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TJ Wilt, Minneapolis VA Cochrane Review Group in Prostate Diseases and the Center for Chronic Disease Outcomes Research; R MacDonald, Minneapolis VA Cochrane Review Group in Prostate Diseases and the Center for Chronic Disease Outcomes Research; D Nelson, Minneapolis VA Cochrane Review Group in Prostate Diseases and the Center for Chronic Disease Outcomes Research; W Howe, Minneapolis VA Cochrane Review Group in Prostate Diseases and the Center for Chronic Disease Outcomes Research.

Objectives: Urinary symptoms due to benign prostatic obstruction (BPO) affect more than half of men age 50 years and over. Terazosin is the alpha antagonist most frequently used in the VA to treat BPO. We conducted a systematic review to evaluate the effectiveness and adverse effects of terazosin for BPO.

Methods: Studies were included if they were randomized trials of at least 1 month duration, involved men with symptomatic BPO and compared terazosin with placebo or active controls. Study, patient characteristics and outcomes data were extracted in duplicate onto standardized forms utilizing a prospectively developed protocol.

Results: 15 studies involving 5,077 subjects met inclusion criteria (placebo controlled (10); alpha blockers (4); finasteride alone or in combination with terazosin as well as placebo (1); microwave therapy (TUMT) (1). Mean age was 65 years; 82% were white, 10% Asian, 6% black. Baseline urologic symptom scale scores and flow rates did not differ between groups and demonstrated that men had moderate BPO. Average duration was 27 weeks (range 4-52). Efficacy outcomes were rarely reported in a fashion that allowed for data pooling but indicated that terazosin improved symptom scores and flow rates. The mean change for Boyarsky symptom score (scale 0-27) was –3.9 points (36% improvement, n=4 studies) for terazosin versus –1.4 points (14%, n=3 studies) for placebo and –5.0 points (n = 1 study) for the alpha antagonist doxaozosin. The mean change for IPSS score (scale 0-35) was –7.3 points (38% improvement, n=2 studies). This was greater than placebo (-3.5 points, 17%) or finasteride (-3.2 points, 20%) and comparable to combination finasteride plus terazosin (6.2 points, 39%). The mean IPSS score change (scale 0-35) was –8.3 points (40%, n=4 studies) and was comparable to the alpha antagonist tamsulosin (43%) but less than TUMT (-12.6 points, 65% improvement). Peak urine flow rates improved with terazosin by 2.2 ml/sec (23%, n=12 studies), placebo 1.0 ml/sec (11%, n=7 studies), finasteride 1.6 ml/sec (15%); tamsulosin 2.9 ml/sec (31%, n=3 studies); doxazosin 3.3 ml/sec (35% n=1 study) and TUMT 5.6 ml/sec (68% n = 1 study). Percent discontinuing therapy was: terazosin 25%; tamsulosin 7%; finasteride 22%; doxazosin NA; placebo 31%. The most frequent adverse effects were dizziness, asthenia, postural hypotension: terazosin 10%, 5%, 3%; finasteride 8%, 7%, 2%; tamsulosin 5%, 0%, 0%; doxazosin 4%, 0%, NA; placebo 3%, 3%, <1%.

Conclusions: Results are limited by the inadequacy of reported data making pooling difficult. Terazosin improves symptoms and flow measures associated with BPO. Effectiveness was superior to placebo or finasteride, comparable to other alpha antagonists but less than TUMT. Adverse effects were generally mild but more frequent than other alpha antagonists and associated with a three-fold increase in therapy discontinuation. Studies should provide long term comparisons with different alpha antagonists and plant extracts and report outcomes in a standardized fashion.

Impact: This review summarizes evidence regarding the effectiveness and adverse effects of terazosin, for the treatment of BPO. These results can be utilized to implement cost effective prostate health care and initiate trials required to close existing knowledge gaps.