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ALLHAT. Blood Pressure Control in Hispanics in the Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT). - PowerPoint PPT PresentationTRANSCRIPT
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
ALLHAT
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From Bernard CheungFrom Bernard CheungOng, et al, Hypertension 2007Ong, et al, Hypertension 2007
Prevalence of Hypertension in U.S. byRace/Ethnicity: 1988-2004
Hypertension Awareness,Treatment and Control
White Non-Hispanic
Mexican American
NHANES II
1976-80
NHANES III
1988-91
HispHANES1982-4
NHANES III
1988-91
Aware 50 74 60 57
Treat 31 56 38 37
Control 10 30 19 21
Changes in Hypertension Awareness, Treatment, and Control
• NHANES 2003-2004 – some improvement among Mexican-Americans, but disparities remain
BP Control
TotalAmong Treated Hypertensives
Mexican American 27% 57%
Non-Hispanic Black 29% 52%
Non-Hispanic White 35% 68%
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
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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
Lower Limit (mm Hg)
Upper Limit (mm Hg)
Status at Visit 1 and Visit 2 SBP DBP SBP DBP
On 1-2 drugs used for hypertension >= 2 months
Visit 1 Visit 2
---
---
---
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160
180
100
110
On drugs for < 2 months or currently untreated
Visit 1 & Visit 2
140 90 180 110
SBP or DBP lower limit must be met at Visit 1 and Visit 2 SBP and DBP upper limit must be met at Visit 1 and Visit 2
ALLHAT
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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
ALLHAT
JAMA. 2000;1967-1975 & Hypertension. 2003;42:239-246.
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
• 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
Study PopulationALLHAT
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
AntihypertensiveTreatment Regimen
Step 1 Dose 1 Dose 2 Dose 3
Chlorthalidone 12.5 mg 12.5 mg 25 mg
Amlodipine 2.5 mg 5 mg 10 mg
Lisinopril 10 mg 20 mg 40 mg
Step 2
Reserpine 0.05 mg qd 0.1 mg qd 0.2 mg qd
Clonidine 0.1 mg bid 0.2 mg bid 0.3 mg bid
Atenolol 25 mg qd 50 mg qd 100 mg qd
Step 3
Hydralazine 25 mg bid 50 mg bid 100 mg bid
ALLHAT
Baseline Characteristics-1ALLHAT
BH WH BNH WNHSample Size 1,090 5,239 10,608 15,705Mean SBP/DBP 147/87 146/85 145/84 145/82Previous HT treatment, % 89 90 91 90Mean age, years 66 67 66 68Women, % 59 56 54 39Current smoking, % 19 18 26 21History of type II diabetes, %
39 40 40 32
ASCVD, % 45 45 45 59LVH by baseline ECG, % 3 2 6 2
Baseline Characteristics-2ALLHAT
BH WH BNH WNHSample Size 1,090 5,239 10,608 15,705Puerto Rican or USVI, % 87 70 0.1 0.1
Education, years 8 9 10 12Mean BMI, kg/m2 30 29 31 30S. Creatinine, mg/dL 1.0 0.9 1.1 1.0F. Glucose, mg/dL 126 128 127 119
Mean Systolic Blood Pressure
by Race and EthnicityALLHAT
Mean Diastolic Blood Pressure
by Race and EthnicityALLHAT
Blood Pressure ControlALLHAT
Number ofAntihypertensive MedicationsALLHAT
Participants withUncontrolled BP on 1 Medication –
Percentage Stepped UpALLHAT
Participants withUncontrolled BP on 2 Medications –
Percentage Stepped UpALLHAT
Relative Odds ofBP Control at Year 2Unadjusted Adjusted*
OR† 95% CI OR† 95% CI
Total
Black Hisp 1.05 0.89 – 1.24 1.04 0.86 – 1.25
White Hisp 1.17 1.09 – 1.27 1.20 1.10 – 1.31
Black nonHisp 0.70 0.66 – 0.74 0.73 0.69 – 0.78
Excluding PR/VI
Black Hisp 1.03 0.70 – 1.51 1.01 0.68 – 1.52
White Hisp 0.99 0.88 – 1.11 1.07 0.94 – 1.22
Black nonHisp 0.70 0.66 – 0.74 0.74 0.69 – 0.78* Adjusted for age, sex, race-ethnicity, history of diabetes, current smoking, history of ASCVD, BMI30 kg/m2, antihypertensive treatment prior to enrollment, baseline SBP, creatinine 1.5 mg/dL, LVH on ECG, treatment assignment.
† Compared with White non-Hispanic
ALLHAT
Summary - 1U.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
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Reserve SlideReserve Slide
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
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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
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