Proscar Demonstrated Effective for BPH
By Joan Unger MS, ARNP
Summary-A recent study at the University of Texas Southwestern Medical Center in Dallas found that finasteride, when compared with a placebo, reduces symptoms and prostate volume, increases urinary flow rate, and reduces the probability of surgery and acute urinary retention associated with benign prostatic hyperplasia. Improvement was noted within four months after beginning and continued throughout the four-year study. Although study results were positive, additional research is needed to demonstrate the safety and efficacy of the drug over long periods of time.
Benign prostatic hyperplasia (bph) is a common age-related disorder that affects 20-80% of men. By age 75, 50% of men will complain of a decrease in the caliber and force of the urinary stream.1 Symptoms may interfere with the patient's normal daily activities and sense of well-being. Untreated, urinary retention, bladder calculi, bladder infection, and renal failure may result. A recent study by McConnell suggests that treatment with Proscar (finasteride) improves urinary symptoms and may preclude surgery.
In 1991, benign prostatic hypertrophy accounted for 1.9 million office visits annually.2 Estimates indicate 5.5 million men would meet guidelines indicating a need to discuss treatment options for BPH.3 More than 250,000 transurethral resections of the prostate (TURP) are performed annually in the United States,4 and TURP is the second most common operation in older men.5 Estimates indicate 25% of men in the United States will be treated for symptomatic BPH by age 80.6
The etiology of BPH is not well understood but seems to be under endocrine control. BPH may arise from an alteration in systemic hormones that act in combination with growth factors stimulating stromal or glandular hyperplasia.
Until recently, medical treatment was directed toward reducing prostatic androgen levels. Reducing circulating levels of testosterone results in loss of sexual function and libido and is unacceptable to many patients. Complications of TURP are uncommon but include urethral stricture, incontinence, and bladder neck contracture. Open prostatectomy is usually reserved for large glands (> 40 grams). Transurethral dilatation, laser ablation, and/or incision of prostate are other options.
In 1997, a study using a pooled series of 4222 men with moderately symptomatic BPH suggested finasteride reduced the occurrence of acute urinary retention (AUR) and surgical interventions. Investigators concluded that treatment with finasteride reduced frequency of AUR by 50% and surgical intervention by more than one-third.7 This was the first study of its kind and had important implications for management of BPH patients.
In February 1998, conclusions of a four-year, double-blind, randomized placebo-controlled study of the effect of finasteride on AUR and BPH appeared.8 Study criteria were moderate to severe symptoms and an enlarged prostate by digital rectal examination (DRE). While DRE has been found to underestimate prostate size compared with transurethral ultrasound, it is still considered useful as a preliminary assessment.9 The study group of 3040 men were treated with finasteride 5 mg daily or placebo and followed for four years.
Ten percent (152) of men in the placebo group (1503) and 5% (69) in the finasteride group (1513) underwent surgery for BPH. Finasteride decreased the risk of AUR, which developed in 7% of the subjects in the placebo group but only 3% of the finasteride group. This reduction in risk for spontaneous AUR is important. AUR is painful and increases morbidity associated with TURP.10
Treatment with finasteride improved urinary flow rates, reduced prostate volume, and decreased symptoms. During the first year, average prostate volume in the finasteride group decreased and showed no increase afterward.
In the placebo group, the prostate volume increased. Among men who completed the study, average decrease in prostate volume in the finasteride group was 18%, compared with an increase of 14% in the placebo group.8
Benefits of Proscar Still Questioned
In spite of encouraging findings, some experts remain skeptical about the benefits of the drug. John H. Wasson, MD, of Dartmouth Medical School in Hanover, NH, warns that Proscar "may be unwarranted for most men with symptoms of this disorder."8 Wasson points out that the drug is costly, about $700 a year.10 He claims there is no evidence that finasteride significantly improves patients' quality of life and says their conditions may not worsen even without treatment.
Researchers found no significant differences between groups in incidence of serious adverse effects. Symptoms of sexual dysfunction, breast enlargement or tenderness, and rashes were noted in 1% or more of the patients. During the first year of the study, decreased libido and impotence were more frequent in the finasteride group. The placebo group reported two cases of breast cancer, but the finasteride group reported none. Prostate biopsies performed during the study revealed the incidence of prostate cancer was 5% in each group.
Other causes of BPH should be ruled out before starting therapy with finasteride.
Finasteride is a 5-alpha reductase inhibitor available in 5 mg tablets. Recommended dose is 5 mg daily for at least six months with reevaluation at six months and periodically thereafter. Users should take adequate contraceptive measures or discontinue use before exposing women of childbearing potential to sperm. Pregnant women and those of childbearing age should not handle crushed tablets. Use caution in patients with hepatic dysfunction and monitor for prostate specific antigen levels, prostatic cancer, and obstructive uropathy. Finasteride may antagonize theophylline.
References
1. Presti J, Stoller M, Carroll P. Urology. In: Tierney L, McPhee S, Papadakis M. Current Medical Diagnosis Treatment. Stamford, CT: Appleton & Lange; 1997: 875-879.
2. Schappert SM. National Ambulatory Medical Care Survey: 1991 summary, National Center for Health Statistics. Vital Health Stat 1994;13:116.
3. Agency for Health Care Policy and Research. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline No. 8, AHCPR Publication No. 940582. Rockville, MD: Department of Health and Human Services; 1994.
4. Graves IJ. Detailed Diagnoses and Procedures, National Hospital Discharge Survey. 1993.
5. National Center for Health Statistics. Vital Health Stat 1995;13:122.
6. Oesterling J. Benign prostatic hyperplasia: medical and minimally invasive treatment options. N Engl J Med 1995;332:99-109.
7. Barry MJ. Medical outcomes research and benign prostatic hyperplasia. Prostate 1990;3:61-74.
8. McConnell J, Gruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N Eng J Med 1998;338: 557-563.
9. Roehrborn C, Girman C, Rhodes T, et al. Correlation between prostate size estimated by digital rectal examination and measured by transrectal ultrasound. Urology 1997;49:548-557.
10. Andersen J, Nickel J. Marshall V, et al. Finasteride significantly reduces acute urinary retention and need for surgery in patients with symptomatic benign prostatic hyperplasia. Urology 1997;49:839-845.
Patient Education Emphasizes Knowing Your ABCDEs
Primary prevention of metastatic melanoma involves acknowledging the risk factors. A history of a blistering sunburn during childhood or adolescence increases the risk of melanoma as an adult. Examples of secondary prevention include self-evaluation of the skin and screening for suspicious lesions. Patients should be educated on the A, B, C, D, and E that will guide them through skin evaluations for melanoma:
A = asymmetry;
B = borders that are irregular;
C = color variations;
D = diameter greater than 6 mm;
E = elevation above the skin surface.
Ulceration and bleeding of the lesions are later signs. In women, the lesions appear more commonly on the extremities, while in men they occur more often on the trunk, head, or neck; however they can arise from any skin surface. According to the National Cancer Institute in Bethesda, MD, people over age 50 who have abnormal moles on their bodies have a greater risk of developing melanoma.
As advanced practice nurses, we need to make prompt referrals to a dermatologist or surgeon when a suspicious lesion is identified.
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