Effect on Acute Urinary Retention or the Need for BPH-Related Surgery: After 4years of treatment, coadministration therapy with dutasteride and tamsulosin did not provide benefit over dutasteride monotherapy in reducing the incidence of AUR or BPH-related surgery. In separate 2-year randomized, double-blind trials, compared with placebo, dutasteride monotherapy was associated with a statistically significantly lower incidence of AUR (1.8% for dutasteride versus 4.2% for placebo; 57% reduction in risk) and with a statistically significantly lower incidence of BPH-related surgery (2.2% for dutasteride versus. 4.1% for placebo; 48% reduction in risk).
Effect on Maximum Urine Flow Rate: The baseline Qmax was approximately 10.7mL/sec for each treatment group. Coadministration therapy was statistically superior to each of the monotherapy treatments in increasing Qmax at Month24, the primary time point for this endpoint. At Month24, the mean increases from baseline (±SD) in Qmax were 2.4(±5.26)mL/sec for coadministration group, 1.9(±5.10)mL/sec for dutasteride, and 0.9(±4.57)mL/sec for tamsulosin, with a mean difference between coadministration and dutasteride of 0.5mL/sec (P=0.003; [95% CI: 0.17, 0.84]), and between coadministration and tamsulosin of 1.5mL/sec (P<0.001; [95% CI: 1.19, 1.86]). This difference was seen by Month6 and continued through Month24. See Figure2.
The additional improvement in Qmax of coadministration therapy over dutasteride monotherapy was no longer statistically significant at Month 48.

Figure 2. Q-max Change From Baseline Over a 24-Month Period (Randomized, Double-Blind, Parallel-Group Study [CombAT Study])

Effect on Prostate Volume: The mean prostate volume at study entry was approximately 55cc. At Month24, the primary time point for this endpoint, the mean percent changes from baseline (±SD) in prostate volume were -26.9% (±22.57) for coadministration therapy, -28.0% (±24.88) for dutasteride, and 0% (±31.14) for tamsulosin, with a mean difference between coadministration and dutasteride of 1.1% (P=NS; [95% CI: -0.6, 2.8]), and between coadministration and tamsulosin of -26.9% (P<0.001; [95% CI: -28.9, -24.9]). Similar changes were seen at Month48: -27.3% (±24.91) for coadministration therapy, -28.0% (±25.74) for dutasteride, and +4.6% (±35.45) for tamsulosin.
16 HOW SUPPLIED/STORAGE AND HANDLING
JALYN Capsules, containing 0.5mg dutasteride and 0.4mg tamsulosin hydrochloride, are oblong hard-shell capsules with a brown body and an orange cap imprinted with “GS7CZ” in black ink. They are available in bottles with child-resistant closures as follows:
Bottle of 30 (NDC 0173-0809-13).
Bottle of 90 (NDC 0173-0809-59).
Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Capsules may become deformed and/or discolored if kept at high temperatures.
Dutasteride is absorbed through the skin. JALYN Capsule