| Methods |
4‐week placebo run‐in; inclusion criteria= mean sitting DBP 95‐109 mm Hg during 2 separate visits during run‐in; 12‐week total double‐blind treatment, initial 4‐week double‐blind treatment at fixed dose of losartan 50 mg monotherapy or losartan 50 mg/HCTZ 0 mg combination (week 0‐4), non‐responders titrated to response at weeks 4 or 8 |
| Participants |
Losartan 50 mg monotherapy: n=193(87 males,106 females); mean age=50.4(10.5) years; baseline sitting SBP=150.9(11.3) mm Hg, DBP=99.9(4.2) mm Hg;
Losartan 50 mg/HCTZ 0 mg: n=59(28 males,31 females); mean age=47.2(9.8) years; baseline sitting SBP=149.1(10.6) mm Hg, DBP=100.2(4.2) mm Hg;
Placebo: n=188(77 males,111 females); mean age=50.6(10.2) years; baseline sitting SBP=151.4(12.1) mm Hg, DBP=99.8(3.9) mm Hg |
| Interventions |
During first 4 weeks of double‐blind treatment:
Losartan 50 mg once daily;
Losartan 50 mg/HCTZ 0 mg once daily;
Placebo;
taken in the morning between 6 AM and 10 AM |
| Outcomes |
Adjusted mean change from baseline in trough sitting SBP/DBP using mercury sphygmomanometer |
| Notes |
Used week 4 BP data only, combined BP data for losartan monotherapy and losartan/HCTZ combination arms; BP change reported; SD of change not reported; endpoint BP and SD not reported; baseline SD reported; imputed baseline SBP SD for SBP SD of change, imputed overall trial mean DBP SD of change; DBP data from Figure 2, p. 1201, SBP data from Figure 3, p. 1202; WDAE reported at endpoint but not at week 4; Jadad score=3; funding source= Merck & Co. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
