Lepor 1996.
| Methods | A multi center, randomized, double‐blind, placebo‐controlled trial. | |
| Participants | Geographic region: US Study setting: Veterans Affairs medical centers N = 1229 (finasteride n = 310; placebo n = 305; terazosin n = 305; combination therapy n = 309) Baseline AUASI: finasteride = 16.2 points; placebo = 15.8 points; terazosin = 16.2; combination = 15.9 Baseline peak urine flow: finasteride = 10.6 mL/s; placebo = 10.4 mL/s; terazosin 10.5 mL/s; combination = 10.4 mL/s Baseline prostate volume: finasteride = 36.2 cc; placebo = 38.4 cc; terazosin = 37.5 cc; combination = 37.2 cc Baseline PSA: finasteride = 2.2 ng/mL; placebo = 2.4 ng/mL; terazosin = 2.2 ng/mL; combination = 2.3 ng/mL Mean age (range): 65 years (45 to 80) Race: White n = 1069 (87%); Black n= 135 (11.0%); Asian/Pacific Islanders n = 12 (1.0%); Native Americans n = 6 (0.5%) Inclusion: mean AUA of at least 8; a mean peak urinary flow rate of ≤ 15 mL/s and ≥ 4 mL/s, with a minimal voided volume of 125 mL, and a mean post‐void residual volume after voiding of < 300 mL (there was no threshold for prostatic enlargement) Exclusion: [Men] "unwilling or unable to give informed consent or if they had taken an experimental drug less than four weeks before being screened; if they had taken an alpha‐adrenergic–agonist drug, a cholinergic agonist or antagonist drug, a topical beta‐adrenergic–antagonist drug for glaucoma, or any antihypertensive drug except a diuretic or an angiotensin‐converting–enzyme inhibitor within two weeks before the lead‐in period; or if they had taken an estrogen, androgen, or drug causing androgen inhibition within the preceding three months. Other criteria for exclusion were an episode of unstable angina pectoris, a myocardial infarction, a transient ischemic attack, or a cerebrovascular accident in the past six months; insulin‐dependent diabetes mellitus; orthostatic hypotension (defined as a difference of more than 20 mm Hg between the systolic blood pressure measured when the man was standing and that measured when he was supine, independent of concomitant changes in pulse or symptoms of postural hypotension) or a history of syncope; a blood pressure of less than 90/70 mm Hg when the man was sitting; a history of carcinoma of the prostate, pelvic irradiation, or urethral stricture; surgery for benign prostatic hyperplasia or bladder‐neck obstruction; current evidence of prostatic carcinoma; active urinary tract disease, cystoscopy, or biopsy of the prostate within the previous two weeks; a history of recurrent urinary tract infections or an infection of the urinary tract, including asymptomatic bacteriuria, within the preceding two months; prior pelvic surgery that was likely to interfere with normal bladder function; any progressive disorder that might prevent the evaluation of drug efficacy and safety; clinically important renal or hepatic impairment (as evidenced by a serum creatinine concentration greater than 2.0 mg per deciliter (177 mmol/L) or a serum alanine aminotransferase concentration more than 1.5 times the upper limit of normal); and a serum concentration of prostate‐specific antigen above 10 ng/mL." Study discontinuations: n = 222 (finasteride n = 67 (21.6%); placebo n = 51 (16.7%); terazosin n = 49 (16.0%); combination n = 55 (17.8%)) Study duration: 52 weeks (including a 4‐week, single‐blind, lead‐in period where participants received placebos and a complete medical history) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "men at each site were randomly assigned by a central computer in equal proportions" |
| Allocation concealment (selection bias) | Low risk | described |
| Blinding (performance bias and detection bias) All outcomes | Low risk | double blinded, but not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | yes |
| Selective reporting (reporting bias) | Low risk | yes |
| Other bias | Low risk | yes |
| Intention‐to‐treat analysis | Low risk | "statistical analyses were based on the intention‐to‐treat principle; that is, the results for all men for whom any follow‐up data were available were included in the analyses of the treatment groups to which the men had been assigned" |
| Non‐industry funded | Unclear risk | Merck a possible funding agent |