dutasteride and Urinary-Retention

Benign prostatic hyperplasia (BPH) is a chronic common disease in many men and is often associated with bothersome lower urinary tract symptoms (LUTS). In many men the disease presents with a progressive course that can result in complications such as acute urinary retention (AUR) and BPH-related surgery. Several factors have been associated with progression such as age and prostate volume (PV). Serum prostate-specific antigen (PSA) level, closely correlated with PV is another useful parameter for determining the risk of BPH progression. Medical therapy is the first and the most frequently used treatment for BPH; surgical treatments represent a second-line option when medical therapy is non effective or when complications are associated. Alpha-blockers achieve rapid symptom relief but do not reduce the overall risk of AUR or BPH-related surgery, presumably because they have no effect on PV. 5alpha-reductase inhibitors (5ARIs) display their effectiveness at long distance decreasing PV; this results in improved symptoms, urinary flow and quality of life, and a reduced risk of AUR and BPH-related surgery. Combination therapy provides greater and more durable benefits than either monotherapy and is a recommended option in treatment guidelines. The Combination of dutasteride and Tamsulosin (CombAT), at a pre-planned 2-year analysis, has shown sustained symptom improvement with combination therapy, significantly greater than with either monotherapy. CombAT is also the first study to show benefit in improving BPH symptoms for combination therapy over the alpha-blocker, tamsulosin, from 9 months of treatment. PubMed database has been used to identify publications on the epidemiology of BPH, risk factors for BPH progression and drug treatment options for the management of BPH.

Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Age Factors; Antineoplastic Agents, Hormonal; Antineoplastic Combined Chemotherapy Protocols; Azasteroids; Biomarkers, Tumor; Disease Progression; Dutasteride; Enzyme Inhibitors; Evidence-Based Medicine; Humans; Male; Practice Guidelines as Topic; Prostate-Specific Antigen; Prostatic Hyperplasia; Quality of Life; Risk Factors; Sulfonamides; Tamsulosin; Treatment Outcome; Urinary Retention

Dutasteride is a new 5-alpha reductase inhibitor for the treatment of men with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. It has been available in the UK since March 2003. It is a competitive inhibitor of both type I and type II isoforms of the 5-alpha reductase enzyme that converts testosterone to the more potent androgen, dihydrotestosterone. Randomised controlled studies have shown dutasteride to be statistically more effective than placebo in reducing lower urinary tract symptoms and increasing maximum urinary flow rates. This is a consequence of a reduction in serum dihydrotestosterone and hormone dependent prostate volume. Dutasteride has also been shown to decrease the absolute risk of urinary retention and the need for prostate-related surgery when compared to placebo taken over a 24-month period. In this review article we discuss the pharmacology and clinical effects of dutasteride, a new dual-acting 5-alpha reductase inhibitor.

Topics: 5-alpha Reductase Inhibitors; Azasteroids; Dutasteride; Humans; Male; Prostatic Hyperplasia; Treatment Outcome; Urinary Retention

To assess the effectiveness and safety of dutasteride 0.5 mg + tamsulosin 0.2 mg combination compared with tamsulosin 0.2 mg in Asian men with moderate-to-severe benign prostatic hyperplasia.. A 4-week, single-blind, placebo, run-in was followed by a 2-year double-blind randomized controlled trial in men age ≥50 years with symptomatic benign prostatic hyperplasia, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen ≥1.5 and ≤10 ng/mL, peak urinary flow >5 and ≤15 mL/s, and voided volume of ≥125 mL. Participants were randomized to oral daily dutasteride 0.5 mg + tamsulosin 0.2 mg combination or tamsulosin 0.2 mg. The primary efficacy end-point was change in International Prostate Symptom Score at year 2.. Data from 607 participants showed a significant reduction in International Prostate Symptom Score (P < 0.05) at month 24, along with greater improvements (P ≤ 0.006) in peak urinary flow at every assessment and significant prostate volume reduction at months 12 and 24 (P < 0.001) in the combination group. Combination therapy was associated with a significant reduction in the risk of acute urinary retention or benign prostatic hyperplasia-related surgery (P = 0.012), primarily due to a significant reduction in the risk of acute urinary retention (P = 0.005). The safety and tolerability profile of combination therapy was consistent with the known profiles for the individual monotherapies.. Dutasteride 0.5 mg + tamsulosin 0.2 mg combination therapy showed better clinical outcomes than tamsulosin 0.2 mg monotherapy, making it an effective and safe treatment option for Asian men with moderate-to-severe benign prostatic hyperplasia.

Topics: 5-alpha Reductase Inhibitors; Aged; Aged, 80 and over; Asian People; Double-Blind Method; Drug Therapy, Combination; Dutasteride; Humans; Male; Middle Aged; Prostate-Specific Antigen; Prostatic Hyperplasia; Severity of Illness Index; Single-Blind Method; Taiwan; Tamsulosin; Treatment Outcome; Urinary Retention

This study aimed to assess the efficacy of combination therapy with dutasteride and silodosin in patients with acute urinary retention (AUR) caused by benign prostatic hyperplasia (BPH). Eighty consecutive patients with a first episode of AUR were enrolled in this study. All patients received silodosin 8 mg and dutasteride 0.5 mg daily. Trial without catheter (TWOC) was attempted every 2 weeks until 12 weeks after the initiation of medication. The primary endpoint was the rate of catheter-free status at 12 weeks. Voided volume (VV), postvoid residual urine (PVR), uroflowmetry, International Prostatic Symptoms Score (IPSS), and quality of life due to urinary symptoms (IPSS-QOL) were also measured. All patients were followed up for more than 12 weeks and were included in this analysis. The success rate of TWOC at 12 weeks was 88.8%. VV and maximum urinary flow rate were significantly higher at 2, 4, 8, and 12 weeks compared with the time of AUR (P < 0.001). IPSS and IPSS-QOL were significantly lower at 2, 4, 8, and 12 weeks compared with the time of AUR (P < 0.001). In conclusion, a combination of dutasteride and silodosin therapy may be effective and safe for patients with AUR due to BPH.

