[Hepatotoxicity by tamsulosin / dutasteride: report of a probable case]. / Hepatotoxicidad por tamsulosina / dutasterida: reporte de un caso probable.

Tamsulosin and dutasteride are drugs widely used to treat benign prostatic hypertrophy. having a good safety profile. There are few reports of liver injury associated with the use of tamsulosin; however, there are no reports of hepatic toxicity from the use of dutasteride and the combined use of tamsulosin/dutasteride. We present the case of a 64-year-old man who developed liver injury after the combined use of tamsulosin/dutasteride, developing a pattern of hepatocellular damage and acute hepatitis symptoms. Viral, autoimmune, and metabolic storage diseases of the liver were ruled out, as well as biliary pathology by means of abdominal ultrasound and resonance cholangiography. In the causality evaluation, CIOMS-RUCAM presented: 6 points (probable) and Naranjo: 4 points (possible). The patient presented a clinical and laboratory response after discontinuing the drug.

Association of silodosin, tamsulosin, and naftopidil with delirium: analysis of the pharmacovigilance database in Japan.

BACKGROUND: An association between adrenergic alpha-1 receptor antagonists and delirium has been suggested, but the details are unclear. AIM: This study investigated the association between adrenergic alpha-1 receptor antagonists and delirium in patients with benign prostatic hyperplasia using the Japanese Adverse Drug Event Report database. METHOD: First, disproportionality analysis compared the frequency of delirium in the adrenergic alpha-1 receptor antagonists silodosin, tamsulosin, and naftopidil. Next, multivariate logistic analysis was performed to examine the association between delirium and adrenergic alpha-1 receptor antagonists where disproportionality was detected. RESULTS: A disproportionality in delirium was observed in patients receiving tamsulosin (reporting odds ratio [ROR] 1.85, 95% confidence interval [CI] 1.38-2.44, P < 0.01) compared with those who did not, and also in patients receiving naftopidil (ROR 2.23, 95% CI 1.45-3.28, P < 0.01) compared with those who did not. Multivariate logistic analysis revealed that in addition to previously reported risk factors for delirium, delirium in patients receiving tamsulosin was significantly increased with concomitant use of anticholinergics (odds ratio 2.73, 95% CI 1.41-5.29, P < 0.01) and delirium in patients receiving naftopidil was significantly increased with concomitant use of beta3-adrenergic receptor agonists (odds ratio 4.19, 95% CI 1.66-10.6, P < 0.01). CONCLUSION: Anticholinergics or beta3-adrenergic receptor agonists to treat overactive bladder in patients receiving tamsulosin and naftopidil was strongly associated with delirium. Confirming the medical history and concomitant medications of patients receiving tamsulosin or naftopidil may contribute to preventing delirium in patients with benign prostatic hyperplasia and to improving their outcomes.

Physiopathology of the Priapism Secondary to Tamsulosin: Clinical Cases of Our Hospital and Literature Review.

OBJECTIVE: To describe two cases of man with the diagnosis of ischemic priapism after the intake of tamsulosin and to revise the scientific literature. METHODS: We present two cases of men that developed an ischemic priapism after the intake of tamsulosin prescribed for STUI and were treated in our hospital. We described the two cases, from the diagnosis until the surgery that was performed. Also, we review the scientific literature about this topic. RESULTS: In one hand, a 67 years old man with the previous diagnosis of diabetes mellitus, hypertension and dyslipidemia that take a one single dosis of tamsulosin and developed a priapism of 9 hours of duration. He was diagnosticated of low-flow priapism that was reverted after the use of intracavernosal phenylephrine. On the other hand, a 61 years old man without any medical condition. He developed a priapism after the intake of also one single dosis of tamsulosin and came to the hospital after 48 hours of the beginning of the erection. In this case, the use of intracavernosal phenylephrine wasn´t effective so we decided to performed a distal shunt between cavernosal and spongy body according to the techniques of Winter, Ebbehoj and Al-Ghorab. All of them without results. At the end, we tried a proximal shunt according Quackles technique, also ineffective. The patient declined another surgery for implantation of a pennis prothesis and went home after four days of hospitalization with the disappearance of the pain. CONCLUSIONS: The tamsulosin is a drug well known by urologist that have a safety profile probed with the years. Nevertheless, it's association with a disease like the priapism forced us to explain to our patients this rare adverse effect.

