Association between PRO 160/120 prescriptions and incidence of benign prostatic hyperplasia complications in Germany: a retrospective cohort study

Figures & data

Table 1. Demographic and clinical characteristics of study patients.

Variable	PRO 160/120	Finasteride	Dutasteride	Tamsulosin	Tamsulosin/ Dutasteride
N	3,035	6,133	418	64,962	3,375
BPH diagnosis (ICD-10: N40)	2,168(71.3%)	4,210 (68.5%)	341 (81.6%)	49,987 (76.8%)	2,854 (84.4%)
Age (Median, IQR)	66.0 (17.0)	71.0 (18.0)	73.0 (12.0)	70.0 (15.0)	74.0 (12.0)
Age <50 years	274 (9%)	995 (16.2%)	8 (1.9%)	2,858 (4.4%)	26 (0.8%)
Age 50–59 years	695 (22.9%)	530 (8.6%)	29 (6.9%)	9,817 (15.1%)	216 (6.4%)
Age 60–69 years	895 (29.5%)	1,178 (19.2%)	103 (24.6%)	18,264 (28.1%)	806 (23.9%)
Age 70–79 years	804 (26.5%)	2,183 (35.6%)	185 (44.3%)	22,645 (34.9%)	1,449 (42.9%)
Age ≥80 years	367 (12.1%)	1,247 (20.3%)	93 (22.2%)	11,378 (17.5%)	878 (26.0%)
Health insurance (Private)	1,268 (41.8%)	1,070 (17.4%)	197 (47.1%)	8,935 (13.8%)	967 (28.7%)
Physician specialty (GP)	2,008 (66.2%)	3,555 (58%)	165 (39.5%)	37,563 (57.8%)	1,428 (42.3%)
Hypertension (ICD-10: I10)	876 (28.9%)	1,497 (24.4%)	96 (23%)	20,039 (30.8%)	775 (23.0%)
Diabetes mellitus (ICD-10: E10–E14)	348 (11.5%)	698 (11.4%)	44 (10.5%)	10,728 (16.5%)	436 (12.9%)
Stroke/TIA (ICD-10: I63, I64, G45)	53 (1.7%)	154 (2.5%)	11 (2.6%)	2,226 (3.4%)	76 (2.3%)
Dementia (ICD-10: F01–F03, G30)	62 (2.0%)	193 (3.1%)	7 (1.7%)	2,218 (3.4%)	94 (2.8%)
Parkinson’s disease (ICD-10: G20, G21)	31 (1%)	87 (1.4%)	10 (2.4%)	916 (1.4%)	60 (1.8%)
Cancer (ICD-10: C00–C97)	238 (7.8%)	651 (10.6%)	52 (12.4%)	8,070 (12.4%)	339 (10.0%)
Tobacco addiction (ICD-10: F17)	41 (1.4%)	57 (0.9%)	1 (0.2%)	964 (1.5%)	15 (0.4%)
Alcohol addiction (ICD-10: F10)	17 (0.6%)	29 (0.5%)	2 (0.5%)	544 (0.8%)	12 (0.4%)
Use of beta blockers (ATC: C07)	483 (15.9%)	760 (12.4%)	56 (13.4%)	11,380 (17.5%)	437 (12.9%)
Use of anticholinergics (ATC: G04BD4)	112 (3.7%)	240 (3.9%)	30 (7.2%)	4,107 (6.3%)	233 (6.9%)

*Baseline characteristics were compared for different therapies using chi-squared tests for categorical variables and Wilcoxon tests for continuous variables. All p-values are below 0.0001.

Table 2. Number of patients with clinical complications between 1 and 365 days after index date.

Outcome	PRO 160/120	Finasteride	Dutasteride	Tamsulosin	Tamsulosin/Dutasteride
Urinary incontinence (ICD-10: N39.4, R32)	47 (1.5%)	103 (1.7%)	8 (1.9%)	1,958 (3.0%)	82 (2.4%)
Polyuria including nocturia(ICD-10: R35)	33 (1.1%)	32 (0.5%)	1 (0.2%)	702 (1.1%)	40 (1.2%)
Urinary retention (ICD-10: R33)	9 (0.3%)	35 (0.6%)	4 (1.0%)	795 (1.2%)	39 (1.2%)
Erectile dysfunction (ICD-10: N48.4, F52.2)	37 (1.2%)	62 (1.0%)	14 (3.3%)	971 (1.5%)	47 (1.4%)
Any of these outcomes	126 (4.2%)	232 (3.8%)	27 (6.5%)	4,426 (6.8%)	208 (6.2%)

*Outcomes were compared for different therapies using chi-squared tests. All p-values are below 0.0001.

