Efficacy and safety of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A 6-months study in real life practice

Seung Wook Lee, Seung Hwan Lee, Cheol Young Oh, Byung Ha Chung, Se Joong Kim, Chun Il Kim, Chul Sung Kim, Choung Soo Kim, Choong Hee Noh, Woo Chul Moon, Choal Hee Park, Soo Bang Ryu, Hwan Cheol Son, Jae Mann Song, Sang Eun Lee, Jeong Gu Lee, Hyuk Soo Chang, Young Beom Jeong, Hee Chang Jung

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Abstract

Purpose: The aim of the study was to evaluate the long-term safety profile and efficacy of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), under daily practice conditions in Korea. Materials and Methods: In this 6-months, open-label, multicenter, non-comparative, observational study, 511 men were enrolled. International Prostate Symptom Score (IPSS), IPSS 8th question (bother score), maximum flow rate (Qmax), Danish Prostate Symptom Score (DAN-PSS) were evaluated at baseline and after 3, 6 months of treatment. Safety was analyzed in all patients exposed to alfuzosin (n=480). Analysis was performed at end-point in the intent to treat population (n=368). Results: Of the 511 enrolled patients in the study, 218 patients (42.7%) dropped out. With alfuzosin, IPSS and bother score significantly improved from baseline by - 6.7±6.4 (- 31.9%, p < 0.001) and - 1.2±1.2 (- 29.3%, p <0.001), respectively. Nocturia also significantly improved from 2.3±1.3 at baseline to 1.8±1.0 at end-point (- 0.6±1.1, p < 0.001). In the subgroup of patients likely to be obstructed (Qmax <10 ml/sec at baseline), Qmax improved from 8.3±1.2 at baseline to 13.7±6.1 at end-point (+5.4±5.8, p=0.001). In patients with pain/discomfort on ejaculation, weighted score significantly improved from 2.4±2.2 at baseline to 1.5±1.9 at end-point (- 31%, p=0.002). There were no clinically relevant changes in sitting systolic BP and diastolic BP at endpoint. Conclusions: Alfuzosin 10 mg once daily administered for 6-months is effective in improving LUTS and quality of life, and is well tolerated from a sexual and cardiovascular perspective, including in elderly men and those receiving anti-hypertensive co-medication.

Original languageEnglish
Pages (from-to)333-339
Number of pages7
JournalKorean Journal of Urology
Volume50
Issue number4
DOIs
Publication statusPublished - 2009 Apr

Keywords

  • Alfuzosin
  • Prostatic hyperplasia

ASJC Scopus subject areas

  • Urology

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    Lee, S. W., Lee, S. H., Oh, C. Y., Chung, B. H., Kim, S. J., Kim, C. I., Kim, C. S., Kim, C. S., Noh, C. H., Moon, W. C., Park, C. H., Ryu, S. B., Son, H. C., Song, J. M., Lee, S. E., Lee, J. G., Chang, H. S., Jeong, Y. B., & Jung, H. C. (2009). Efficacy and safety of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A 6-months study in real life practice. Korean Journal of Urology, 50(4), 333-339. https://doi.org/10.4111/kju.2009.50.4.333