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PubMed1995

Tamsulosin, a selective alpha 1c-adrenoceptor antagonist: a randomized, controlled trial in patients with benign prostatic 'obstruction' (symptomatic BPH). The European Tamsulosin Study Group.

OBJECTIVE: To evaluate the efficacy and safety of tamsulosin 0.4 mg once daily (as a modified-release formulation) compared with placebo in patients with benign prostatic enlargement, lower urinary tract symptoms and prostatic 'obstruction' (symptomatic benign prostatic hyperplasia [BPH]). PATIENTS AND METHODS: Of 313 patients with symptomatic BPH enrolled in a 2-week placebo run-in period, 296 were subsequently randomized to receive either placebo (98 patients) or tamsulosin 0.4 mg once daily (198 patients) for 12 weeks. The primary variables assessed to determine efficacy were maximum urinary flow rate (Qmax) from free-flow measurements and the total Boyarsky symptom score. RESULTS: Tamsulosin produced greater improvements in Qmax (1.4 mL/s, 13.1%) than did placebo (0.4 mL/s, 3.8%) (P = 0.028) and a greater decrease in total symptom score (3.4 points, 35.8% reduction) than did placebo (2.2 points, 23.7% reduction) (P = 0.002). Significantly more tamsulosin-treated patients (67%) than placebo-treated patients (44%) had a > or = 25% decrease in total symptom score after 12 weeks (P < 0.001). Treatment with tamsulosin for 12 weeks also produced significant improvements in average urinary flow rate (P = 0.040), irritative (P = 0.013) and obstructive (P = 0.014) symptom scores and symptoms of nocturia (P = 0.022) and hesitancy (P = 0.004). Tamsulosin was tolerated well by the patients. The incidence of adverse events emerging during treatment was comparable in the tamsulosin- and placebo-treated groups (34% and 24% respectively, P = 0.109), as was the incidence of cardiovascular-related adverse events (5% and 7% respectively; P = 0.596). There were no significant differences in changes in blood pressure or pulse rates between the tamsulosin- and placebo-treated groups. CONCLUSION: Tamsulosin 0.4 mg once daily is safe, well tolerated and clinically effective in improving symptoms and urinary flow rate in patients with symptomatic BPH.

Adrenergic alpha-Antagonists↗
PubMed1996

Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. A meta-analysis of two randomized, placebo-controlled, multicentre studies in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group.

OBJECTIVE: This meta-analysis of two European studies evaluated the efficacy and safety of modified-release tamsulosin 0.4 mg once daily compared with placebo in patients with benign prostatic enlargement, lower urinary tract symptoms and prostatic obstruction (symptomatic BPH). METHODS: Patients entered a 2-week placebo run-in period, followed by randomization to treatment with tamsulosin (382 patients) or placebo (193 patients) once daily for 12 weeks. RESULTS: Maximum urinary flow rate improved to a greater extent in the tamsulosin group (1.6 ml/s, 16%) than the placebo group (0.6 ml/s, 6%) (p = 0.002). Total Boyarsky symptom score also improved to a greater extent in the tamsulosin group (3.3 points, 35.1% reduction) than the placebo group (2.4 points, 25.5% reduction) (p = 0.002). Significantly more tamsulosin patients (66%) than placebo patients (49%) had a > or = 25% decrease in total symptom score at endpoint (p < 0.001). Twelve weeks of treatment with tamsulosin also produced significant improvements in average urinary flow rate (p = 0.005) and voiding or "obstructive" (p = 0.008) and storage or "irritative' (p = 0.017) symptom scores. The incidence of drug-related adverse events was comparable for the tamsulosin and placebo groups (13 and 12% respectively, p = 0.802). The same applies to the incidence of adverse events commonly attributed to alpha 1-adrenoceptor antagonists, such as dizziness, headache, postural hypotension, syncope, asthenia, somnolence and rhinitis. There were no clinically significant changes in blood pressure or pulse rate in tamsulosin patients compared with placebo patients both in hypertensive and normotensive BPH patients. CONCLUSION: Tamsulosin 0.4 mg once daily is safe, well-tolerated and improves both the symptoms and urinary flow rate in patients with benign prostatic obstruction (symptomatic BPH).

Administration, Oral↗
PubMed2001

Pharmacological effect of tamsulosin in relation to dog plasma and tissue concentrations: prostatic and urethral retention possibly contributes to uroselectivity of tamsulosin.

