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A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil ± hydrochlorothiazide.
J Clin Hypertens (Greenwich). 2011 Jun; 13(6):404-12.JC

Abstract

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. .

Authors+Show Affiliations

University of Maryland School of Medicine, Baltimore, MD, USA. mweir@medicine.umaryland.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

21649839

Citation

Weir, Matthew R., et al. "A Titrate-to-goal Study of Switching Patients Uncontrolled On Antihypertensive Monotherapy to Fixed-dose Combinations of Amlodipine and Olmesartan Medoxomil ± Hydrochlorothiazide." Journal of Clinical Hypertension (Greenwich, Conn.), vol. 13, no. 6, 2011, pp. 404-12.
Weir MR, Hsueh WA, Nesbitt SD, et al. A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil ± hydrochlorothiazide. J Clin Hypertens (Greenwich). 2011;13(6):404-12.
Weir, M. R., Hsueh, W. A., Nesbitt, S. D., Littlejohn, T. J., Graff, A., Shojaee, A., Waverczak, W. F., Qian, C., Jones, C. J., & 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. Journal of Clinical Hypertension (Greenwich, Conn.), 13(6), 404-12. https://doi.org/10.1111/j.1751-7176.2011.00437.x
Weir MR, et al. A Titrate-to-goal Study of Switching Patients Uncontrolled On Antihypertensive Monotherapy to Fixed-dose Combinations of Amlodipine and Olmesartan Medoxomil ± Hydrochlorothiazide. J Clin Hypertens (Greenwich). 2011;13(6):404-12. PubMed PMID: 21649839.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil ± hydrochlorothiazide. AU - Weir,Matthew R, AU - Hsueh,Willa A, AU - Nesbitt,Shawna D, AU - Littlejohn,Thomas J,3rd AU - Graff,Alan, AU - Shojaee,Ali, AU - Waverczak,William F, AU - Qian,Chunlin, AU - Jones,Christopher J, AU - Neutel,Joel M, Y1 - 2011/02/05/ PY - 2011/6/9/entrez PY - 2011/6/9/pubmed PY - 2011/10/14/medline SP - 404 EP - 12 JF - Journal of clinical hypertension (Greenwich, Conn.) JO - J Clin Hypertens (Greenwich) VL - 13 IS - 6 N2 - 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. . SN - 1751-7176 UR - https://www.unboundmedicine.com/medline/citation/21649839/A_titrate_to_goal_study_of_switching_patients_uncontrolled_on_antihypertensive_monotherapy_to_fixed_dose_combinations_of_amlodipine_and_olmesartan_medoxomil_±_hydrochlorothiazide_ L2 - https://doi.org/10.1111/j.1751-7176.2011.00437.x DB - PRIME DP - Unbound Medicine ER -