Long‐term therapy with the dual 5α‐reductase inhibitor dutasteride is well tolerated in men with symptomatic benign prostatic hyperplasia
2005; Wiley; Volume: 97; Issue: 1 Linguagem: Inglês
10.1111/j.1464-410x.2005.05909.x
ISSN1464-410X
AutoresClaude Schulman, PETER POMMERVILLE, K. Höfner, Barton Wachs,
Tópico(s)Hormonal and reproductive studies
ResumoOBJECTIVE To examine the long‐term (4‐year) safety and tolerability of dutasteride in the treatment of symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS Patients who completed the double‐blind phase of three dutasteride Phase III studies were eligible to enter a 2‐year open‐label extension, during which all patients received dutasteride 0.5 mg. Safety was assessed, including adverse‐event reporting, clinical laboratory assessments, yearly physical examinations, and vital sign assessments. RESULTS In all, 2340 patients entered the open‐label phase, 1188 of whom previously received dutasteride during the double‐blind phase of the study. The most common drug‐related adverse events (occurring in ≥ 1%) were effects on sexual function, which decreased with a longer duration of therapy. Gynaecomastia was reported in a small percentage of men throughout the 4‐year study period. The incidence of individual sexual functional adverse events that led to withdrawal was ≤ 1% (0.3–1.0%) during the 4‐year study period. Dutasteride had no relevant effects on vital signs or clinical laboratory variables. CONCLUSION These data show that dutasteride is well tolerated during long‐term use for the treatment of symptomatic BPH.
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