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24-hour ambulatory blood pressure monitoring and spirapril in mild to severe essential hypertension: a randomized dose comparison.

Abstract
This was a multicentre randomized, double-blind, parallel-group study to compare the antihypertensive efficacy of spirapril at 3 mg with 12 mg once daily, as determined by 24-hour ambulatory blood pressure monitoring (ABPM), in patients with mild to severe essential hypertension. Following a 4-week placebo run-in phase, 52 male and female outpatients, aged 23-67 years with mild to severe essential hypertension [diastolic blood pressure (DBP) > or = 100 mmHg and < 120 mmHg] were randomized to receive spirapril at either 3 mg or 12 mg once daily for 8 weeks. At the end of active treatment and using the standard mercury sphygmomanometer, the number of responders (sitting DBP < 90 mmHg, but decrease > or = 10 mmHg) was the same in both groups (32% and 37%). There were mean decrease in both systolic blood pressure (SBP) and DBP at trough with both 3 mg and 12 mg doses: -9/-7 mmHg and -12/-7 mmHg, respectively. The rate of normalization (trough DBP < or = 90 mmHg) was 12% and 30% with the 3 mg and 12 mg doses, respectively. Of the 44 patients whose daytime ABPM could be compared, one of 20 patients taking 3 mg of spirapril, and 9 of 24 taking 12 mg of spirapril achieved a DBP < or = 90 mmHg for all time intervals while awake. The differences in blood pressure-lowering were significant with both SBP and DBP during the day and at the end of the dosing interval (p < 0.001 and p < 0.01, respectively). The changes from baseline at 24 hours postdose for SBP/DBP were -3/-6 mmHg with 3 mg and -14/-12 mmHg with 12 mg of spirapril.(ABSTRACT TRUNCATED AT 250 WORDS)
AuthorsG Vreugdenhil, G A van Montfrans, M C Jacobs, J H de Bruijn, D P Veerman, P N van Es, B Mellein, C Guitard, T Thien, P W de Leeuw
JournalBlood pressure. Supplement (Blood Press Suppl) Vol. 2 Pg. 23-30 ( 1994) ISSN: 0803-8023 [Print] Sweden
PMID8061842 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Angiotensin-Converting Enzyme Inhibitors
  • Angiotensin II
  • Enalapril
  • spirapril
  • Peptidyl-Dipeptidase A
  • Renin
Topics
  • Adult
  • Aged
  • Angiotensin II (drug effects)
  • Angiotensin-Converting Enzyme Inhibitors (administration & dosage, adverse effects)
  • Blood Pressure (physiology)
  • Blood Pressure Determination
  • Double-Blind Method
  • Enalapril (administration & dosage, adverse effects, analogs & derivatives)
  • Female
  • Humans
  • Hypertension (blood, drug therapy, physiopathology)
  • Male
  • Middle Aged
  • Monitoring, Physiologic
  • Peptidyl-Dipeptidase A (drug effects)
  • Renin (drug effects)

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