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

Roehrborn, Claus G.; Siami, Paul; Barkin, Jack; Damião, Ronaldo; Major-Walker, Kim; Nandy, Indrani; Morrill, Betsy; Gagnier, R. Paul; Montorsi, Francesco

doi:10.1016/j.eururo.2009.09.035

Cited by 654 publications

(626 citation statements)

References 14 publications

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“…The four AE ongoing at the end of treatment resolved within 6 weeks after the last dose of dutasteride. The sexual AE profile of dutasteride treatment for male lower urinary tract symptoms/BPH has been consistent in previous randomized control trials 9, 10. Interestingly, most sexual AE occur in the first 6 months of dutasteride treatment in BPH clinical trials9, 10 and the likelihood of patients experiencing such AE even decreases over time.…”

Section: Discussionsupporting

confidence: 81%

“…The sexual AE profile of dutasteride treatment for male lower urinary tract symptoms/BPH has been consistent in previous randomized control trials 9, 10. Interestingly, most sexual AE occur in the first 6 months of dutasteride treatment in BPH clinical trials9, 10 and the likelihood of patients experiencing such AE even decreases over time. Furthermore, it has previously been reported in the combAT study9 that impotence was the most frequently reported sexual AE in patients with BPH who received treatment with dutasteride.…”

Section: Discussionsupporting

confidence: 81%

See 1 more Smart Citation

Prospective randomized study of sexual function in men taking dutasteride for the treatment of androgenetic alopecia

Tsai

Choi

Kim

et al. 2018

The Journal of Dermatology

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Treatment with 5α‐reductase inhibitors has been associated with sexual adverse events such as impotence (erectile dysfunction) and decreased libido. The primary objective of this study was to evaluate adverse events related to sexual function, based on their frequency, duration, persistence and associated treatment discontinuations, in men treated with dutasteride for androgenetic alopecia. Participants were randomized to receive double‐blind dutasteride 0.5 mg or placebo once daily for 24 weeks, followed by open‐label dutasteride 0.5 mg for an additional 24 weeks. Sexual adverse events were followed up until resolution or for up to 24 weeks after the last dose. Overall, 117 men, 23–50 years of age, were randomized. The incidence of sexual adverse events was approximately twofold higher in the dutasteride group (16%) than the placebo group (8%) during the double‐blind period; the overall incidence of sexual adverse events was lower (5%) during the open‐label period. All adverse events were mild to moderate in severity and considered treatment‐related. The adverse events resolved while on study treatment or after the end of treatment and did not lead to treatment discontinuation. A limitation of this study was the small sample size. The sexual adverse events of impotence, decreased libido and ejaculation disorders reported in this study were expected and reversible.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionsupporting

confidence: 81%

Prospective randomized study of sexual function in men taking dutasteride for the treatment of androgenetic alopecia

Tsai

Choi

Kim

et al. 2018

The Journal of Dermatology

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“…However, the patients who could continue tamsulosin showed durable symptomatic improvement for 5 years, as shown in several previous reports. [1][2][3][4][5]7,9 The major reason for discontinuation in the present study was loss to follow up (self-discontinuation). Although the proportion of those lost to follow up, 44.6% of those taking tamsulosin, over 5 years in the present study seemed to be lower than the 48.2% for naftopidil for 4 years in our previous study, 8 it was impossible to directly compare the two results because of differences in study design.…”

Section: Discussionmentioning

confidence: 97%

“…The Combination of Avodart and Tamsulosin study showed that the long-term outcome of a1-blockers was not always promising, [9][10][11] especially for patients with a large PV and high PSA level. We also showed that patients who had a large PV at baseline, as well as severe IPSS at 12 weeks after treatment, were more likely to have treatment failure during a 4-year follow-up period.…”

Section: Introductionmentioning

confidence: 99%

α1‐blocker tamsulosin as initial treatment for patients with benign prostatic hyperplasia: 5‐year outcome analysis of a prospective multicenter study

