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 |
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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 |
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Outcomes | Change from baseline in trough sitting SBP/DBP using sphymomanometer Change from baseline in trough standing SBP/DBP using sphymomanometer WDAE |
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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). |