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AVODART: CLINICAL STUDIES

Monotherapy

Avodart 0.5 mg / day (n = 2,167) or placebo (n = 2,158) was evaluated in male subjects with BPH in three 2-year multicenter, placebo-controlled, double-blind studies, each with 2-year open-label extensions (n = 2,340). More than 90% of the study population was caucasian. Subjects were at least 50 years of age with a serum PSA >= 1.5 ng / mL and < 10 ng / mL and BPH diagnosed by medical history and physical examination, including enlarged prostate (>= 30 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index (AUA-SI). Most of the 4,325 subjects randomly assigned to receive either dutasteride or placebo completed 2 years of double-blind treatment (70% and 67%, respectively). Most of the 2,340 subjects in the study extensions completed 2 additional years of open-label treatment (71%).

Effect on symptom scores: Symptoms were quantified using the AUA-SI, a questionnaire that evaluates urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) by rating on a 0 to 5 scale for a total possible score of 35, with higher numerical total symptom scores representing greater severity of symptoms. The baseline AUA-SI score across the 3 studies was approximately 17 units in both treatment groups.

Subjects receiving dutasteride achieved statistically significant improvement in symptoms versus placebo by month 3 in 1 study and by month 12 in the other 2 pivotal studies. At month 12, the mean decrease from baseline in AUA-SI total symptom scores across the 3 studies pooled was -3.3 units for dutasteride and -2.0 units for placebo with a mean difference between the 2 treatment groups of -1.3 (range: -1.1 to -1.5 units in each of the 3 studies, P < 0.001) and was consistent across the 3 studies. At Month 24, the mean decrease from baseline was -3.8 units for dutasteride and -1.7 units for placebo with a mean difference of -2.1 (range: -1.9 to -2.2 units in each of the 3 studies, P < 0.001). The improvement in BPH symptoms seen during the first 2 years of double-blind treatment was maintained throughout an additional 2 years of open-label extension studies.

These studies were prospectively designed to evaluate effects on symptoms based on prostate size at baseline. In men with prostate volumes >= 40 cc, the mean decrease was -3.8 units for dutasteride and -1.6 units for placebo, with a mean difference between the 2 treatment groups of -2.2 at month 24. In men with prostate volumes < 40 cc, the mean decrease was -3.7 units for dutasteride and -2.2 units for placebo, with a mean difference between the 2 treatment groups of -1.5 at month 24.

Effect on acute urinary retention and the need for BPH-related surgery: Efficacy was also assessed after 2 years of treatment by the incidence of AUR requiring catheterization and BPH-related urological surgical intervention. Compared with placebo, Avodart (Dutasteride) was associated with a statistically significantly lower incidence of AUR (1.8% for Avodart vs. 4.2% for placebo, P < 0.001; 57% reduction in risk, [95% CI: 38% to 71%]) and 588 with a statistically significantly lower incidence of surgery (2.2% for Avodart (Dutasteride) vs. 4.1% for placebo, P < 0.001; 48% reduction in risk, [95% CI: 26% to 63%]).

Effect on prostate volume: A prostate volume of at least 30 cc measured by transrectal ultrasound was required for study entry. The mean prostate volume at study entry was approximately 54 cc.

Statistically significant differences (Avodart versus placebo) were noted at the earliest post-treatment prostate volume measurement in each study (Month 1, Month 3, or Month 6) and continued through Month 24. At Month 12, the mean percent change in prostate volume across the 3 studies pooled was -24.7% for dutasteride and -3.4% for placebo; the mean difference (dutasteride minus placebo) was -21.3% (range: -21.0% to -21.6% in each of the 3 studies, P < 0.001). At Month 24, the mean percent change in prostate volume across the 3 studies pooled was -26.7% for dutasteride and -2.2% for placebo with a mean difference of -24.5% (range: -24.0% to -25.1% in each of the 3 studies, P < 0.001). The reduction in prostate volume seen during the first 2 years of double-blind treatment was maintained throughout an additional 2 years of open-label extension studies.

Effect on maximum urine flow rate: A mean peak urine flow rate (Qmax) of <= 15 mL/sec was required for study entry. Qmax was approximately 10 mL / sec at baseline across the 3 pivotal studies.

Differences between the 2 groups were statistically significant from baseline at Month 3 in all 3 studies and were maintained through Month 12. At Month 12, the mean increase in Qmax across the 3 studies pooled was 1.6 mL / sec for Avodart (Dutasteride) and 0.7 mL / sec for placebo; the mean difference (dutasteride minus placebo) was 0.8 mL / sec (range: 0.7 to 1.0 mL / sec in each of the 3 studies, P < 0.001). At Month 24, the mean increase in Qmax was 1.8 mL / sec for dutasteride and 0.7 mL / sec for placebo, with a mean difference of 1.1 mL / sec (range: 1.0 to 1.2 mL / sec in each of the 3 studies, P < 0.001). The increase in maximum urine flow rate seen during the first 2 years of double-blind treatment was maintained throughout an additional 2 years of open-label extension studies.