Physiopathology of the Priapism Secondary to Tamsulosin: Clinical Cases of Our Hospital and Literature Review

Objective: To describe two cases of man with the diagnosis of ischemic priapism after the intake of tamsulosin and to revise the scientific literature. Methods: We present two cases of men that developed an ischemic priapism after the intake of tamsulosin prescribed for STUI and were treated in our hospital. We described the two cases, from the diagnosis until the surgery that was performed. Also, we review the scientific literature about this topic. Results: In one hand, a 67 years old man with the previous diagnosis of diabetes mellitus, hypertension and dyslipidemia that take a one single dosis of tamsulosin and developed a priapism of 9 hours of duration. He was diagnosticated of low-flow priapism that was reverted after the use of intracavernosal phenylephrine. On the other hand, a 61 years old man without any medical condition. He developed a priapism after the intake of also one single dosis of tamsulosin and came to the hospital after 48 hours of the beginning of the erection. In this case, the use of intracavernosal phenylephrine wasn´t effective so we decided to performed a distal shunt between cavernosal and spongy body according to the techniques of Winter, Ebbehoj and Al-Ghorab. All of them without results. At the end, we tried a proximal shunt according Quackles technique, also ineffective. The patient declined another surgery for implantation of a pennis prothesis and went home after four days of hospitalization with the disappearance of the pain. Conclusions: The tamsulosin is a drug well known by urologist that have a safety profile probed with the years. Nevertheless, it's association with a disease like the priapism forced us to explain to our patients this rare adverse effect (AU)

Objetivo: Describir la fisiopatología del priapismoasociado a tamsulosina a través de dos casos clínicos tratados en nuestro centro.Método: Se presentan dos casos de varones que desarrollan un priapismo isquémico tras la toma de tamsulosina yque fueron tratados en nuestro hospital. Describimos amboscasos, desde el diagnóstico hasta el tratamiento. Además,revisamos la literatura científica sobre dicho tema.Resultado: Introducimos el caso de un hombre de 67años con comorbilidad cardiovascular que desarrolla un priapismo isquémico de 9 horas de duración que revirtió confenilefrina intracavernosa. Por otro lado, se presenta el casode un varón de 61 años sin patología de base con un priapismo de 48 horas que no mejoró tras tratamiento conservador ni tras cirugía de derivación cavernoso-esponjosa.Conclusiones: La tamsulosina es un fármaco seguroque en, raras ocasiones, puede asociarse a un priapismo isquémico. (AU)

Use of α1-adrenoceptor antagonists tamsulosin and alfuzosin and the risk of Alzheimer's disease.

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.

Alpha Blocker-Associated Intraoperative Floppy Iris Syndrome.

Objective To evaluate the literature related to the use of alpha1-blockers and the risk of intraoperative floppy iris syndrome (IFIS), particularly in cataract surgery. IFIS is characterized by floppiness or billowing of the iris, iris prolapse, and progressive miosis, possibly leading to severe complications. It is thought to be associated with adrenergic alpha-1 receptor antagonists commonly used to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia. Data Sources A literature search was conducted in Pubmed, EMBASE, and Web of Science through May 2021 with MeSH terms and keywords 'intraoperative floppy iris syndrome,' ' adrenergic alpha-1 receptor antagonists,' and 'cataract surgery.' Study Selection and Data Extraction Relevant articles were reviewed and included. In addition, reference lists from identified publications were reviewed to identify additional reports and studies of interest. Data Synthesis Numerous reports have linked IFIS to multiple risk factors including age, gender, hypertension, and the use of adrenergic alpha-1 receptor antagonists, most notably tamsulosin. Tamsulosin selectively blocks the adrenergic alpha-1 receptor in the iris dilator muscle, preventing mydriasis during cataract surgery. Other adrenergic alpha-1 receptor antagonists, including terazosin, doxazosin, alfuzosin, and sildosin, have also been linked to IFIS; however, their relationship to IFIS is not as well defined. Conclusion Patients should be educated regarding potential adverse effects and discuss this with their health care providers prior to cataract surgery. In addition, health care providers should be aware of the adverse effect and take steps to reduce the risk of surgical complications.

Priapism - A rare side effect of alpha blockers: Report of 2 cases and literature review.

Priapism is a prolonged unintended erectile state unrelated to sexual stimulation or sexual desire. There is a very rare relationship between the use of alpha blockers and the development of priapism. Here, we describe 2 cases of alpha blocker induced priapism and a literature review. One of these cases is related to the use of silodosin and the other is related to the use of tamsulosin. So far, 18 alpha blocker induced priapism cases have been reported. We are presenting the first case of silodosin induced priapism and the eighth case of priapism secondary to tamsulosin. Despite silodosin having a much greater affinity for the α1-a receptor than the α1-b receptor, as represented in this case it can cause this rare side effect. Before starting alpha blocker treatment, side effects such as priapism, which may be very rare but may cause serious problems, should be kept in mind.

Tamsulosin and risk of priapism: A causality assessment using Austin Bradford Hill Criteria.

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 (IC025  = 4.1; PRR025  = 19.9; ROR025  = 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.

[Intraoperative floppy iris syndrom (IFIS) associated with tamsulosin]. / Intraoperatives Floppy Iris Syndrom (IFIS) bei Tamsulosineinnahme.

BACKGROUND: Tamsulosin is one of the most commonly prescribed alpha-1A antagonists for the treatment of benign prostatic syndrome (BPS). Patients treated with tamsulosin often develop intraoperative floppy iris syndrome (IFIS) during cataract surgery. This leads to increasing miosis and an undulating iris, which increases the risk of complications significantly and can cause permanent damage. AIM OF THE WORK: The aim is to raise awareness for the effects of tamsulosin intake before cataract surgery. MATERIAL AND METHODS: We conducted a critical review of publications on the association of IFIS in cataract surgery with alpha-receptor blockers. RESULTS AND DISCUSSION: Tamsulosin has a risk of complications of up to 80 %, whereas doxazosin and alfuzosin only have a 15-20 % chance of complications. Tamsulosin therefore represents a significant risk factor for permanent secondary damage after cataract surgery. Even after discontinuing tamsulosin, IFIS was still observed after up to 3 years. Nevertheless, pausing of tamsulosin intake is recommended. An alternative preparation should therefore be preferred in patients who have not yet had cataract surgery. If patients are already pseudophakic, tamsulosin can be given without concern.

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.

