Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study

J. Curtis Nickel, Claus Roehrborn, Francesco Montorsi, Timothy H. Wilson, Roger S. Rittmaster

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Purpose: Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population. Materials and Methods: REDUCE was a 4-year, randomized, double-blind, placebo controlled study of prostate cancer risk reduction with 0.5 mg dutasteride vs placebo in men 50 to 75 years old with prostate specific antigen 2.5 to 10 ng/ml and a negative prostate biopsy in the previous 6 months. In this analysis we investigated change from baseline in Chronic Prostatitis Symptom Index in men with prostatitis-like pain (Chronic Prostatitis Symptom Index pain subscore 5 or greater) and prostatitis-like syndrome (perineal or ejaculatory pain plus Chronic Prostatitis Symptom Index pain subscore 4 or greater), the proportion of subjects with at least a moderate Chronic Prostatitis Symptom Index response (6-unit or greater improvement) and reports of new onset clinical prostatitis. Results: Of 5,379 men with a total baseline Chronic Prostatitis Symptom Index score 678 (12.6%) had prostatitis-like pain and 427 (7.9%) had prostatitis-like syndrome. Chronic Prostatitis Symptom Index total score decreased significantly at 48 months in the dutasteride group vs placebo in men with prostatitis-like pain (p <0.0001) and with prostatitis-like syndrome (t test p = 0.03). There were significantly more Chronic Prostatitis Symptom Index responders with dutasteride vs placebo in the prostatitis-like pain (49% vs 37%, respectively, p = 0.0033) and prostatitis-like syndrome (46% vs 35%, Fisher's exact test p = 0.0265) subgroups. Prostatitis was reported as an adverse event by significantly more men randomized to placebo (3.6%) than to dutasteride (2.5%, p = 0.003). Conclusions: Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen.

Original languageEnglish (US)
Pages (from-to)1313-1318
Number of pages6
JournalJournal of Urology
Volume186
Issue number4
DOIs
StatePublished - Oct 2011

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Prostatitis
Placebos
Pain
Dutasteride
Chronic Pain
Prostate-Specific Antigen
Prostatic Neoplasms

Keywords

  • 5-alpha reductase inhibitors
  • dutasteride
  • prostatitis

ASJC Scopus subject areas

  • Urology

Cite this

Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. / Nickel, J. Curtis; Roehrborn, Claus; Montorsi, Francesco; Wilson, Timothy H.; Rittmaster, Roger S.

In: Journal of Urology, Vol. 186, No. 4, 10.2011, p. 1313-1318.

Research output: Contribution to journalArticle

Nickel, J. Curtis ; Roehrborn, Claus ; Montorsi, Francesco ; Wilson, Timothy H. ; Rittmaster, Roger S. / Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. In: Journal of Urology. 2011 ; Vol. 186, No. 4. pp. 1313-1318.
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abstract = "Purpose: Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population. Materials and Methods: REDUCE was a 4-year, randomized, double-blind, placebo controlled study of prostate cancer risk reduction with 0.5 mg dutasteride vs placebo in men 50 to 75 years old with prostate specific antigen 2.5 to 10 ng/ml and a negative prostate biopsy in the previous 6 months. In this analysis we investigated change from baseline in Chronic Prostatitis Symptom Index in men with prostatitis-like pain (Chronic Prostatitis Symptom Index pain subscore 5 or greater) and prostatitis-like syndrome (perineal or ejaculatory pain plus Chronic Prostatitis Symptom Index pain subscore 4 or greater), the proportion of subjects with at least a moderate Chronic Prostatitis Symptom Index response (6-unit or greater improvement) and reports of new onset clinical prostatitis. Results: Of 5,379 men with a total baseline Chronic Prostatitis Symptom Index score 678 (12.6{\%}) had prostatitis-like pain and 427 (7.9{\%}) had prostatitis-like syndrome. Chronic Prostatitis Symptom Index total score decreased significantly at 48 months in the dutasteride group vs placebo in men with prostatitis-like pain (p <0.0001) and with prostatitis-like syndrome (t test p = 0.03). There were significantly more Chronic Prostatitis Symptom Index responders with dutasteride vs placebo in the prostatitis-like pain (49{\%} vs 37{\%}, respectively, p = 0.0033) and prostatitis-like syndrome (46{\%} vs 35{\%}, Fisher's exact test p = 0.0265) subgroups. Prostatitis was reported as an adverse event by significantly more men randomized to placebo (3.6{\%}) than to dutasteride (2.5{\%}, p = 0.003). Conclusions: Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen.",
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AU - Rittmaster, Roger S.

