Methods |
2‐ to 4‐week placebo run‐in; inclusion criteria= patients with isolated systolic hypertension, defined as mean trough sitting SBP 140‐200 mm Hg and mean trough sitting DBP 70‐89 mm Hg; 12‐week total double‐blind treatment, 4‐week double‐blind treatment at initial fixed dose of losartan monotherapy (week 0‐4), non‐responders titrated to losartan 50 mg/HCTZ 12.5 mg combination after 4 weeks |
Participants |
Losartan 50 mg: n=157(71 males,86 females); mean age=66.9(9.7) years; baseline sitting SBP=165.3(12.1) mm Hg, DBP=83.6(5.4) mm Hg, HR=73.5(8.7) bpm;
Placebo: n=151(72 males,79 females); mean age=66.7(9.5) years; baseline sitting SBP=166.1(12.1) mm Hg, DBP=84.4(5.6) mm Hg, HR=73.7(8.3) bpm |
Interventions |
Losartan 50 mg once daily;
Placebo;
taken between 6 AM and 10 AM |
Outcomes |
Mean change from baseline in trough sitting SBP using mercury sphygmomanometer |
Notes |
Used week 4 SBP data only; BP change reported, SD of change not reported, endpoint BP and SD not reported, baseline SD reported but not appropriate; imputed overall trial mean SBP SD of change; BP data from text, p. 105; 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 |