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      Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment—the QUALIPROST study

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          Abstract

          Purpose

          To evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice.

          Methods

          Prospective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS.

          Results

          1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % ( n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % ( n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % ( n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW ( p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar.

          Conclusions

          Improvements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.

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          Most cited references48

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          The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

          Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy. Copyright 2003 Massachusetts Medical Society
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            The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study.

            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 =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).
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              Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients?

              We assessed the relationship between changes in scores for the American Urological Association (AUA) symptom index and benign prostatic hyperplasia (BPH) impact index with patient global ratings of improvement in a large Veterans Affairs trial comparing different pharmacological therapies for BPH. The primary analyses compared absolute score changes from baseline with global ratings of improvement at 13 weeks for 1,218 men. Subjects who rated themselves as being slightly improved had a mean decrease in AUA symptom index and BPH impact index scores of 3.1 and 0.4 points, respectively. However, the baseline scores strongly influenced this relationship. These data provide guidance for investigators using the AUA symptom index and BPH impact index as outcome measures.
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                Author and article information

                Contributors
                +34-934833085 , jose.manasanch@pierre-fabre.com
                Journal
                Int Urol Nephrol
                Int Urol Nephrol
                International Urology and Nephrology
                Springer Netherlands (Dordrecht )
                0301-1623
                1573-2584
                25 January 2016
                25 January 2016
                2016
                : 48
                : 645-656
                Affiliations
                [ ]Urology Department, Hosp. Clínic Univ., IDIBAPS, Barcelona, Spain
                [ ]Urology Department, Hosp. Univ. Puerta de Hierro, Majadahonda, Madrid Spain
                [ ]Urology Department, Hosp. Univ. Basurto, Bilbao, Spain
                [ ]Urology Department, Hosp. Univ. Virgen del Rocío, Sevilla, Spain
                [ ]Urology Department, Hosp. Univ. La Fe, Valencia, Spain
                [ ]Urology Department, Hosp. Univ. Puerto Real, Cádiz, Spain
                [ ]Urology Department, Hosp. Univ. Parc Taulí Sabadell, Sabadell, Barcelona Spain
                [ ]Llefià Primary Care Center, Badalona, Barcelona Spain
                [ ]Urology Department, Complejo Hospitalario Universitario de Granada, Granada, Spain
                [ ]Urology Department, Hosp. Univ. Carlos Haya, Málaga, Spain
                [ ]Pierre Fabre Ibérica S.A., Ramon Trias Fargas, 7-11, 3º, 08005 Barcelona, Spain
                Article
                1206
                10.1007/s11255-015-1206-7
                4839045
                26810324
                d9681e57-4c3f-4fde-9eb3-25ecb620ba5d
                © The Author(s) 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 19 October 2015
                : 28 December 2015
                Funding
                Funded by: Pierre Fabre Ibérica, S.A.
                Categories
                Urology - Original Paper
                Custom metadata
                © Springer Science+Business Media Dordrecht 2016

                Nephrology
                luts,bph,quality of life,real-life practice,bii,ipss
                Nephrology
                luts, bph, quality of life, real-life practice, bii, ipss

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