Summary of clinical studies: Data from 3 large, well-controlled efficacy studies demonstrate that treatment with Avodart (0.5 mg once daily) reduces the risk of both AUR and BPH-related surgical intervention relative to placebo, improves BPH-related symptoms, decreases prostate volume, and increases maximum urinary flow rates. These data suggest that Dutasteride (Avodart) arrests the disease process of BPH in men with an enlarged prostate.

Combination with Alpha-Blocker Therapy (CombAT)

The efficacy of combination therapy (Avodart 0.5 mg / day plus tamsulosin 0.4 mg / day, n = 1,610) was compared with this medicine alone (n = 1,623) or tamsulosin alone (n = 1,611) in a 4-year multicenter, randomized, double-blind study. Study entry criteria were similar to the double-blind, placebo-controlled monotherapy efficacy trials described above. Eighty-eight percent (88%) of the enrolled study population was caucasian. Approximately 52% of subjects had previous exposure to 5-alpha-reductase inhibitor or alpha adrenergic antagonist treatment. Of the 4,844 subjects randomly assigned to receive treatment, 69% of subjects in the combination group, 67% in the group receiving Avodart, and 61% in the tamsulosin group completed 4 years of double-blind treatment.

Effect on symptom score: Symptoms were quantified using the first 7 questions of the International Prostate Symptom Score (IPSS) (identical to the AUA-SI). The baseline score was approximately 16.4 units for each treatment group. Combination therapy was statistically superior to each of the monotherapy treatments in decreasing symptom score at Month 24, the primary time point for this endpoint. At Month 24 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.2 (±7.14) for combination, -4.9 (±6.81) for Avodart (Dutasteride), and -4.3 (±7.01) for tamsulosin, with a mean difference between combination and this medication of -1.3 units (P < 0.001; [95% CI: -1.69, -0.86]), and between combination and tamsulosin of -1.8 units (P < 0.001; [95% CI: -2.23, -1.40]). A significant difference was seen by Month 9 and continued through Month 48. At Month 48 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.3 (±7.40) for combination, -5.3 (±7.14) for Dutasteride (Avodart), and -3.8 661 (±7.74) for tamsulosin, with a mean difference between combination and Avodart of -0.96 units (P < 0.001; [95% CI: -1.40, -0.52]), and between combination and tamsulosin of -2.5 units (P < 0.001; [95% CI: -2.96, -2.07]).

Effect on acute urinary retention or the need for BPH-related surgery: After 4 years of treatment, combination therapy with dutasteride and tamsulosin did not provide benefit over monotherapy with Avodart in reducing the incidence of AUR or BPH-related surgery.

Effect on maximum urine flow rate: The baseline Qmax was approximately 10.7 mL / sec for each treatment group. Combination therapy was statistically superior to each of the monotherapy treatments in increasing Qmax at Month 24, the primary time point for this endpoint. At Month 24, the mean increases from baseline (±SD) in Qmax were 2.4 (±5.26) mL / sec for combination, 1.9 (±5.10) mL / sec for Avodart (Dutasteride), and 0.9 (±4.57) mL / sec for tamsulosin, with a mean difference between combination and this drug of 0.5 mL / sec (P = 0.003; [95% CI: 0.17, 0.84]), and between combination and tamsulosin of 1.5 mL / sec (P < 0.001; [95% CI: 1.19, 1.86]). This difference was seen by Month 6 and continued through Month 24.

The additional improvement in Qmax of combination therapy over monotherapy with Dutasteride (Avodart) was no longer statistically significant at Month 48.

Effect on prostate volume: The mean prostate volume at study entry was approximately 55 cc. At Month 24, the primary time point for this endpoint, the mean percent changes from baseline (±SD) in prostate volume were -26.9% (±22.57) for combination therapy, -28.0% (±24.88) for Avodart, and 0% (±31.14) for tamsulosin, with a mean difference between combination and Dutasteride (Avodart) of 1.1% (P = NS; [95% CI: -0.6, 2.8]), and between combination and tamsulosin of -26.9% (P < 0.001; [95% CI: -28.9, -24.9]). Similar changes were seen at Month 48: -27.3% (±24.91) for combination therapy, -28.0% (±25.74) for Avodart, and +4.6% (±35.45) for tamsulosin.


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