The efficacy and safety of add-on therapy with tadalafil 5mg daily for patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH) refractory to alfuzosin 10mg daily.
Professor Jung Jun Kim (1), Professor Hyun Woo Kim, Professor Joon Chul Kim, Professor Jong Bo Choi, Professor Dong Hwan Lee
(1) Department Of Urology, Incheon St. Mary's Hospital, The Catholic University Of Korea, South Korea, (2) Department of Urology, Eun Pyeong St. Mary's Hospital, The Catholic University of Korea, (3) Department of Urology, Bucheon St. Mary’s Hospital, The Catholic University of Korea, (4) Department of Urology, Ajou University Hospital, Ajou University, (5) Department of Urology, Incheon St. Mary’s Hospital, The Catholic University of Korea
To evaluate the efficacy and safety of add-on therapy with tadalafil 5mg daily for patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH) treated with the alfuzosin 10mg daily.
We retrospectively analyzed 237 patients with LUTS/BPH with an International Prostate Symptom Score (IPSS) of >10 after ≥4 weeks of alfuzosin 10mg monotherapy from May 2016 through April 2019 at single medcal center. The patients subsequently received alfuzosin 10mg daily (monotherapy group, n= 52) or alfuzosin 10mg daily plus tadalafil 5.0 mg once daily (add-on therapy group, n=185) for 12 weeks accordingly. The temporary self-titration of tadalafil dosage down to 2.5 mg daily to reduce the discomfort was allowed for initial 4 weeks of add-on. The subjective and objective profile of LUTS/BPH was evaluated and compared after 12 weeks of each treatment. The primary endpoint is the change of subjective symptom assessed by IPSS/QoL. We also evaluated and compared the change in the voiding diary profile, maximum urine flow rate (Qmax), and post-void residual urine volume (RV) and adverse events.
Of 237 patients, 228 (91.9%) sustained monotherapy (n= 48, 92.3%) or add-on therapy (n=170, 91.9%) for total 12 wks. The baseline IPSS/QoL, voiding diary profile, Qmax and RV was not different between groups. The improvement of subjective symptom assessed by both total (-6.7±2.2 vs -0.8±1.2) and QoL (-1.1±0.4 vs -0.2±0.3) score of IPSS was more significant in add-on group. Both of voiding and storage sub-scores were more improved in add-on group. Among questionnaires, change of residual urine sense (Q1) and nocturia (Q7) was more significant among add-on group. Qmax improvement was larger among add-on group, however, the absolute improvement in add-on group was only 1.1±0.8 ml/sec. According to voiding diary, the decrease of nocturnal frequency was more significant in add-on group (-0.7±0.2 vs -0.2±0.3). Most of the discontinuation report of add-on group (86.7%, 13/15) was due to adverse event such as headache, hot flush or nasal congestion.
Add-on therapy with tadalafil could be a therapeutic option for male LUTS/BPH refractory to alfuzosin monotherapy to improve subjective symptom and quality of life. The improvement of nocturia could be potential benefit of this add-on.