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Review of the Design and Initial Findings for Pre-specified Outcomes and Subgroups

ALLHAT. ALLHAT Revisited How have the Initial Findings Held Up Five Years Later?. Review of the Design and Initial Findings for Pre-specified Outcomes and Subgroups. Paul K. Whelton, M.D., M.Sc. Loyola University Medical Center Maywood, Illinois, U.S.A. ALLHAT.

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Review of the Design and Initial Findings for Pre-specified Outcomes and Subgroups

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  1. ALLHAT ALLHAT Revisited How have the Initial Findings Held Up Five Years Later? Review of the Design and Initial Findings for Pre-specified Outcomes and Subgroups Paul K. Whelton, M.D., M.Sc. Loyola University Medical Center Maywood, Illinois, U.S.A.

  2. ALLHAT Predefined Subgroups -Age (<65 y; 65+y) -Gender -Race (Black; Non-Black) -Diabetes (Diabetic; Non-Diabetic) BP Trial Primary End Points: -Fatal CHD & Non-Fatal MI BP Trial Secondary End Points: -All-cause mortality -Stroke -Combined CHD –Fatal CHD, non-fatal MI, coronary revascularization, hospitalized angina -Combined CVD – combined CHD, stroke, lower extremity revascularization, treated angina, fatal / hospitalized / treated heart failure (HF), hospitalized or outpatient peripheral arterial disease (PAD) -Other – renal (reciprocal serum creatinine, ESRD, estimated GFR) and cancer

  3. The Antihypertensive and Lipid-LoweringTreatment to Prevent Heart Attack Trial Island ofNew Foundland Quebec Prince EdwardIsland CANADA CANADA New Brunswick Quebec Washington Nova Scotia Maine Ontario Minnesota Montana North Dakota Michigan Oregon NH VT Wisconsin Idaho New York MA South Dakota CT Michigan Wyoming RI Iowa Pennsylvania Nebraska NJ Nevada MD DE Ohio Utah Illinois Indiana WV Kansas California Virginia Colorado Missouri Kentucky N. Carolina Oklahoma Arizona Tennessee Arkansas S. Carolina New Mexico MEXICO Texas Georgia Alabama (Area Enlarged) Louisiana St. Croix, Virgin Islands Mississippi Florida Puerto Rico(Area Enlarged) MEXICO 33 -Primary sponsor: NIH-NHLBI -Concurrent support from the VA -Assistance from pharmaceutical companies but no role in scientific conduct of trial -623 Clinical Centers -USA, Canada, Caribbean -Diverse practice settings Program Office, NHLBI CTC, UT

  4. ALLHAT Baseline Characteristics(33, 357 Participants)

  5. ALLHAT Treatment Regimen Doses were escalated in an attempt to achieve a BP <140/80 mm Hg

  6. Percent Taking Blinded Study Drug or Drug from Same Class ALLHAT Lisinopril Amlodipine Chlorthalidone

  7. ALLHAT Mean Systolic and Diastolic BP,by Treatment Group 150 Systolic BP 145 140 Amlodipine 135 Lisinopril ~ ~ mm Hg 90 Chlorthalidone Diastolic BP 85 80 Lisinopril 75 Chlorthalidone Amlodipine 70 Months of Follow-up

  8. ALLHAT Biochemical ResultsSr. Cholesterol & Potassium * p<.05 compared to chlorthalidone † Ann Intern Med. 1999;130:461-470 JAMA 2002;288:2981-97

  9. ALLHAT Biochemical ResultsFasting Glucose *p<.05 compared to chlorthalidone JAMA 2002;288:2981-97

  10. ALLHAT 0.50 1 2 0.50 1 2 Lisinopril Chlorthalidone BetterBetter AmlodipineChlorthalidone BetterBetter Summary of Outcomes Relative Risks (95% CI) JAMA 2002;288:2981-97

  11. ALLHAT Total 1.15 (1.02, 1.30) Total 0.93 (0.82, 1.06) Age < 65 1.21 (0.97, 1.52) Age < 65 0.93 (0.73, 1.19) Age >= 65 1.13 (0.98, 1.30) Age >= 65 0.93 (0.81, 1.08) Men 1.10 (0.94, 1.29) Men 1.00 (0.85, 1.18) Women 1.22 (1.01, 1.46) Women 0.84 (0.69, 1.03) Black 1.40 (1.17, 1.68) Black 0.93 (0.76, 1.14) Non-Black 1.00 (0.85, 1.17) Non-Black 0.93 (0.79, 1.10) Diabetic 1.07 (0.90, 1.28) Diabetic 0.90 (0.75, 1.08) Non-Diabetic 1.23 (1.05, 1.44) Non-Diabetic 0.96 (0.81, 1.14) 0.50 1 2 0.50 1 2 Lisinopril Chlorthalidone BetterBetter Amlodipine Chlorthalidone BetterBetter Stroke, by Treatment Group. RR (95% CI) in Predefined Subgroups Amlodipine/Chlorthalidone Lisinopril/Chlorthalidone P = .01 for interaction

  12. ALLHAT BP Trial Design and Initial Findings Summary • 5 y efficacy trial of antihypertensive drug regimens in 42,418 participants. Regimens designed to be similar except for double blinded treatment with • chlorthalidone (C), amlodipine (A), lisinopril (L) or doxazosin • Doxazosin comparison stopped prematurely due to difference in CVD events • Baseline characteristics similar in 33,357 C, A and L participants • Strong representation of important subgroups • Excellent adherence to assigned study drugs • The three regimens differed slightly but significantly in BP control, Sr. Cholesterol, Sr. Potassium and fasting blood sugar • No difference in the primary outcome for C vs. A or C vs. L • C was better than A for HF • C was better than L for stroke, combined CVD events and HF. There was a significant C vs. L treatment X race interaction for the stroke outcome. • The ALLHAT findings suggest thiazide-type diuretics are the preferred first-step antihypertensive drug therapy unless there is a contraindication to their use

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