Pumpkin seed oil (Cucurbita pepo) versus tamsulosin for benign prostatic hyperplasia symptom relief: a single-blind randomized clinical trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is very common in aging men. We aimed to compare the effects of tamsulosin and pumpkin (Cucurbita pepo) seed oil on BPH symptoms. METHODS: This single-blind randomized clinical trial included patients with BPH aged ≥ 50 years referred to the Urology Clinic of Shahid Beheshti Hospital, Hamadan, Iran, from August 23, 2019 to February 19, 2020. Patients were randomized into two groups. One group received 0.4 mg tamsulosin every night at bedtime and the other received 360 mg pumpkin seed oil twice a day. Patients' age, weight, height, and body mass index (BMI) were recorded. The International Prostate Symptom Score (IPSS) was filled out by the patients at baseline and then 1 month and 3 months after the initiation of treatment. The BPH-associated quality of life (QoL), serum prostate-specific antigen, prostate and postvoid residual volume, and maximum urine flow were also assessed at baseline and 3 months later. Drug side effects were also noted. RESULTS: Of the 73 patients included in this study with a mean age of 63.59 ± 7.04 years, 34 were in the tamsulosin group and 39 in the pupkin seed oil group. Patients were comparable with respect to age, weight, height, BMI, and baseline principal variables in both groups. Also, there was no significant difference between groups in terms of principal variables at any time point. However, there was a significant decrease in IPSS and a significant improvement in QoL in both groups. Although the decrease in IPSS from baseline to 1 month and 3 months was significantly higher in the tamsulosin group compared to the pumpkin group (P = 0.048 and P = 0.020, respectively), the decrease in IPSS from 1 to 3 months was similar (P = 0.728). None of the patients in the pumpkin group experienced drug side effects, while dizziness (5.9%), headache (2.9%), retrograde ejaculation (2.9%), and erythema with pruritus occurred in the tamsulosin group. CONCLUSIONS: Pumpkin (Cucurbita pepo) seed oil relieved BPH symptoms with no side effects, but was not as effective as tamsulosin. Further studies are required to confirm the role of pumpkin seed oil as an option for the treatment of BPH symptoms. Trial registration Iranian Registry of Clinical Trials, IRCT20120215009014N340. Registered 19.02.2020. Retrospectively registered, https://en.irct.ir/trial/45335 .

Efficacy and tolerability of doxazosin gastro-intestinal therapeutic system versus tamsulosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: A systematic review and meta-analysis.

BACKGROUND: Alpha1-adrenoceptor antagonists (α1-blockers) are first-line drugs for the treatment of lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). Doxazosin gastrointestinal therapeutic system (GITS) and tamsulosin belong to the 2 most frequently prescribed α1-blockers. This systematic review and meta-analysis was performed to compare the efficacy and tolerability of these 2 α1-blockers. METHODS: A systematic review of published randomized controlled trials in English or Chinese language was performed using the PubMed, EMBASE, Cochrane Library, CNKI, Wanfang, and Vip databases. After data extraction and quality assessment, the meta-analysis was performed to compare clinical parameters (International Prostate Symptom Score [IPSS] total [IPSS-T], storage [IPSS-S], voiding [IPSS-V], maximum urine flow [Qmax], and postvoid residual) and adverse events (AEs) that changed after first drug intake. RESULTS: After the screening, 8 eligible randomized controlled trials with 1316 patients were identified. Doxazosin-GITS showed a significantly higher efficacy compared with tamsulosin (IPSS-T P < .001, IPSS-S P < .001, and IPSS-V P < .001). There were no significant differences between the 2 drugs for changes in Qmax (P = .477) or postvoid residual (P = .739). The overall AEs were significantly lower in the doxazosin-GITS group (risk ratio: 0.77; 95% CI: 0.54-1.08; P = .036). However, dizziness (P = .387), headache (P = .745), asthenia (P = .693), postural hypotension (P = .114), and retrograde ejaculation (P = .187) were similar between the 2 groups. CONCLUSIONS: This meta-analysis indicates that doxazosin-GITS has significantly higher efficacy and lower AEs than tamsulosin in patients with lower urinary tract symptoms/benign prostate hyperplasia.

Intraoperative Floppy Iris Syndrome Induced by Tamsulosin: The Risk and Preventive Strategies.

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 in vitro or in vivo 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.

Triple Therapy with Tamsulosin, Dutasteride, and Imidafenacin for Benign Prostatic Hyperplasia in Patients with Overactive Bladder Symptoms Refractory to Tamsulosin: Subgroup Analyses of the DIrecT Study.

AIM: To verify if the efficacy of the triple therapy with tamsulosin, dutasteride, and imidafenacin (TDI) is influenced by any background characteristics in patients with overactive bladder (OAB). METHODS: A subanalysis of data from the DIrecT study was conducted. Superiority of TDI over tamsulosin and dutasteride in terms of efficacy based on the Overactive Bladder Symptom Score (OABSS), total International Prostate Symptom Score (IPSS), IPSS quality of life index, and postvoid residual (PVR) was evaluated in binary subgroups. RESULTS: In the treatment groups, there was a significant interaction of total OABSS with testosterone level (≥4.8 vs. <4.8 ng/mL, p = 0.043) and PVR (≥20 vs. <20 mL, p = 0.018). For the total IPSS, no significant interaction was found except for the IPSS QOL index. For the IPSS QOL index, a significant interaction was found with testosterone level (≥4.8 vs. <4.8 ng/mL, p < 0.0001) as well as with total IPSS and total OABSS. For the PVR, no significant interaction was found except with total OABSS. CONCLUSIONS: Triple therapy with TDI is suggested to be a therapeutic option for benign prostatic hyperplasia in patients with residual OAB symptoms refractory to tamsulosin and in patients with various background characteristics regardless of severity of OAB symptoms. Trial Registry No. UMIN 000011980.

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to evaluate the efficacy of tamsulosin, administered preoperatively, for the prevention of postoperative urinary retention (POUR). POUR is a common complication of abdominal surgery, leading to the use of urinary catheters, which are a risk factor for urinary tract infection. Tamsulosin is a uroselective alpha-1a blocker used for the treatment of lower urinary tract symptoms. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was undertaken from August 2015 to May 2018. Adults undergoing elective inpatient abdominal surgery were randomized to receive either tamsulosin 0.4 mg or placebo daily for 7 d before surgery and continuing for up to 7 d postoperatively. The primary outcome was need for at least a single intermittent catheterization postoperatively. Secondary outcomes included first postvoid residual volume, number of catheterizations, need for replacement of an indwelling catheter, hospital length of stay, and urinary tract infection within 30 d of surgery. RESULTS: A total of 158 participants were enrolled, with a final analytic cohort of 141 participants. The two groups had similar baseline characteristics, operative characteristics, and timing of catheter removal. There was no difference in the incidence of POUR between the two groups (26% in tamsulosin versus 31% in placebo, P = 0.49). There was also no difference in any of the secondary outcomes between the two groups. Epidural usage, open surgery, and age <50 were identified as risk factors for POUR. CONCLUSIONS: Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.

Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.

OBJECTIVES: To investigate the cardiovascular safety of mirabegron add-on treatment to tamsulosin in male patients with residual overactive bladder symptoms. METHODS: This was a post hoc analysis of MATCH, the first double-blind, placebo-controlled study comparing mirabegron and placebo as add-on therapy to tamsulosin for treatment of overactive bladder in men with lower urinary tract symptoms. The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up. RESULTS: Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group). Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients. There were no clinically meaningful changes from baseline in blood pressure, and changes in pulse rate were small (+1.2 bpm in the tamsulosin + mirabegron group). Increased pulse rate was more frequent with tamsulosin + mirabegron than with tamsulosin + placebo in older patients, although within the normal range. CONCLUSIONS: Cardiovascular-related adverse events were uncommon in both treatment groups. Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms.

The impact of tamsulosin on cognition in Alzheimer disease with benign prostate hyperplasia: A study using the Hallym Smart Clinical Data Warehouse.

