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

Hirschl 1999.

Methods Single‐site study (Austria) 
 Open label. 
 Method of randomization / allocation: Not reported 
 Duration of treatment: until response or maximum dose allowed 
 Follow‐up:24 hrs
Participants 46 patients with high blood pressure and evidence of pulmonary oedema
Inclusion Criteria:
Patients found with Pulmonary edema (rales over both lungs) plus SBP > 200 mmHg or DBP > 100 mm Hg.
Exclusion Criteria: 
 If the patient required intubation or had cardiopulmonary arrest before initiating therapy.
Baseline characteristics for the two randomized groups: 
 Nitroglycerine (NTG) n=23 
 Enalaprilat(ENA) n=23 
 age ( years) 
 NTG=74 
 ENA= 74 
 Male/female 
 NTG=12/11 vs. ENA=9/14 
 race: NR 
 BP (mm Hg): 
 NTG=206/116 
 ENA=211/115 
 Patients previously receiving antihypertensive NTG=9/23 vs. ENA= 8/23 
 Diabetes NTG=6/23 vs. ENA= 4/23 
 Previous myocardial infarction NTG=4/23 vs. ENA= 6/23
Interventions Nitroglycerine (NTG) n=23 
 Enalaprilat(ENA) n=23 
 Dose regimen: 
 NTG = Sublingual, initial dose 0.8 mg as: repetitive application of 0.8 mg every 10 min. until a cumulative dose of 3.2 mg. 
 ENA = Initial dose: 2.5 mg IV; repetitive application of 2.5 mg every 30 min until a cumulative dose of 10 mg.
The mean dose of drug given until admission was 1.6 ± 0.6mg of nitroglycerine and 3.7±1.5 mg of enalaprilat .
Withdrawals due to adverse events were not reported. 
 The number of patients requiring a second drug to reduce blood pressure was not reported. 
 The time to achieve the target blood pressure was not reported. 
 The mean time of drug infusion is not reported.
Outcomes Obtained from this trial 
 Total SAE: NR 
 Mortality: nil at 24 hours of follow‐up. 
 Total non‐fatal CVE: NR. 
 Individual CVE 
 Nitroglycerine (N)= 0/23 
 Enalapril= 2/23; (1 asystole, 1 intubation). 
 Withdrawals due to adverse events: NR 
 Blood pressure: 
 Data was obtained from text (p.211). Weighted mean BP change was calculated as follow: 
 Nitroglycerine: SBP ‐52.3 ± 18; DBP ‐34.6 ± 12 
 Enalapril : SBP ‐55.6 ± 19; DBP ‐34.3 ± 11 
 Standard deviation of the change was not reported but imputed from end point. 
 Heart rate: 
 Weighted mean HR change was also calculated from data provided in the text (p.211) as follow: 
 Nitroglycerine: ‐29 ± 7 
 Enalapril: ‐33.5 ± 12 
 Standard deviation of the change was not reported but imputed from end point.
Primary outcome of trial: 
 The aim of the antihypertensive treatment was Reduction of systolic blood pressure below 160 mm Hg and diastolic BP below 90 mm Hg at admission to the emergency department. 
 Secondary outcome: Chest x‐ray congestion, adverse events, metabolic and respiratory parameters.
Notes Funding: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear