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Lepor H, Williford W, Barry M et al: The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia.

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This paper reports on a post hoc analysis of the planned 2-year results from the CombAT study, and explores the effects of dutasteride, tamsulosin, and their combination on storage and voiding symptoms in men with moderate-to-severe LUTS and enlarged prostate, as measured by subscores of the International Prostate Symptom Score (IPSS).

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Two patients from the tamsulosin group experienced serious AEs: one patient had precordial pain related to the study drug; the other patient had a cardiac valve disorder and symptoms of myocardial infarction, which were considered unrelated to the study drug.

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In another embodiment of the present invention, a fixed dose combination includes a dutasteride component and a tamsulosin component where the tamsulosin component includes a plurality of beads, wherein each bead includes a discrete layer that includes tamsulosin; in a first portion of the plurality of beads, each bead further includes a pH dependent layer and is devoid of a pH independent layer; and in a second portion of the plurality of beads, each bead further includes a pH independent layer and is devoid of a pH dependent layer.

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