In the present study the pharmacokinetics and pharmacodynamics of tamsulosin were investigated in anesthetized male dogs. Hypogastric nerve stimulation elevated the intraurethral pressure (IUP), which was inhibited dose dependently by intraduodenal administration of tamsulosin (3-30 microg/kg). The inhibition peaked about 90 min after dosing and lasted up to 240 min. The basal mean blood pressure did not change significantly during the observation period. The plasma, prostatic, and urethral concentrations of tamsulosin were determined by the liquid chromatography-mass spectrometry/mass spectrometry method. The plasma concentration reached the maximal level within 30 min after dosing and gradually declined thereafter. The maximal total plasma concentration of tamsulosin (C(max, t)) and its unbound concentration (C(max, u)) correlated with the maximal effect on IUP response [r(2) = 0.81 (p<0.01, n = 15) and r(2) = 0.84 (p<0.01, n = 15), respectively]. Each individual unbound plasma concentration did not correlate, however, with its associated inhibition of IUP response (r(2) = 0.04, n = 126). Although the plasma concentration of tamsulosin decreased nearly to the lower limit of quantitation 240 min after dosing, the prostatic and urethral concentrations remained high, i.e., 13 to 44 times greater than the plasma concentration. Our data demonstrate that the maximal inhibition by tamsulosin of IUP response is well correlated with the maximal plasma concentration in the early phase. The sustained effect of tamsulosin on IUP response that follows may be related to prostatic and urethral retention of tamsulosin.

Adrenergic alpha-Antagonists↗
PubMed1998

Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group.

OBJECTIVES: To evaluate the efficacy and safety of two once-daily doses of tamsulosin, the first selective alpha1A-antagonist studied in clinical trials. METHODS: Patients with benign prostatic hyperplasia (BPH) were randomized to receive either tamsulosin (0.4 and 0.8 mg/day) or placebo (n = 756). Primary efficacy parameters were improvement in the total American Urological Association (AUA) symptom score and peak urinary flow (Qmax). Secondary efficacy parameters were improvement in measurements at individual double-blind visits corresponding to the primary efficacy parameters; percentage of patients with a 3-mL/s increase in Qmax; total AUA irritative, obstructive, and bother scores; individual AUA symptom scores; total, irritative, obstructive, and individual Boyarsky symptom scores; average urinary flow rate and other uroflowmetric parameters; and investigator's global assessment. RESULTS: Statistically significant improvements in all efficacy parameters were observed in tamsulosin-treated compared with placebo-treated patients. Additionally, the 0.4-mg/day dose demonstrated a rapid onset of action (4 to 8 hours) based on Qmax after the first dose of double-blind medication. A review of the safety parameters demonstrated excellent tolerance at 1 week after the initial 0.4-mg/day dose and continued tolerance during the additional 12 weeks of 0.4- and 0.8-mg/day dosing. The incidence of positive orthostatic test results in the tamsulosin groups was comparable to that observed in the placebo group. Adverse events were comparable in the 0.4-mg/day tamsulosin and placebo groups and were somewhat higher in the 0.8-mg/day tamsulosin group. CONCLUSIONS: Tamsulosin was effective, safe, and well tolerated in the target BPH population at both the 0.4- and 0.8-mg/day dose levels, without the blood pressure-lowering effects typical of nonselective alpha-adrenergic antagonists.

Adrenergic alpha-Antagonists↗
PubMed1997

Comparison of tamsulosin with alfuzosin in the treatment of patients with lower urinary tract symptoms suggestive of bladder outlet obstruction (symptomatic benign prostatic hyperplasia). The European Tamsulosin Study Group.

OBJECTIVE: To compare the efficacy and tolerability of the alpha 1 A-subtype selective drug tamsulosin with the nonsubtype-selective agent alfuzosin in the treatment of patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), often termed symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: The study comprised 256 patients with benign prostatic enlargement and LUTS suggestive of BOO (symptomatic BPH) who received tamsulosin 0.4 mg once daily or alfuzosin 2.5 mg three times daily during 12 weeks of treatment. The response was assessed by measurements of maximum urinary flow rate (Qmax), a symptom score (Boyarsky) and blood pressure at regular intervals. RESULTS: Tamsulosin and alfuzosin produced comparable improvements in Qmax and total Boyarsky symptom score. Both treatments were well tolerated with respect to adverse events. Tamsulosin had no statistically significant effect on blood pressure compared with baseline but alfuzosin induced a significant reduction in both standing and supine blood pressure, compared with baseline (P < 0.05). CONCLUSION: Tamsulosin is the first adrenoceptor antagonist that is selective for the alpha 1 A-subtype; this specificity may explain its lack of effect on blood pressure compared with alfuzosin, an agent that is not receptor subtype specific. Moreover, this finding may partly explain why tamsulosin, in contrast to other currently available alpha 1-adrenoceptor antagonists, can be administered without dose titration. Another advantage compared with alfuzosin (and prazosin) is the once-daily dosing regimen of tamsulosin.

