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

Figures & data

Table 1 Study inclusion at screening and baseline

Inclusion criteria	Visit 1 screening	Visit 2 baseline
Male	√
Age ≥45 years	√
Willing to complete 3-day micturition diary and questionnaires correctly	√
Total IPSS score ≥8	√	√
Qmax >5 mL/sec and ≤12 mL/sec	√
Vvoid ≥120 mL	√
Normal range of biochemistry test results		√
Normal range of hematology test results		√

Abbreviations: IPSS, International Prostate Symptom Score; Qmax, maximal urinary flow rate; Vvoid, voided volume.

Table 2 Study exclusion criteria

Exclusion criteria
History of urinary retention ≥12 months
History or diagnosis including carcinoma/pelvic radiation therapy, neurogenic bladder, chronic inflammation, stone in ureter, outflow tract obstruction, uncontrolled narrow-angle glaucoma, myasthenia gravis, urinary/gastric retention, diabetic neuropathy, cardiovascular/cerebrovascular disease, abnormal electrocardiogram, and other medical conditions in which use of anticholinergics is contraindicated
Current urinary tract infection more than three episodes within 12 months
Previous/planned prostate surgery, such as transurethral resection of prostate, transurethral needle ablation of prostate, and laser surgery of prostate
Use of concomitant medication: benign prostate hyperplasia drugs within 2 weeks prior to visit 1, including α-adrenergic receptor antagonists and plant extracts, 5-alpha reductase inhibitors within 3 months prior to visit 1, including combined α/β-adrenergic receptor antagonists, α-agonists, cholinergics or anticholinergics, study drug interacting, end prior to visit 1 (those drugs that affect the pharmacodynamics of alfuzosin), other medications including long-term therapy (more than 1 month prior to randomization) with anticholinergic or cholinergic side effects, calcium channel antagonists, phosphodiesterase type 5 inhibitors and β-blockers
Participation in clinical trial within 1 month prior to visit 1
Renal/hepatic impairment

Table 3 Baseline demographic and clinical characteristics for all randomly assigned patients

Variable	Group 1	Group 2	Total	P-value
At screening
Hypertension, n (%)
Yes	24 (17.6)	37 (26.4)	61 (77.90)	0.08
No	112 (82.4)	103 (73.6)	215 (29.34)
Mean age, years	63.04±7.63	64.98±7.61	64.02±7.67	0.05
≤65 years, n (%)	55 (40.4)	72 (51.4)	127 (46)	0.07
>65 years, n (%)	81 (59.6)	68 (48.6)	149 (54)
BMI, kg/m^2	24.02±2.33	24.89±2.24	24.47±2.32	0.84
Mean prostatic volume, mL	34.04±15.51	34.60±16.79	34.07±16.15	0.97
Duration of LUTS, months (range)	29.30 (5–165)	34.74 (5–254)	32.06 (5–254)	0.23
At randomization
Total IPSS score	18.79±6.08	19.15±5.66	18.98±5.86	0.26
Moderate (8–19)	79 (59.8%)	75 (54.3%)	154 (57%)	0.39
Severe (20–35)	53 (40.2%)	63 (45.7%)	116 (43%)
IPSS-QoL index	3.85±1.13	3.95±1.15	3.90±1.14	0.57
Mild (0–1)	5 (3.7%)	5 (3.6%)	10 (3.7%)
Moderate (2–4)	94 (69.6%)	88 (63.8%)	182 (66.7%)	0.56
Severe (5–6)	36 (26.7%)	45 (32.6%)	81 (29.7%)
PSA level, ng/mL	1.69±1.76	1.61±1.52	1.65±1.64	0.68
≤0.6	37 (27.4%)	32 (23.4%)	69 (25.4%)
0.7–1.0	37 (27.4%)	35 (25.5%)	72 (26.5%)	0.21
1.1–2.09	24 (17.8%)	39 (28.5%)	63 (23.2%)
>2.10	37 (27.4%)	31 (22.6%)	68 (25%)
Qmax, mL/sec	14.05±7.68	13.07±7.01	13.55±7.35	0.27
Qave, mL/sec	7.31±4.68	6.54±3.99	6.92±4.35	0.15
Vvoid, mL	230.44±139.65	219.86±136.66	225.05±137.97	0.53
PVR volume, mL	36.46±41.73	39.62±42.76	38.09±42.21	0.54

Notes: Data expressed as the mean ± standard deviation. Categorical variables are presented as the case number and percentage. Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined with antihypertensive medication.

Abbreviations: BMI, body mass index; LUTS, lower urinary tract symptoms; IPSS, International Prostate Symptom Score; QoL, quality of life; PSA, prostate-specific antigen; Qmax, maximum flow rate; Qave, average flow rate; Vvoid, voided volume; PVR, post-void residual.

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.

Table 4 Mean change in efficacy measures from baseline to endpoint for groups 1 and 2

Category	Group 1, n=100	Group 2, n=112	Mean difference group 2 versus group 1 adjusted mean (95% CI)	P-value
	Change from baseline	Change from baseline
IPSS
Total IPSS score	−6.29±5.74	−5.84±6.96	0.45 (−1.26, 2.16)	0.61
IPSS-QoL	−0.94±1.28	−0.82±1.17	0.12 (−0.21, 0.45)	0.47
Uroflowmetry
Qmax, mL/sec	1.28±6.59	2.29±7.08	0.93 (−0.83, 2.85)	0.28
Qave, mL/sec	0.06±5.74	0.95±3.79	0.89 (−0.43, 2.21)	0.18
Vvoid, mL	−5.20±174.77	−10.88±120.39	−5.68 (−46.55, 35.19)	0.78
PVR, mL	2.28±43.01	−7.40±36.74	−9.68 (−20.51, 1.15)	0.08

Notes: Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined with antihypertensive medication.

Abbreviations: CI, confidence interval; IPSS, International Prostate Symptom Score; QoL, quality of life; Qmax, maximum flow rate; Qave, average flow rate; Vvoid, voided volume; PVR, post-voided volume.

Table 5 Withdrawals and adverse events from therapy

	Group 1 (n=136) n (%)	Group 2 (n=140) n (%)	Risk ratio, 95% CI	P-value
Withdrawals, all causes	36 (26.4)	28 (20.0)	0.75 (0.48, 1.17)	0.21
Subjects discontinuing because of AEs	7 (5.15)	9 (6.43)	1.25 (0.48, 3.26)	0.64
Subjects with one TEAE or more	18 (13.24)	25 (17.85)	1.34 (0.77, 2.35)	0.29
Vasodilation-related
Headache	2 (1.47)	3 (2.14)	1.45 (0.24, 8.58)	0.67
Dizziness/postural dizziness	8 (5.88)	6 (4.28)	0.72 (0.25, 2.04)	0.54
Hypotension/postural hypotension	1 (0.74)	2 (1.43)	1.94 (0.17, 21.17)	0.58
Syncope	0 (0)	2 (1.43)	4.85 (0.23, 100.27)	0.31
Sexual function-related	2 (1.47)	2 (1.43)	0.97 (0.14, 6.79)	0.97

Notes: Group 1, alfuzosin 10 mg monotherapy; group 2, alfuzosin 10 mg combined anti-hypertension medications therapy. P-value, Fisher’s exact test.

Abbreviations: CI, confidence interval; TEAE, treatment-emergent adverse event; AEs, adverse events.