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ALLHAT 6/5/2006 - 1 CARDIOVASCULAR DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED BY BASELINE GLOMERULAR FILTRATION RATE (3 GROUPS by GFR)

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Presentation on theme: "ALLHAT 6/5/2006 - 1 CARDIOVASCULAR DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED BY BASELINE GLOMERULAR FILTRATION RATE (3 GROUPS by GFR)"— Presentation transcript:

1 ALLHAT 6/5/2006 - 1 CARDIOVASCULAR DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED BY BASELINE GLOMERULAR FILTRATION RATE (3 GROUPS by GFR)

2 ALLHAT 6/5/2006 - 2 Introduction Over 13 million Americans are estimated to have chronic kidney disease (CKD) Patients with CKD are at very high risk for cardiovascular disease (CVD) There are limited data about the comparative effects of antihypertensive therapy on CVD outcomes in CKD patients Since risk of CVD is much higher than risk for ESRD in CKD patients, choices of therapy need to be guided by effects on CVD outcomes 17.7% (n=7116) of ALLHAT participants had an estimated GFR <60 ml/min/1.73m 2 at baseline

3 ALLHAT 6/5/2006 - 3 Other Studies Many trials that studied patients with CKD do not have adequate assessment / reporting or power to evaluate CV events –HOPE demonstrated increased CV risk in patients with renal insufficiency and that ramipril reduced risk in this subgroup compared to placebo –IDNT and RENAAL showed similar CV event rates with ARB vs CCB (IDNT) and placebo (RENAAL), except hospitalization for first heart failure in RENAAL was lower with the ARB –AASK (beta blocker, ACE, CCB) showed no difference in CV event rates

4 4 *Estimated (eGFR) (ml/min/1.73 m 2 ) calculated by simplified MDRD equation (Levey et al., J Am Soc Nephrol 11, A 0828. 2000.) **p<.05 compared with normal GFR NOTE: Within each GFR stratum, there was no significant difference in these characteristics between patients assigned to amlodipine or lisinopril compared with patients assigned to chlorthalidone. Normal GFR (  90) Mild  GFR (60-89) Moderate or severe  GFR (<60) N8,12618,1095,662 Mean age, y63.367.3**70.7** Black non-Hisp, %43.127.7**25.5** Women, %46.644.5**52.3** Mean SBP146 147** Mean DBP8584**83** Type 2 diabetes, %45.232.8**33.4** History of CHD**, %21.226.3**30.5** Baseline Characteristics Stratified By Estimated GFR* ALLHAT

5 6/5/2006 - 5 Relative Risk of Combined CVD by Baseline GFR Group (Adjusted for Age, Race, Gender, BMI, SBP, DBP, HDL- cholesterol, LDL-cholesterol, fasting triglycerides, history of diabetes, and cigarette smoking) Estimated (eGFR) (ml/min/1.73 m 2 ) calculated by simplified MDRD equation * P <0.001 vs. GFR90+ * *

6 ALLHAT 6/5/2006 - 6 Blood Pressure at 4 Years by Treatment Group and Baseline GFR GFRChlorAmlodLisin SBP - mean (sd,N)  90 133.4 (15.2, 2276)134.6 (14.4, 1462)*135.6 (17.3, 1301)* 60-89133.6 (15.5, 5310)134.5 (14.6, 3127)*135.2 (16.9, 3024)* <60135.5 (17.1, 1511)135.9 (17.0, 869)136.4 (18.2, 813) DBP - mean (sd,N)  90 76.8 (9.5, 2276)76.4 (9.0, 1462)77.6 (10.1, 1301)* 60-8976.5 (9.6, 5308)75.8 (9.6, 3127)*76.3 (10.2, 3024) <6075.6 (9.9, 1511)74.2 (9.8, 869)*75.7 (11.2, 813) * p<0.05 compared with chlorthalidone

