Research Article| Volume 19, ISSUE 2, P243-258, March 1997

Efficacy and tolerability of finasteride in symptomatic benign prostatic hyperplasia: a primary care study

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      Because increasing numbers of men are seeking treatment for benign prostatic hyperplasia (BPH) from primary care physicians, we sought to assess the efficacy and tolerability of finasteride in a primary care setting. In this randomized, double-masked study, 2112 men with symptomatic BPH received either finasteride (n = 1589) or placebo (n = 523) for 1 year. At 3, 6, 9, and 12 months, urinary symptoms were measured using the American Urological Association Symptom Index (AUASI). Quality of life was assessed using the BPH Impact Index (BII), which assessed bother, worry, physical discomfort, and restriction in activities. Both patients and investigators assessed overall urologic status. Investigators assessed the effect of the drug on plasma lipids in a subset of patients. Patients treated with finasteride had a statistically significant mean decrease in AUASI scores compared with patients treated with placebo beginning at month 6 and continuing throughout the study. At month 12, adjusted mean decreases in AUASI scores were −4.96 for finasteride versus −3.71 for placebo. Statistically significant differences in favor of finasteride were also noted on BII at months 9 and 12. Patient and investigator overall assessments showed greater improvement in the finasteride group beginning at month 6. The incidence of drug-related sexual adverse experiences was significantly greater in finasteride-treated patients but led to withdrawal in only 2.2% of these patients. Overall lipid profile was not significantly altered in either group. Based on improvement in symptoms and quality of life, and on its favorable tolerability profile, finasteride should be considered by primary care physicians for management of symptomatic BPH.


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        • Berry SJ
        • Coffey DS
        • Walsh PC
        • et al.
        The development of human benign prostatic hyperplasia with age.
        J Urol. 1984; 132: 474-478
        • Jacobsen SJ
        • Girman CJ
        • Guess HA
        • et al.
        New diagnostic and treatment guidelines for benign prostatic hyperplasia. Potential impact in the United States.
        Arch Intern Med. 1995; 155: 477-481
        • McConnell JD
        • Barry MJ
        • Bruskewitz RC
        • et al.
        Benign prostatic hyperplasia: Diagnosis and treatment.
        Clinical Practice Guideline, Number 8. Agency for Health Care Policy and Research, US Department of Health and Human Services, Rockville, Md1994 (AHCPR Publication No. 94-0582)
        • White JW
        The results of double castration on hypertrophy of the prostate.
        Ann Surg. 1985; 25: 1-59
        • Peters CA
        • Walsh PC
        The effect of nafarelin acetate, a luteinizing-hormone-releasing hormone agonist on benign prostatic hyperplasia.
        NEJM. 1987; 317: 599-604
        • Schröder FH
        • Westerhof M
        • Bosch JR
        • et al.
        Benign prostatic hyperplasia treated by castration or the LH-RH analogue buserelin: A report of 6 cases.
        Eur Urol. 1987; 12: 318-321
        • Gormley GJ
        • Stoner E
        • Bruskewitz RC
        • et al.
        The effect of finasteride in men with benign prostatic hyperplasia.
        NEJM. 1992; 327: 1187-1191
        • The Finasteride Study Group
        Finasteride (MK-906) in the treatment of benign prostatic hyperplasia.
        Prostate. 1993; 22: 291-299
        • Stoner E
        • Finasteride Study Group
        Three-year safety and efficacy data on the use of finasteride in the treatment of benign prostatic hyperplasia.
        Urology. 1994; 43: 284-294
        • Lepor H
        • Stoner E
        Long-term results of medical therapies for benign prostatic hyperplasia.
        Curr Opin Urol. 1995; 5: 18-24
        • Moore E
        • Bracken B
        • Bremmer W
        • et al.
        Proscar®: Five-year experience.
        Eur Urol. 1993; 28: 304-309
        • Boyle P
        • Gould AL
        • Roehrborn CG
        Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: Meta-analysis of randomized clinical trials.
        J Urol. 1996; 48: 398-405
        • Sorva R
        • Kuusi T
        • Taskinen MR
        • et al.
        Testosterone substitution increases the activity of lipoprotein lipase and hepatic lipase in hypogonadal males.
        Atherosclerosis. 1988; 69: 191-197
        • Marin P
        • Oden B
        • Bjorntorp P
        Assimilation and mobilization of triglycerides in subcutaneous abdominal and femoral adipose tissue in vivo in men: Effects of androgens.
        J Clin Endocrinol Metab. 1995; 80: 239-243
        • Barry MJ
        • Fowler FJ
        • O'Leary MP
        • et al.
        The American Urological Association Symptom Index for benign prostatic hyperplasia.
        J Urol. 1992; 148: 1549-1557
        • Barry MJ
        • Fowler FJ
        • O'Leary MP
        • et al.
        Measuring disease-specific health status in men with benign prostatic hyperplasia. Measurement Committee of The American Urological Association.
        Med Care. 1995; 33 (Suppl 4): AS145-AS155
        • Epstein RS
        • Deverka PA
        • Chute CG
        • et al.
        Validation of a new quality of life questionnaire for benign prostatic hyperplasia.
        J Clin Epidemiol. 1992; 45: 1431-1445
        • Steiner PM
        • Freidel J
        • Bremner WF
        • Stein EA
        Standardization of micromethods for plasma cholesterol, triglyceride, and HDL-cholesterol with the lipid clinics' methodology.
        J Clin Chem. 1981; 19 (Abstract): 850
        • Andersen JT
        • Ekman P
        • Wolf H
        • et al.
        • The Scandinavian BPH Study Group
        Can finasteride reverse the progress of benign prostatic hyperplasia? A two-year placebo-controlled study.
        Urology. 1995; 46: 631-637
        • Girman CJ
        • Kolman C
        • Liss CL
        • et al.
        Effects of finasteride on health-related quality of life in men with symptomatic benign prostatic hyperplasia.
        Prostate. 1996; 29: 83-90
        • Byrnes CA
        • Morton AS
        • Liss CL
        • et al.
        • CUSP Investigators
        Efficacy, tolerability, and effect on health-related quality of life of finasteride versus placebo in men with symptomatic benign prostatic hyperplasia: A community based study.
        Clin Ther. 1995; 17: 956-969
        • Guess HA
        • Heyse JF
        • Gormley GJ
        The effect of finasteride on prostate-specific antigen in men with benign prostatic hyperplasia.
        Prostate. 1993; 22: 31-37
        • Guess HA
        • Heyse JF
        • Gormley GJ
        • et al.
        Effect of finasteride on serum PSA concentration in men with benign prostatic hyperplasia. Results from the North American Phase III Clinical Trial.
        Urol Clin North Am. 1993; 20: 627-636
        • Plawker MW
        • Fleisher JM
        • Nitti VW
        • Macchia RJ
        Primary care practitioners: An analysis of their perceptions of voiding dysfunction and prostate cancer.
        J Urol. 1996; 155: 601-604