Adrenergic alpha-Antagonists↗
PubMed1998

Clinical comparison of selective and non-selective alpha 1A-adrenoceptor antagonists for bladder outlet obstruction associated with benign prostatic hyperplasia: studies on tamsulosin and terazosin in Chinese patients. The Chinese Tamsulosin Study Group.

To examine the clinical usefulness of selective and non-selective alpha 1-adrenoceptor antagonists, we compared a selective (tamsulosin) and non-selective (terazosin) alpha 1-adrenoceptor antagonists in the treatment of Chinese patients with benign prostatic hyperplasia (BPH). The study was a single-blind, randomized, multicenter design to compare a fixed dose of tamsulosin (0.2 mg) or terazosin (2 mg) given once daily after breakfast for four weeks. A total of 212 patients were enrolled with 201 patients included in the analysis. The primary variables assessed were changes in total International Prostatic Symptom Score (IPSS), maximum urinary flow rate (Qmax), and average urinary flow rate (AFR) four weeks after dosing. Adverse events were recorded through the treatment period. Both tamsulosin and terazosin produced significant improvements in total IPSS (total score of 11.8 +/- 4.5; decrease in 45.1% and total score of 13.3 +/- 5.3; decrease in 39.0%, respectively) (p < 0.001), Qmax (13.2 +/- 4.1 mL/s, 37.5% increase and 13.6 +/- 3.6 mL/s, 30.8% increase, respectively) (p < 0.001) and AFR (7.7 +/- 3.3 mL/s, 37.5% increase and 7.8 +/- 3.1 mL/s, 25.8% increase, respectively) (p < 0.001) at endpoint. Tamsulosin was superior to terazosin in improvement of total IPSS (p < 0.05) and AFR (p < 0.05). The incidence of adverse events by administration of tamsulosin was less than that by terazosin (13 and 50, respectively; p < 0.01). Among the adverse event, incidence of dizziness (p < 0.001) and hypotension (p < 0.01) by administration of terazosin were significantly greater than that by tamsulosin. Both systolic and diastolic blood pressure of sitting position decreased significantly in patients treated with terazosin (p < 0.01). These results suggest that tamsulosin, a selective alpha 1A-adrenoceptor antagonist, was superior to terazosin, a non-selective alpha 1-adrenoceptor antagonist, in efficacy and adverse events in patients with symptomatic BPH.

Adrenergic alpha-1 Receptor Antagonists↗
PubMed1997

Tamsulosin 0.4 mg once daily: tolerability in older and younger patients with lower urinary tract symptoms suggestive of benign prostatic obstruction (symptomatic BPH). The European Tamsulosin Study Group.

OBJECTIVES: To compare the safety and tolerability of tamsulosin 0.4 mg once daily in younger (< 65 years) and older (> or = 65 years) patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). METHODS: In a retrospective analysis of two European double-blind, randomized, placebo-controlled trials, safety was assessed in 574 younger or older patients treated with tamsulosin or placebo for 12 weeks. RESULTS: The incidence of adverse events, drug-related adverse events, serious adverse events and discontinuations due to adverse events was similar in older and younger tamsulosin-treated patients and was not significantly different from placebo. Although abnormal ejaculation was slightly more common in younger than older men receiving tamsulosin, the difference was not statistically significant from the placebo groups in both age groups. The incidence of adverse events possibly associated with vasodilation in tamsulosin-treated younger and older patients was 8.4 and 4.2%, respectively; these were comparable with the values for placebo-treated patients: 7.5 and 6%, respectively. Baseline systolic blood pressure was higher in older than younger patients, but there were minimal changes in blood pressure or pulse rate in tamsulosin- or placebo-treated patients in either age group. CONCLUSIONS: Tamsulosin is well tolerated and suitable for use in older and younger patients with LUTS suggestive of BPO (symptomatic BPH).

Adrenergic alpha-Antagonists↗
PubMed1998

[Clinical efficacy and reduction effect on prostatic volume of chlormadinone acetate combined with tamsulosin hydrochloride in benign prostatic hyperplasia patients insufficiently treated with tamsulosin hydrochloride only].

Alpha adrenergic blocker has become the first choice in the medical treatment of benign prostatic hyperplasia (BPH). The efficacy of alpha adrenergic blocker has been suggested to be related to the prostatic tissue components, and to be ineffective in treating the clinical symptoms caused by BPH in some cases. The efficacy and prostate reduction of an anti-androgenic agent, chlormadinone acetate, combined with alpha adrenergic blocker, tamsulosin hydrochloride, were evaluated using 40-BPH patients insufficiently treated with tamsulosin hydrochloride alone. Fifty mg of chlormadinone acetate and 0.2 mg of tamsulosin hydrochloride were administered orally once a day for 16 weeks to patients with a prostate subjective symptoms score, I-PSS, of greater than 13 or a peak flow rate of less than 12 ml/s, even after the treatment with 0.2 mg of tamsulosin hydrochloride alone for more than four weeks. Total I-PSS decreased significantly after four weeks. The total irritative symptom score did not change for 16 weeks, but the total obstructive symptom score decreased significantly, as did the total I-PSS. In objective data, the estimated volume of both total prostate and the transition zone on transrectal ultrasonogram decreased significantly at the end of the treatment, and the peak flow rate decreased significantly after 12 weeks. These findings suggest that the addition of chlormadinone acetate may be a reasonable alternative in the treatment of BPH patients responding insufficiently to tamsulosin hydrochloride alone, and that combination therapy using chlormadinone acetate and tamsulosin hydrochloride may be useful for BPH patients with serious obstructive symptoms.

Adrenergic alpha-Antagonists↗
PubMed1998

Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group.

OBJECTIVES: To evaluate the long-term efficacy and safety of once-daily tamsulosin (0.4 and 0.8 mg), a unique selective alpha1A-adrenoceptor antagonist in patients with benign prostatic hyperplasia (BPH). METHODS: This trial extended a 13-week, Phase III multicenter placebo-controlled, double-blind outpatient trial for an additional 40 weeks. Of 618 patients, 418 (68%) continued into the extension phase on the same double-blind medication and dose. The primary efficacy parameters were total American Urological Association (AUA) symptom score and maximum urinary flow (Qmax). RESULTS: The mean changes in AUA symptom score from baseline to end point were statistically significant in all groups (P <0.001). Significant improvements were observed in Qmax for both tamsulosin groups but not for the placebo group. The statistically significant improvements from baseline in efficacy parameters observed for each tamsulosin group at the end of the 13-week Phase III trial were maintained during the long-term extension phase. Tamsulosin at both dosages was well tolerated as maintenance therapy. Clinically significant orthostatic hypotension was not observed. Vital sign changes in either hypertensive or normotensive patients were not clinically significantly different across the three groups. CONCLUSIONS: Tamsulosin once-daily at 0.4 or 0.8 mg was shown to be effective, safe, and well tolerated in the target BPH population during long-term use.

Adrenergic alpha-Antagonists↗
PubMed1996

Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. Analysis of a multinational, multicentre, open-label study assessing the long-term efficacy and safety in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group.

OBJECTIVE: This open-label extension study evaluated the efficacy and safety of tamsulosin (0.4 mg as a modified release formulation) once daily in patients with benign prostatic enlargement, lower urinary tract symptoms and benign prostatic obstruction (symptomatic BPH) for up to 60 weeks. METHODS: Patients were enrolled from two European, 12-week, placebo-controlled trials. This 60-week interim analysis includes the patients (n = 244) randomized to tamsulosin in the two placebo-controlled trials. RESULTS: The significant improvements in the primary efficacy parameters, maximum urinary flow rate (Qmax) and total Boyarsky symptom score, that were observed during the placebo-controlled trials, were sustained throughout the long-term extension study. Mean Qmax improved from baseline (before initiation of tamsulosin) to endpoint by 13.7% (p < 0.001) and remained between 11.5 and 12 ml/s during the entire follow-up period. Total Boyarsky symptom score improved by 36.2% from baseline to endpoint (p < 0.001). Similarly, the percentage of treatment responders, defined as an increase in Qmax of > or = 30% or a decrease in total symptom score of > or = 25%, remained constant throughout the 60-week period. At endpoint, 69% of patients demonstrated this clinically significant total Boyarsky symptom score response. During the 60-week study period, 51 patients (21%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of which were dizziness and abnormal ejaculation, both occurring in 5% of patients. There were no clinically significant changes in blood pressure or pulse rate during the study. CONCLUSION: Long-term tamsulosin therapy is safe, well tolerated and improvements in urinary flow and symptoms are maintained for at least 60 weeks of treatment.

