Rubio‐G 1999.
Methods | Single‐site study (Mexico) Open label trial Method of randomization /allocation: not reported Duration of treatment: single dose Follow‐up: 6 hrs | |
Participants | 60 patients with high blood pressure and evidence of end organ organ damage Inclusion Criteria: Mean arterial pressure > 130 mmHg and evidence of end organ damage. Exclusion Criteria: Liver failure, chronic renal failure, drug or ethanol abuse, pregnancy. * Baseline characteristics for the two randomized groups: Isosorbide dinitrate aerosol (I): n= 30 Nifedipine (N): n= 30 mean age ± SD (years) I:51 13 N: 51±11 Race: NR BP: (mm Hg) NR Data was extracted from graphs and text based on ITT analysis Distribution of patients according to the type of end organ damage at admission Encephalopathy I:18 N:18 Intracraneal Haemorrage I:2 N:4 Stroke I:5 N:4 Myocardial Ischaemia I:2 N:0 Acute pulmonary edema I:2 N:1 Retinal haemorrhage I:0 N:2 Pulmonary congestion by CXR I:0 N:1 Papilledema I:1 N:0 |
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Interventions | Isosorbide dinitrate aerosol (I): n= 30
Nifedipine (N): n= 30 I: Initial dose 1.25 mg through oral mucosa when admitted and a second dose given 15 min later when MAP decreased less than 15%. N: 10 mg sublingually as a single dose. |
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Outcomes | Outcomes obtained from this trial Total SAE: NR Mortality: NR Total non‐cardiovascular events: NR Individual Cardiovascular events: Nifedipine = 2/30 (subepicardial ischemia) Isosorbide= 0/30 Withdraw due to adverse events= NR Blood pressure Data was obtained from text (page 474). The calculated weighted mean BP change was: Isosorbide: SBP ‐34±15, DBP‐29±7 Nifedipine: SBP ‐37±26, DBP‐29±6 Standard deviation of change was not reported but imputed from end point Heart rate Data was obtained from text (page 474) The calculated weighted mean HR change was: Isosorbide: ‐13±14 Nifedipine: 10±23 Standard deviation of change was not reported but imputed from end point | |
Notes | Funding: Not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |