REPORTS : CARDIOVASCULAR DISEASE AND RISK FACTORS TRIPLE-COMBINATION TREATMENT WITH OLMESARTAN MEDOXOMIL / AMLODIPINE / HYDROCHLOROTHIAZIDE IN HISPANIC / LATINO PATIENTS WITH HYPERTENSION : THE TRINITY STUDY

OBJECTIVE(S) Evaluate efficacy/safety of olmesartan medoxomil (OM)/amlodipine (AML)/ hydrochlorothiazide (HCTZ) in Hispanic/Latino adults with hypertension. DESIGN Randomized, double-blind, 12-week, parallel-group study followed by a 40-week open-label extension phase. SETTING Clinical sites (317) in the United States and Puerto Rico. PATIENTS OR PARTICIPANTS Individuals > or =18 years of age with mean seated blood pressure (BP) > or =140/100 or > or =160/90 mm Hg divided into Hispanic/Latino (369) and non-Hispanic/Latino (2122) subgroups. INTERVENTIONS Participants were randomized to OM 40/AML 10 mg, OM 40/HCTZ 25 mg, AML 10/HCTZ 25 mg, or OM 40/AML 10/HCTZ 25 mg during the double-blind phase. During the open-label extension, all participants received OM 40/AML 5/HCTZ 12.5 mg; participants not reaching BP goal within 2 weeks were randomly titrated to OM 40/AML 10/HCTZ 12.5 mg or OM 40/AML 5/HCTZ 25 mg, then to OM 40/AML 10/ HCTZ 25 mg after another 2 weeks. MAIN OUTCOME MEASURE Change in mean seated diastolic BP (SeDBP) from baseline (double-blind phase). RESULTS Triple-drug therapy vs the dual therapies resulted in greater mean reduction in SeBP (Hispanic/Latino: 35.0/20.9 mm Hg vs 27.8-30.9/15.3-17.7 mm Hg; non-Hispanic/Latino: 39.0/21.7 mm Hg vs 28.9-31.5/14.6-17.8 mm Hg) and enabled more participants to reach BP goal (Hispanic/Latino: 56.8% vs 40.6%-51.2%; non-Hispanic/Latino: 65.7% vs 33.8%-46.6%) irrespective of ethnicity. The efficacy of triple-drug therapy in achieving BP goal was sustained long-term (40-week open-label extension period) in Hispanic/Latino (63.3%) and non-Hispanic/ Latino (64.2%) participants. Triple-drug therapy was well tolerated in Hispanic/Latino and non-Hispanic/Latino participants. CONCLUSIONS In this study, OM/AML/HCTZ was an effective treatment option in Hispanic/ Latino patients with hypertension.

[1]  S. U M M A R Y O F R E V I S I O N S.  Summary of Revisions for the 2013 Clinical Practice Recommendations , 2012, Diabetes Care.

[2]  Vicki L. Burt,et al.  Trends in Antihypertensive Medication Use and Blood Pressure Control Among United States Adults With Hypertension: The National Health and Nutrition Examination Survey, 2001 to 2010 , 2012, Circulation.

[3]  D. Barnes,et al.  Mexican Immigrants’ and Mexican Americans’ Perceptions of Hypertension , 2012, Qualitative health research.

[4]  A. Shojaee,et al.  Efficacy and tolerability of fixed-dose amlodipine/olmesartan medoxomil with or without hydrochlorothiazide in Hispanic and non-Hispanic patients whose blood pressure is uncontrolled on antihypertensive monotherapy , 2012, Therapeutic advances in cardiovascular disease.

[5]  N. J. Guzman.  Epidemiology and Management of Hypertension in the Hispanic Population , 2012, American Journal of Cardiovascular Drugs.

[6]  S. Oparil,et al.  Long‐Term Efficacy and Safety of Triple‐Combination Therapy With Olmesartan Medoxomil and Amlodipine Besylate and Hydrochlorothiazide for Hypertension , 2012, Journal of clinical hypertension.

[7]  S. Oparil,et al.  Moderate versus intensive treatment of hypertension using amlodipine/valsartan and with the addition of hydrochlorothiazide for patients uncontrolled on angiotensin receptor blocker monotherapy: results in racial/ethnic subgroups. , 2011, Journal of the American Society of Hypertension : JASH.

[8]  J. Izzo,et al.  Hypertension in diverse populations: a New York State Medicaid clinical guidance document. , 2011, Journal of the American Society of Hypertension : JASH.

[9]  Amelia Perez.  Self-Management of Hypertension in Hispanic Adults , 2011, Clinical nursing research.

[10]  H. Black,et al.  24‐Hour Ambulatory Blood Pressure Response to Combination Valsartan/Hydrochlorothiazide and Amlodipine/Hydrochlorothiazide in Stage 2 Hypertension by Ethnicity: The EVALUATE Study , 2010, Journal of clinical hypertension.

[11]  William B. Lobb,et al.  Nonadherence to angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers among high-risk patients with diabetes in Medicare Part D programs. , 2010, Journal of the American Pharmacists Association : JAPhA.

[12]  S. Oparil,et al.  Triple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study. , 2010, Clinical therapeutics.

[13]  N. Poulter,et al.  Compliance, Safety, and Effectiveness of Fixed-Dose Combinations of Antihypertensive Agents: A Meta-Analysis , 2010, Hypertension.

[14]  Giuseppe Mancia,et al.  Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document , 2009, Blood pressure.

[15]  David R. Williams,et al.  Understanding social disparities in hypertension prevalence, awareness, treatment, and control: the role of neighborhood context. , 2007, Social science & medicine.

[16]  Jackson T. Wright,et al.  Blood Pressure Control in Hispanics in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial , 2007, Hypertension.

[17]  S. Bangalore,et al.  Fixed-dose combinations improve medication compliance: a meta-analysis. , 2007, The American journal of medicine.

[18]  J. Newhouse,et al.  Hypertension treatment in a medicare population: adherence and systolic blood pressure control. , 2007, Clinical therapeutics.

[19]  V. Durkalski,et al.  Therapeutic Inertia Is an Impediment to Achieving the Healthy People 2010 Blood Pressure Control Goals , 2006, Hypertension.

[20]  Julia B Anderson.  Unraveling health disparities: Examining the dimensions of hypertension and diabetes through community engagement , 2005, Journal of health care for the poor and underserved.

[21]  Carol R Horowitz,et al.  How do Urban African Americans and Latinos View the Influence of Diet on Hypertension? , 2004, Journal of health care for the poor and underserved.

[22]  Daniel W. Jones,et al.  Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. , 2003, Hypertension.

[23]  Joel W. Cohen,et al.  Racial and Ethnic Differences in Access to and Use of Health Care Services, 1977 to 1996 , 2000, Medical care research and review : MCRR.

[24]  Mark D. Huffman,et al.  Heart disease and stroke statistics--2013 update: a report from the American Heart Association. , 2013, Circulation.

[25]  Vital signs: awareness and treatment of uncontrolled hypertension among adults--United States, 2003-2010. , 2012, MMWR. Morbidity and mortality weekly report.

[26]  D. Siscovick,et al.  Association between language and risk factor levels among Hispanic adults with hypertension, hypercholesterolemia, or diabetes. , 2009, American heart journal.

[27]  W. Kannel,et al.  Cardiovascular disease prevention and care in Latino and Hispanic subjects. , 2007, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[28]  Hypertension-related mortality among Hispanic subpopulations--United States, 1995-2002. , 2006, MMWR. Morbidity and mortality weekly report.