Singleton 1989.
Methods | 1‐week washout; 2‐week single‐blind placebo run‐in period; inclusion criteria=sitting DBP 95‐105 mm Hg for 2 consecutive weeks; 7‐week double‐blind treatment, consisting of 3‐week dose titration period (to preassigned dose group) followed by 4‐week "maintenance" period at preassigned fixed dose unless limited by side effects | |
Participants | All patients: n=220 (166 prazosin GITS, 54 placebo); n=205 patients included in efficacy analysis; Prazosin GITS 2.5 mg: n=49 (32 males, 17 females); 35 white, 12 black, 2 other; mean age=54.4(11.3) years; baseline sitting SBP=150.3(14.1) mm Hg, DBP=99.4(3.2) mm Hg, HR=76.5(8.8) bpm; baseline standing SBP=150.6(13.6) mm Hg, DBP=100.5(5.8) mm Hg, HR=80.1(9.0) bpm Prazosin GITS 10 mg; n=56 (38 males, 18 females); 44 white, 10 black, 2 other; mean age=54.1(12.2) years; baseline sitting SBP=150.0(13.2) mm Hg, DBP=100.6(3.0) mm Hg, HR=76.0(9.1) bpm; baseline standing SBP=149.5(14.1) mm Hg, DBP=101.8(5.4) mm Hg, HR=77.5(8.8) bpm Prazosin GITS 20 mg; n=52 (32 males, 20 females); 40 white, 10 black, 2 other; mean age=57.1(10.5) years; baseline sitting SBP=155.6(16.1) mm Hg, DBP=100.1(3.0) mm Hg, HR=75.7(8.8) bpm; baseline standing SBP=154.6(16.5) mm Hg, DBP=101.8(5.0) mm Hg, HR=78.6(8.7) bpm Placebo: n=48 (28 males, 20 females); 42 white, 5 black, 1 other; mean age=55.0(10.6) years; baseline sitting SBP=151.9(14.8) mm Hg, DBP=99.5(3.2) mm Hg, HR=77.6(8.0) bpm; baseline standing SBP=150.8(17.1) mm Hg, DBP=101.3(5.9) mm Hg, HR=81.2(8.4) bpm |
|
Interventions | Prazosin GITS 2.5 mg once daily Prazosin GITS 10 mg once daily Prazosin GITS 20 mg once daily Placebo |
|
Outcomes | Change from baseline in trough sitting SBP/DBP using sphymomanometer Change from baseline in trough standing SBP/DBP using sphymomanometer Change from baseline in trough sitting HR Change from baseline in trough standing HR WDAE |
|
Notes | GITS=gastrointestinal therapeutic system; BP change reported, SD of change not reported, endpoint BP and SD not reported; baseline BP and SD reported; imputed baseline SBP SD for SBP SD of change, imputed overall trial mean DBP SD of change; trough BP data from Table IV, p. 47S | |
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 | 15/220 patients (9/166 receiving prazosin GITS; 6/54 receiving placebo) who were lost to follow‐up or withdrew prematurely not included in efficacy analysis. |
Selective reporting (reporting bias) | Low risk | BP lowering efficacy was primary outcome. HR and safety/tolerability data reported. |
Other bias | High risk | Funding source is manufacturer of prazosin GITS (Pfizer). |