et al. 2012

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Abbreviations & AcronymsObjective: To comprehensively analyze the 5-year outcomes of tamsulosin treatment for patients with benign prostatic hyperplasia. Methods: Tamsulosin (0.2 mg/day) was given to 112 patients who had International Prostate Symptom Scores Ն8. They were prospectively followed for 5 years with periodic evaluation. If tamsulosin had to be discontinued, the reason was determined. Treatment failure was considered in the case of disease progression (postvoid residual urine volume Ն200 mL, acute urinary retention, febrile urinary tract infection or hydronephrosis as a result of bladder outlet obstruction), conversion to other a1-blockers or need for surgery. An intention-to-treat analysis was carried out. Results: A total of 34 patients (30.4%) continued the same medication for the overall study period, whereas 78 patients (69.6%) discontinued the medication. International Prostate Symptom Scores, Benign Prostatic Hyperplasia Problem Index and Quality of Life Index were significantly improved over the 5-year period. Treatment failure was observed in 21 patients (18.8%). Baseline prostate volume and postvoid residual urine volume were independent factors to predicting treatment failure. A total of 21 patients (18.8%) discontinued tamsulosin because of an improvement of symptoms. They were younger and had lower prostate-specific antigen levels than the remaining 91 patients. Their symptoms were stable even 1 year after termination of therapy. Conclusions: Long-term efficacy of tamsulosin was observed, although only a small portion of patients continued the treatment. a1-blocker monotherapy might be not appropriate for achieving a good long-term outcome in patients with a large prostate volume and a large amount of postvoid residual urine volume. Persistent improvement of symptoms, even after termination of tamsulosin, was observed in young patients with low prostate-specific antigen levels.

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“…storage symptoms; a-blockers are already efficacious after some days of treatment; they significantly and substantially reduce LUTS (IPSS) within weeks (decrease in IPSS by 30-40 % on average after placebo run-in and up to 50 % in open-label trials); significantly improve urinary flow rate within hours (by 20-25 %); significantly improve health-related quality of life; have a long-lasting effect on symptoms, thereby reducing symptomatic disease progression; and work independently of the patient's age, prostate volume, and initial symptom severity. However, ablockers cannot prevent (acute) urinary retention or need for prostatec surgery in long-term studies, especially in patients with enlarged prostates at baseline ([40 cc) [14].…”

mentioning

confidence: 99%

Latest Developments in the Assessment and Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: What is Clinically Relevant?

Oelke

2015

Clin Drug Investig

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Lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are prevalent and increase with aging. Epidemiological studies have shown that approximately 40 % of men aged C50 years have bothersome LUTS/BPH [1]. It is therefore not surprising that LUTS/BPH are positioned at 7th place in the most frequently diagnosed and most costly diseases in men aged C50 years [2]. Healthcare-seeking behavior is triggered by LUTS severity and LUTS phenotypes. Men often consult their doctors when they have severe LUTS or experience urinary urgency or nocturia [1,3]. LUTS/BPH have a multifactorial etiology and can be caused by the prostate, bladder, urethra, pelvic floor, central or peripheral nervous system, ureters, or even by the kidneys in case of nocturnal polyuria [4]. LUTS can be divided into storage (e.g., urgency, frequency, nocturia), voiding (e.g., hesitancy, poor stream, intermittency), and post-micturition symptoms (post-void dribbling, feeling of incomplete bladder emptying) [5].The majority of guidelines on LUTS/BPH have been established by urologists [4,6,7] but can also be-more or less easily-implemented by other medical specialties. Different healthcare systems worldwide have different regulations and defined responsibilities regarding which medical specialty should primarily assess and treat men with LUTS/BPH. While almost three-quarters of men with LUTS/BPH in Germany are diagnosed and treated by urologists [8], the majority of men in other countries, for example Australia or the UK, are managed by primary-care physicians. Specialized training programs and experience with patients with LUTS/BPH are therefore mandatory for different medical specialties.Careful assessment helps to identify the underlying pathophysiology of LUTS. Simple patient history or a symptom questionnaire cannot distinguish between LUTS of benign or malignant origin because the type of symptom or symptom severity is nonspecific for the underlying disease. This may limit the widespread assessment and treatment of LUTS by non-urologic professionals because special assessment tools-before treatment initiation-are usually not available in the offices of primary-care physicians (e.g., uroflowmeter, transrectal ultrasound, multichannel urodynamics, urethrocystoscopy). It is therefore crucial to know when nonurologists should transfer their patients to specialized urology care. An expert panel recommended specialized urology support in particular when physicians are in doubt of the origin or benign character of LUTS, in cases of macroscopic hematuria, or in men with absolute indications for prostate surgery [9].Adherence to guidelines is crucial for every medical specialty dealing with LUTS/BPH because real-life practice in the USA has shown that doctors who follow guidelines perform significantly less prostate surgery than doctors who do not [10]. Doctors with poor adherence to guidelines will have performed prostate surgery within the first year of diagnosis in 11 % of patients, whereas doctors with good adherence to guide...

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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

Cited by 654 publications

References 14 publications

Prospective randomized study of sexual function in men taking dutasteride for the treatment of androgenetic alopecia

Prospective randomized study of sexual function in men taking dutasteride for the treatment of androgenetic alopecia

α1‐blocker tamsulosin as initial treatment for patients with benign prostatic hyperplasia: 5‐year outcome analysis of a prospective multicenter study

Latest Developments in the Assessment and Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: What is Clinically Relevant?

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