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. 2008 Jan 23;2008(1):CD003653. doi: 10.1002/14651858.CD003653.pub3

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
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.
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