Administration, Oral↗
PubMed1999

Tamsulosin: 3-year long-term efficacy and safety in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction: analysis of a European, multinational, multicenter, open-label study. European Tamsulosin Study Group.

OBJECTIVE: This open-label extension study evaluated the efficacy and safety of tamsulosin (0.4 mg as a modified release formulation) once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) treated for up to 3 years. METHODS: Patients were enrolled from two European, 12-week, placebo-controlled trials. This analysis reports on 355 patients randomized originally to tamsulosin (n = 244) or placebo (n = 111) in the two placebo-controlled trials with follow-up data for up to 3 years. RESULTS: The significant improvements in the primary efficacy parameters, maximum urinary flow rate (Q(max)) and total Boyarsky symptom score that were observed during the placebo-controlled trials were sustained throughout the long-term extension study for up to 3 years in patients who remained on therapy. Mean Q(max) increased from baseline (range 0.7-1.8 ml/s; p < 0.05 vs. baseline) and remained between 11.5 and 12 ml/s during the entire follow-up period. Total Boyarsky symptom score also improved from baseline (range -3.7 to -4.1 (or -39 to -44%); p < 0.001 vs. baseline). Similarly, the percentage of treatment responders, defined as an increase in Q(max) of >/=30% or a decrease in total symptom score of >/=25%, remained constant throughout the 3-year period. The number of patients who had a clinically significant total Boyarsky symptom score response ranged between 69 and 80%. During the 3-year study period, 95 patients (27%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of which (occurring in </=6% of patients) were dizziness and abnormal ejaculation. There were no clinically significant changes in blood pressure or pulse rate during the study. CONCLUSION: Long-term tamsulosin therapy is safe, well-tolerated and improvements in urinary flow and symptoms are maintained in patients with LUTS suggestive of BPO who remain on treatment for up to 3 years.

Administration, Oral↗
PubMed2007

A prospective study of the efficacy of Serenoa repens, tamsulosin, and Serenoa repens plus tamsulosin treatment for patients with benign prostate hyperplasia.

INTRODUCTION: Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia (BPH) in recent times. The best described and studied phytotherapeutic agent is Serenoa repens (SR). MATERIALS AND METHODS: This prospective study was designed to have 3 arms including SR 320 mg per day (N = 20), Tamsulosin (TAM) 0.4 mg per day (N = 20) and SR + TAM (N = 20) to reveal the superiority or equivalence between these treatment regimens in BPH. RESULTS: The groups were not statistically different with regard to increase in maximal urinary flow rate (Q (max)) and decrease in International Prostate Symptom Score (I-PSS) (P > 0.05). No adverse effect was detected in SR therapy group. CONCLUSION: Treatment of BPH by both SR and TAM seems to be effective alone. None of them had superiority to another and additionally, combined therapy (SR + TAM) does not provide extra benefits. Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH.

Adrenergic alpha-1 Receptor Antagonists↗
PubMedDate not supplied

Multicenter drug use evaluation of tamsulosin and availability of guidance criteria for nonformulary use in the veterans affairs health system.

