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The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ALLHAT study overview Double-blind, randomized trial to determine whether.

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Presentation on theme: "The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ALLHAT study overview Double-blind, randomized trial to determine whether."— Presentation transcript:

1 The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ALLHAT study overview Double-blind, randomized trial to determine whether the occurrence of fatal CHD or nonfatal MI is lower for high-risk hypertensive patients treated with newer agents (amlodipine, lisinopril, or doxazosin) compared with a diuretic (chlorthalidone) Cohort 42,418 patients (55 years old) from 623 sites in North America –Stage 1 or 2 hypertension –1 additional risk factor for CHD Comparisons between chlorthalidone and amlodipine and chlorthalidone and lisinopril have been reported together, excluding the doxazosin arm (n=9,062), which was terminated early ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org CHD=coronary heart disease; MI=myocardial infarction

2 ALLHAT Study Design n=13,854 2,235 (16.1%) stopped drug Chlorthalidone n=15,255 Amlodipinen=9,048 Randomized n=42,418 n=15,255 339 (2.2%) lost to follow-up 80 (0.5%) refused follow-upn=9,048 200 (2.2%) lost to follow-up 58 (0.6%) refused follow-up n=6,210 n=6,210 1,873 (30.2%) stopped drug n=9,054 218 (2.4%) lost to follow-up 58 (0.6%) refused follow-up n=8,215 1,357 (16.5%) stopped drug n=3,769 n=3,769 1,052 (27.9%) stopped drug YEAR 1 n=8,158 1,842 (22.6%) stopped drug n=3,605 1,399 (38.8%) stopped drug Lisinopriln=9,054 YEAR 5 ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org Intent-to- Treat Analysis Doxazosin n=9,062 Discontinued early at 3.3 yrs

3 ALLHAT Endpoints Primary endpoint Composite of fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI) Other predefined endpoints –all-cause mortality –stroke –combined CHD – nonfatal MI, CHD death, coronary revascularization, hospitalized angina –combined cardiovascular disease – combined CHD, stroke, lower extremity revascularization, treated angina, fatal/ hospitalized/treated congestive heart failure, hospitalized or outpatient peripheral arterial disease –other – renal ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org

4 Chlorthalidone n=15,255 Amlodipine n=9,048 Lisinopril n=9,054 systolicdiastolicsystolicdiastolicsystolicdiastolic Mean BP (mmHg)146841468414684 Treated (90%)145831458314584 Untreated (10%)156891579015689 Mean age (yrs)67 Black (%)3536 Women (%)47 46 Current smoking (%)22 History of CHD (%)262425 Type 2 diabetes (%)363736 ALLHAT Baseline Characteristics ALLHAT Research Group. JAMA. 2002;288:2981-2997. www.hypertensiononline.org BP=blood pressure CHD=coronary heart disease

5 ALLHAT Mean Systolic and Diastolic Blood Pressure During Follow-up Systolic BP (mmHg) Follow-up, yrs 0123456 0123456 Diastolic BP (mmHg) Chlorthalidone Amlodipine Lisinopril Chlorthalidone Amlodipine Lisinopril ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association. www.hypertensiononline.org SBP=systolic blood pressure DBP=diastolic blood pressure Compared to chlorthalidone: DBP significantly lower in amlodipine group (~1 mmHg). Compared to chlorthalidone: SBP significantly higher in amlodipine (~1 mmHg) and lisinopril (~2 mmHg) groups.