Table 3. Association between PRO 160/120 prescriptions and the incidence of urinary incontinence, polyuria, incl. nocturia, urinary retention, erectile dysfunction (multivariable logistic regression models).

	Incidence of urinary incontinence		Incidence of polyuria, incl. nocturia		Incidence of urinary retention		Incidence of erectile dysfunction
Cohort	Addjusted Odds ratio (95% CI)*	p-value	Addjusted Odds ratio (95% CI)**	p-value	Addjusted Odds ratio (95% CI)*	p-value	Addjusted Odds ratio (95% CI)***	p-value
PRO 160/120	Reference		Reference		Reference		Reference
Finasteride	0.85 (0.60–1.21)	0.378	0.46 (0.28–0.74)	0.002	1.57 (0.75–3.28)	0.229	0.93 (0.62–1.41)	0.741
Dutasteride	0.95 (0.44–2.05)	0.901	0.18 (0.02–1.34)	0.095	2.49 (0.76–8.16)	0.130	2.79 (1.49–5.25)	0.001
Tamsulosin	1.48 (1.10–1.98)	0.010	0.93 (0.65–1.32)	0.686	3.39 (1.75–6.57)	<0.001	1.27 (0.91–1.78)	0.154
Tamsulosin/Dutasteride	1.12 (0.78–1.62)	0.531	0.92 (0.57–1.46)	0.711	2.81 (1.35–5.82)	0.006	1.21 (0.78–1.88)	0.389

*Logistic regression model adjusted for age group, health insurance, General Practitioner, diabetes mellitus, stroke/TIA, dementia, Parkinson’s disease, cancer, alcohol addiction, use of anticholinergics. **Logistic regression model adjusted for age group, health insurance, General Practitioner, diabetes mellitus, dementia, cancer, alcohol addiction, use of beta blockers, use of anticholinergics. ***Logistic regression model adjusted for age group, health insurance, General Practitioner, diabetes mellitus, Parkinson’s disease, tobacco addiction, use of beta blockers, use of anticholinergics.

Table 4. Association between PRO 160/120 prescriptions and the incidence of urinary incontinence, polyuria, incl. nocturia, urinary retention, erectile dysfunction (multivariable logistic regression models) in cohorts matched by age.

	Incidence of urinary incontinence		Incidence of polyuria, incl. nocturia		Incidence of urinary retention		Incidence of erectile dysfunction
Cohort	Addjusted Odds ratio (95% CI)*	p-value	Addjusted Odds ratio (95% CI)**	p-value	Addjusted Odds ratio (95% CI)*	p-value	Addjusted Odds ratio (95% CI)***	p-value
PRO 160/120	Reference		Reference		Reference		Reference
Finasteride (n = 2,845 pairs)	0.89 (0.61–1.44)	0.758	0.50 (0.27–0.92)	0.027	1.63 (0.67–3.93)	0.279	1.15 (0.69–1.93)	0.596
Dutasteride (n = 415 pairs)	1.10 (0.39–3.08)	0.864	0.17 (0.02–1.37)	0.096	1.88 (0.34–10.43)	0.470	14.79 (1.93–113.44)	0.010
Tamsulosin (n = 3,006) pairs	1.24 (0.84–1.83)	0.272	0.77 (0.45–1.30)	0.328	3.52 (1.60–7.73)	0.002	1.09 (0.67–1.76)	0.726
Tamsulosin/Dutasteride (n = 2,156 pairs)	1.16 (0.74–1.80)	0.523	0.87 (0.48–1.58)	0.641	3.02 (1.28–7.12)	0.012	1.80 (0.99–3.29)	0.054

*Logistic regression model adjusted for health insurance, General Practitioner, diabetes mellitus, stroke/TIA, dementia, Parkinson’s disease, cancer, alcohol addiction, use of anticholinergics. **Logistic regression model adjusted for health insurance, General Practitioner, diabetes mellitus, dementia, cancer, alcohol addiction, use of beta blockers, use of anticholinergics. ***Logistic regression model adjusted for health insurance, General Practitioner, diabetes mellitus, Parkinson’s disease, tobacco addiction, use of beta blockers, use of anticholinergics.

Data availability statement

Derived data supporting the findings of this study are available from the corresponding author on reasonable request.