7 ALLHAT 6/5/2006 - 7 Evaluating Treatment Effects by Subgroup Significant Test for Treatment x Subgroup Interaction? YesNo Significant treatment difference within 1 or more subgroups? YesInteractionNo interaction NoInteractionNo interaction Interaction – Use subgroup estimates of treatment effects No interaction – Use estimate of treatment effect in total population

8 ALLHAT 6/5/2006 - 8 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 8.7 (0.6) 252 / 3648 7.6 (0.7) 141 / 2274 0.90 (0.73 - 1.10) 0.29 GFR 60-8910.9 (0.4) 740 / 8360 10.9 (0.6) 427 / 4850 0.98 (0.87 – 1.10) 0.72 GFR <6015.2 (0.9) 318 / 2613 16.0 (1.2) 194 / 1516 1.06 (0.89 – 1.27) 0.50 Total11.5 (0.3) 1362 / 15,255 11.3 (0.4) 798 / 9048 0.98 (0.91 – 1.08) 0.81 Differences among treatment group effects by baseline GFR group are not statistically significant. CHD (Nonfatal MI & Fatal CHD) by Baseline GFR & Treatment – Amlodipine vs Chlorthalidone ALLHAT

9 6/5/2006 - 9 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 8.7 (0.6) 252 / 3648 9.0 (0.8) 157 / 2204 1.04 (0.86 – 1.27) 0.67 GFR 60-8910.9 (0.4) 740 / 8360 10.6 (0.6) 421 / 4899 0.97 (0.86 – 1.09) 0.59 GFR <6015.2 (0.9) 318 / 2613 15.1 (1.1) 184 / 1533 1.00 (0.84 – 1.20) 0.97 Total11.5 (0.3) 1362 / 15,255 11.4 (0.4) 796 / 9054 0.99 (0.91 – 1.08) 0.81 Differences among treatment group effects by baseline GFR group are not statistically significant. CHD (Nonfatal MI & Fatal CHD) by Baseline GFR & Treatment – Lisinopril vs Chlorthalidone ALLHAT

10 6/5/2006 - 10 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 10.0 (0.9) 133 / 1667 9.2 (1.2) 72 / 1026 0.88 (0.66 – 1.18) 0.40 GFR 60-8913.9 (0.8) 304 / 2755 14.4 (1.1) 184 / 1626 1.01 (0.84 – 1.21) 0.96 GFR <6019.3 (1.7) 132 / 881 21.1 (2.4) 83 / 506 1.07 (0.81 – 1.41) 0.63 Total13.5 (0.6) 592 / 5528 13.8 (0.8) 358 / 3323 0.99 (0.87 – 1.13) 0.93 Differences among treatment group effects by baseline GFR group are not statistically significant. CHD (Nonfatal MI & Fatal CHD) by Baseline GFR & Treatment in Diabetic Participants – Amlodipine vs Chlorthalidone ALLHAT

11 6/5/2006 - 11 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 10.0 (0.9) 133 / 1667 9.7 (1.1) 79 / 981 1.02 (0.77 – 1.35) 0.87 GFR 60-8913.9 (0.8) 304 / 2755 13.2 (1.1) 167 / 1563 0.98 (0.81 – 1.18) 0.81 GFR <6019.3 (1.7) 132 / 881 18.3 (2.0) 76 / 501 1.03 (0.78 – 1.37) 0.83 Total13.5 (0.6) 592 / 5528 12.8 (0.7) 339 / 3212 1.00 (0.87 – 1.14( 0.97 Differences among treatment group effects by baseline GFR group are not statistically significant. CHD (Nonfatal MI & Fatal CHD) by Baseline GFR & Treatment in Diabetic Participants – Lisinopril vs Chlorthalidone ALLHAT

12 6/5/2006 - 12 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 25.6 (0.9) 803 / 3648 25.3 (1.1) 487 / 2274 0.97 (0.86 – 1.08) 0.56 GFR 60-8929.6 (0.6) 2125 / 8360 31.2 (0.8) 1312 / 4850 1.06 (0.99 – 1.14) 0.08 GFR <6038.7 (1.2) 870 / 2613 41.1 (1.5) 537 / 1516 1.08 (0.97 – 1.20) 0.18 Total30.9 (0.5) 3941 / 15,255 32.0 (0.6) 2432 / 9048 1.04 (0.99 – 1.09) 0.12 Combined CVD = CHD death, nonfatal MI, stroke, coronary revascularization procedures, hospitalized or treated angina, treated or hospitalized HF, and peripheral arterial disease (hospitalized, or outpatient revascularization) Differences among treatment group effects by baseline GFR group are not statistically significant. Combined CVD by Baseline GFR & Treatment - Amlodipine vs Chlorthalidone ALLHAT

13 6/5/2006 - 13 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 25.6 (0.9) 803 / 3648 29.1 (1.2) 526 / 2204 1.11 (0.99 – 1.24) 0.06 GFR 60-8929.6 (0.6) 2125 / 8360 31.3 (0.8) 1330 / 4899 1.09 (1.02 – 1.17) 0.02 GFR <6038.7 (1.2) 870 / 2613 41.3 (1.5) 547 / 1533 1.12 (1.01 – 1.25) 0.04 Total30.9 (0.5) 3941 / 15,255 33.3 (0.6) 2514 / 9054 1.10 (1.05 – 1.16) <0.001 Combined CVD = CHD death, nonfatal MI, stroke, coronary revascularization procedures, hospitalized or treated angina, treated or hospitalized HF, and peripheral arterial disease (hospitalized, or outpatient revascularization) Differences among treatment group effects by baseline GFR group are not statistically significant. Combined CVD by Baseline GFR & Treatment – Lisinopril vs Chlorthalidone ALLHAT

14 6/5/2006 - 14 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 27.9 (1.3) 402 / 1667 30.4 (1.8) 256 / 1026 1.04 (0.89 – 1.22) 0.61 GFR 60-8934.3 (1.1) 814 / 2755 35.2 (1.4) 499 / 1626 1.03 (0.92 – 1.15) 0.62 GFR <6043.1 (2.0) 326 / 881 50.4 (2.7) 224 / 506 1.20 (1.01 – 1.42) 0.04 Total33.9 (0.8) 1609 / 5528 36.2 (1.0) 1030 / 3323 1.06 (0.98 – 1.15) 0.12 Combined CVD = CHD death, nonfatal MI, stroke, coronary revascularization procedures, hospitalized or treated angina, treated or hospitalized HF, and peripheral arterial disease (hospitalized, or outpatient revascularization) Differences among treatment group effects by baseline GFR group are not statistically significant. Combined CVD by Baseline GFR & Treatment in Diabetic Participants - Amlodipine vs Chlorthalidone ALLHAT

15 6/5/2006 - 15 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 27.9 (1.3) 402 / 1667 31.4 (1.8) 257 / 981 1.12 (0.95 – 1.31) 0.17 GFR 60-8934.3 (1.1) 814 / 2755 35.0 (1.4) 482 / 1563 1.07 (0.96 – 1.20) 0.24 GFR <6043.1 (2.0) 326 / 881 44.2 (2.5) 193 / 501 1.08 (0.90 – 1.29) 0.40 Total33.9 (0.8) 1609 / 5528 35.5 (1.0) 985 / 3212 1.08 (1.00 – 1.17) 0.049 Combined CVD = CHD death, nonfatal MI, stroke, coronary revascularization procedures, hospitalized or treated angina, treated or hospitalized HF, and peripheral arterial disease (hospitalized, or outpatient revascularization) Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Combined CVD by Baseline GFR & Treatment in Diabetic Participants - Lisinopril vs Chlorthalidone

