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

Cubeddu 1988.

Methods 2‐week screening period; 4‐week single‐blind placebo run‐in period; inclusion criteria=supine and standing DBP >95 mm Hg during screening period, and supine and standing DBP >90 mm Hg during screening period and placebo run‐in; 9‐week double‐blind treatment, consisting of 3 upward titration schedules up to pre‐assigned dose of doxazosin (2, 4, or 8 mg) or placebo; this titration schedule was followed until "goal" BP was achieved, defined as reduction in supine or standing diastolic BP of ≥10 mm Hg from baseline and to less than 90 mm Hg at 24h postdose; if adverse effects (limiting or persisting side effects) or significant laboratory toxicity prevented further upward titration, then patient was discontinued from study
Participants Doxazosin 2 mg: n=38 (25 males, 13 females); 26 white, 11 black, 1 other; mean age=52.4 (range 28‐68) years; n=34 with baseline BP reported; baseline standing SBP=150.5 mm Hg, DBP=102.2 mm Hg, HR=79.6 bpm; baseline supine BP=152.7 mm Hg, DBP=98.8 mm Hg, HR=73.1 bpm
Doxazosin 4 mg: n=31 (20 males, 11 females); 22 white, 9 black; mean age=50.6 (range 32‐66) years; n=25 with baseline BP reported; baseline standing SBP=147.4 mm Hg, DBP=102.2 mm Hg, HR=80.0 bpm; baseline supine BP=149.4 mm Hg, DBP=99.8 mm Hg, HR=71.9 bpm
Doxazosin 8 mg: n=33 (17 males, 16 females); 19 white, 13 black, 1 not recorded; mean age=49.4 (range 26‐66) years; n=25 with baseline BP reported; baseline baseline standing SBP=147.5 mm Hg, DBP=102.4 mm Hg, HR=79.6 bpm; baseline supine BP=150.3 mm Hg, DBP=99.9 mm Hg, HR=72.9 bpm
Placebo: n=33 (22 males, 11 females); 18 white, 15 black; mean age=50.5 (range 33‐71) years; n=30 with baseline BP reported; baseline standing SBP=140.9 mm Hg, DBP=99.7 mm Hg, HR=84.5 bpm; baseline supine BP=145.8 mm Hg, DBP=98.8 mm Hg, HR=76.5 bpm
Interventions Doxazosin 2 mg once daily
Doxazosin 4 mg once daily
Doxazosin 8 mg once daily
Placebo
Taken upon awakening
Outcomes Trough standing SBP/DBP using mercury sphygmomanometer
Trough supine SBP/DBP using mercury sphygmomanometer
Peak standing SBP/DBP using mercury sphygmomanometer
Trough standing HR
Trough supine HR
Peak standing HR
WDAE
Notes BP change and SE of change reported, endpoint BP reported, endpoint SD not reported, baseline BP reported, baseline SD not reported; calculated SD of change from N and SE of change; BP and HR data from Table 5, p. 163
Mean doxazosin doses prior to final BP observation were 2, 4, and 7.7 mg for 2, 4, and 8 mg groups, respectively; 1 of 34 patients in 2 mg group was receiving 1 mg doxazosin and only 2 of 25 patients in 8 mg group were receiving a lower dose (4 mg)
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 21/135 patients (4/38 doxazosin 2 mg; 6/31 doxazosin 4 mg; 8/33 doxazosin 8 mg; 3/33 placebo) who "discontinued during the double‐blind period" not included in efficacy analysis.
Reasons for discontinuations not described.
Selective reporting (reporting bias) Low risk BP lowering efficacy was primary outcome.
HR and safety/tolerability data reported.
Other bias Unclear risk Funding source not reported.