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. 2012 Aug 15;2012(8):CD004643. doi: 10.1002/14651858.CD004643.pub3

Gillenwater 1995.

Methods 0 to 4‐week screening/washout period; 2‐week placebo run‐in period; inclusion criteria=sitting DBP 90‐114 mm Hg; 14‐week double‐blind treatment, consisting of 5‐week dose titration period (initial dose of 1 mg once daily, increased sequentially at weekly intervals to randomized, fixed dose level) followed by 9‐week fixed dose period
Participants All patients: n=248 (199 doxazosin, 49 placebo) male patients ≥45 years old with benign prostatic hyperplasia and mild to moderate hypertension; baseline SBP=163(23) mm Hg, DBP=103(8) mm Hg
Doxazosin 2 mg: n=47; mean age=64.8(8.5) years; baseline SBP/DBP not reported
Doxazosin 4 mg: n=52; mean age=64.4(7.5) years; baseline SBP/DBP not reported
Doxazosin 8 mg: n=50; mean age=63.9(8.4) years; baseline SBP/DBP not reported
Doxazosin 12 mg: n=50; mean age=62.8(8.9) years; baseline SBP/DBP not reported
Placebo: n=49; mean age=64.5(7.7) years; baseline SBP/DBP not reported
Interventions Doxazosin 2 mg once daily
Doxazosin 4 mg once daily
Doxazosin 8 mg once daily
Doxazosin 12 mg once daily
Placebo
Taken in the morning
Outcomes Change from baseline in trough sitting SBP/DBP using sphymomanometer
Change from baseline in trough standing SBP/DBP using sphymomanometer
WDAE
Notes BP change reported; SD of change not reported; endpoint BP and SD not reported; baseline BP and SD not reported; imputed overall trial mean SD of change for SBP and DBP; BP data from Figure 3, p. 114
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not described.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 32/248 patients (8/47 doxazosin 2 mg; 6/52 doxazosin 4 mg; 5/50 doxazosin 8 mg; 5/50 doxazosin 12 mg; 8/49 placebo) not included in efficacy analysis. 7/32 patients had no follow‐up efficacy measurements and 25/32 did not meet inclusion criterion for maximum urinary flow rate
Selective reporting (reporting bias) High risk Baseline BP data not reported. Peak sitting/standing BP not fully reported.
Quote: "Changes in heart rate were slight and comparable in both treatment groups."
Comment: Quantitative HR data not reported.
Safety/tolerability data reported.
Other bias High risk Quote: "Other reasons for exclusion were intolerance/sensitivity to quinazoline derivatives..."
Comment: Patient selection bias.
Funding source is manufacturer of doxazosin (Pfizer).