6 ALLHAT BP Controlled to <140/90 mmHg LisinoprilAmlodipineChlorthalidone www.hypertensiononline.org † ALLHAT Research Group. JAMA. 2002;288:2981-2997. % Patients with BP <140/90 mmHg *P<0.001 for amlodipine vs chlorthalidone †P<0.001 for lisinopril vs chlorthalidone † † *†

7 ALLHAT Treatment and Blood Pressure Control 6 mos1 yr3 yr5 yr 1 Drug2 Drugs 3 Drugs Patients (%) Cushman WC, et al. J Clin Hypertens. 2002;4:393-405. www.hypertensiononline.org Average # of drugs Blood pressure controlled <140/90 mmHg 49.8%55.2%62.3%65.6% 1.4 1.7 2.0 1.3

8 ALLHAT Primary Outcome by Treatment Group Cumulative Fatal CHD and Nonfatal MI event rate (%) Time to event, yrs 0123456 15255 9048 9054 7 No. at Risk Chlorthalidone Amlodipine Lisinopril 14477 8576 8535 13820 8218 8123 13102 7843 7711 11362 6824 6662 6340 3870 3832 2956 1878 1770 209 215 195 Chlorthalidone Amlodipine Lisinopril www.hypertensiononline.org ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

9 Relative Risk (95% CI) Relative Risk (95% CI) TOTAL 0.98 (0.90-1.07) 0.99 (0.91-1.08) Age <65 0.99 (0.85-1.16) 0.95 (0.81-1.12) Age 65 0.97 (0.88-1.08) 1.01 (0.91-1.12) Men 0.98 (0.87-1.09) 0.94 (0.85-1.05) Women 0.99 (0.85-1.15) 1.06 (0.92-1.23) Black 1.01 (0.86-1.18) 1.10 (0.94-1.28) Nonblack 0.97 (0.87-1.08) 0.94 (0.85-1.05) Diabetic 0.99 (0.87-1.13) 1.00 (0.87-1.14) Nondiabetic 0.97 (0.86-1.09) 0.99 (0.88-1.11) 0.512 12 ALLHAT CHD Death and Nonfatal MI www.hypertensiononline.org Favors lisinopril Favors chlorthalidone Favors amlodipine Favors chlorthalidone ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

10 Relative Risk (95% CI) Relative Risk (95% CI) TOTAL 0.96 (0.89-1.02) 1.00 (0.94-1.08) Age <65 0.96 (0.83-1.10) 0.93 (0.81-1.08) Age 65 0.96 (0.88-1.03) 1.03 (0.95-1.12) Men 0.95 (0.87-1.04) 0.99 (0.91-1.08) Women 0.96 (0.86-1.07) 1.02 (0.91-1.13) Black 0.97 (0.87-1.09) 1.06 (0.95-1.18) Nonblack 0.94 (0.87-1.03) 0.97 (0.89-1.06) Diabetic 0.96 (0.87-1.07) 1.02 (0.91-1.13) Nondiabetic 0.95 (0.87-1.04) 1.00 (0.91-1.09) 0.512 2 ALLHAT All-Cause Mortality www.hypertensiononline.org Favors lisinopril Favors chlorthalidone Favors amlodipine Favors chlorthalidone 1 ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

11 Relative Risk (95% CI) Relative Risk (95% CI) TOTAL 1.04 (0.99-1.09) 1.10 (1.05-1.16) Age <65 1.03 (0.94-1.12) 1.05 (0.97-1.15) Age 65 1.05 (0.99-1.12) 1.13 (1.06-1.20) Men 1.04 (0.98-1.11) 1.08 (1.02-1.15) Women 1.04 (0.96-1.13) 1.12 (1.03-1.21) Black 1.06 (0.96-1.16) 1.19 (1.09-1.30) Nonblack 1.04 (0.97-1.10) 1.06 (1.00-1.13) Diabetic 1.06 (0.98-1.15) 1.08 (1.00-1.17) Nondiabetic 1.02 (0.96-1.09) 1.12 (1.05-1.19) 0.52 2 ALLHAT Combined CV Disease www.hypertensiononline.org Favors amlodipine Favors chlorthalidone Favors lisinopril Favors chlorthalidone 11 ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

