Persson 1996.
Methods | Randomized, double‐blind, placebo‐controlled trial (parallel arms). Wash‐out period = 4 weeks. Multicenter; conducted in Germany and Sweden | |
Participants | DBP 95 to 114 mmHg. Mean age 70 years. Males 57%. Baseline BP was 171/102 in the treatment group and 172/103 in the control group | |
Interventions | Moexipril 7.5 mg (N = 50) or 15 mg/d (N = 53), HCTZ 25 mg/d (N = 50) or placebo (N = 48) Trial duration = 8 weeks | |
Outcomes | Change from the baseline in mean trough sitting and standing SBP and DBP (at 2, 4, 6 and 8 weeks); BP response rate; trough:peak BP ratios; pulse rate; ECG, urinalysis, hematology, body weight, serum biochemistry; plasma renin activity (PRA) and aldosterone. Subgroup analysis was performed based on mild versus moderate hypertension | |
Notes | A sample size calculation was not provided. This study included elderly patients only (65 to 80 years of age). Elderly patients present with a different set of problems, some of which are more concomitant illnesses and metabolic differences, so results of this study may differ. Study authors stated that age and DBP of patients at baseline were not significantly different (P value = NS) across treatment groups. Biochemical data (except for PRA and aldosterone) not available. Mortalities not given | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "This was a multicentre, randomised, double‐blind, placebo‐controlled, parallel study..." (line 1 under "Patients and Methods" p.259) "...patients were randomised to treatment with moexipril 7.5 mg, moexipril 15 mg, HCTZ or placebo for 8 weeks." (line 8 under "Protocol" p.260). No further information was given |
Allocation concealment (selection bias) | Unclear risk | Not stated by study authors |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "This was a multicentre, randomised, double‐blind, placebo‐controlled, parallel study..." (line 1 under "Patients and Methods" p.259). No further information was given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary efficacy analysis was based on an intention‐to‐treat (ITT) technique Exclusions: 88/289 (30%) of patients were excluded from the study during the single‐blind, placebo run‐in period prior to randomization. The specific reasons were not given Attrition: a total of 17/201 (8.4%) of patients withdrew from the study for the following reasons: 6 ‐ "withdrawn consent, protocol violations, or failure to meet criteria for continuation"; 4 ‐ "inadequate therapeutic response (1 patient receiving moexipril (group was not given: 7.5 mg or 15 mg?) and 3 on placebo); and 7 ‐ "adverse experiences". Note that data were pooled, not presented as separate according to each treatment group WDAEs: 7/201 (3.5%) of patients withdrew due to "adverse experiences". The reasons included, 3/50 (6%) of patients in the HCTZ treatment group: 1 ‐ "malignancy", 1 ‐ atrial fibrillation" and 1 ‐ "serum creatinine increased"; and 1/48 (2.1%) patient in the placebo group for "myocardial infarction". (Note: the other 3 patients were receiving a non‐thiazide drug) |
Selective reporting (reporting bias) | Unclear risk | Variability of the mean in baseline patient demographics and characteristics and in results for serum biochemistry (except aldosterone and plasma renin activity), heart rate, ECG and urinalysis were not given. SEM (standard error of the mean) was included in BP data and in PRA and aldosterone; instead of SD Trough: peak ratios were reported in the results section of the study, but not documented in the methods as an outcome to be measured. Mortalities: not given. SAEs: 2 patients in the HCTZ treatment group, 1 each for "haemorrhoid bleeding" and "second‐degree heart block". No patients in the placebo group had SAEs. Total AEs: 28% (14/50) of patients in the HCTZ group and 35% (17/48) of patients on placebo. The authors listed only the most commonly occurring AEs, "headache" and "respiratory symptoms" |
Industry sponsorship | Unclear risk | Sponsor not reported |