Methods |
2‐week single‐blind placebo run‐in; inclusion criteria= sitting DBP 95‐115 mm Hg after run‐in; 8‐week total double‐blind treatment, 4‐week low‐dose treatment (week 0‐4), forced titration at week 4 to high‐dose, 4‐week high‐dose treatment (week 4‐8) |
Participants |
Valsartan 80 mg: n=551(313 males,238 females); mean age=55.7(10.9) years; baseline sitting SBP=157.0(16.3) mm Hg, DBP=101.4(4.6) mm Hg, HR=73.9(9.8) bpm;
Losartan 50 mg: n=545(309 males,236 females); mean age=54.9(10.5) years; baseline sitting SBP=157.4(15.9) mm Hg, DBP=101.6(5.1) mm Hg, HR=73.7(9.0) bpm;
Placebo: n=273(157 males,116 females); mean age=55.2(10.5) years; baseline sitting SBP=157.8(16.3) mm Hg, DBP=101.9(5.2) mm Hg, HR=73.6(9.7) bpm |
Interventions |
Valsartan 80 mg once daily;
Losartan 50 mg once daily;
Placebo;
taken in the morning |
Outcomes |
Trough sitting SBP/DBP using mercury sphygmomanometer; |
Notes |
Used week 4 BP data only; BP change and SD of change not reported, endpoint BP reported, endpoint SD not reported, baseline SD reported; imputed baseline SBP SD for SBP SD of change; imputed overall trial mean DBP SD of change; BP data from text and Figure 1, p. 416; Jadad score=4; funding source= Novartis Pharma |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |