Treatment of hypertensive emergency. Comparison of a new dosage form of the calcium antagonist nitrendipine with nifedipine capsules.
OBJECTIVE
To present the efficacy and tolerability of a new oral dosage form of the calcium antagonist nitrendipine compared to nifedipine capsules in patients with hypertensive emergency.


METHODS
Multicenter randomized double blind clinical study.


METHODS
23 study centres (hospitals) in Germany.


METHODS
161 patients between 20 and 70 years with acutely elevated blood pressure (systolic 200-250 mmHg, diastolic between 110-140 mmHg) with and without concomitant clinical symptoms.


METHODS
Double blind treatment with 10 mg nifedipine or 5 mg nitrendipine. Nifedipine was administered as capsules, nitrendipine was given from a small plastic tube (vial), containing 1 ml alcoholic solution. Every patient received in addition to the test medication a placebo corresponding to the other product. Patients with insufficient treatment after 45 min were given either an additional capsule of 10 mg nifedipine or a further vial containing 5 mg nitrendipine according to their group and maintaining the double dummy procedure.


RESULTS
Blood pressure and heart rate were measured repeatedly during 4 h, before and 90 min after beginning of the treatment a 12 channel resting ECG was recorded. At 45 min after administration the blood pressure had fallen significantly from 216.0/117.4 mmHg to 170.0/93.3 mmHg under nifedipine and from 216.9/117.3 mmHg to 177.4/94.4 mmHg under nitrendipine. 61.6% of the nifedipine patients and 58.8% of the nitrendipine patients had already reached blood pressure values < 180/100 mmHg after 45 min and in both groups 83% of these patients were still in this limit at the end of the observation period after 4 h. Tolerability was very good in both groups.


CONCLUSIONS
The new dosage form of nitrendipine (vial with 1 ml of alcoholic solution) represents an alternative in the treatment of hypertensive emergency.
Rohr
G
G
Mannheim Faculty of Clinical Medicine, University of Heidelberg, Germany.
Reimnitz
P
P
Blanke
P
P
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002214:Capsules; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004630:Emergencies; D005260:Female; D005858:Germany; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage* / Q000009:adverse effects; D009568:Nitrendipine / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
D002214:Capsules; D009568:Nitrendipine; D009543:Nifedipine