Nelson 1983.
Methods | Single‐centre (US), randomized, single‐blind, controlled trial Method of randomization/ allocation: NR Duration of treatment : 1.5 h Follow‐up: 48 h | |
Participants | 28 patients with acute heart‐failure blood pressure levels that met our threshold for this category of patients. Base‐line characteristics for the two randomized groups: Isosorbide (N): n=14 Furosemide (F): n=14 Mean age in years N: 56 F: 56 Mean SBP ± SE N: 130±7 F: 119±4 Mean DBP ± SE N: 75±3 F: 72±2 |
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Interventions | Isosorbide (N): n=14
Furosemide (F): n=14 Dose regimen: N: Intravenous infusion of isosorbide dinitrate at initial dose of 50 mcg /kg and max 200 mcg/kg/h F: IV infusion of furosemide 1 mg/kg Study treatment lasted 1.5 hours after randomization and the target was to reduce systemic BP by 10 mm Hg. Treatment started between 5‐14 h of AMI Mean dose administrated : Isosorbide dinitrate: mean cumulative dose 13.2 mg (146 mcg/min ‐considering 90 min of infusion). Furosemide: mean dose 80 mg Co‐interventions: NR |
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Outcomes | Obtained from this trial for the two randomized groups: Isosorbide (N) group: n=14 Furosemide (F) group: n=14 Total SAE: NR Mortality : nil during 48 hours of follow‐up Total Non‐fatal CVE: NR Individual CVE: NR Withdrawals due to adverse events: NR Blood pressure: Data was obtained from table II page 731. The calculated BP weighted mean change was: Isosorbide: SBP: ‐6.6±22.4; DBP‐1.6±18.7 Furosemide: SBP: 1.6±18.7; DBP 1±11.2 The standard deviation of the change was not reported but it was imputed from the end point. Heart Rate: Data was obtained from table II page 731. The calculated HR weighted mean change was: Isosorbide: 3±18.7 Furosemide: 2±14.96 The standard deviation of the change was not reported but it was imputed from the end point. | |
Notes | Funding: Yorkshire Regional Hospital: West Riding Medical Research trust. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |