| Methods |
4‐ to 6‐week placebo run‐in; inclusion criteria= sitting DBP 95‐114 mm Hg on 2 consecutive visits after beginning of placebo run‐in; 4‐week double‐bind treatment at fixed dose; after 4 weeks, patients with inadequate BP response had their doses doubled during the second 4 weeks; hydrochlorothiazide 25 mg was added during final 4 weeks |
| Participants |
All patients: n=418 patients randomized to double‐blind treatment; n=380 who completed 4 weeks of double‐blind treatment included in efficacy analysis;
Fosinopril 5 mg: n=83 randomized; for efficacy analysis n=74(53 males,21 females); mean age=53.2 years; baseline sitting SBP=151.7 mm Hg, DBP=101.4 mm Hg;
Fosinopril 10 mg: n=84 randomized; for efficacy analysis n=71(55 males,16 females); mean age=53.5 years; baseline sitting SBP=148.6 mm Hg, DBP=100.9 mm Hg;
Fosinopril 20 mg: n=84 randomized; for efficacy analysis n=79(51 males,28 females); mean age=54.2 years; baseline sitting SBP=153.2 mm Hg, DBP=102.4 mm Hg;
Fosinopril 40 mg: n=85 randomized; for efficacy analysis n=79(52 males, 27 females); mean age=50.9 years; baseline sitting SBP=153.0 mm Hg, DBP=102.2 mm Hg;
Placebo: n=82 randomized; for efficacy analysis n=77(52 males,25 females); mean age=53.2 years; baseline sitting SBP=151.7 mm Hg, DBP=101.4 mm Hg |
| Interventions |
Fosinopril 5 mg once daily;
Fosinopril 10 mg once daily;
Fosinopril 20 mg once daily;
Fosinopril 40 mg once daily;
Placebo |
| Outcomes |
Mean change in trough sitting SBP/DBP using mercury sphygmomanometer;
Mean change in trough standing SBP/DBP using mercury sphygmomanometer |
| Notes |
BP change reported, SD of change not reported, endpoint BP and SD not reported; baseline SD not reported; imputed overall trial mean SD of change for SBP and DBP; change in SBP data from Figure 2, p. 524; change in DBP data from Table II, p. 526; Jadad score=3; funding source= Bristol‐Myers Squibb |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
