A Titrate-to-Goal Study of Switching Patients Uncontrolled on Antihypertensive Monotherapy to Fixed-Dose Combinations of Amlodipine and Olmesartan Medoxomil ± Hydrochlorothiazide
Article first published online: 5 FEB 2011
© 2011 Wiley Periodicals, Inc.
The Journal of Clinical Hypertension
Volume 13, Issue 6, pages 404–412, June 2011
How to Cite
Weir, M. R., Hsueh, W. A., Nesbitt, S. D., Littlejohn, T. J., Graff, A., Shojaee, A., Waverczak, W. F., Qian, C., Jones, C. J. and Neutel, J. M. (2011), A Titrate-to-Goal Study of Switching Patients Uncontrolled on Antihypertensive Monotherapy to Fixed-Dose Combinations of Amlodipine and Olmesartan Medoxomil ± Hydrochlorothiazide. The Journal of Clinical Hypertension, 13: 404–412. doi: 10.1111/j.1751-7176.2011.00437.x
- Issue published online: 7 JUN 2011
- Article first published online: 5 FEB 2011
- Manuscript received: November 30, 2010; Revised: January 20, 2011; Accepted: January 20, 2011
In the prospective, open-label, titrate-to-goal Blood Pressure Control in All Subgroups With Hypertension (BP-CRUSH) study, 999 patients with hypertension uncontrolled on monotherapy (mean age, 55.6±11.4 years; baseline blood pressure [BP], 153.7±9.2/91.9±8.6 mm Hg) were switched to fixed-dose amlodipine/olmesartan medoxomil (AML/OM) 5/20 mg. Patients were uptitrated every 4 weeks to AML/OM 5/40 mg and 10/40 mg to achieve BP <120/70 mm Hg. Patients were subsequently uptitrated every 4 weeks to AML/OM+hydrochlorothiazide (HCTZ) 10/40+12.5 mg and 10/40+25 mg to achieve BP <125/75 mm Hg. The primary end point, the cumulative percentage of patients achieving seated systolic BP <140 mm Hg (<130 mm Hg for patients with diabetes) by week 12, was 75.8%. The mean (±standard error) BP changes from baseline during the titration periods ranged from −14.2±0.4 mm Hg/−7.7±0.3 mm Hg for AML/OM 5/20 mg to −25.1±0.7 mm Hg/−13.7±0.4 mm Hg for AML/OM+HCTZ 10/40+25 mg. By week 20, the cumulative BP threshold of <140/90 mm Hg was achieved by 90.3% of patients. An ambulatory BP monitoring substudy (n=243) showed that 24-hour efficacy was maintained. Treatment-emergent adverse events (TEAEs), mostly mild to moderate in severity, occurred in 529 patients (53.0%). Drug-related TEAEs occurred in 255 patients (25.5%). This well-tolerated, treat-to-goal algorithm enabled a large proportion of patients with uncontrolled hypertension on monotherapy to safely achieve BP control on single-pill AML/OM combination therapy or triple therapy with the addition of HCTZ. J Clin Hypertens (Greenwich). 2011;13:404–412. ©2011 Wiley Periodicals, Inc.