| Methods |
4‐ to 5‐week single‐blind placebo run‐in; inclusion criteria= sitting DBP 95‐110 mm Hg after weeks 3 and 4 of placebo therapy, with the two readings not differing by more than 8 mm Hg; a fifth week of placebo treatment was optional if patients did not meet eligibility criteria at week 4 of run‐in; 12‐week total double‐blind treatment, 6‐week fixed dose therapy, then titrated to response at week 6 |
| Participants |
Irbesartan 75 mg: n=104(71 males,33 females); mean age=53 years; baseline sitting SBP=148.9(14.2) mm Hg, DBP=100.6(4.4) mm Hg, HR=73(9) bpm;
Irbesartan 150 mg: n=98(62 males,36 females); mean age=53 years; baseline sitting SBP=147.8(12.9) mm Hg, DBP=99.5(4.0) mm Hg, HR=72(8) bpm;
Placebo: n=117(80 males,37 females); mean age=53 years; baseline sitting SBP=148.0(14.2) mm Hg, DBP=99.9(3.8) mm Hg, HR=72(9) bpm |
| Interventions |
Irbesartan 75 mg once daily;
Irbesartan 150 mg once daily;
Placebo;
taken between 6 AM and 10 AM |
| Outcomes |
Mean change from baseline in trough sitting SBP/DBP using mercury sphygmomanometer |
| Notes |
Used week 6 BP data only; BP change and SE of change reported, endpoint BP and SD not reported, baseline SD reported; calculated SD from N and SE; BP data from Table II, p. 222; Jadad score=4; funding source= Bristol‐Myers Squibb |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
