Fiddes 1997.
| Methods | Randomized, double‐blind, placebo‐controlled trial (parallel groups). Wash‐out period = 4 weeks. Multicenter, conducted in USA | |
| Participants | DBP 95 to 114 mmHg. Mean age 69.7 years. Males 55%. Baseline BP was 159.3/98.8 mmHg in the treatment group and 160.3/99.8 in the control group | |
| Interventions | Indapamide 1.25 mg/d (N = 103) or placebo (N = 101) Treatment duration = 8 weeks | |
| Outcomes | Mean change from the baseline in standing and supine DBP and SBP (at 2‐week intervals); response rate, heart rate, body weight, ECG, serum biochemistry, hematology and urinalysis | |
| Notes | Sample size calculation was not provided. The study authors did not state whether there were statistically significant differences between indapamide and placebo treatment groups in baseline patient demographics and characteristics. The minimum age of 65 years for patients to be included in the study was much older than most other studies assessed in this review. This elderly population may present with a different profile of underlying diseases not seen in young adult patients of 18 years of age or older. Patients with low serum potassium during the trial were given potassium supplements. For BP and biochemical data the number of subjects changes over the duration of treatment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "This was a multicentre, randomised study..." (line 1 under "Design" p.240) "[Patients] were randomised to receive indapamide 1.25 mg or placebo..." (line 5 from top of p.240). No further information was given |
| Allocation concealment (selection bias) | Unclear risk | Not stated by study authors |
| Blinding (performance bias and detection bias) All outcomes | High risk | "This was a multicentre, randomised study consisting of two periods: a single‐blind placebo washout period and a double‐blind treatment period." (line 1 under "Design" p.240) "Eligible patients were...entered into an 8‐week double‐blind treatment period." (line 4 from top of p.240). The investigator at his/her discretion gave hypokalemic patients potassium supplementation which could have broken the blinding No further information was given |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Efficacy and safety analysis was based on an "all‐treated patient population" (line 1 under "Statistical Analysis" p.240) Exclusions: the number of patients excluded from the study during the placebo run‐in period prior to randomization was not given Attrition: 11/103 (11%) and 16/101 (16%) of patients from the indapamide and placebo groups, respectively, withdrew from the study. Reasons for withdrawals included (IND versus PLB): 4 versus 6 patients ‐ adverse events, 1 versus 6 ‐ ineffective therapy, 1 versus 2 ‐ protocol deviations, 1 versus 1 ‐ withdrawn consent, 2 versus 0 ‐ lost to follow‐up and 2 versus 1 ‐ other reasons WDAEs: 5/103 (5%) patients receiving indapamide and 6/101 (6%) receiving placebo withdrew due to adverse events; precise reasons were not given. Note: 11 WDAEs is contrary to the number (n = 10) the study accounted for on line 9 under "Results" p.241 |
| Selective reporting (reporting bias) | High risk | Variability was not included in baseline patient demographics and characteristics or in baseline mean BP readings. Body weight was reported at baseline, but not at endpoint. Heart rate and ECG were measured but not reported. Reporting of biochemical data was based on a selection of measured parameters, therefore some data like hematology and urinalysis were missing. Baseline standing BP was measured but not reported and the variability in mean change in standing BP at endpoint was not reported. Medical history of patients was not given. Mortalities: 1 patient in the indapamide group died from arteriosclerosis and 1 patient in the placebo group died from a myocardial infarction). SAEs: 2/103 (1.9%) patients on indapamide and 5/101 (5%) patients on placebo. Total AEs: 32/103 (31%) patients on indapamide and 38/101 (38%) patients on placebo. A list of AEs (with description) occurring in at least 2% of patients was provided |
| Industry sponsorship | Unclear risk | Sponsor not reported |