This prospective study evaluated the safety of tadalafil 5 mg taken once a day (OAD) in terms of hypotensive side effects and whether it improves lower urinary tract symptoms (LUTS) and restores sexual function in patients with erectile dysfunction (ED) who are receiving concomitant α-blocker (AB) therapy for benign prostatic hyperplasia (BPH).
A total of 158 LUTS/BPH patients receiving AB therapy for ≥3 months were given tadalafil 5 mg OAD. Before treatment with tadalafil (V1) and 4 (V2) and 12 (V3) weeks after starting tadalafil, blood pressure, heart rate, International Prostate Symptom Score (IPSS), maximal urine flow rate (Qmax), post-voiding residual (PVR) urine volume, and International Index of Erectile Dysfunction-5 (IIEF-5) were measured. Of the 158 LUTS/BPH patients, a total of 119 completed the trial. Blood pressure (systolic and diastolic) and heart rate did not change. IPSS and IIEF-5 improved significantly but Qmax and PVR did not; however, in the 39 men with a low baseline Qmax (≤ 10 mL/sec), Qmax rose significantly from 7.97±1.44 (baseline) to 8.91±1.60 mL/sec (V3, p = 0.012). The remaining patients (baseline Qmax>10 mL/sec) did not change. At V2 and V3, adverse side effects were observed in ten (7.30%) and six men (5.04%), respectively. Facial flushing was the most common adverse side effect (six men at V2 and four men at V3), followed by headache (two men each at V2 and V3) and dizziness (two men at V2). Two patients dropped out of the study because of adverse side effects. In conclusion, tadalafil 5 mg OAD in combination with AB appeared to have few adverse effects on hypotensive events and can improve LUTS and restore sexual function.
Written by:
Lee JY, Park SY, Jeong TY, Moon HS, Kim YT, Yoo TK, Choi HY, Park HY, Lee SW. Are you the author?
Reference: J Androl. 2011 Aug 25. Epub ahead of print.
doi: 10.2164/jandrol.111.013185
PubMed Abstract
PMID: 21868753
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