Drug-Related Adverse Experiences |
||||
(%) |
(%) |
|||
|
|
|
|
|
N = 1524 and 1516, finasteride vs placebo, respectively | ||||
Impotence | 8.1 | 3.7 | 5.1 | 5.1 |
Decreased
Libido |
6.4 | 3.4 | 2.6 | 2.6 |
Decreased
Volume of Ejaculate |
3.7 |
0.8 |
1.5 |
0.5 |
Ejaculation
Disorder |
0.8 | 0.1 | 0.2 | 0.1 |
Breast
Enlargement |
0.5 | 0.1 | 1.8 | 1.1 |
Breast
Tenderness |
0.4 | 0.1 | 0.7 | 0.3 |
Rash | 0.5 | 0.2 | 0.5 | 0.1 |
Incidence ≥2% in One or More Treatment Groups: Drug-Related Clinical Adverse Experiences in MTOPS |
|||||
Adverse Experience |
(N=737) (%) |
4 mg or 8 mg (%) |
(N=768) (%) |
(N=786) (%) |
|
Body as a whole | |||||
Asthenia | 7.1 | 15.7 | 5.3 | 16.8 | |
Headache | 2.3 | 4.1 | 2.0 | 2.3 | |
Cardiovascular | |||||
Hypotension | 0.7 | 3.4 | 1.2 | 1.5 | |
Postural Hypotension | 8.0 | 16.7 | 9.1 | 17.8 | |
Metabolic and Nutritional | |||||
Peripheral Edema | 0.9 | 2.6 | 1.3 | 3.3 | |
Nervous | |||||
Dizziness | 8.1 | 17.7 | 7.4 | 23.2 | |
Libido Decreased | 5.7 | 7.0 | 10.0 | 11.6 | |
Somnolence | 1.5 | 3.7 | 1.7 | 3.1 | |
Respiratory | |||||
Dyspnea | 0.7 | 2.1 | 0.7 | 1.9 | |
Rhinitis | 0.5 | 1.3 | 1.0 | 2.4 | |
Urogenital | |||||
Abnormal Ejaculation | 2.3 | 4.5 | 7.2 | 14.1 | |
Gynecomastia | 0.7 | 1.1 | 2.2 | 1.5 | |
Impotence | 12.2 | 14.4 | 18.5 | 22.6 | |
Sexual Function Abnormal | 0.9 | 2.0 | 2.5 | 3.1 |
Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15) |
|
|
|
Bioavailability | 63% (34 to 108%)
|
Clearance (mL/min) | 165 (55) |
Volume of Distribution (L) | 76 (14) |
Half-Life (hours) | 6.2 (2.1) |
Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 5 mg/day in Older Men |
||
|
|
|
|
|
|
AUC (ng•hr/mL) | 389 (98) | 463 (186) |
Peak Concentration (ng/mL) | 46.2 (8.7) | 48.4 (14.7) |
Time to Peak (hours) | 1.8 (0.7) | 1.8 (0.6) |
Half-Life (hours)
|
6.0 (1.5) | 8.2 (2.5) |
All Treatment Failures in a Long-Term Efficacy and Safety Study |
|||||
|
|
|
|
|
|
|
N=1503 |
N=1513 |
Risk |
|
Value |
All Treatment Failures | 37.1 | 26.2 | 0.68 | (0.57 to 0.79) | <0.001 |
Surgical
Interventions for BPH |
10.1 | 4.6 | 0.45 | (0.32 to 0.63) | <0.001 |
Two consecutive
symptom scores ≥20 |
9.2 | 6.7 | |||
Bladder Stone | 0.4 | 0.5 | |||
Incontinence | 2.1 | 1.7 | |||
Renal Failure | 0.5 | 0.6 | |||
UTI | 5.7 | 4.9 | |||
Discontinuation
due to worsening of BPH, lack of improvement, or to receive other medical treatment |
21.8 | 13.3 |
Count and Percent Incidence of Primary Outcome Events by Treatment Group in MTOPS |
|||||
|
|
||||
N=737 |
N=756 |
N=768 |
N=786 |
N=3047 |
|
|
|
|
|
|
|
AUA 4-point rise | 100 (13.6) | 59 (7.8) | 74 (9.6) | 41 (5.2) | 274 (9.0) |
Incontinence | 8 (1.1) | 11 (1.5) | 9 (1.2) | 3 (0.4) | 31 (1.0) |
Recurrent UTI/urosepsis | 2 (0.3) | 2 (0.3) | 0 (0.0) | 1 (0.1) | 5 (0.2) |
Creatinine rise | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Total Events | 128 (17.4) | 85 (11.2) | 89 (11.6) | 49 (6.2) | 351 (11.5) |
Change from Baseline in AUA Symptom Score by Treatment Group at Year 4 in MTOPS |
||||
N=534 |
N=582 |
N=565 |
N=598 |
|
Baseline Mean (SD) | 16.8 (6.0) | 17.0 (5.9) | 17.1 (6.0) | 16.8 (5.8) |
Mean Change
AUA Symptom Score (SD) |
-4.9 (5.8) | -6.6 (6.1) | -5.6 (5.9) | -7.4 (6.3) |
Comparison to
Placebo (95% CI) |
-1.8
(-2.5, -1.1) |
-0.7
(-1.4, 0.0) |
-2.5
(-3.2, -1.8) |
|
Comparison to
Doxazosin alone (95% CI) |
-0.7
(-1.4, 0.0) |
|||
Comparison to
Finasteride alone (95% CI) |
-1.8
(-2.5, -1.1) |