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BENIGN
PROSTATIC HYPERPLASIA: PROSCAR |
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Department of Urology,
Columbia University College of Physicians and Surgeons,
New York, New York, USA.
To evaluate the safety and efficacy
of Finasteride 5 mg during a 10-year period in men
with enlarged prostates from a single center who participated
in the double-blind and extension phases of the multicenter,
Phase III, North American benign prostatic hyperplasia
(BPH) trial. It is important that the long-term safety
and efficacy of drugs intended for chronic administration
in men with BPH be well understood.The Phase III North
American BPH trial involved a 1-year, placebo-controlled,
double-blind study, followed by a 5-year open extension
with Finasteride 5 mg/day. The trial enrolled men
with symptomatic BPH, an enlarged prostate on digital
rectal examination, and no evidence of prostate cancer.
Of the 46 patients originally enrolled from our institution,
43 were randomized to receive Finasteride or placebo,
of whom 41 (95%) completed the double-blind study
and entered the 5-year extension. Thirty (73%) of
these 41 patients completed the 5-year extension.
Patients continued to be followed up by their physicians
for an additional 5 years, for a total follow-up of
at least 10 years.Twenty-four (56%) of the original
43 patients randomized to Finasteride or placebo were
judged as successfully treated during the 10-year
Finasteride follow-up (17 patients taking Finasteride
alone at 10 years and 7 patients who were taking Finasteride
alone when they discontinued during the 10-year follow-up
for reasons not related to Finasteride treatment).
Altogether, 22 (51%) of the original 43 randomized
patients continued Finasteride treatment at 10 years
(17 taking Finasteride alone, 4 taking Finasteride
plus an alpha-blocker, and 1 taking Finasteride for
treatment of hematuria). Finasteride was well tolerated,
with no new adverse experiences occurring with increasing
duration of exposure to the drug.This long-term follow-up
study has demonstrated that appropriately selected
patients with symptomatic BPH and enlarged prostates
are likely to have a long-term response to taking
Finasteride 5 mg daily.
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Service d'Urologie, Hopital
Saint-Louis, Paris, France.
Benign prostatic hyperplasia (BPH)
is increasingly common in medical practice, as a result
of the inevitable aging of the population. The current
therapeutic strategy includes three alternatives:
watchful waiting, medical treatment and invasive therapy.
Finasteride is one of the pharmacological options
available. Many clinical studies have demonstrated
its efficacy and good safety profile in patients with
BPH. The survey we report provides new insights into
what has to date been a purely therapeutic approach
by taking into consideration patients' expectations
and their perception of Finasteride treatment. Results
indicate that the main preoccupation for patients
with BPH is that the pharmacological treatment will
reduce the risk of major urological complications
and the need for surgery (treatment characteristics
considered as very or extremely important by 88 and
93% of patients, respectively). Decreasing symptoms
and improving quality of life take second place after
these primary concerns. Patient perception of Finasteride
is excellent. Nearly all patients are satisfied by
the efficacy of the treatment, 89% of them reporting
good to extremely good improvement of symptoms, the
rapid onset of relief being particularly important.
The efficacy of Finasteride is not hindered by any
tolerability issues and is further strengthened by
its ease of use. Although this novel survey includes
a number of biases, it nevertheless demonstrates that
treatment of BPH with Finasteride is well accepted
by patients and satisfies their expectations. In addition,
it provides a mass of general epidemiological data
on patients with BPH, as well as on current medical
practice regarding this condition.
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Department of Urology,
Feinberg School of Medicine, Northwestern University,
Tarry Building Room 11-715, 303 East Chicago Avenue,
Chicago, IL 60611-3008, USA.
The vast majority of patients presenting
to their physicians with concerns about voiding are
seeking quick resolution of a disturbed urination
pattern. The primacy of their concern over symptoms
is appropriate, given the current focus on amelioration
of voiding complaints in the treatment of lower urinary
tract symptoms. Patients also ask about the risks
of symptom progression and how this should impact
their decision to choose either medical or surgical
intervention. The concept of benign prostatic hyperplasia
(BPH) progression has recently become a growing area
of interest as new information emerges concerning
the natural history of BPH and the identification
of risk factors for progression. The impact of medical
treatment on the prevention of BPH progression is
slowly becoming apparent. The Proscar Long-Term Efficacy
and Safety Study trial (Proscar; Merck & Co.,
Whitehouse Station, NJ) revealed a reduced risk of
acute urinary retention and the requirement for invasive
treatment with the long-term use of Finasteride. More
recent data from the Medical Therapy of Prostate Symptoms
trial revealed that symptomatic men with BPH who were
treated with a combination of an a-blocker and a 5-a
reductase inhibitor showed significantly delayed clinical
progression of their symptoms compared with treatment
with each drug individually. Combination therapy appears
to be more effective than doxazosin or Finasteride
alone in producing significant improvements in American
Urological Association Symptom Index and flow rate
changes. Interestingly, Finasteride and combination
therapy reduced the long-term risk of acute urinary
retention.
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