Topics: Acute Disease; Aged; Aged, 80 and over; Drug Therapy, Combination; Dutasteride; Humans; Indoles; Kaplan-Meier Estimate; Male; Prospective Studies; Prostatic Hyperplasia; Time Factors; Treatment Outcome; Urinary Retention; Urination

To examine, using post hoc analysis, the influence of baseline variables on changes in international prostate symptom score (IPSS), maximum urinary flow rate (Qmax ) and IPSS quality of life (QoL) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) treated with either the α-blocker tamsulosin or the dual 5-alpha reductase inhibitor dutasteride, alone or in combination, as part of the 4-year Combination of Avodart and Tamsulosin (CombAT) study.. CombAT was a 4-year, multicentre, randomized, double-blind, parallel-group study in 4844 men ≥50 years of age with a clinical diagnosis of BPH by medical history and physical examination, an IPSS ≥12 points, prostate volume (PV) ≥30 mL, total serum PSA level ≥1.5 ng/mL, and Qmax >5 mL/s and ≤15 mL/s with a minimum voided volume ≥125 mL. Eligible subjects were randomized to receive oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. Baseline variable subgroups analysed were as follows: PV (30 to <40; 40 to <60; 60 to <80; ≥80 mL), PSA level (1.5 to <2.5; 2.5 to <4; ≥4 ng/mL), age (median: <66, ≥66 years), IPSS (median: <16, ≥16; IPSS thresholds, <20, ≥20), IPSS QoL score (question 8, Q8) (median: <4, ≥4), Qmax (median: <10.4, ≥10.4 mL/s), BPH impact index (BII) (median: <5, ≥5) and body mass index (BMI, median: <26.8, ≥26.8 kg/m(2) ). Within each baseline variable subgroup, changes in IPSS, Qmax and IPSS QoL Q8 from baseline were evaluated using a generalized linear model with effects for baseline IPSS, Qmax or IPSS QoL Q8 and treatment group at each post-baseline assessment up to and including the month 48 visit using a last observation carried forward approach. The treatment comparisons of combination therapy vs dutasteride and combination therapy vs tamsulosin were performed from the general linear model with statistical significance defined as P ≤ 0.01.. Combination therapy resulted in a significantly greater improvement from baseline IPSS at 48 months vs tamsulosin monotherapy across all baseline subgroups. The benefit of combination therapy over dutasteride was confined to groups with lower baseline PV (<60 mL) and PSA (<4 ng/mL). In groups with baseline PV ≥60 mL and PSA ≥4 ng/mL, dutasteride and combination therapy show similar improvements in symptoms. Combination therapy resulted in significantly improved Qmax compared with tamsulosin but not dutasteride monotherapy. Qmax improvement appeared to increase with PV and PSA level in combination therapy subjects. The proportion of subjects with an IPSS QoL ≤2 (at least mostly satisfied) at 48 months was significantly higher with combination therapy than with dutasteride for subgroups with PV 40-60 mL and PSA level <4 ng/mL and than with tamsulosin for all PSA subgroups and PV subgroups ≥40 mL.. CombAT data support the use of long-term combination therapy with dutasteride and tamsulosin in patients considered at risk for progression of BPH, as determined by high PV (≥30 mL) and high PSA (≥1.5 ng/mL). Combination therapy, dutasteride monotherapy and tamsulosin monotherapy all improved Qmax , but to different extents (combination therapy > dutasteride >> tamsulosin), suggesting that dutasteride contributes most to the Qmax benefit in combination therapy. Combination therapy provided consistent improvement over tamsulosin in LUTS across all analysed baseline variables at 48 months. Compared with dutasteride, the superiority of combination therapy at 48 months was shown in patients with PV <60 mL or PSA <4 ng/mL.

Topics: 5-alpha Reductase Inhibitors; Acute Disease; Administration, Oral; Aged; Azasteroids; Double-Blind Method; Drug Therapy, Combination; Dutasteride; Humans; Male; Middle Aged; Prostate-Specific Antigen; Prostatic Hyperplasia; Prostatism; Sulfonamides; Tamsulosin; Treatment Outcome; Urinary Retention; Urination

To assess the role of dutasteride in preventing clinical progression of benign prostatic hyperplasia in asymptomatic men with larger prostates.. Post hoc analysis of four year, double blind Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. 1617 men randomised to dutasteride or placebo with a prostate size >40 mL and baseline International Prostate Symptom Score (IPSS) <8. Subjects who took medications for benign prostatic hyperplasia were excluded at study entry.. Placebo or dutasteride 0.5 mg daily.. Comparison of risk of clinical progression of benign prostatic hyperplasia at four years (defined as a ≥ 4 point worsening on IPSS, acute urinary retention, urinary tract infection, or surgery related to benign prostatic hyperplasia).. 825 participants took placebo, 792 took dutasteride. A total of 464 (29%) experienced clinical progression benign prostatic hyperplasia, 297(36%) taking placebo, 167 (21%) taking dutasteride (P<0.001). The relative risk reduction was 41% and the absolute risk reduction 15%, with a number needed to treat (NNT) of 7. Among men who had acute urinary retention and surgery related to benign prostatic hyperplasia, the absolute risk reduction for dutasteride was 6.0% and 3.8%, respectively. On multivariable regression analysis adjusting for covariates, dutasteride significantly reduced clinical progression of benign prostatic hyperplasia with an odds ratio of 0.47 (95% CI 0.37 to 0.59, P<0.001). Analysis of time to first event yielded a hazard ratio of 0.673 (P<0.001) for those taking dutasteride. Sexual adverse events were most common and similar to prior reports.. Further prospective studies may be warranted to demonstrate generalisability of these results.. This study is the first to explore the benefit of treating asymptomatic or mildly symptomatic men with an enlarged prostate. Dutasteride significantly decreased the incidence of benign prostatic hyperplasia clinical progression.

Topics: 5-alpha Reductase Inhibitors; Aged; Asymptomatic Diseases; Azasteroids; Disease Progression; Double-Blind Method; Drug Monitoring; Dutasteride; Erectile Dysfunction; Humans; Male; Middle Aged; Prostate; Prostate-Specific Antigen; Prostatic Hyperplasia; Regression Analysis; Risk Assessment; Treatment Outcome; Urinary Retention; Urinary Tract Infections

• To investigate the influence of baseline variables on the 4-year incidence of acute urinary retention (AUR), benign prostatic hyperplasia (BPH)-related surgery and overall clinical progression in men treated with tamsulosin, dutasteride, or a combination of both.. • The 4-year Combination of Avodart® and Tamsulosin (CombAT) study was a multicenter, randomized, double-blind, parallel-group study of clinical outcomes in men aged ≥ 50 years with symptomatic (International Prostate Symptom Score [IPSS]≥ 12) BPH, with prostate-specific antigen (PSA) levels of ≥ 1.5 ng/mL and ≤ 10 ng/mL, and a prostate volume (PV) of ≥ 30 mL. • Eligible patients received tamsulosin 0.4 mg, dutasteride 0.5 mg, or a combination of both. • The primary endpoint was time to first AUR or BPH-related surgery. Secondary endpoints included clinical progression of BPH and symptoms. Posthoc analyses of the influence of baseline variables (including age, IPSS health-related quality of life [HRQL], PV, PSA, IPSS, peak urinary flow rate [Q(max) ] and body-mass index [BMI]) on the incidence of AUR or BPH-related surgery, clinical progression of BPH, and symptoms were performed.. • There were 4844 men in the intent-to-treat population. Overall baseline characteristics were similar across all patient groups. • Regardless of baseline subgroup, the incidence of AUR or BPH-related surgery was higher in men treated with tamsulosin than in those treated with dutasteride or combined therapy. • Combined therapy was statistically better than tamsulosin in reducing the risk of AUR or BPH-related surgery in subgroups of baseline PV > 42.0 mL, in all subgroups of baseline PSA level, and all other baseline subgroups (P ≤ 0.001). • Across treatment groups, the incidence of clinical progression was highest in men with a baseline IPSS of < 20 or IPSS HRQL score of < 4. The incidence of clinical progression was also higher in men receiving tamsulosin than dutasteride or combined therapy in all baseline subgroups, except for men with a baseline PV of < 40 mL. Combined therapy reduced the relative risk (RR) of clinical progression compared with tamsulosin across all baseline subgroups and compared with dutasteride across most baseline subgroups. • Symptom deterioration was the most common progression event in each treatment group regardless of baseline subgroup, except in those men with an IPSS of ≥ 20 at baseline. Combined therapy reduced the RR of symptom deterioration compared with tamsulosin across all but one baseline subgroup (the reduction was not significant for men with a baseline PV of < 40 mL) and compared with dutasteride in most subgroups.. • Men with a baseline PV of ≥ 40 mL and any baseline PSA level of ≥1.5 ng/mL had greater reductions in the RR of AUR or BPH-related surgery and greater reductions in the RR of clinical progression and symptom deterioration on combined therapy or dutasteride monotherapy than on tamsulosin monotherapy. • These analyses support the long-term use of combined therapy with dutasteride plus tamsulosin in men with moderate-to-severe BPH symptoms and a slightly enlarged prostate.

Topics: 5-alpha Reductase Inhibitors; Aged; Azasteroids; Drug Therapy, Combination; Dutasteride; Epidemiologic Methods; Humans; Male; Middle Aged; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Treatment Outcome; Urinary Retention

CombAT (Combination of Avodart and Tamsulosin) was a randomised, double-blind study in men (n=4844) aged ≥ 50 years with a clinical diagnosis of BPH. Patients were randomised to daily tamsulosin 0.4 mg, dutasteride 0.5 mg or both for 4 years. The primary endpoint was time to acute urinary retention (AUR) or BPH-related surgery. Secondary endpoints included BPH clinical progression, symptoms and maximum urinary flow rate. A post hoc analysis of data from the European subgroup was conducted. A total of 2925 men were randomised to treatment in Europe as part of CombAT (tamsulosin, n=972; dutasteride, n=970; combination, n=983). Combination therapy significantly reduced the relative risk of AUR or BPH-related surgery compared with either monotherapy at 4 years, and also significantly reduced the risk of BPH clinical progression. Combination therapy also provided significantly greater symptom improvement than either monotherapy at 4 years. Safety and tolerability of dutasteride plus tamsulosin was consistent with previous experience of this combination and with the monotherapies. These data provide further evidence to support the use of long-term combination therapy (dutasteride plus tamsulosin) in men with moderate-to-severe lower urinary tract symptoms because of BPH and prostatic enlargement. The results in the European subgroup are generally consistent with those in the overall study population.

Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Aged; Azasteroids; Disease Progression; Drug Therapy, Combination; Dutasteride; Humans; Male; Middle Aged; Prostatic Hyperplasia; Severity of Illness Index; Sulfonamides; Tamsulosin; Treatment Outcome; Urinary Retention

To investigate the effect of dutasteride versus placebo on the symptoms and associated complications of male lower urinary tract symptoms and benign prostatic hyperplasia (BPH) across a range of prostate volumes and BPH symptoms in men evaluated for prostate cancer risk reduction in the 4-year REduction by DUtasteride of prostate Cancer Events (REDUCE) trial.. REDUCE was a multicenter, randomized, double-blind, placebo-controlled study of prostate cancer risk reduction with daily dutasteride 0.5 mg or placebo. Eligible men were aged 50-75 years, with a prostate-specific antigen level of 2.5-10 ng/mL and a prostate volume of ≤80 cm3. The prespecified and post hoc analyses were performed on the incidence of acute urinary retention, BPH-related surgery, and urinary tract infections, as well as on changes in prostate volume, International Prostate Symptom Score, BPH Impact Index, and maximal urinary flow rate (Qmax).. A total of 8122 men were included in the efficacy population. During the 4-year study, the International Prostate Symptom Score increased in placebo-treated patients, while dutasteride-treated patients had a stabilized or decreased International Prostate Symptom Score and improved BPH Impact Index and quality of life due to urinary symptom scores across all prostate volume quintiles (including prostate glands smaller than those studied in previous dutasteride trials). 48 months, the incidence of acute urinary retention or BPH-related surgery was significantly less in the dutasteride group (2.5%) than in the placebo group (9%) overall (P<.001) and in each baseline prostate volume quintile (P<.01).. During the 4-year study, dutasteride was associated with a decreased risk of BPH progression in men with mild-to-moderate symptoms and normal or enlarged prostates.

Topics: 5-alpha Reductase Inhibitors; Aged; Azasteroids; Double-Blind Method; Dutasteride; Humans; Male; Middle Aged; Organ Size; Prostate; Prostatic Hyperplasia; Prostatic Neoplasms; Risk Reduction Behavior; Urinary Retention

Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement.. To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression.. The Combination of Avodart and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men > or =50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score > or =12, prostate volume > or =30 cm(3), prostate-specific antigen 1.5-10 ng/ml, and maximum urinary flow rate (Q(max)) >5 and < or =15 ml/s with minimum voided volume > or =125 ml.. Oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both.. The 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Q(max), prostate volume, safety, and tolerability.. Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation.. The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. CLINICALTRIALS.GOV IDENTIFIER: NCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).

Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-Antagonists; Aged; Azasteroids; Brazil; Disease Progression; Double-Blind Method; Drug Therapy, Combination; Dutasteride; Enzyme Inhibitors; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; North America; Proportional Hazards Models; Prostatic Hyperplasia; Risk Assessment; Risk Factors; Severity of Illness Index; Sulfonamides; Tamsulosin; Time Factors; Treatment Outcome; Urinary Retention; Urologic Surgical Procedures, Male

The efficacy and tolerability of dutasteride (0.5 mg daily for 2 years) in African-Americans (n=161), compared with Caucasians (n=3961), was assessed in a post hoc analysis of data from three Phase III clinical trials. Dutasteride significantly reduced serum dihydrotestosterone levels by >90% and significantly improved subjective (symptom score) and objective (prostate volume, peak urinary flow rate, risk of benign prostatic hyperplasia-related surgery and acute urinary retention) outcomes in both African-Americans and Caucasians. For all efficacy measures, there was no statistically significant treatment-by-race interaction and dutasteride was well tolerated in both racial groups. Therefore, dutasteride demonstrated similar efficacy and safety profiles in African-Americans and Caucasians.

Topics: 5-alpha Reductase Inhibitors; Acute Disease; Aged; Aged, 80 and over; Azasteroids; Biomarkers; Black or African American; Dihydrotestosterone; Double-Blind Method; Dutasteride; Enzyme Inhibitors; Humans; Linear Models; Male; Middle Aged; Proportional Hazards Models; Prostate-Specific Antigen; Prostatic Hyperplasia; Severity of Illness Index; Testosterone; Treatment Outcome; Urinary Retention; Urination; Urodynamics; Urologic Surgical Procedures, Male; White People

To examine the effect of the dual-action 5alpha-reductase inhibitor dutasteride on benign prostatic hyperplasia (BPH)-specific health status, as measured by the BPH Impact Index (BII), and to identify baseline and treatment risk factors for those most bothered by their BPH symptoms at the end of the protocol.. Data were derived from three randomized, double-blind, placebo-controlled, 2-year studies conducted in 4325 men with lower urinary tract symptoms caused by benign prostatic enlargement. Each study comprised a 1-month single-blind placebo run-in period, followed by randomization to oral dutasteride 0.5 mg once daily or placebo for 2 years. Patients eligible for inclusion were consenting men aged >/= 50 years with moderate to severe symptoms (American Urological Symptom Index, AUA-SI, score >/= 12), a prostate volume of >/= 30 mL, a serum prostate-specific antigen (PSA) level of >/= 1.5 or < 10 ng/mL, and a maximum urinary flow rate (Qmax) of /= 5 (greatest symptomatic burden) treatment with dutasteride improved the scores by 2.41, while the scores in placebo-treated patients only improved by 1.64. Dutasteride-treated patients with a baseline BII score of < 5 (least symptom burden) had a clinically significant improvement in health status, while placebo-treated patients deteriorated. Regression analysis showed that men with a combination of a baseline BII item-3 score of 3 (bothered a lot) and a high symptom score (AUA-SI >/= 20) were more likely to be bothered by their symptoms at the end of the study. Men receiving placebo were also more likely to be bothered at the end of the study than were those receiving dutasteride.. Dutasteride treatment is associated with clinically significant improvements in BII score, reflecting improvements in the quality of life of men with BPH. Taken together with previously reported improvements in prostate volume, lower urinary tract symptoms and urinary flow, and diminution of the risk of acute urinary retention and the need for BPH-related surgery, dutasteride offers demonstrable efficacy in the management of BPH.

Topics: 5-alpha Reductase Inhibitors; Azasteroids; Dutasteride; Health Status; Humans; Male; Middle Aged; Prostatic Hyperplasia; Quality of Life; Risk Factors; Single-Blind Method; Treatment Outcome; Urinary Retention

It is unclear how cumulative multivariable effects of clinically relevant covariates impact response to pharmacological treatments for lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE).. To develop models to predict treatment response in terms of International Prostate Symptom Score (IPSS) and the risk of acute urinary retention (AUR) or BPE-related surgery, based on large data sets and using as predictors baseline characteristics that commonly define the risk of disease progression.. A total of 9167 patients with LUTS/BPE at risk of progression in three placebo-controlled dutasteride trials and one comparing dutasteride, tamsulosin, and dutasteride + tamsulosin combination therapy (CT) were included in the analysis to predict response to placebo up to 24 mo and active treatment up to 48 mo.. The vast majority of patients benefit from dutasteride or CT when compared with tamsulosin alone. The predicted IPSS improvement with dutasteride or CT increased with greater PV and severity of symptoms at baseline. The tamsulosin effect was lower with greater baseline PV and tended to decrease over time. Predicted AUR/surgery risk was greater with tamsulosin versus CT or dutasteride; this risk increased with larger PV, higher PVR, and lower Q. Predictive modelling based on large data sets and visualisation of the risk for individual profiles can improve our understanding of how risk factors for disease progression interact and affect response to different treatments, reinforcing the importance of an individualised approach for LUTS/BPE management.. We used data from previous studies to develop statistical models for predicting how men with lower urinary tract symptoms or benign prostate enlargement and at risk of disease complications respond to certain treatments according to their individual characteristics.

Topics: Azasteroids; Disease Progression; Drug Therapy, Combination; Dutasteride; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Treatment Outcome; Urinary Retention

To evaluate the effect of delayed start of combination therapy (CT) with dutasteride 0.5 mg and tamsulosin 0.4 mg on the risk of acute urinary retention or benign prostatic hyperplasia (BPH)-related surgery (AUR/S) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) at risk of disease progression.. Using a time-to-event model based on pooled data from 10,238 patients from Phase III/IV dutasteride trials, clinical trial simulations (CTS) were performed to assess the risk of AUR/S up to 48 months in moderate-to-severe LUTS/BPH patients following immediate and delayed start of CT for those not responding to tamsulosin monotherapy. Simulation scenarios (1300 subjects/arm) were investigated, including immediate start (reference) and alternative delayed start (six scenarios 1-24 months). AUR/S incidence was described by Kaplan-Meier survival curves and analysed using log-rank test. The cumulative incidence of events as well as the relative and attributable risks were summarised stratified by treatment.. Survival curves for patients starting CT at month 1 and 3 did not differ from those who initiated CT immediately. By contrast, significant differences (p < 0.001) were observed when switch to CT occurs ≥ 6 months from the initial treatment. At month 48, AUR/S incidence was 4.6% vs 9.5%, 11.0% and 11.3% in patients receiving immediate CT vs. switchers after 6, 12 and 24 months, respectively.. Start of CT before month 6 appears to significantly reduce the risk of AUR/S compared with delayed start by ≥ 6 months. This has implications for the treatment algorithm for men with LUTS/BPH at risk of disease progression.

Topics: 5-alpha Reductase Inhibitors; Acute Disease; Adrenergic alpha-1 Receptor Antagonists; Disease Progression; Drug Combinations; Dutasteride; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Risk Assessment; Severity of Illness Index; Symptom Assessment; Tamsulosin; Time Factors; Urinary Retention

In the treatment of lower urinary tract in combination with benign prostatic hyperplasia, alpha-blockers are most often prescribed, but in certain cases, the appointment of 5-reductase inhibitors is justified. This article analyzes relevant studies of recent years regarding the validity of the use of dutasteride (Gardium) 0.5 mg per day. Dutasteride can effectively reduce the total score of IPSS to 30%. It increases a volumetric urine flow rate 2-3 ml/sec, significantly reduces the chance of acute urinary retention in 70-88% in various studies, and reduces the frequency of hospitalization by 66%. Dutasteride also increases the likelihood of timely diagnosis of prostate cancer by 23%. Erectile dysfunction is a common side effect, serving as a reason for refusal of therapy is erectile dysfunction, which occurs in 16% of cases, and the probability of which is the highest in the first months during conservative therapy.

Topics: 5-alpha Reductase Inhibitors; Dutasteride; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Treatment Outcome; Urinary Retention

Prostate biopsy complications have important consequences that may affect patient compliance with rebiopsy schemes. However, to our knowledge this has not been studied in earnest. Thus, we evaluated whether previous prostate biopsy related complications and the type of complication were associated with repeat prostate biopsy compliance in a clinical trial with study mandated systematic biopsies.. We retrospectively analyzed the records of 4,939 men 50 to 75 years old who underwent 2-year prostate biopsy and were recommended to undergo 4-year prostate rebiopsy in the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study. The analyzed biopsy complications were hematuria, urinary tract infection, acute urinary retention and hemospermia.. A total of 260 men (5.3%) had a 2-year prostate biopsy related complication, including hematuria in 180 (3.6%), urinary tract infection in 36 (0.7%), acute urinary retention in 26 (0.5%) and hemospermia in 102 (2.1%). A total of 474 men (9.6%) were noncompliant with 4-year rebiopsy. On univariable analysis any previous complication (OR 1.56, 95% CI 1.08-2.24, p = 0.018), urinary tract infection (OR 2.72, 95% CI 1.23-6.00, p = 0.013), acute urinary retention (OR 4.24, 95% CI 1.83-9.81, p = 0.016) and hemospermia (OR 1.78, 95% CI 1.03-3.06, p = 0.037) were associated with rebiopsy noncompliance. Hematuria was not associated with rebiopsy noncompliance (OR 1.19, 95% CI 0.74-1.91, p = 0.483). Results were unchanged on multivariable analysis, including for any complication (OR 1.65, 95% CI 1.08-2.26, p = 0.018), for urinary tract infection (OR 2.62, 95% CI 1.07-3.21, p = 0.029), for acute urinary retention (OR 4.51, 95% CI 1.93-10.54, p = 0.001), for hemospermia (OR 1.85, 95% CI 1.07-3.21, p = 0.029) and for hematuria (OR 1.19, 95% CI 0.74-1.93, p = 0.472).. In men who undergo repeat prostate biopsy a previous biopsy related complication and the type of complication were associated with lower compliance with rebiopsy schemes. Patients who experience biopsy related complications are ideal candidates to receive intervention regarding the importance of prostate rebiopsy to prevent noncompliance.

Topics: Aged; Biopsy, Large-Core Needle; Clinical Trials as Topic; Dutasteride; Hematuria; Hemospermia; Humans; Male; Middle Aged; Patient Compliance; Patient Education as Topic; Postoperative Complications; Prostate; Prostatic Neoplasms; Reoperation; Retrospective Studies; Treatment Outcome; Urinary Retention; Urinary Tract Infections

Topics: 5-alpha Reductase Inhibitors; Azasteroids; Dutasteride; Finasteride; Humans; Male; Prostatic Hyperplasia; Urinary Retention

Topics: Contracture; Dutasteride; Finasteride; Humans; Male; Postoperative Complications; Prostatic Hyperplasia; Risk Factors; Transurethral Resection of Prostate; Urethral Stricture; Urinary Bladder Neck Obstruction; Urinary Retention

To evaluate the role of intravesical prostatic protrusion (IPP) as a predictive factor for adverse clinical outcomes in patients treated with dutasteride for lower urinary tract symptoms secondary to benign prostatic enlargement (BPE).. In total, 111 patients treated with dutasteride for symptomatic BPE were analyzed. Stepwise multivariate logistic regression was applied to evaluate predictors for acute urinary retention (AUR) or benign prostatic hyperplasia (BPH)-related surgery. We applied an IPP cutoff value of 10 mm. The clinical variables were assessed using univariate analysis.. Of 111 patients, 27 (24.3%) developed AUR or required surgical intervention. On multivariate analysis, IPP remained as the independent predictor for AUR and need for BPH-related surgery (odds ratio, 1.27; P < .001). Both international prostate symptom score and maximum urinary flow rate significantly improved in patients with low IPP (P  =  .03 and P  <  .001, respectively), but not in those with high IPP. No significant reduction was found in the degree of IPP despite the significant reduction in prostate volume after dutasteride treatment (P  =  .84 and P  <  .001, respectively). The 3-year cumulative incidence of AUR or BPH-related surgery in the low IPP group vs the high IPP group was 9.9% vs 71.5%, respectively (P  <  .001).. High IPP is associated with a higher risk of treatment resistance, AUR, or the need for prostatic surgery in patients receiving dutasteride treatment for symptomatic BPE. Dutasteride might not be effective for IPP reduction.