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N2 - Purpose: Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population. Materials and Methods: REDUCE was a 4-year, randomized, double-blind, placebo controlled study of prostate cancer risk reduction with 0.5 mg dutasteride vs placebo in men 50 to 75 years old with prostate specific antigen 2.5 to 10 ng/ml and a negative prostate biopsy in the previous 6 months. In this analysis we investigated change from baseline in Chronic Prostatitis Symptom Index in men with prostatitis-like pain (Chronic Prostatitis Symptom Index pain subscore 5 or greater) and prostatitis-like syndrome (perineal or ejaculatory pain plus Chronic Prostatitis Symptom Index pain subscore 4 or greater), the proportion of subjects with at least a moderate Chronic Prostatitis Symptom Index response (6-unit or greater improvement) and reports of new onset clinical prostatitis. Results: Of 5,379 men with a total baseline Chronic Prostatitis Symptom Index score 678 (12.6%) had prostatitis-like pain and 427 (7.9%) had prostatitis-like syndrome. Chronic Prostatitis Symptom Index total score decreased significantly at 48 months in the dutasteride group vs placebo in men with prostatitis-like pain (p <0.0001) and with prostatitis-like syndrome (t test p = 0.03). There were significantly more Chronic Prostatitis Symptom Index responders with dutasteride vs placebo in the prostatitis-like pain (49% vs 37%, respectively, p = 0.0033) and prostatitis-like syndrome (46% vs 35%, Fisher's exact test p = 0.0265) subgroups. Prostatitis was reported as an adverse event by significantly more men randomized to placebo (3.6%) than to dutasteride (2.5%, p = 0.003). Conclusions: Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen.

AB - Purpose: Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population. Materials and Methods: REDUCE was a 4-year, randomized, double-blind, placebo controlled study of prostate cancer risk reduction with 0.5 mg dutasteride vs placebo in men 50 to 75 years old with prostate specific antigen 2.5 to 10 ng/ml and a negative prostate biopsy in the previous 6 months. In this analysis we investigated change from baseline in Chronic Prostatitis Symptom Index in men with prostatitis-like pain (Chronic Prostatitis Symptom Index pain subscore 5 or greater) and prostatitis-like syndrome (perineal or ejaculatory pain plus Chronic Prostatitis Symptom Index pain subscore 4 or greater), the proportion of subjects with at least a moderate Chronic Prostatitis Symptom Index response (6-unit or greater improvement) and reports of new onset clinical prostatitis. Results: Of 5,379 men with a total baseline Chronic Prostatitis Symptom Index score 678 (12.6%) had prostatitis-like pain and 427 (7.9%) had prostatitis-like syndrome. Chronic Prostatitis Symptom Index total score decreased significantly at 48 months in the dutasteride group vs placebo in men with prostatitis-like pain (p <0.0001) and with prostatitis-like syndrome (t test p = 0.03). There were significantly more Chronic Prostatitis Symptom Index responders with dutasteride vs placebo in the prostatitis-like pain (49% vs 37%, respectively, p = 0.0033) and prostatitis-like syndrome (46% vs 35%, Fisher's exact test p = 0.0265) subgroups. Prostatitis was reported as an adverse event by significantly more men randomized to placebo (3.6%) than to dutasteride (2.5%, p = 0.003). Conclusions: Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen.

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