12 ALLHAT Stroke by Treatment Group 0123456 15255 9048 9054 7 No. at Risk Chlorthalidone Amlodipine Lisinopril 14515 8617 8543 13934 8271 8172 13309 7949 7784 11570 6937 6765 6385 3845 3891 3217 1813 1828 567 506 949 Cumulative event rate (%) Chlorthalidone Amlodipine Lisinopril Time to event, yrs www.hypertensiononline.org ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

13 Relative Risk (95% CI) Relative Risk (95% CI) TOTAL 0.93 (0.82-1.06) 1.15 (1.02-1.30) Age <65 0.93 (0.73-1.19) 1.21 (0.97-1.52) Age 65 0.93 (0.81-1.08) 1.13 (0.98-1.30) Men 1.00 (0.85-1.18) 1.10 (0.94-1.29) Women 0.84 (0.69-1.03) 1.22 (1.01-1.46) Black 0.93 (0.76-1.14) 1.40 (1.17-1.68) Nonblack 0.93 (0.79-1.10) 1.00 (0.85-1.17) Diabetic 0.90 (0.75-1.08) 1.07 (0.90-1.28) Nondiabetic 0.96 (0.81-1.14) 1.23 (1.05-1.44) 0.512 2 ALLHAT Stroke www.hypertensiononline.org Favors amlodipine Favors chlorthalidone Favors lisinopril Favors chlorthalidone 1 ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

14 ALLHAT Heart Failure by Treatment Group 0123456 15255 9048 9054 7 No. at Risk Chlorthalidone Amlodipine Lisinopril 14528 8535 8496 13898 8185 8096 13224 7801 7689 11511 6785 6698 6369 3775 3789 3016 1780 1837 384 210 313 Cumulative event rate (%) Chlorthalidone Amlodipine Lisinopril Time to event, yrs www.hypertensiononline.org P<0.001 for chlorthalidone vs amlodipine and chlorthalidone vs lisinopril ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

15 Relative Risk (95% CI) Relative Risk (95% CI) TOTAL 1.38 (1.25-1.52) 1.20 (1.09-1.34) Age <65 1.51 (1.25-1.82) 1.23 (1.01-1.50) Age 65 1.33 (1.18-1.49) 1.20 (1.06-1.35) Men 1.41 (1.24-1.61) 1.19 (1.03-1.36) Women 1.33 (1.14-1.55) 1.23 (1.05-1.43) Black 1.47 (1.24-1.74) 1.32 (1.11-1.58) Nonblack 1.33 (1.18-1.51) 1.15 (1.01-1.30) Diabetic 1.42 (1.23-1.64) 1.22 (1.05-1.42) Nondiabetic 1.33 (1.16-1.52) 1.20 (1.04-1.38) 0.52 2 ALLHAT Heart Failure www.hypertensiononline.org Favors amlodipine Favors chlorthalidone Favors lisinopril Favors chlorthalidone 11 ALLHAT Research Group. JAMA. 2002;288:2981-2997. Copyright ©2002, American Medical Association.

16 ALLHAT Conclusions Better control of systolic BP was achieved with chlorthalidone than with amlodipine or lisinopril There were no differences in risk for CHD death/nonfatal MI between chlorthalidone and amlodipine or lisinopril In secondary endpoints, chlorthalidone was associated with lower risk for –stroke, combined CVD, and HF compared with lisinopril –HF compared with amlodipine MI=myocardial infarction CHD=coronary heart disease HF=heart failure www.hypertensiononline.org ALLHAT Research Group. JAMA. 2002;288:2981-2997.

17 ALLHAT Implications Unless contraindicated, or unless specific indications are present that would favor use of another drug class, diuretics should be the initial drug of choice in antihypertensive regimens Only 30 percent of patients achieve both systolic BP <140 mmHg and diastolic BP <90 mmHg on monotherapy Many high-risk hypertensive patients will require 2 or more drugs for BP control www.hypertensiononline.org ALLHAT Research Group. JAMA. 2002;288:2981-2997.

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