Improvements in benign prostatic hyperplasia‐specific quality of life with dutasteride, the novel dual 5α‐reductase inhibitor

Abstract

£ 15 mL/s. BII scores were recorded at baseline and each study visit. Clinically and statistically significant changes in BII scores from baseline were investigated for each study visit. Logistical regression analysis was used to assess the significance of baseline prostate volume, symptoms, BII item 3, baseline Q max , serum dihydrotestosterone, testosterone, PSA, age and weight in predicting the BII score at 2 years. RESULTSDutasteride, but not placebo, resulted in clinically and statistically significant improvements in mean BII score from 6 months. Of patients with a baseline BII score of ≥ 5 (greatest symptomatic burden) treatment with dutasteride improved the scores by 2.41, while the scores in placebotreated patients only improved by 1.64. Dutasteride-treated patients with a baseline BII score of <5 (least symptom burden) had a clinically significant improvement in health status, while placebo-treated patients deteriorated. Regression analysis showed that men with a combination of a baseline BII item-3 score of 3 (bothered a lot) and a high symptom score (AUA-SI ≥ 20) were more likely to be bothered by their symptoms at the end of the study. Men receiving placebo were also more likely to be bothered at the end of the study than were those receiving dutasteride. CONCLUSIONSDutasteride treatment is associated with clinically significant improvements in BII score, reflecting improvements in the quality of life of men with BPH. Taken together with previously reported improvements in prostate volume, lower urinary tract symptoms and urinary flow, and diminution of the risk of acute urinary retention and the need for BPH-related surgery, dutasteride offers demonstrable efficacy in the management of BPH. KEYWORDSbenign prostatic hyperplasia, dutasteride, health status, quality of life, bother, BPH Impact Index OBJECTIVESTo examine the effect of the dual-action 5 areductase inhibitor dutasteride on benign prostatic hyperplasia (BPH)-specific health status, as measured by the BPH Impact Index (BII), and to identify baseline and treatment risk factors for those most bothered by their BPH symptoms at the end of the protocol. PATIENTS AND METHODSData were derived from three randomized, double-blind, placebo-controlled, 2-year studies conducted in 4325 men with lower urinary tract symptoms caused by benign prostatic enlargement. Each study comprised a 1-month single-blind placebo run-in period, followed by randomization to oral dutasteride 0.5 mg once daily or placebo for 2 years. Patients eligible for inclusion were consenting men aged ≥ 50 years with moderate to severe symptoms (American Urological Symptom Index, AUA-SI, score ≥ 12), a prostate volume of ≥ 30 mL, a serum prostate-specific antigen (PSA) level of ≥ 1.5 or < 10 ng/mL, and a maximum urinary flow rate (Q max ) of

Dutasteride significantly improves quality of life measures in patients with enlarged prostate

“…Consistent improvements in QOL measures were also seen in a study by O'Leary et al, 17 who previously assessed the effect of dutasteride on QOL using the BPH impact index questionnaire in patients randomized to treatment with dutasteride or placebo. The BPH impact index is a validated questionnaire 12 that measures the impact of symptoms that may affect a patient's health status and which serves as a practical approach to deciding whether medical or surgical intervention is necessary.…”

Clinical guideline for male lower urinary tract symptoms

“…23 Investigations on QOL in men with LUTS have been almost limited to benign prostatic hyperplasia. Analyses using the Short Form-36 and other generic QOL questionnaires 24 or disease-specific instruments have uniformly shown that LUTS, storage symptoms in particular, have negative effects on QOL, 25 and that medical therapy 26 and surgical interventions 27 improve the lowered QOL. Few investigations have looked into the relationship between LUTS and QOL.…”

Combination therapy with dutasteride and tamsulosin for the treatment of symptomatic enlarged prostate

“…Each of seven symptoms (frequency, urgency, weak stream, intermittency, incomplete emptying, straining to urinate, and nocturia) are scored by the patient on a 0-5 scale based on their frequency. A score of less than 7 indicates mild symptoms; a score of [8][9][10][11][12][13][14][15][16][17][18][19] indicates moderate symptoms, and a score of greater than 19 indicates severe symptoms. In addition to symptoms that may have a negative impact on the quality of life, BPH/BPE can result in acute urinary retention, Dovepress recurrent urinary tract infections (UTI), bladder stones, urinary incontinence, gross hematuria and renal failure.…”