Studies suggest that the use of alpha-blockers increases the risk of dementia in patients with benign prostate hyperplasia (BPH). Due to study limitations, the relationship between the use of alpha-blockers, such as tamsulosin, and the risk of dementia is still unclear. However, alpha1-adrenoreceptors are also present in the brain, so there is potential for adverse effects on cognitive function. Therefore, we investigated possible associations between the use of alpha-blockers and aggravation of cognitive decline in dementia patients using a clinical data analytic solution called the Smart Clinical Data Warehouse (CDW).We retrospectively investigated clinical data using the Smart CDW of Hallym University Medical Center from 2009 to 2019. We enrolled patients with probable Alzheimer disease (AD) who had completed the Mini-Mental State Examination (MMSE) at least twice during follow-up, and who had BPH. We compared the difference in MMSE scores between patients who took tamsulosin for >1000 days and those who did not take any alpha-blocker. We tested the effect of tamsulosin on cognitive decline in patients with AD, using propensity score-matched logistic regression analysis.Eligible cases were included in the tamsulosin (n = 68) or no-medication (n = 153) groups. After propensity score matching, clinical characteristics such as educational attainment and vascular risk factors were similar in the tamsulosin and no-medication groups. The MMSE scores did not differ significantly between the tamsulosin and no-medication groups (P = .470).The results suggest that tamsulosin for BPH is not associated with worsening of the cognitive decline in patients with AD.

Tamsulosin Associated with Interstitial Lung Damage in CYP2D6 Variant Alleles Carriers.

Drugs are serious but underestimated causative agents of interstitial lung disease (ILD). Both cytotoxic and immune mechanisms may be involved in drug-induced ILD (DI-ILD). We aimed to investigate whether polymorphisms of relevant CYP enzymes involved in the metabolization of tamsulosin might explain the pathologic mechanism of the DI-ILD in the cases with suspected tamsulosin DI-ILD. We collected 22 tamsulosin-associated DI-ILD cases at two ILD Expertise Centers in the Netherlands between 2009 and 2020. CYP2D6, CYP2C9, CYP2C19, CYP3A4, and CYP3A5 single nucleotide polymorphisms were genotyped and compared with a control group of 78 healthy Caucasian male volunteers. Nine cases were phenotyped as CYP2D6 poor metabolizers and 13 as CYP2D6 intermediate metabolizers. The phenotypes of the cases differed significantly from those of the healthy controls, with more poor metabolizers. After withdrawal of tamsulosin, the pulmonary condition of three cases had improved, six patients had stabilized, and one patient stabilized after reducing the tamsulosin dose. The described 22 cases suggest that an association between the presence of CYP2D6 allelic variants and tamsulosin-associated ILD is highly likely. These cases highlight the importance of both clinical and genetic risk stratification aimed to achieve a more accurate prevention of DI-ILD in the future and enhance the quality of life of patients.

To evaluate the efficacy and safety of different kinds of PDE5-Is with tamsulosin as a medical therapy for LUTS secondary to benign prostatic hyperplasia: A protocol for systematic review and meta analysis.

BACKGROUND: Drug therapy for lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH) is a major and popular method. However, the therapeutic strategy is still not clear enough up to now. The purpose of this study was to compare the relative safety and efficacy of different types of phosphodiesterase type 5 inhibitors (PDE5-Is) with tamsulosin for the treatment of LUTS secondary to BPH. METHODS: Databases including PubMed, OpenGrey, Embase, Cochrane Library, and Web of Science will be searched to identify qualified studies. We will use the Stata version 13.0 to conduct the network meta-analysis (NMA) with a random or fixed effects model of Bayesian framework. International prostate symptom score (IPSS), maximum urinary flow fate (Qmax) and their credible intervals (CI) will be used to compare every medical intervention with the efficacy and safety, including sildenafil plus tamsulosin, tadalafil plus tamsulosin, vardenafil plus tamsulosin. And the ranking of probability of different interventions will be estimated by comparing the surface under the cumulative ranking curve (SUCRA). RESULTS: A high quality-synthesis of the current evidence for comparing with different doses or types of PDE5-Is combined with tamsulosin to the treatment of LUTS secondary to BPH will be provided. CONCLUSIONS: This NMA and systematic review will generate evidence to help choose the best combination for treatment of LUTS secondary to BPH.PROSPERO registration number: PROSPERO CRD 42019139062.