📃 Paper Title: The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group
🧍 Author: J D McConnell
🕒 Year: 1998
📚 Journal: The New England Journal of Medicine
🌎 Country: USA
ㅤContext to the study:
Can you tell me about a study that identified the efficacy of finasteride in treating men with urinary obstruction and prostatic enlargement?
ㅤ✅ Take-home message of study:
Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow
rate, and reduces the probability of surgery and acute urinary retention.
ㅤ Multicentre, double-blind, randomised placebo-controlled study
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Study participants:
3040 men from 95 centres recruited between 1990 and 1992 with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years.
Exclusions:
PSA>10ng/ml
history of chronic prostatitis
previous prostate or bladder cancer or surgery
recurrent UTIs
men on antiandrogens, or alpha adrenergic antagonists.
note men with PSA between 4.0 and 9.9ng/ml were required to have negative prostate biopsy prior to enrolment onto the study.
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Key study outcomes:
Complete data on 2760 men; 1513 finasteride, 1503 placebo arm.
Mean decrease in symptom score (on a scale of 0-34 points, 'quasi-AUA symptom score' assessing nocturia, impairment of size and force of stream, urinary frequency, delayed, strained or interrupted urination and incomplete emptying of bladder)
Finasteride: 3.3 points
Placebo: 1.3 points
*p<0.001
Acute Urinary Retention:
Finasteride: n=42, 3%
Placebo: n=99, 7%
*57% reduction of risk with finasteride. p<0.001
BPH Surgery:
Finasteride: n=69, 5%
Placebo: n=152, 10%
*55% reduction of risk with finasteride. p<0.001
Change in Prostate volume on MRI (measured in 13 centres annually)
Finasteride: 18% decrease
Placebo: 14% increase
p<0.001
Change in urinary flow rates, p<0.001
Finasteride 1.9ml/s increase
Placebo 0.2ml/s increase
p<0.001
NNT for four years to reduce an event (AUR or surgery): 15 (95% CI 1-23)
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Study Limitations:
High rate of discontinuation of study drugs (524 men, 34% discontinued finasteride, compared to 633 men, 42% discontinued placebo)
Enrolled mod-severe symptoms with enlarged prostate gland on DRE: Not generalisable to men who have symptoms without prostatic enlargement.
Predominantly white population (95.5% placebo, 94.9 finasteride)
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