Blood Pressure-Lowering Efficacy of the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone: A Factorial Study

Domenic Sica, George L. Bakris, William B. White, Michael A. Weber, William Cushman, Patrick Huang, Andrew Roberts, Stuart Kupfer

Research output: Contribution to journalArticle

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Abstract

This study compared the efficacy and safety of fixed-dose combinations (FDCs) of the angiotensin II receptor blocker azilsartan medoxomil (AZL-M) and the thiazide-like diuretic chlorthalidone (CLD) with the individual monotherapies in a double-blind factorial study. A total of 1714 patients with clinic systolic blood pressure (SBP) 160mmHg to 190mmHg inclusive were randomized to AZL-M 0mg, 20mg, 40mg, or 80mg and/or chlorthalidone 0mg, 12.5mg, or 25mg. The primary efficacy end point was change from baseline to 8weeks in trough (hour 22-24) SBP by ambulatory blood pressure (BP) monitoring (ABPM). Patients' mean age was 57years; 47% were men and 20% were black. Baseline trough BP was approximately 165/95mmHg and 151/91mmHg by clinic and ABPM measurements, respectively. For the pooled AZL-M/CLD 40/25-mg and 80/25-mg FDC groups, SBP reduction by ABPM at trough was 28.9mmHg and exceeded AZL-M 80mg and CLD 25mg monotherapies by 13.8mmHg and 13mmHg, respectively (P<.001 for both comparisons). Discontinuation rates and elevations in serum creatinine were dose-dependent and occurred more often in the AZL-M/CLD groups. In patients with stage 2 hypertension, treatment with the combination of AZL-M and CLD resulted in substantially greater SBP reduction compared with either agent alone.

Original languageEnglish (US)
Pages (from-to)284-292
Number of pages9
JournalJournal of Clinical Hypertension
Volume14
Issue number5
DOIs
StatePublished - May 1 2012

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Chlorthalidone
Blood Pressure
Sodium Chloride Symporter Inhibitors
azilsartan medoxomil
Ambulatory Blood Pressure Monitoring
Angiotensin Receptor Antagonists
Double-Blind Method
Creatinine
Hypertension
Safety

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Cardiology and Cardiovascular Medicine

Cite this

Blood Pressure-Lowering Efficacy of the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone : A Factorial Study. / Sica, Domenic; Bakris, George L.; White, William B.; Weber, Michael A.; Cushman, William; Huang, Patrick; Roberts, Andrew; Kupfer, Stuart.

In: Journal of Clinical Hypertension, Vol. 14, No. 5, 01.05.2012, p. 284-292.

Research output: Contribution to journalArticle

Sica, Domenic ; Bakris, George L. ; White, William B. ; Weber, Michael A. ; Cushman, William ; Huang, Patrick ; Roberts, Andrew ; Kupfer, Stuart. / Blood Pressure-Lowering Efficacy of the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone : A Factorial Study. In: Journal of Clinical Hypertension. 2012 ; Vol. 14, No. 5. pp. 284-292.
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