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Results of Monotherapy in ALLHAT: On-treatment Analyses ALLHAT Outcomes for participants who received no step-up drugs.

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Presentation on theme: "Results of Monotherapy in ALLHAT: On-treatment Analyses ALLHAT Outcomes for participants who received no step-up drugs."— Presentation transcript:

1 Results of Monotherapy in ALLHAT: On-treatment Analyses ALLHAT Outcomes for participants who received no step-up drugs

2 Objective and Rationale To compare major outcomes for pts remaining on blinded monotherapy. Aim: to remove effects of step-up drugs that may have differed in effectiveness depending on Step 1 class. Main limitation: departure from intent-to- treat introduces possible confounding. ALLHAT

3 Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Practice-based, randomized trial conducted at 623 N. American & Caribbean sites Antihypertensive component –42,418 high-risk hypertensives >= 55 years –whether newer agents reduce incidence of CHD compared to a diuretic –double-blind –no placebo ALLHAT

4 Major Outcomes Nonfatal MI/CHD death (primary) All-cause mortality Stroke Combined CHD – nonfatal MI, CHD death, coronary revascularization, hospitalized angina Combined CVD – combined CHD, stroke, lower extremity revascularization, treated angina, fatal / hospitalized / treated heart failure (HF), hospitalized or outpatient PAD ALLHAT

5 42,418 high-risk hypertensive patients 90% previously treated 10% untreated STEP 1 AGENTS Chlorthalidone 12.5-25 mg Amlodipine 2.5-10 mg Lisinopril 10-40 mg Doxazosin 1-8 mg N=15,255 N=9,048 N=9,054 N=9,061 STEP 2 AND 3 AGENTS (5 years) Atenolol 28.0% Clonidine 10.6% Reserpine 4.3% Hydralazine 10.9% Hypertension Trial ALLHAT

6 Year 1 Cohort Criteria On only Step 1 (blinded) therapy at the year 1 (first annual) follow-up visit Have not had a cardiovascular event during the first year following randomization Have at least one follow-up visit following the first annual visit ALLHAT

7 Percent Remaining on Step 1 Monotherapy at Subsequent Annual Visits Step 1 DrugYear 2Year 3Year 4Year 5Yrs. 1-5 Chlorthalidone (n=7387) 77.777.677.977.136.2 Amlodipine (n=4275) 75.477.176.975.233.6 Lisinopril (n=3638) 73.975.376.273.831.3 Doxazosin (n=3180) 71.672.972.170.626.6 ALLHAT n=number in year 1 cohort

8 Cox Regression Analyses Baseline variables –Age, gender, race, ethnicity, SBP, DBP, previous antihypertensive med use, aspirin use –History of atherosclerotic CVD, coronary revascularization, diabetes, CHD, LVH, smoking –Serum potassium, creatinine, total & HDL cholesterol, fasting glucose and triglycerides Time-dependent variables –On/off Step 1 monotherapy, SBP, DBP, serum potassium, creatinine, total cholesterol –Variables updated annually –Missing value  values from previous year brought forward ALLHAT

9 Baseline Characteristics CALD No. randomized7387427536383180 Age, yr, mean66.766.666.566.6 % women48.847.945.2*46.2* Race, % White57.559.064.5*62.2* Black37.136.229.932.6 Other5.44.85.75.2 ALLHAT *p<0.05; overall race distribution significantly different in lisinopril and doxazosin treatment groups compared to chlorthalidone group

10 Baseline Characteristics CALD Previous AHT RX, %88.388.086.987.5 BP, mm Hg, mean Treated143/83 142/83 Untreated155/89156/90155/89155/88 Prior CABG/PTCA, %9.6 11.5*10.6 Taking aspirin, %32.133.534.9*34.4* HDL-C, mg/dl, mean47.347.546.4*46.6 Serum potassium, mmol/l, mean 4.3 4.4* *p<0.05 ALLHAT

11 Systolic Blood Pressure ALLHAT

12 Improvement in SBP from Baseline ALLHAT

13 Adjusted* Analyses for Major Cardiovascular Outcomes: Amlodipine vs. Chlorthalidone ALLHAT OutcomeHR95% CIP CHD (Primary)1.160.99, 1.380.07 Mortality1.030.90, 1.170.67 Combined CHD1.110.98, 1.260.09 Stroke1.060.84, 1.350.60 Combined CVD1.141.03, 1.25<0.01 Heart failure (all)1.491.22, 1.82<0.001 Heart failure (H+F)1.551.24, 1.92<0.001 *Baseline-adjusted for age, gender, race, ethnicity, smoking status, BP, BP meds, LVH, aspirin use, fasting glucose, creatinine, total cholesterol, HDL cholesterol, potassium; history of ASCVD, diabetes, CHD, coronary revascularization

14 Adjusted* Analyses for Major Cardiovascular Outcomes: Lisinopril vs. Chlorthalidone OutcomeHR95% CIP CHD (Primary)0.970.81, 1.170.75 Mortality1.040.90, 1.190.60 Combined CHD0.980.86, 1.120.79 Stroke1.070.83, 1.370.59 Combined CVD1.000.90, 1.110.99 Heart failure (all)1.090.87, 1.380.44 Heart failure (H+F)1.120.87, 1.440.38 ALLHAT *Baseline-adjusted for age, gender, race, ethnicity, smoking status, BP, BP meds, LVH, aspirin use, fasting glucose, creatinine, total cholesterol, HDL cholesterol, potassium; history of ASCVD, diabetes, CHD, coronary revascularization

15 Adjusted* Analyses for Major Cardiovascular Outcomes: Doxazosin vs. Chlorthalidone OutcomeHR95% CIP CHD (Primary)1.020.80, 1.300.88 Mortality1.060.87, 1.280.59 Combined CHD0.990.83, 1.180.89 Stroke1.020.73, 1.420.91 Combined CVD1.090.96, 1.250.18 Heart failure (all)1.711.29, 2.26<0.001 Heart failure (H+F)1.741.27, 2.37<0.001 ALLHAT *Baseline-adjusted for age, gender, race, ethnicity, smoking status, BP, BP meds, LVH, aspirin use, fasting glucose, creatinine, total cholesterol, HDL cholesterol, potassium; history of ASCVD, diabetes, CHD, coronary revascularization

16 Heart Failure in ALLHAT ALLHAT * * * * * * * * * *P<0.05 † Time-dependent analyses adjusted for the following time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol. Also adjusted for baseline variables: age, gender, ethnicity, BP, LVH, smoker, aspirin use, BP meds at baseline; history of atherosclerotic cardiovascular disease, coronary revascularization, diabetes, CHD. †

17 Stroke in ALLHAT ALLHAT *P<0.05 * * † Time-dependent analyses adjusted for the following time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol. Also adjusted for baseline variables: age, gender, ethnicity, BP, LVH, smoker, aspirin use, BP meds at baseline; history of atherosclerotic cardiovascular disease, coronary revascularization, diabetes, CHD. †

18 Stroke in ALLHAT: Black Participants ALLHAT *P<0.05 * * † Time-dependent analyses adjusted for the following time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol. Also adjusted for baseline variables: age, gender, ethnicity, BP, LVH, smoker, aspirin use, BP meds at baseline; history of atherosclerotic cardiovascular disease, coronary revascularization, diabetes, CHD. † *

19 Conclusions (1) Heart failure, increased in the assigned (intent-to-treat) Step 1 amlodipine and doxazosin treatment groups compared to the chlorthalidone group, is similarly increased in these treatment groups in this Step 1 monotherapy cohort. ALLHAT

20 Conclusions (2) The previously reported higher rates for stroke and CCVD, including heart failure, in the lisinopril group compared to the chlorthalidone group, do not reach significance in this monotherapy cohort. –The restricted cohort lessens the sample size. –BP differences are greatly diminished with this restricted cohort. –Participants with early CVD events are not included. ALLHAT

21 Conclusions (3) Unknown confounding factors may further influence results, and thus caution in interpretation is warranted. ALLHAT

22 Alternate Slides

23 Heart Failure in ALLHAT Relative Risk A vs CL vs CD vs C ALLHAT population (ITT)1.38*1.19*1.80* Year 1 monother. cohort: Unadjusted 1.39*1.091.64* Year 1 monother. cohort: Baseline-adjusted 1.49*1.091.71* Year 1 monother. cohort: Time-dependent † 1.43*1.101.72* ALLHAT † Time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol; also adjusted for baseline variables * P < 0.05

24 Stroke in ALLHAT Relative Risk A vs CL vs CD vs C ALLHAT population (ITT)0.931.15*1.26* Year 1 monother. cohort: Unadjusted 0.970.981.03 Year 1 monother. cohort: Baseline-adjusted 1.061.071.02 Year 1 monother. cohort: Time-dependent † 1.011.031.05 ALLHAT † Time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol; also adjusted for baseline variables * P < 0.05

25 Stroke in ALLHAT: Black Participants Relative Risk A vs CL vs CD vs C ALLHAT Black population (ITT) 0.931.40*1.38* Year 1 monother. cohort: Unadjusted 1.031.291.38 Year 1 monother. cohort: Baseline-adjusted 1.251.391.61 Year 1 monother. cohort: Time-dependent † 1.121.321.58* ALLHAT † Time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol; also adjusted for baseline variables * P < 0.05

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