Topics: 5-alpha Reductase Inhibitors; Aged; Dutasteride; Humans; Lower Urinary Tract Symptoms; Male; Prognosis; Prostatic Hyperplasia; Retrospective Studies; Treatment Failure; Urinary Bladder; Urinary Retention

The number of Nigerian men presenting with benign prostatic hyperplasia is on the rise because of increase awareness about the ailment. With the renewed effort by the national health insurance scheme to cover the informal sector, it becomes imperative to determine the cost implication for managing Benign Prostatic Hyperplasia (BPH) and the cost effective drug combination to be adopted. The objective of this study is to estimate cost effective analysis (CEA) of fixed -dose combination of dutasteride and tamsulosin compared with dutasteride monotherapy from the health service provider perspective design.. An interactive Markov's model was used to generate incremental cost per QALY and incremental cost per life years gained. 2.9 million Men who were 50 years of age were fed into the model. The outcome measures included: costs of drug treatment, consultation, acute urinary retention (AUR), transurethral resection of prostate (TURP), hospitalisation post TURP, and quality adjusted life years (QALYs), incremental cost per life years gained, and incremental cost per QALY gained.. Fixed-dose combination of dutasteride and tamsulosin (FDCT) produced an Incremental cost-effectiveness ratios of US$1481.92 per Quality adjusted for life-years saved.. Universal FDCT provision for Nigeria has major economic implications. This study in the context of its limitations has demonstrated the cost effectiveness of FDCT for the long term treatment of patients with moderate to severe BPH from the perspective of a developing country. Currently, there are few studies available to give economic data evidence to policy makers in Nigeria which is applicable to developing countries with similar economies. As such, the findings in this study will be relevant to policy makers in these countries.

Topics: Cost-Benefit Analysis; Drug Combinations; Dutasteride; Health Care Costs; Hospitalization; Humans; Male; Markov Chains; Middle Aged; Nigeria; Prostatic Hyperplasia; Quality-Adjusted Life Years; Socioeconomic Factors; Sulfonamides; Tamsulosin; Treatment Outcome; Urinary Retention

Previous studies have suggested a greater benefit for various outcomes in men diagnosed with benign prostatic hyperplasia (BPH) who are treated with dutasteride than for men treated with finasteride. This study investigates whether the rates of BPH-related prostate surgery and acute urinary retention (AUR) differ between dutasteride and finasteride users in the Netherlands.. From the PHARMO Database Network, men aged ≥50 years with a dispensing of dutasteride or finasteride with or without concomitant alpha-blocker treatment between March 1, 2003 and December 31, 2011 were selected. The incidence of BPH-related prostate surgery and AUR was determined during dutasteride or finasteride treatment and stratified by type of initial BPH-treatment (5-ARI monotherapy or combination with alpha-blocker) and prescriber (general practitioner (GP) or urologist). Comparison of the incidence of BPH-related prostate surgery and AUR between the treatment groups was done by Cox proportional hazard regression.. 11,822 dutasteride users and 5,781 finasteride users were identified. Most users started treatment in combination with an alpha-blocker. Overall, dutasteride users had a lower risk of BPH-related prostate surgery was lower among dutasteride users than finasteride users (HR: 0.75; 95 % CI: 0.56-0.99). This lower risk among dutasteride users was also seen when stratifying by monotherapy or combination therapy (HR: 0.73; 95 % CI: 0.54-0.98 for monotherapy and HR: 0.85; 95 % CI: 0.74-0.97 for combination therapy). However, the association was only present among men treated by urologists. For AUR the rates were low and no statistical significant difference was observed between dutasteride and finasteride users.. The risk of undergoing BPH-related prostate surgery was lower among men using dutasteride compared to men using finasteride. The association was observed for monotherapy as well as combination therapy, however, only among men who received their prescription from a urologist.

Topics: 5-alpha Reductase Inhibitors; Acute Disease; Aged; Aged, 80 and over; Dutasteride; Finasteride; Humans; Incidence; Male; Middle Aged; Prostatectomy; Prostatic Hyperplasia; Urinary Retention

Benign prostatic hyperplasia (BPH) is a common disease in men that is characterized by lower urinary tract symptoms. Pharmacologic treatment with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) is recommended to alleviate symptoms, prevent disease progression that can lead to complications, and reduce health care costs.. To compare clinical, economic, and health care resource utilization outcomes among BPH patients treated with early continuous combination AB and 5ARI therapy (dutasteride vs. finasteride) using administrative claims data from the United States.. A retrospective analysis of administrative claims data from 2003-2013 was conducted to compare outcomes between patients with claims for early combination therapy with dutasteride + AB and patients with claims for early finasteride + AB. The study population included males aged older than 50 years with at least 1 medical claim with a diagnosis of BPH and pharmacy dispensing for AB and 5ARI therapies. Outcomes included acute urinary retention (AUR), prostate-related surgery, clinical progression, medical and pharmacy costs, and health care resource utilization. Inverse probability of treatment (IPT) weighted Cox proportional hazards, linear, and Poisson regression models were used to assess the association between outcomes and early combination therapy as appropriate.. A total of 2,778 patients were included in the early finasteride + AB treatment cohort, and 4,125 patients were included in the early dutasteride + AB cohort. Dutasteride users were younger than finasteride users (mean age: 64.8 vs. 67.5 years, P < 0.001) and had a greater mean number of urologist visits (10.7 vs. 7.9, P < 0.001) during baseline. After adjusting for confounding using IPT weighting, no statistically significant difference was observed between dutasteride and finasteride for AUR (hazard ratio [HR] = 0.845, 95% CI = 0.660-1.070, P = 0.1643), prostate-related surgery (HR = 0.806, 95% CI = 0.568-1.171, P = 0.2525), and clinical progression (HR = 0.834, 95% CI = 0.663-1.043, P = 0.1122). While dutasteride was associated with higher pharmacy costs per month (adjusted monthly cost difference = $79, 95% CI = $45-$105), total all-cause medical costs were not significantly different between the 2 cohorts (adjusted monthly cost difference = -$44, 95% CI = -$110-$22).. Clinical and economic outcomes were similar between the early dutasteride + AB and early finasteride + AB cohorts, with no statistically significant differences detected.. Funding for this study was provided by GlaxoSmithKline (HO-14-15325 and AVO110072). Bell and Swensen are employees of GlaxoSmithKline. DerSarkissian, Xiao, Duh, and Lefebvre are employed by Analysis Group, a consulting company that received research grants from GlaxoSmithKline to conduct this study. Study concept and design were contributed by Bell, Swensen, Lefebvre, and Duh. Bell and Duh acquired the data. DerSarkissian and Xiao performed the statistical analysis and interpreted the data along with Lefebvre, Duh, and Bell. DerSarkissian and Bell drafted the manuscript. All authors contributed equally to critically revising the manuscript and providing final approval of the submitted manuscript.

Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-Antagonists; Aged; Aged, 80 and over; Cohort Studies; Disease Progression; Dutasteride; Finasteride; Health Care Costs; Humans; Longitudinal Studies; Male; Middle Aged; Prostatic Hyperplasia; Retrospective Studies; Treatment Outcome; United States; Urinary Retention

The purpose of this study was to explore the budget impact of dutasteride plus tamsulosin fixed-dose combination (DUT + TAM FDC) versus tamsulosin monotherapy, in the treatment of patients with benign prostatic hyperplasia (BPH) from the perspective of the Greek healthcare insurance system.. A Microsoft Excel-based model was developed to estimate the financial consequences of adopting DUT + TAM FDC within the Greek healthcare setting. The model, compared six mutually exclusive health states in two alternative treatment options: current standard of care and the introduction of DUT + TAM FDC in the market. The model used clinical inputs from the CombAT study; data on resource use associated with the management of BPH in Greece were derived from expert panel, and unit cost data were derived from official reimbursement tariffs. A payer perspective was taken into account. As patient distribution data between public and private sectors are not available in Greece two scenarios were investigated, considering the whole eligible population in each scenario. A 4 year time horizon was taken into account and included treatment costs, number of transurethral resections of the prostate (TURPs) and acute urinary retention (AUR) episodes avoided.. The clinical benefit from the market adoption of DUT + TAM FDC in Greece was 1,758 TURPs and 972 episodes of AUR avoided cumulatively in a four year period. The increase in total costs from the gradual introduction of DUT + TAM FDC to the Greek healthcare system ranges from €1.3 million in the first year to €5.8 million in the fourth year, for the public sector, and €1.2 million to €4.0 million, for the private sector. This represents an increase of 1.91% to 7.94% for the public sector and 1.10% 3.29% in the private sector, during the 4-year time horizon.. Budget impact analysis (BIA) results indicated that the gradual introduction of DUT + TAM FDC, would increase the overall budget of the disease, however providing better clinical outcomes. DUT + TAM FDC drug acquisition cost is partly offset by the reduction in the costs associated with the treatment of the disease.

Topics: Azasteroids; Budgets; Cost-Benefit Analysis; Drug Therapy, Combination; Dutasteride; Greece; Humans; Male; Middle Aged; Office Visits; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Transurethral Resection of Prostate; Urinary Retention; Urological Agents

The outcome of trial of voiding without catheter in patients treated combination therapy with dutasteride and alpha1-adrenergic receptor blocker for acute urinary retention caused by benign prostatic hyperplasia was not reported. We evaluated the clinical efficacy of combination therapy with dutasteride in patients with unsuccessful trial without catheter after treatment with an alpha1-adrenergic receptor blocker monotherapy for acute urinary retention caused by benign prostatic hyperplasia.. Patients with acute urinary retention due to prostatic hyperplasia were catheterized and treated alpha1-adrenergic receptor blocker monotherapy. After two weeks later, patients were put on trial without catheter. 52 patients who were unsuccessful trial without catheter administered combination therapy with dutasteride and alpha1-adrenergic receptor blocker. We use criteria that voiding urine volume over 100 ml and post-void residual urine volume below 100 ml in deciding whether catheter should be removed.. 33 (63.5%) men did not require re-catheterization within 7 months after combination therapy. The successful rate of Performance Status (PS) 0-1 group was significantly superior to that of PS 2-4 group.. PS 0-1 men catheterized for AUR can void more successfully after catheter removal than PS 2-4 men if treated with combination therapy.

Topics: Acute Disease; Adrenergic alpha-1 Receptor Antagonists; Aged; Aged, 80 and over; Azasteroids; Drug Therapy, Combination; Dutasteride; Humans; Male; Middle Aged; Prostatic Hyperplasia; Retrospective Studies; Severity of Illness Index; Treatment Failure; Treatment Outcome; Urinary Catheters; Urinary Retention; Urological Agents

To evaluate, in a pilot study, the efficacy and safety of combining a braided poly(lactic-co-glycolic acid) (PLGA, a copolymer of l-lactide and glycolide) urethral stent and dutasteride in the treatment of acute urinary retention (AUR) due to benign prostatic enlargement (BPE).. Ten men with AUR due to BPE were treated as outpatients. A biodegradable braided PLGA urethral stent was inserted into the prostatic urethra, using a specially designed insertion device under visual control. Dutasteride treatment was started and the patients were followed up for 3 months after insertion of the stents.. In all patients the stents were placed successfully with the new insertion device. All men were able to void after inserting the stent. At 1 month five patients voided freely with a low residual urine volume (<150 mL), two voided but had a high residual urine volume and a suprapubic catheter was placed, and three needed a suprapubic or an indwelling catheter before 1 month, due to AUR or comorbidities. At 3 months five patients were voiding with no problems.. We have developed a new and effective insertion device for biodegradable braided prostatic stents. The new braided-pattern stent overcomes the earlier problems of migration and sudden breakage into large particles associated with biodegradable spiral stents. However, the mechanical properties of the new stent need to be improved and tested in a longer follow-up. We consider that this new biodegradable braided-pattern urethral stent could provide a new option in the future treatment of AUR.

Topics: Acute Disease; Aged; Aged, 80 and over; Azasteroids; Biocompatible Materials; Dutasteride; Enzyme Inhibitors; Humans; Lactic Acid; Male; Middle Aged; Pilot Projects; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Prostatic Hyperplasia; Stents; Treatment Outcome; Urethra; Urinary Retention

To determine comparative differences on rates of acute urinary retention (AUR) and prostate-related surgeries among patients aged > or =65 years treated with dutasteride or finasteride.. For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for enlarged prostate patients aged > or =65 years treated with 5-alpha reductase inhibitors (5ARIs) regardless of alpha-blocker use. Charlson Comorbidity Index, Thomson Medstat Disease Staging, and propensity score matching techniques were used for comparative analysis.. A total of 5090 patients met selection criteria. After 1 year of 5ARI therapy, the AUR rate was lower for dutasteride (12%) when compared with finasteride (14.7%) (odds ratio [OR], 0.79; P = .0042). Risks for prostate-related surgeries were also lower among dutasteride-treated patients (3.9% vs 5.1%, respectively; OR, 0.77; P = .03).. Important therapeutic outcome differences exist between dutasteride and finasteride. Patients treated with dutasteride were significantly less likely to experience AUR and prostate-related surgeries than finasteride patients.

