DeQuattro 1997.
Methods | 4‐week placebo run‐in; inclusion criteria= sitting DBP 95‐114 mm Hg during final 2 wks of run‐in; 6‐week double‐blind treatment | |
Participants | Trandolapril 0.5 mg: n=41; baseline SBP=155.4(15.7) mm Hg, DBP=100.3(4.4) mm Hg; Trandolapril 2 mg: n=67; baseline SBP=151.4(16.5) mm Hg, DBP=99.8(4.6) mm Hg; Trandolapril 8 mg: n=43; baseline SBP=150.7(16.3) mm Hg, DBP=99.5(4.2) mm Hg; Placebo: n=53; baseline SBP=154.8(15.1) mm Hg, DBP=100.3(4.6) mm Hg; All patients (trandolapril monotherapy, verapamil monotherapy + verapamil/trandolapril combination treatment arms): n=726(456 males,270 females); mean age=54.7(10.9) years; baseline sitting SBP=151.8(16.2) mm Hg, DBP=100.4(6.1) mm Hg | |
Interventions | Trandolapril 0.5 mg once daily; Trandolapril 2 mg once daily; Trandolapril 8 mg once daily; Placebo; administered in the morning (8 AM ± 1 h) | |
Outcomes | Mean change from baseline in trough supine SBP/DBP using mercury sphygmomanometer; WDAE | |
Notes | Supine baseline BP reported in duplicate publication for each treatment arm; BP change reported, SD of change not reported, endpoint BP and SD not reported; imputed baseline SBP SD for SBP SD of change; imputed overall trial mean DBP SD of change; data from Table II, p. 367; duplicate publications=Levine 97, DeQuattro 97(NEJM); Jadad score=3; funding source= Knoll Pharma Change in sitting SBP data is not the same as data reported in Levine 1997. Reviewers have decided to use data from DeQuattro 1997 (primary reference) because unadjusted endpoint data is provided. At this time, DBP data that is only available in Levine 1997 will not be used unless an explanation for the discrepancy in BP data is adequately explained by authors. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |