24-Hour blood pressure control by once-daily administration of irbesartan assessed by ambulatory blood pressure monitoring

Roberto Fogari, Sergio Ambrosoli, Luca Corradi, Ezio Degli Esposti, Lucio Mos, Renato Nami, Francesco Nicrosini, Achille C. Pessina, Antonio Salvetti, Alvaro Vaccarella, Alberto Zanchetti, Ann Martin, Richard A. Reeves

Research output: Contribution to journalArticle

Abstract

Objectives. To compare 24 h ambulatory blood pressure and trough office blood pressure lowerings after 8 weeks of therapy with 75 mg irbesartan once a day, 150 mg irbesartan once a day, and 75 mg irbesartan twice a day versus placebo; and to assess safety and tolerability of irbesartan therapy. Design. Multicenter, double-blind, randomized, placebo-controlled trial. Setting. Sixteen centers in Italy. Patients. Caucasian patients (n = 215) aged ≤ 18 years with seated diastolic blood pressure 95-110 mmHg and ambulatory diastolic blood pressure (ADBP) ≤ 85 mmHg. Primary outcome. Mean 24 h ADBP after 8 weeks of irbesartan therapy. Results. Mean changes (value before treatment minus value after treatment) in ADBP for placebo, 75 mg irbesartan once a day, 150 mg irbesartan once a day, and 75 mg irbesartan twice a day were -0.2, -5.4, -7.2, and -7.2 mmHg, respectively; respective changes in ambulatory systolic blood pressure were +1.6, -8.3, -10.5, and -9.7 mmHg. All irbesartan regimens reduced trough office seated diastolic blood pressure and seated systolic blood pressure after 2 and 8 weeks of treatment (all P <0.01, versus placebo except for seated systolic blood pressure in patients in the 75 mg irbesartan once a day group). Trough:peak ratios were ≤ 55% with 150 mg irbesartan once a day. Percentages of patients whose blood pressures were normalized with 150 mg irbesartan once a day (45%) and 75 mg irbesartan twice a day (47%) were greater than those with placebo (14%, P <0.01) and with 75 mg irbesartan once a day (19%, NS, versus placebo). Adverse events with irbesartan were similar to those with placebo. Conclusions. All irbesartan regimens significantly reduced mean 24 h ADBP and ambulatory systolic blood pressure, and were well tolerated. Administration of 150 mg irbesartan once a day provided significant reduction of blood pressure for 24 h, equivalent to that obtained with the same daily dose divided into two separate administrations.

Original languageEnglish
Pages (from-to)1511-1518
Number of pages8
JournalJournal of Hypertension
Volume15
Issue number12 I
DOIs
Publication statusPublished - 1997

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Keywords

  • Ambulatory blood pressure monitoring
  • Angiotensin II receptor antagonist
  • Hypertension
  • Irbesartan
  • Placebo-controlled trial

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology

Cite this

Fogari, R., Ambrosoli, S., Corradi, L., Esposti, E. D., Mos, L., Nami, R., Nicrosini, F., Pessina, A. C., Salvetti, A., Vaccarella, A., Zanchetti, A., Martin, A., & Reeves, R. A. (1997). 24-Hour blood pressure control by once-daily administration of irbesartan assessed by ambulatory blood pressure monitoring. Journal of Hypertension, 15(12 I), 1511-1518. https://doi.org/10.1097/00004872-199715120-00020