patients receiving Tamsulosin and Tadalafil, respectively. The means (SD) of the baseline age for the Tamsulosin and Tadalafil groups were equal to 60.6 (6.8) and 58.8 (6.7), respectively (p-value = 0.213). The models revealed no impact of the atherosclerosis risk level on the drugs' effects (p-values = 0.378, 0.975, 0.743 for IPSS, QMAX, and VOID, respectively).
CONCLUSIONS
The present study's findings could not show the impact of atherosclerosis risk levels on the efficiency of Tamsolusin and Tadalafil in men with LUTS.
PubMed: 35846856
DOI: 10.1016/j.amsu.2022.104137 -
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 -
Frontiers in Medicine 2022Although several previous studies have investigated the relationship between tamsulosin use and surgical complications of cataract surgery, no population-based cohort...
PURPOSE
Although several previous studies have investigated the relationship between tamsulosin use and surgical complications of cataract surgery, no population-based cohort study has been conducted for the Asian population. We aimed to investigate the relationship between tamsulosin use and surgical complications of cataract surgery in the Korean elderly population.
METHODS
This nationwide population-based retrospective cohort study included elderly patients (≥60 years) who had undergone cataract surgery in the period from 2003 to 2015. Baseline characteristics were age, sex, income, residence, and systemic, and ocular comorbidities (glaucoma, myopia, eye trauma, diabetes mellitus with ophthalmic manifestations, severe cataract, age-related macular degeneration). The exposure of interest was tamsulosin use within 1 year before cataract surgery. Logistic regression model was used to evaluate the relationship of tamsulosin use with surgical complications of cataract surgery.
RESULTS
The rate of surgical complications of cataract surgery was 0.88% (375/42,539) in the non-tamsulosin group and 0.83% (71/8,510) in the tamsulosin group. The groups showed no significant difference in the risk of surgical complications of cataract surgery in the unadjusted model [odds ratio (OR) = 0.946; 95% confidence interval (CI):0.733-1.220; = 0.669]. Additionally, tamsulosin use was not significantly associated with surgical complications of cataract surgery in the fully adjusted model accounting for age, income, residence, and systemic and ocular comorbidities (OR = 0.997; 95% CI: 0.749-1.325; = 0.981).
CONCLUSIONS
The rate or risk of surgical complications of cataract surgery does not change with tamsulosin use. We suggest that better surgical techniques and surgeons' cognizance of the patient's tamsulosin use could improve surgical outcomes, without increasing surgical complications.
PubMed: 35665322
DOI: 10.3389/fmed.2022.882131