Health and Prostate

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Benign prostatic hyperplasia (BPH) refers to a complex of symptoms that can include difficult, painful or frequent urination, interrupted stream, hesitancy in starting to urinate and a feeling of incomplete emptying after urination. These symptoms are caused by pressure exerted on the urethra as the prostate gland grows larger with age. Unless the urethra is so obstructed that urine cannot pass through, the condition is not dangerous, but it affects most men at some point in their advanced years and can significantly impair well-being.

The treatment of BPH has most commonly involved either surgery to cut out part of the prostate and thereby ease the pressure on the urethra, or watchful waiting, in which the patient is monitored closely but not actively treated. A number of drug therapies have recently been added to the treatment arsenal against benign prostatic hyperplasia. Finasteride works by inhibiting the production of the enzyme 5-alpha reductase, which converts testosterone into dihydrotestosterone. In this way it prevents further prostatic growth and can even reduce the volume of the prostate in many men.

Generic Name Drug: Finasteride

Trade Names Drug: Proscar, Propecia, Penester, Prosteride, Finasterid Alternova, Finasterid IVAX, Fincar, Finpecia, Finpros, Finax, Finast, Finara, Finalo, Gefina, Appecia, Hyplafin, Tectum, Prezepa

Finasteride has been proved safe and effective against BPH in three placebo-controlled studies of six months to one year’s duration. These studies also revealed the very pronounced effect of placebo against symptoms of BPH. Many men receiving placebo experience improvements in symptom scores and in urinary flow rates. This Scandinavian study wanted to see what results finasteride and placebo would have after two years of therapy, and particularly whether the benefits of placebo would persist over this longer time frame.

Seven hundred and seven men were enrolled at 59 Scandinavian centres in five countries. Men with severe intravesical obstruction, for which surgery is most often recommended, were not included in the study. All study subjects had mild to moderate symptoms of BPH, for which the primary aim of treatment is to relieve symptoms and prevent the need for invasive therapy. During a one-month lead-in period, all subjects received placebo in order to minimize the well-known placebo effect on BPH symptoms. Men were then randomly assigned to receive either 5 mg finasteride per day or placebo for the next 24 months.

A physical exam was accomplished at the start of the study and repeated after 12 and then 24 months of therapy. This included a digital rectal exam and laboratory tests such as PSA (prostate specific antigen) measurement. Urinary flow rates and residual urine volume after voiding were also tested on these three occasions. As well, all of the men completed a questionnaire every four months, rating the severity of nine urinary symptoms, five of them obstructive, on a scale of zero to six. The effectiveness of each regimen was judged by changes in symptom scores, maximum flow rate and prostate volume over the study period.

The beneficial effect of placebo noted in previous studies was evident in this study as well after 12 months of therapy, with many men showing mild improvements in total symptom scores and stable prostate volume. However, during the second year of therapy, those receiving placebo ceased to benefit, and symptom scores returned to levels seen at the start of the study. Men receiving finasteride, on the other hand, continued to improve on all markers of benign prostatic hyperplasia over the entire study period.

When changes over the course of the study were calculated for each group, the finasteride group had a mean decrease of 2.0 in total symptom score, dropping from 13.4 to 11.4 (out of a maximum possible score of 54), while those receiving placebo saw their symptom scores increase by 0.2. Obstructive symptom scores dropped by 1.5 ml/second in the finasteride group, but only by 0.2 ml/sec in the placebo group. The maximum urinary flow rate achieved by the finasteride group increased by 1.5, while falling by 0.3 in the placebo group. Prostate volume fell by 19.2 cm3 in men receiving finasteride while increasing by 11.5 cm3 in those receiving placebo.

In summary, after two years of therapy with finasteride (Proscar), BPH symptoms were markedly improved for men receiving finasteride, showing that the drug can, in fact, reverse the natural progression of benign prostatic hyperplasia. The benefits of placebo did not persist over the second year of therapy, eliminating the possibility that the benefits of finasteride could be due to the placebo effect.

Comment: The exciting thing is that this is the first drug (Proscar) that actually shrinks the prostate. The study data suggested the possibility that this drug could even save some patients from surgery by shrinking the prostate before urinary retention gets so severe that it becomes a medical emergency – we are now investigating that more thoroughly. Other treatments have only focused on symptoms, not on the underlying cause. Hopefully the future will bring drugs that are more selective. Our obligation as medical professionals is to select appropriate therapy for the patient and not subject them to treatment that won’t help them. You wouldn’t submit patients to major surgery if there was only a 50% chance that it would help, particularly for a benign condition. So the future must be to get tools to predict who will be a good responder from the outset.

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