OBJECTIVE: The U.S. Department of Veterans Affairs (VA) Pharmacy Benefits Management Strategic Healthcare Group (PBM-SHG) and its Medical Advisory Panel developed national criteria (guidelines) for the appropriate use of tamsulosin in the VA. Drug use evaluation (DUE) was performed to (a) determine the prescribing patterns (indications and patient follow-up monitoring as measured by a clinician.s note regarding evaluation of therapeutic response or report of adverse drug event) of tamsulosin, (b) assess the impact of the availability (not active dissemination) of national criteria for nonformulary use of tamsulosin, and (c) project the cost avoidance if generic terazosin was substituted for tamsulosin in those patients who were prescribed tamsulosin outside of appropriate use criteria. METHODS: Geographically dispersed VA medical centers were identified for which tamsulosin utilization was significantly above and below the national average (4.8% of all prescriptions for alpha [alpha]-blockers) in January 2001. A data collection form for medical record abstraction was designed to capture the patient.s diagnosis, reported indication for tamsulosin, history of previous alpha-blocker use, tamsulosin follow-up evaluation, and the individual facility.s method of implementation of criteria for nonformulary use. Patients receiving a prescription for tamsulosin during a 3-month period preceding the posting of national criteria, and patients with a first-time prescription for tamsulosin during a 3-month period after the national criteria were posted were randomly selected by the PBM and assigned for chart review at each site. RESULTS: Data for 332 patients were collected from 6 different sites over a 6-month period for each pregroup and postgroup beginning August 2001 and January 2002, respectively. Tamsulosin was prescribed for appropriate indications in 66% of patients, potentially appropriate indications in 4% of patients, and inappropriate indications in 30% of patients. Of the 206 patients (62%) who were prescribed tamsulosin as a result of a reported adverse event with a previous alpha-blocker, only 29% of the cases (N = 59) showed evidence that an attempt was made to reduce the dose of the first alpha-blocker to abate the side effects. Followup monitoring was conducted in 78% of tamsulosin patients, of whom 55% reported effectiveness of tamsulosin, and 6% reported side effects attributable to tamsulosin. No meaningful differences in prescribing patterns were found between the pregroups and postgroups relative to the posting of the criteria for nonformulary use. Two sites had some form of the criteria made available to physicians, while 4 sites had not implemented the national criteria. Extrapolation of the results to the VA system-wide yielded a conservative estimate of 480,993 dollars in potential cost avoidance for 1 quarter (July to September 2002) when corrected for patients prescribed tamsulosin outside of the criteria for nonformulary use. CONCLUSIONS: Despite the availability of national criteria for nonformulary use of tamsulosin, the results reveal that these criteria were not followed by prescribers. The DUE reinforced the need for more effective implementation and dissemination of criteria for appropriate use of tamsulosin. A formal education process is necessary to encourage appropriate use of formulary alpha-blockers and to attenuate the increased cost associated with the inappropriate prescribing of the nonformulary drug.

Adrenergic alpha-Antagonists↗
PubMed2002

Tamsulosin: an update of its role in the management of lower urinary tract symptoms.

UNLABELLED: Tamsulosin is a selective alpha1A- and alpha1D-adrenoceptor antagonist. These alpha1-receptors are predominant in the prostate, prostatic capsule, prostatic urethra and bladder. The relaxation of prostate and bladder smooth muscles may result in improvement in maximum urine flow (Qmax) and reduction of lower urinary tract symptoms (LUTS). Tamsulosin 0.4 and 0.8 mg/day in a modified-release formulation was significantly more effective than placebo in large (n >250) double-blind, randomised, multicentre, 12- to 13- week clinical trials in patients with LUTS. A greater increase in Qmax from baseline was seen in patients receiving tamsulosin 0.4 or 0.8 mg/day (1.4 to 1.79 ml/sec from a baseline of 9.46 to 10.7 ml/sec) than in placebo recipients (0.4 to 0.93 ml/sec from a baseline of 9.75 to 10.4 ml/sec); the between-group difference was significant in two of three studies. Tamsulosin 0.4 or 0.8 mg/day improved total Boyarsky symptom scores from baseline by a significantly greater extent (by 3.0 to 5.2 points from a baseline of 9.5 to 11.1 points) than placebo (1.9 to 3.2 points from a baseline of 9.3 to 11.0 points). In noncomparative extension studies, the improvement in efficacy parameters with tamsulosin treatment was maintained for up to 4 years. Tamsulosin is effective in patients with mild to severe LUTS, patients with diabetes mellitus or those aged > or = 65 years and does not interfere with the antihypertensive action of nifedipine, enalapril or atenolol. Tamsulosin 0.4 mg/day for 12 weeks and tamsulosin 0.2 mg/day for 4 weeks were as effective as alfuzosin 2.5mg three times daily and terazosin 2 mg/day, respectively, in improving Qmax and symptom scores in randomised comparative trials. With the exception of a numberically greater incidence of abnormal ejaculation, dizziness and rhinitis, the incidence of adverse events with tamsulosin 0.4 mg/day was similar to that seen with placebo in randomised, double-blind studies. The overall incidence of symptoms indicative of orthostasis was 1.4% with tamsulosin 0.4 or 0.8 mg/day treatment. Tamsulosin had less effect on blood pressure than alfuzosin or terazosin. CONCLUSION: Tamsulosin, an alpha1-adrenoceptor antagonist, has a well established place in the treatment of LUTS and has a tolerability profile similar to that of placebo (apart from a higher incidence of abnormal ejaculation, dizziness and rhinitis). Comparative data have shown tamsulosin to be as effective as other alpha1-adrenoceptor antagonists at increasing Qmax and improving symptom scores. However, tamsulosin is unlikely to produce orthostatic hypotensive adverse effects or interfere with concomitant antihypertensive drug therapy. Therefore, tamsulosin is a useful therapeutic option in the management of patients with moderate to severe LUTS.

