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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): CLINICAL TRIALS

Dutasteride with Tamsulosin (Duodart) co-administered

The following statements reflect the information available on dutasteride and tamsulosin when administered together as separate medications. No clinical studies have been conducted with the fixed-dose combination Duodart capsule.

Dutasteride 0.5 mg/day (n=1,623), tamsulosin 0.4 mg/day (n=1,611) or the combination of dutasteride 0.5 mg plus tamsulosin 0.4 mg (n=1,610) [total number of patients = 4844] were evaluated in men with moderate to severe symptoms of BPH who had prostate volumes >= 30mL and a PSA values within the range 1.5 - 10 ng/mL in a multicenter, multinational, randomized double-blind, parallel group study. Approximately 52% of subjects had previous exposure to 5alpha-reductase inhibitor or alpha-blocker treatment. Efficacy endpoints during the first 2 years of treatment were change in International Prostate Symptoms Score (IPSS), maximum urine flow rate (Qmax) and prostate volume. IPSS is an 8-item instrument based on AUA-SI with an additional question on quality of life. This study was designed as a 4 year study with a pre-defined analysis at 2 years.

Dutasteride monotherapy

The efficacy and safety of dutasteride 0.5 mg/day in the treatment and prevention of progression of BPH in 4325 males (aged 47 to 94 years with BPH who had enlarged prostates (greater than 30ccs) and a Prostate Specific Antigen (PSA) value within the range 1.5-10 ng/mL) was demonstrated in three pivotal, randomised, double-blind, placebo-controlled, 2-year multicentre studies (ARIA3001, ARIA3002 and ARIB3003). Of the 4325 males enrolled in the studies, 2167 received dutasteride and 2158 received placebo.

Pooled data from the three pivotal studies show that, in men with BPH, dutasteride reduces the risk of both acute urinary retention (AUR) and the need for surgical intervention (SI). Improvements in BPH related symptoms, increased maximum urinary flow rates, and decreasing prostate volume suggest dutasteride reverses the progression of BPH in men with an enlarged prostate.

Pooled efficacy data from the three pivotal studies is summarised below.

Acute Urinary Retention (AUR) and Surgical Intervention

Relative to placebo dutasteride significantly reduces both the risk and incidence of AUR by 57% (4.2% for placebo versus 1.8% for dutasteride) and the need for BPH-related surgical intervention by 48% (4.1% for placebo versus 2.2% for dutasteride) over 24 months.

Lower Urinary Tract Symptoms (LUTS) assessed by AUA-SI

Symptoms were quantified using the AUA-SI (American Urological Association Symptom Index), a seven-item questionnaire that evaluates urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) by rating on a 0 to 5 scale with a maximum score of 35. Entry criteria included a screening score of >= 12 (moderate to severe symptoms). A reduction in score signifies an improvement in symptoms.

The baseline AUA-SI score across the three studies was approximately 17 units in both treatment groups. Statistically significant improvements in symptom score in patients treated with dutasteride compared to placebo were noted from Month 6 through to Month 24 (p < 0.001). At Month 24, the mean decrease from baseline in AUA-SI symptom scores was -4.8 units for dutasteride and -2.4 units for placebo.

Maximum Urinary Flow (Qmax)

Baseline Qmax was approximately 10 mL/sec (normal Qmax >= 15 mL/sec) in both treatment groups across the three studies. Statistically significant improvement in Qmax in patients treated with dutasteride compared to placebo was noted from Month 1 through to Month 24. At Month 24, treatment urinary flow had improved by 0.8 mL/sec and 2.4 mL/sec in the placebo and dutasteride groups respectively.

Prostate Volume

In patients treated with dutasteride, prostate volume was shown to reduce as early as one month after initiation of treatment and reductions continued through to Month 24 (p < 0.001). Dutasteride led to a mean reduction of prostate volume of 23.6% (from 54.9cc at baseline to 42.1cc) at Month 12 compared with a mean reduction of 0.5% (from 54.0cc to 53.7cc) in the placebo group. At 24 months, dutasteride decreased prostate volume by 25.7% (from 54.9cc at baseline to 41.2cc) compared with an increase of 1.7% (from 54.0cc to 54.1cc) in the placebo group.

Pooled safety data from the three pivotal studies show that the adverse reaction profile of dutasteride (0.5 mg/day for 24 months) was similar to that of placebo.

Breast neoplasia

In dutasteride BPH monotherapy clinical trials, providing 3374 patient years of exposure to dutasteride, there were 2 cases of breast cancer reported in dutasteride-treated patients, one after 10 weeks and one after 11 months of treatment, and 1 case in a patient who received placebo. The relationship between long-term use of dutasteride and male breast cancer is unknown.

Tamsulosin monotherapy

Tamsulosin rapidly (from one week) increases maximum urinary flow rate by reducing smooth muscle tension in the prostate and urethra, thereby relieving obstruction. It also improves the complex of irritative and obstructive symptoms in which bladder instability and tension of the smooth muscles of the lower urinary tract play an important role.


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