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ALLHAT. Blood Pressure Control in Hispanics in the Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
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ALLHAT Blood Pressure Control in Hispanics in the Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Karen L. Margolis, Linda B. Piller, Charles E. Ford, Mario Henriquez, William C. Cushman, Paula T. Einhorn, Pedro J. Colon, Sr., Donald G. Vidt, Rudell Christian, Nathan D. Wong, Jackson T. Wright, Jr., David C. Goff, Jr., for the ALLHAT Collaborative Research Group Hypertension. 2007;50:854-861
Prevalence of Hypertension in U.S. byRace/Ethnicity: 1988-2004 Population With Hypertension (%) From Bernard Cheung Ong, et al, Hypertension 2007
White Non-Hispanic Mexican American NHANES II 1976-80 NHANES III 1988-91 Hisp HANES 1982-4 NHANES III 1988-91 Aware 50 74 60 57 Treat 31 56 38 37 Control 10 30 19 21 Hypertension Awareness,Treatment and Control
Changes in Hypertension Awareness, Treatment, and Control • NHANES 2003-2004 – some improvement among Mexican-Americans, but disparities remain
Reasons for Racial and Ethnic Differences in BP Control? • Lack of access to health care • Inability to afford medication • Other socioeconomic factors • Beliefs about hypertension • Language barriers • Poor MD-patient communication • Family influences • Diet • Metabolic risk factors • Other biological factors insufficient treatment or resistance to treatment
ALLHAT AntihypertensiveTrial Design • Randomized, double-blind, concurrently controlled practice-based clinical trial in 42,418 participants with hypertension comparing 4 commonly-used antihypertensive drugs. • ALLHAT investigated whether there was a difference in fatal CHD & nonfatal MI (primary endpoint) among patients randomized to CCB, ACEI, or alpha-blocker compared to a thiazide-type diuretic. • Step-up medications as needed for BP control.
ALLHAT Secondary Outcomes • All-cause mortality • Stroke • Combined CHD – nonfatal MI, CHD death, coronary revascularization, hospitalized angina • Combined CVD – combined CHD, stroke, lower extremity revascularization, other treated angina, treated HF • Other – renal (reciprocal serum creatinine, ESRD, estimated GFR), diabetes, and cancer
ALLHAT Inclusion Criteria • Men and women aged > 55 years • Seated blood pressure (2 categories): 1) Treated for @ least 2 months (1-2 drugs). 2) Not on drugs or on drugs <2 months. • Additional risk factor or target organ damage.
ALLHAT BP Eligibility Criteria
ALLHAT Doxazosin Arm Terminated Early • Statistically significant 25% higher rate of major secondary endpoint, combined CVD outcomes (2-fold higher rate of heart failure and 20% higher risk of stroke) • Futility of finding a significant difference for primary CHD outcome JAMA. 2000;1967-1975 & Hypertension. 2003;42:239-246.
ALLHAT Randomized Design of ALLHAT BP Trial 42,418 High-risk hypertensive patients Consent / Randomize Amlodipine Chlorthalidone Doxazosin Lisinopril Follow until death or end of study (4-8 years, mean 4.9 years)
ALLHAT Study Population • 42,418 participants randomized (Feb. 1994 through Jan. 1998) • After excluding doxazosin arm – 33,357 • 3% Black Hispanic (BH) • 16% White Hispanic (WH) • 33% Black nonHispanic (BNH) • 48% White nonHispanic (WNH) • 73% of Hispanics were from Puerto Rico
ALLHAT Treatment • Access to high-quality hypertension care • Study medications at no cost • Required dosage titration and additional medications if SBP 140 or DBP 90 mmHg.
ALLHAT Antihypertensive Treatment Regimen
ALLHAT Baseline Characteristics-1
ALLHAT Baseline Characteristics-2
ALLHAT Mean Systolic Blood Pressureby Race and Ethnicity
ALLHAT Mean Diastolic Blood Pressureby Race and Ethnicity
ALLHAT Blood Pressure Control
ALLHAT Number of Antihypertensive Medications
ALLHAT Participants with Uncontrolled BP on 1 Medication – Percentage Stepped Up
ALLHAT Participants with Uncontrolled BP on 2 Medications – Percentage Stepped Up
ALLHAT Relative Odds ofBP Control at Year 2
ALLHAT Summary - 1 U.S. population 14.1% Hispanic/Latino in 2004 • Hispanic ALLHAT participants had equivalent or superior BP control compared with non-Hispanics • Equal access to care • No-cost medications • Also reported in INVEST • Hispanic Blacks had slightly lower levels of BP control compared with Hispanic whites, similar BP control to non-Hispanic whites, and better BP control than non-Hispanic Blacks.
ALLHAT Summary - 2 • Compared with non-Hispanic whites, Hispanics less likely to have health insurance or regular source of care, less likely to receive preventive services • Linked to lower rates of BP screening and treatment in Hispanics • Primary care clinics in Boston – Hispanic participants less likely to have meds intensified, but if intensified, equally likely to achieve BP control THUS: • Hispanic patients likely to face barriers to hypertension screening, initiation of therapy, and appropriate intensification of therapy.
ALLHAT Conclusions • Low rate of BP control in US Hispanics not due to biological factors. • Controlled in 2/3 of Hispanic ALLHAT participants • Commonly-available medications, including thiazide-type diuretics • Focus on improving: • Hypertension knowledge and awareness • Doctor-patient communication • Access to medical care • Affordable medications • BP control in Hispanic patients is an achievable goal and should therefore be declared a public health priority
ALLHAT Summary - 3 • Other explanations for better BP control among Hispanic participants? • Adherence to med may have been lower among Hispanics prior to randomization (slightly higher BP levels) – more Hispanics essentially “untreated”? • Systematic bias in BP measurements • 0 terminal digit preference associated with underestimates of BP, undertreatment of hypertension • Relatively high frequency (24% for SBP at 1 year) – 42% in Hispanics vs 21% in non-Hispanics) – especially high in PR and USVI • No evidence for systematic effort to inflate BP control rates
ALLHAT Clinical Inertia • Failure to advance therapy despite suboptimal BP control • Reinforces need for effective methods to improve BP control through comprehensive programs • Patients • Providers • Health care systems