Adrenergic alpha-Antagonists↗
PubMed1997

A dose-ranging study of the efficacy and safety of tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist, in patients with benign prostatic obstruction (symptomatic benign prostatic hyperplasia).

OBJECTIVE: To evaluate the efficacy and safety in a dose-ranging study of tamsulosin (once-daily) as a modified-release formulation compared with placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO), and to establish the optimum dosage for phase III clinical studies. PATIENTS AND METHODS: Of 169 patients with LUTS associated with BPO enrolled in a 3 week placebo run-in period, 126 were subsequently randomized to receive placebo (28), or 0.2 mg (35), 0.4 mg (30), or 0.6 mg (33) of tamsulosin once daily for 4 weeks. Free-flow and pressure-flow measurements, and modified Boyarsky symptom scores were used to determine efficacy. Safety was evaluated by monitoring adverse events and vital signs (including 8 h after the first dose), and by laboratory determinations. RESULTS: Tamsulosin 0.4 mg and 0.6 mg produced significantly greater improvements in maximum urinary flow rate (Qmax) (2.2 mL/s, 22.6%, and 1.8 mL/s, 20.2%, respectively) than did placebo (-0.1 mL/s, -0.9%). The results from the pressure-flow studies confirmed the results for Qmax in the free flow studies, with optimum and significant effects for tamsulosin 0.4 mg. This also applied for detrusor pressure at maximum flow, which decreased by 26.6 cmH2O (-28.2%) on 0.4 mg tamsulosin whereas it increased by 4.9 cm H2O (5.7%) on placebo. The greatest reductions in total symptom score were obtained with tamsulosin 0.4 mg and 0.6 mg (4.1, -28.7%, and 4.4 points, -28.2%, respectively) compared with reductions of 3.4 (-20.1%) in the tamsulosin (0.2 mg) and 2.9 points (-17.7%) in the placebo groups. The difference in effects on total symptom score between treatment groups was not statistically significant, which can be attributed to the small sample size. Tamsulosin was well tolerated; at least one adverse event was reported by 29%, 23%, 27% and 36% of patients in the placebo and tamsulosin 0.2 mg, 0.4 mg and 0.6 mg groups, respectively. There were no apparent tamsulosin dose-dependent changes in vital signs from baseline to the end of 4 weeks of randomized treatment. Tamsulosin caused no statistically significantly greater changes in blood pressure than placebo during the initial 8 h after the first dose. There were no clinically significant changes in laboratory variables. CONCLUSION: Tamsulosin is well tolerated and effective in improving urinary flow and relieving LUTS associated with BPO. Optimal effects are achieved with tamsulosin 0.4 mg administered once daily.

