Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands
Efﬁcacy of extended-release doxazosin and doxazosin standard in patients with concomitant benign prostatic hyperplasia and sexual dysfunction ROGER S. KIRBY, MICHAEL P. O’LEARY* and CULLEY CARSON†
St. George’s Hospital, London, UK, *Harvard Medical School, Boston, MA, and †University of North Carolina, NC, USA Accepted for publication 17 October 2004
OBJECTIVE To report a comprehensive retrospective analysis of the favourable effects of doxazosin extended-release (XL) and doxazosin standard on the sexual health of patients with comorbid benign prostatic hyperplasia (BPH) and erectile dysfunction (ED), augmenting a previous study of 680 patients with symptomatic BPH.
RESULTS Of 680 patients randomized into the trial, 237 (35%) had ED at baseline; in these patients there were statistically and clinically signiﬁcant improvements in each of the ﬁve IIEF domains with XL and standard doxazosin (P £ 0.0019), with the range of improvement being from 13% to 41%. There were no signiﬁcant differences between treatment groups. Doxazosin XL consistently improved sexual function, as assessed by the individual questions of the IIEF questionnaire. There was no statistically signiﬁcant difference between groups for any sexual function question analysed. CONCLUSION Doxazosin XL and standard improved sexual function in men with concomitant BPH and ED at baseline. This may represent an action independent of relieving lower urinary tract symptoms, because the beneﬁcial effect of doxazosin was reported in patients with no symptomatic BPH. KEYWORDS doxazosin, sexual dysfunction, erectile dysfunction, BPH, extended release
PATIENTS AND METHODS Men with BPH and aged 50–80 years participated in a randomized, doubleblind, double-dummy, parallel-group, multicentre trial, completing a 2-week, single-blind, placebo run-in period before receiving doxazosin XL 4 or 8 mg once daily or doxazosin standard 1–8 mg once daily for 13 weeks. Baseline sexual function and changes from baseline after treatment with doxazosin were evaluated from responses of the International Index of Erectile Function (IIEF) questionnaire (with dysfunction deﬁned as a score of £3 for any question) and the ﬁve domains for erectile function (intercourse satisfaction, orgasmic function, sexual desire and overall sexual satisfaction).
2 0 0 5 B J U I N T E R N A T I O N A L | 9 5 , 1 0 3 – 1 0 9 | doi:10.1111/j.1464-410X.2005.05252.x
K I R BY ET AL.
INTRODUCTION BPH is characterized by BOO that is primarily caused by an enlarged prostate gland and increased smooth muscle tone in the bladder neck . The LUTS that result from BPH and BOO can be stratiﬁed as voiding or storage symptoms. It is the degree of the bothersomeness of the overall symptom complex and the degree to which this has compromises the patient’s quality of life (QoL) that most often are the impetus for patients with BPH to seek treatment . Bothersome symptoms, which include urgency, frequency and nocturia, contribute to lack of sleep, anxiety and worry, reduced mobility, interference with leisure activities, interference with usual daily activities, compromised sense of well-being, lack of energy/fatigue and negative general perceptions of health. BPH is the most prevalent benign urological condition, with the risk and severity of symptoms increasing as men age. Based on autopsy data, the prevalence of BPH increases from 30–50% in men aged 60 years to ª90% in men aged ≥80 years . As men age, sexual dysfunction and/or erectile dysfunction (ED) can occur, and is exacerbated by age, cigarette smoking, diabetes, hypertension and its associated...