A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil +/- hydrochlorothiazide.
Author(s): Weir MR, Hsueh WA, Nesbitt SD, Littlejohn TJ 3rd, Graff A, Shojaee A, Waverczak WF, Qian C, Jones CJ, Neutel JM
Affiliation(s): University of Maryland School of Medicine, Baltimore, MD, USA. firstname.lastname@example.org
Publication date & source: 2011-06, J Clin Hypertens (Greenwich)., 13(6):404-12. Epub 2011 Feb 5.
Publication type: Clinical Trial, Phase IV; Multicenter Study; Randomized Controlled Trial
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. . (c) 2011 Wiley Periodicals, Inc.