Adrenergic alpha-Antagonists↗
PubMed2003

Tamsulosin for benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate which can result in bothersome lower urinary tract symptoms. The treatment goal for men with BPH is to relieve these bothersome symptoms. OBJECTIVES: This systematic review assessed the effects of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) compatible with BPH. SEARCH STRATEGY: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers. SELECTION CRITERIA: Trials were eligible if they (1) randomized men with BPH to receive tamsulosin in comparison with placebo, other BPH medications or surgical interventions and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements, and (3) had a treatment duration of 30 days or longer. Eligibility was assessed by at least two independent observers. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, and outcomes were extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of tamsulosin with placebo, medical or surgical interventions was the change in urologic symptom scale scores. Secondary outcomes included changes in urinary flow measures (peak urine flow rate). The main outcome measure for adverse effects was the number of men reporting adverse effects. MAIN RESULTS: Fourteen studies involving 4,122 subjects met inclusion criteria. Study duration ranged from 4-26 weeks, and no placebo-controlled study lasted longer than 13 weeks. The mean age of subjects was 64 years. Baseline symptom scores and urine flow rates demonstrated that men had moderate LUTS. Tamsulosin improved symptoms and peak urine flow relative to placebo. The weighted mean differences (WMD) for mean change from baseline for the Boyarsky symptom score for 0.4 mg and 0.8 mg doses of tamsulosin relative to placebo were -1.1 points (95% CI = -1.49, -0.72; 12% improvement) and -1.6 points (95% CI = -2.3, -1.0; 16% improvement), respectively. The WMD for mean change from baseline in peak urine flow were 1.1 mL/sec (95% CI = 0.59, 1.51) and 1.1 mL/sec (95% CI= 0.65, 1.48) for 0.4 mg and 0.8 mg, respectively. Tamsulosin (0.2 mg-0.4 mg) was as effective as other alpha antagonists and the phytotherapeutic agent Permixon in improving symptoms and flow rates though the doses of all alpha-antagonists studied may not have been optimal. Discontinuations from treatment for any reason and discontinuations "due to adverse events" were similar in the low dose tamsulosin (0.2 mg) and placebo groups but increased to 16% in trials utilizing a 0.8 mg dose of tamsulosin. Low dose tamsulosin was generally well tolerated although not all the trials reported specific adverse events. The most frequently reported adverse events that were significantly greater than placebo included dizziness, rhinitis and abnormal ejaculation. Adverse effects increased markedly as tamsulosin dosing increased, and were reported in 75% of men receiving the 0.8 mg dose. Men receiving a 0.2 mg dose tamsulosin were less likely to discontinue treatment compared to men receiving terazosin. REVIEWER'S CONCLUSIONS: Tamsulosin provided a small to moderate improvement in urinary symptoms and flow compared to men receiving placebo in men with BPH. Effectiveness was similar to other alpha antagonists and increased only slightly with higher doses. Long term effectiveness and ability to reduce complications due to BPH progression could not be determined. Adverse effects were generally mild but their frequency, including withdrawals, increased substantially with the higher doses that are generally available for treatment.

Adrenergic alpha-Antagonists↗
PubMed2006

Effects of acute treatment with tamsulosin versus alfuzosin on ejaculatory function in normal volunteers.

PURPOSE: The frequency of ejaculatory dysfunction in men varies among the alpha-blockers used in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. We assessed the effect of acute administration of tamsulosin, alfuzosin and placebo on ejaculate volume and sperm concentration in post-ejaculate urine, and addressed the mechanism of action of tamsulosin and alfuzosin on ejaculation. MATERIALS AND METHODS: Using a randomized, 3-way crossover design, the effects of 5 days of treatment with 0.8 mg tamsulosin daily, 10 mg alfuzosin daily and placebo on ejaculation in healthy adult men were compared. The primary end points of the study were ejaculate volume and sperm concentration in post-ejaculate urine on each treatment. To aid in clinical interpretation of primary efficacy end points, each primary end point was transformed into a binary outcome, that is subjects with a greater than 20% decrease in ejaculate volume and subjects with a greater than 20% increase in sperm concentration in post-ejaculate urine. RESULTS: In healthy volunteers who completed the study (48), tamsulosin resulted in significantly decreased ejaculate volume (-2.4 +/- 0.17 ml) compared to alfuzosin (+0.3 +/- 0.18 ml, p < 0.0001 vs tamsulosin) or placebo (+0.4 +/- 0.18 ml, p < 0.0001 vs tamsulosin, p = nonsignificant vs alfuzosin). Among completers the incidence of more than 20% decreased ejaculate volume was significantly greater with tamsulosin (89.6%) compared to alfuzosin (20.8%, p < 0.0001 vs tamsulosin) or placebo (12.5%, p < 0.0001 vs tamsulosin, p = nonsignificant vs alfuzosin). While on tamsulosin 35.4% of 48 completers had complete lack of ejaculation (anejaculation) and no subjects experienced anejaculation while on alfuzosin or placebo. CONCLUSIONS: On 0.8 mg tamsulosin daily ejaculatory function in subjects was marked by decreased ejaculate volume in almost 90% of subjects and anejaculation in approximately 35% of participants. These ejaculatory disorders with tamsulosin were not attributed to retrograde ejaculation. In contrast, anejaculation was not observed in any subjects in the alfuzosin or placebo groups.

Adrenergic alpha-Antagonists↗