Topics: 5-alpha Reductase Inhibitors; Acute Disease; Aged; Aged, 80 and over; Azasteroids; Dutasteride; Enzyme Inhibitors; Finasteride; Humans; Male; Prostatectomy; Prostatic Hyperplasia; Retrospective Studies; United States; Urinary Retention

This article presents background information and highlights key findings from a managed care perspective related to enlarged prostate (EP) in Medicare-eligible patients. This article does not provide a comprehensive review of EP but instead attempts to increase the current understanding of EP through discussion of its prevalence in men aged > or =65 years, its associated economic burden, and some available treatment options. This supplement includes 3 additional articles, all of which present data from a naturalistic, managed care setting. The article by Fenter et al assesses differences in outcomes between elderly EP patients treated with finasteride and those treated with dutasteride in relation to the risks of acute urinary retention and prostate-related surgery. Issa et al conduct a comparative analysis of the combined use of alpha-blockers and 5-alpha reductase inhibitors to treat EP. The final article compares medical costs incurred within the first year of initiating treatment for EP patients receiving finasteride versus dutasteride. This supplement is intended to assist managed care formulary decision makers in evaluating key clinical and economic data that differentiate dutasteride and finasteride within the Medicare-aged population. Although the information presented is not designed to illustrate the superiority of one product over the other, it answers important questions in relation to treating EP in elderly men and raises substantial issues beyond medication costs.

Topics: 5-alpha Reductase Inhibitors; Aged; Aged, 80 and over; Azasteroids; Dutasteride; Enzyme Inhibitors; Finasteride; Humans; Male; Medicare; Prostatic Hyperplasia; Treatment Outcome; United States; Urinary Retention

The purpose of this study was to examine the rates of acute urinary retention (AUR) and surgery after initiating 5-alpha reductase inhibitor (5ARI) therapy and to compare the 2 currently available 5ARIs, dutasteride and finasteride, in a real-world, managed care setting. This study constitutes the first direct comparison of therapeutic outcome between a mono 5ARI (finasteride) and a dual 5ARI (dutasteride).. This is a retrospective descriptive and comparative analysis of the rates of AUR and prostate surgery in patients with benign prostatic hyperplasia (BPH) treated with 5ARI therapy, either dutasteride or finasteride. Data were obtained from the PharMetrics Integrated Medical and Pharmaceutical Database (PIMPD) (Watertown, Mass) during a 6-year period. The PIMPD is a large national healthcare database that represents a total of 85 managed health plans and covers more than 45 million patients. The data analysis included all patients aged 50 years or older diagnosed with BPH who were treated with 5ARIs (dutasteride 0.5 mg/day or finasteride 5 mg/day) for up to 12 months during the 6-year period of January 1, 1999, to March 1, 2005. Patients meeting the selection criteria were evaluated for a total of 12 months with regard to the likelihood of experiencing AUR or prostate-related surgery.. After 5 months of 5ARI therapy, the rate of AUR during months 5 to 12 was found to be significantly lower in the dutasteride group compared with the finasteride group (5.3% vs 8.3%). After controlling for background covariates, dutasteride-treated patients were 49.1% less likely to experience AUR than patients treated with finasteride (P = .0207). Patients treated with dutasteride were also less likely to undergo prostate-related surgery, with 1.4% of dutasteride treated patients and 3.4% of patients receiving finasteride undergoing surgery; differences in surgery rates, however, were not statistically significant (P = .0745), even after controlling for background covariates. CONCLUSTION: Although the 2 drugs, dutasteride and finasteride, belong to the same category of 5ARIs, this large retrospective multivariate analysis potentially indicates differences in therapeutic outcomes. In this study, patients treated with dutasteride were less likely to experience AUR and demonstrated a trend toward being less likely to experience surgery than patients treated with finasteride.

Topics: Acute Disease; Age Distribution; Aged; Azasteroids; Dutasteride; Finasteride; Follow-Up Studies; Humans; Incidence; Male; Managed Care Programs; Middle Aged; Multivariate Analysis; Probability; Prostatectomy; Prostatic Neoplasms; Retrospective Studies; Risk Assessment; Sensitivity and Specificity; Severity of Illness Index; Treatment Outcome; Urinary Retention; Urodynamics

To develop a prediction model, or nomogram, that would predict the probability that a man with benign prostatic hyperplasia would experience acute urinary retention (AUR) or require surgical intervention (SI) within 2 years, with or without dutasteride therapy.. We modeled 4294 men treated in the Phase III dutasteride benign prostatic hyperplasia trials. These men were characterized at baseline by a number of parameters, including the American Urological Association Symptom Index, Benign Prostatic Hyperplasia Impact Index questionnaire, prior use of selective alpha1-blockers, prostate volume, prostate-specific antigen level, and maximal flow rate. Cox proportional hazards regression analysis was used to relate these baseline variables to their future probability of AUR/SI within 2 years. The nomogram was internally validated with bootstrapping to assess its discrimination and calibration. Discrimination was quantified as the concordance index.. The nomogram appeared to be accurately calibrated and discriminating (concordance index 0.71, P <0.001).. We constructed a nomogram for predicting the probability that a man would experience AUR or require SI within 2 years of benign prostatic hyperplasia diagnosis. At 24 months of follow-up, 7.4% of placebo patients and 3.7% of dutasteride patients had experienced AUR and/or SI, representing a 50% relative risk reduction and a 3.7% absolute risk reduction. For the greatest risk patient randomized to the Phase III dutasteride trial, the nomogram predicted a maximal risk of 27%, significantly greater than the median risk of the placebo-treated patients.

Topics: Acute Disease; Azasteroids; Dutasteride; Humans; Male; Middle Aged; Nomograms; Predictive Value of Tests; Prostatic Hyperplasia; Urinary Retention

Topics: Aged, 80 and over; Azasteroids; Dutasteride; Finasteride; Humans; Male; Pacemaker, Artificial; Postoperative Complications; Transurethral Resection of Prostate; Urinary Retention