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 |
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Interventions | Doxazosin 2 mg once daily Doxazosin 4 mg once daily Doxazosin 8 mg once daily Placebo Taken upon awakening |
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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 |
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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) |
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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. |