Multicenter, prospective, comparative cohort study evaluating the efficacy and safety of alfuzosin 10 mg with regard to blood pressure in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia with or without antihypertensive medications

Abstract

Background: The objective of this study was to assess the efficacy and safety of alfuzosin 10 mg monotherapy or combined antihypertensive medication on blood pressure (BP) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) with or without antihypertensive medication.

Methods: This was a 3-month, multicenter, randomized, open-label study in 335 patients aged ≥45 years with a clinical diagnosis of BPH/LUTS by medical history and clinical examination, a total International Prostatic Symptom Score (IPSS) ≥8 points, a maximum flow rate >5 mL/sec and ≤15 mL/sec, and a voided volume ≥120 mL. Eligible subjects were randomized to receive alfuzosin 10 mg as monotherapy (group 1) or alfuzosin 10 mg + antihypertensive combination therapy (group 2). Based on baseline BP and hypertensive history with or without antihypertensive medications at first medical examination, group 1 was divided into two subgroups of normotensive and untreated hypertensive patients, and group 2 into two subgroups of controlled hypertensive and uncontrolled hypertensive patients. The primary study outcomes were change in IPSS, BP, and heart rate from baseline. Secondary outcomes were change in IPSS-quality of life score, maximum flow rate, average flow rate, voided volume, and post-voided volume.

Results: The overall BP change was not significantly different between groups 1 and 2 (systolic BP, P=0.825; diastolic BP, P>0.999). In patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or combined with antihypertensive therapy significantly decreased systolic and diastolic BP. The mean difference in total IPSS and IPSS-quality of life scores from baseline between groups 1 and 2 was 0.45 (95% CI: -1.26, 2.16) and 0.12 (95% CI: -0.21, 0.45), respectively (both P>0.05). Maximum flow rate, average flow rate, voided volume, and post-voided volume at endpoint were numerically, but not significantly, changed from baseline (all P>0.05).

Conclusion: This study shows that alfuzosin 10 mg is effective and well tolerated in patients with BPH/LUTS with or without antihypertensive medications. However, in patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or in combination with antihypertensive medication appears to decrease systolic and diastolic BP, and these patients should be warned about a decrease in BP on initiation of therapy.

Keywords: alfuzosin; antihypertensive medication; benign prostatic hyperplasia; blood pressure; lower urinary tract symptoms.

Figure 1

CONSORT (consolidated standards of reporting trials) diagram showing the disposition of participants. Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined antihypertensive therapy. Abbreviations: AE, adverse event; IPSS, International Prostatic Symptom Score.

Figure 2

Mean supine blood pressure and HR values stratified by normotensive and untreated hypertensive status in group 1 and controlled hypertensive and uncontrolled hypertensive status in group 2 at baseline and at endpoint. (A) Systolic blood pressure, (B) diastolic blood pressure, and (C) HR. Notes: Data are expressed as the mean ± standard deviation. *P<0.001, **P<0.05. Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined with antihypertensive medication. Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; min, minute.

Figure 3

Mean change in supine blood pressure and HR from baseline to endpoint stratified by normotensive and untreated hypertensive status in group 1 and controlled hypertensive and uncontrolled hypertensive status in group 2. (A) Mean change in SBP; (B) mean change in DBP, and (C) mean change in HR. Notes: Data are expressed as the mean ± standard error. *P<0.001, **P<0.05. Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined with antihypertensive medication. Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; min, minute.

Figure 4

Mean change in efficacy measures from baseline to endpoint in groups 1 and 2. (A) Total IPSS score, (B) IPSS-QoL, (C), Qmax, (D), Qave, (E), Vvoid, and (F) PVR. Notes: Data are expressed as the mean ± standard deviation. *P<0.001, **P<0.05. Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined with antihypertensive medication. Abbreviations: IPSS, International Prostate Symptom Score; PVR, post-voiding residual volume; Qave, average flow rate; Qmax, maximum flow rate; QoL, quality of life; Vvoid, voided volume.