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Results of Monotherapy in ALLHAT: On-treatment Analyses

ALLHAT. Results of Monotherapy in ALLHAT: On-treatment Analyses. Outcomes for participants who received no step-up drugs. ALLHAT. Objective and Rationale. To compare major outcomes for pts remaining on blinded monotherapy.

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Results of Monotherapy in ALLHAT: On-treatment Analyses

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

  2. ALLHAT Objectiveand 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.

  3. ALLHAT 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

  4. ALLHAT 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

  5. ALLHAT Hypertension Trial 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=9,061 N=9,054 N=9,048 N=15,255 STEP 2 AND 3 AGENTS (5 years) Hydralazine 10.9% Clonidine 10.6% Atenolol 28.0% Reserpine 4.3%

  6. ALLHAT 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

  7. ALLHAT Percent Remaining on Step 1 Monotherapy at Subsequent Annual Visits n=number in year 1 cohort

  8. ALLHAT 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

  9. ALLHAT Baseline Characteristics *p<0.05; overall race distribution significantly different in lisinopril and doxazosin treatment groups compared to chlorthalidone group

  10. ALLHAT Baseline Characteristics *p<0.05

  11. ALLHAT Systolic Blood Pressure

  12. ALLHAT Improvement in SBP from Baseline

  13. ALLHAT Adjusted* Analyses for Major Cardiovascular Outcomes:Amlodipine vs. Chlorthalidone *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. ALLHAT Adjusted* Analyses for Major Cardiovascular Outcomes:Lisinopril vs. Chlorthalidone *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. ALLHAT Adjusted* Analyses for Major Cardiovascular Outcomes:Doxazosin vs. Chlorthalidone *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. ALLHAT Heart Failure in 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. ALLHAT Stroke in 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. ALLHAT Stroke in ALLHAT: Black Participants * † * * *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. ALLHAT 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.

  20. ALLHAT 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.

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

  22. Alternate Slides

  23. ALLHAT Heart Failure in ALLHAT * P < 0.05 †Time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol; also adjusted for baseline variables

  24. ALLHAT Stroke in ALLHAT * P < 0.05 †Time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol; also adjusted for baseline variables

  25. ALLHAT Stroke in ALLHAT: Black Participants * P < 0.05 †Time-dependent variables: SBP, DBP, on/off treatment, and serum potassium, creatinine, and cholesterol; also adjusted for baseline variables

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