Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart® and Tamsulosin) trial rationale and study design

Siami, Paul; Roehrborn, Claus G.; Barkin, Jack; Damião, Ronaldo; Wyczółkowski, Marek; Duggan, Annette; Major-Walker, Kim; Morrill, Betsy

doi:10.1016/j.cct.2007.07.008

Cited by 72 publications

(67 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…23 The CombAT study was designed to build on this knowledge, focusing on men with moderate-to-severe LUTS and at increased risk of BPH progression (symptomatic BPH and prostate volume X30 cm 3 ). 24,25 Two-year results from CombAT demonstrated superior improvement in LUTS with combination treatment, compared with monotherapy with either dutasteride or tamsulosin. 24 This article reports a post hoc analysis of the 2-year efficacy and safety of combined therapy with the 5ARI dutasteride and the a-blocker tamsulosin, compared with each agent alone, in Asian men with symptomatic BPH and enlarged prostate (X30 cm 3 ).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH

Chung

Roehrborn

Siami³

et al. 2008

Prostate Cancer Prostatic Dis

View full text Add to dashboard Cite

Although ethnicity-based differences in prostate size and physiology have been reported, results of benign prostatic hyperplasia (BPH) treatment trials in predominantly Caucasian patients are assumed to be applicable to non-Caucasian populations. This post hoc analysis investigated whether an Asian subpopulation of men with moderate-to-severe BPH in the CombAT study achieves treatment responses in line with those of the overall study population. In this doubleblind, randomized, parallel-group trial, 325 Asian men were assigned to treatment with 0.5 mg dutasteride once daily, 0.4 mg tamsulosin once daily or the combination. Decrease in international prostate symptom score (IPSS) at month 24 from baseline (the primary endpoint) was significantly greater with combination treatment compared with tamsulosin (Po0.05), and numerically, but not statistically significantly, greater compared with dutasteride. Mean IPSS was reduced from baseline by 7.5 (±0.84) in the combination group, by 6.3 (±0.86) in the dutasteride group and by 4.5 (±0.78) in the tamsulosin group, resulting in respective mean IPSS at months 24 of 11.4 (±0.60), 12.7 (±0.70) and 14.3 ( ± 0.74). The adverse event profile was similar to that observed in the overall CombAT population, and drug-related adverse events were more common with combination therapy (26%) than with tamsulosin (15%) or dutasteride (9%). No unexpected adverse events emerged. In conclusion, in Asian men with moderate-to-severe lower urinary tract symptoms and an enlarged prostate, combination therapy achieved significantly greater improvements from baseline BPH symptoms, flow rate, quality of life, reduced prostate volume and improved treatment satisfaction compared with tamsulosin monotherapy.

show abstract

Section: Introductionmentioning

confidence: 99%

“…These men were a subpopulation of those participating in the 4-year CombAT study. 24,25 The aim of this analysis was to determine whether men in this ethnic group, achieve treatment responses in line with those seen in the overall study population of men with moderate-to-severe LUTS and prostate enlargement.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH

Chung

Roehrborn

Siami³

et al. 2008

Prostate Cancer Prostatic Dis

View full text Add to dashboard Cite

show abstract

“…9 Briefly, eligible patients were randomised in a 1:1:1 ratio to receive once-daily double-blind treatment with 0.5 mg dutasteride plus 0.4 mg tamsulosin, 0.5 mg dutasteride plus tamsulosinmatched placebo or 0.4 mg tamsulosin plus dutasteridematched placebo. Occurrence of AUR, BPH-related surgery, urinary tract infection, urosepsis and overflow or urge incontinence was assessed every 3 months.…”

Section: Methodsmentioning

confidence: 99%

“…9 Two-year analyses of CombAT data showed that dutasteride plus tamsulosin provided significantly greater improvements in symptoms and patient-reported quality of life vs either monotherapy. 10,11 At 4 years, combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery.…”

Section: Introductionmentioning

confidence: 99%

The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study

Haillot

Fraga

Maciukiewicz³

et al. 2011

Prostate Cancer Prostatic Dis

View full text Add to dashboard Cite

CombAT (Combination of Avodart and Tamsulosin) was a randomised, double-blind study in men (n ¼ 4844) aged X50 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 ¼ 972; dutasteride, n ¼ 970; combination, n ¼ 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.

show abstract

“…3 For the BPH patient who has an enlarged prostate with a size >30 mL, previous large clinical trials such as the MTOPS trial and CombAT trial showed the effectiveness of combination therapy with a 5-a-reductase inhibitor and an ablocker. 4,5 Although the risks and treatment for the enlarged prostate have been reported, there have not been many reports on evaluation of the PV. Currently, there is no convenient method to evaluate the PV other than by ultrasonographic examination.…”

Section: Introductionmentioning

confidence: 99%

Does digital rectal examination predict prostate volume greater than 30 mL?

2017

View full text Add to dashboard Cite

Abbreviations & Acronyms BPH = benign prostatic hyperplasia DRE = digital rectal examination F = flat LUTS = lower urinary tract symptoms LUTS/BPH = lower urinary tract symptoms suggestive of benign prostatic hyperplasia Ma = markedly enlarged Mo = moderately enlarged N = normal PV = prostate volume S = slightly enlarged TRUS = transrectal ultrasound Objectives: To investigate the accuracy of digital rectal examination in estimating prostate volume in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods: A community-based study was carried out in Japan to investigate the prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. A total of 457 men were screened and deemed eligible for the present analysis. Findings on digital rectal examination were compared with prostate volume measurement by transrectal ultrasound. Five groups were identified on digital rectal examination: flat, normal, slightly enlarged, moderately enlarged and markedly enlarged. Results: The median age and prostate volume were 64 years and 19.7 mL, respectively. Prostate volumes for the flat, normal, slightly enlarged, moderately enlarged, and markedly enlarged groups were 16.4, 18.3, 27.0, 41.9 and 86.3 mL, respectively. There were significant differences in prostate volume between the groups. The positive predictive value was 94.1% if flat, and normal were assumed to have a prostate volume <30 mL. The value was 80.8% if moderately enlarged, and markedly enlarged were assumed to have a prostate volume ≥30 mL. Of the men in the slightly enlarged group, 61.0% had a prostate volume <30 mL. Conclusions: It is possible to stratify prostate volume according to digital rectal examination. We could determine the prostates in the flat and normal groups to have a prostate volume <30 mL, and those in the moderately enlarged and markedly enlarged groups to have a prostate volume ≥30 mL by digital rectal examination with high accuracy. Transrectal ultrasound was required for those in the slightly enlarged group.

show abstract

Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart® and Tamsulosin) trial rationale and study design

Cited by 72 publications

References 23 publications

Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH

Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH

The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study

Does digital rectal examination predict prostate volume greater than 30 mL?

Contact Info

Product

Resources

About