Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years

Perry B. Hudson, Rex Boake, John Trachtenberg, Nicholas A. Romas, Sidney Rosenblatt, Perinchery Narayan, Jack Geller, Michael M. Lieber, Mostafa Elhilali, Richard Norman, Anthony Patterson, Jean Paul Perreault, Gholam H. Malek, Reginald C. Bruskewitz, Johnny B. Roy, K. O. Amy, Carol A. Jacobsen, Elizabeth Stoner

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Abstract

Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 rag. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12- month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years. Results. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P <0.001), the quasi-American Urological Association symptom score was decreased by 4.5 points, and maximal urinary flow was increased by 2.3 mL/s (P <0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time. Conclusions. Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.

Original languageEnglish (US)
Pages (from-to)690-695
Number of pages6
JournalUrology
Volume53
Issue number4
DOIs
StatePublished - Apr 1 1999

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Finasteride
Prostatic Hyperplasia
Prostate
Digital Rectal Examination
Placebos
Safety
Therapeutics

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Hudson, P. B., Boake, R., Trachtenberg, J., Romas, N. A., Rosenblatt, S., Narayan, P., ... Stoner, E. (1999). Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. Urology, 53(4), 690-695. https://doi.org/10.1016/S0090-4295(98)00666-9

Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. / Hudson, Perry B.; Boake, Rex; Trachtenberg, John; Romas, Nicholas A.; Rosenblatt, Sidney; Narayan, Perinchery; Geller, Jack; Lieber, Michael M.; Elhilali, Mostafa; Norman, Richard; Patterson, Anthony; Perreault, Jean Paul; Malek, Gholam H.; Bruskewitz, Reginald C.; Roy, Johnny B.; Amy, K. O.; Jacobsen, Carol A.; Stoner, Elizabeth.

In: Urology, Vol. 53, No. 4, 01.04.1999, p. 690-695.

Research output: Contribution to journalArticle

Hudson, PB, Boake, R, Trachtenberg, J, Romas, NA, Rosenblatt, S, Narayan, P, Geller, J, Lieber, MM, Elhilali, M, Norman, R, Patterson, A, Perreault, JP, Malek, GH, Bruskewitz, RC, Roy, JB, Amy, KO, Jacobsen, CA & Stoner, E 1999, 'Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years', Urology, vol. 53, no. 4, pp. 690-695. https://doi.org/10.1016/S0090-4295(98)00666-9
Hudson PB, Boake R, Trachtenberg J, Romas NA, Rosenblatt S, Narayan P et al. Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. Urology. 1999 Apr 1;53(4):690-695. https://doi.org/10.1016/S0090-4295(98)00666-9
Hudson, Perry B. ; Boake, Rex ; Trachtenberg, John ; Romas, Nicholas A. ; Rosenblatt, Sidney ; Narayan, Perinchery ; Geller, Jack ; Lieber, Michael M. ; Elhilali, Mostafa ; Norman, Richard ; Patterson, Anthony ; Perreault, Jean Paul ; Malek, Gholam H. ; Bruskewitz, Reginald C. ; Roy, Johnny B. ; Amy, K. O. ; Jacobsen, Carol A. ; Stoner, Elizabeth. / Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. In: Urology. 1999 ; Vol. 53, No. 4. pp. 690-695.
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abstract = "Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 rag. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12- month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years. Results. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6{\%} at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7{\%} (P <0.001), the quasi-American Urological Association symptom score was decreased by 4.5 points, and maximal urinary flow was increased by 2.3 mL/s (P <0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time. Conclusions. Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.",
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T1 - Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years

AU - Hudson, Perry B.

AU - Boake, Rex

AU - Trachtenberg, John

AU - Romas, Nicholas A.

AU - Rosenblatt, Sidney

AU - Narayan, Perinchery

AU - Geller, Jack

AU - Lieber, Michael M.

AU - Elhilali, Mostafa

AU - Norman, Richard

AU - Patterson, Anthony

AU - Perreault, Jean Paul

AU - Malek, Gholam H.

AU - Bruskewitz, Reginald C.

AU - Roy, Johnny B.

AU - Amy, K. O.

AU - Jacobsen, Carol A.

AU - Stoner, Elizabeth

PY - 1999/4/1

Y1 - 1999/4/1

N2 - Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 rag. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12- month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years. Results. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P <0.001), the quasi-American Urological Association symptom score was decreased by 4.5 points, and maximal urinary flow was increased by 2.3 mL/s (P <0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time. Conclusions. Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.

AB - Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 rag. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12- month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years. Results. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P <0.001), the quasi-American Urological Association symptom score was decreased by 4.5 points, and maximal urinary flow was increased by 2.3 mL/s (P <0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time. Conclusions. Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.

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