16 ALLHAT 6/5/2006 - 16 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 4.0 (0.4) 118 / 3648 3.5 (0.5) 70 / 2274 0.95 (0.70 – 1.27) 0.71 GFR 60-895.2 (0.3) 366 / 8360 4.7 (0.4) 185 / 4850 0.85 (0.71 – 1.02) 0.08 GFR <607.6 (0.6) 157 / 2613 8.8 (1.0) 100 / 1516 1.12 (0.87 – 1.44) 0.38 Total5.6 (0.2) 675 / 15,255 5.4 (0.3) 377 / 9048 0.93 (0.82 – 1.06) 0.28 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Stroke by Baseline GFR & Treatment - Amlodipine vs Chlorthalidone

17 ALLHAT 6/5/2006 - 17 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 4.0 (0.4) 118 / 3648 5.7 (0.6) 101 / 2204 1.43 (1.10 – 1.87) 0.01 GFR 60-895.2 (0.3) 366 / 8360 5.9 (0.4) 239 / 4899 1.12 (0.95 – 1.31) 0.19 GFR <607.6 (0.6) 157 / 2613 7.9 (0.8) 99 / 1533 1.10 (0.86 – 1.42) 0.45 Total5.6 (0.2) 675 / 15,255 6.3 (0.3) 457 / 9054 1.15 (1.02 – 1.30) 0.02 Differences among treatment group effects by baseline GFR group are not statistically significant. Stroke by Baseline GFR & Treatment – Lisinopril vs Chlorthalidone ALLHAT

18 6/5/2006 - 18 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 4.4 (0.6) 55 / 1667 3.9 (0.8) 33 / 1026 0.98 (0.63 – 1.50) 0.92 GFR 60-897.7 (0.6) 176 / 2755 6.4 (0.7) 83 / 1626 0.77 (0.59 – 1.00) 0.05 GFR <608.7 (1.1) 63 / 881 10.9 (1.7) 42 / 506 1.17 (0.79 – 1.72) 0.44 Total7.1 (0.4) 314 / 5528 6.6 (0.5) 172 / 3323 0.90 (0.75 – 1.08) 0.26 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Stroke by Baseline GFR & Treatment in Diabetic Participants - Amlodipine vs Chlorthalidone

19 ALLHAT 6/5/2006 - 19 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 4.4 (0.6) 55 / 1667 7.0 (1.1) 53 / 981 1.66 (1.14 – 2.43) 0.01 GFR 60-897.7 (0.6) 176 / 2755 7.8 (0.8) 99 / 1563 1.00 (0.78 – 1.28) 1.00 GFR <608.7 (1.1) 63 / 881 8.3 (1.5) 33 / 501 0.94 (0.62 – 1.43) 0.78 Total7.1 (0.4) 314 / 5528 7.6 (0.6) 193 / 3212 1.07 (0.90 – 1.28) 0.45 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Stroke by Baseline GFR & Treatment in Diabetic Participants - Lisinopril vs Chlorthalidone

20 ALLHAT 6/5/2006 - 20 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 5.1 (0.5) 147 / 3648 6.4 (0.6) 121 / 2274 1.34 (1.02 – 1.71) 0.02 GFR 60-896.7 (0.4) 435 / 8360 9.8 (0.5) 380 / 4850 1.55 (1.34 – 1.79) <0.001 GFR <6013.1 (0.9) 259 / 2613 15.0 (1.2) 174 / 1516 1.18 (0.96 – 1.44) 0.11 Total7.7 (0.3) 870 / 15,255 10.2 (0.4) 706 / 9048 1.40 (1.26 – 1.55) <0.001 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Heart Failure by Baseline GFR & Treatment - Amlodipine vs Chlorthalidone

21 ALLHAT 6/5/2006 - 21 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 5.1 (0.5) 147 / 3648 6.1 (0.6) 110 / 2204 1.25 (0.97 – 1.61) 0.08 GFR 60-896.7 (0.4) 435 / 8360 6.9 (0.4) 278 / 4899 1.10 (0.94 – 1.28) 0.25 GFR <6013.1 (0.9) 259 / 2613 15.8 (1.1) 191 / 1533 1.29 (1.06 – 1.58) 0.01 Total7.7 (0.3) 870 / 15,255 8.7 (0.4) 612 / 9054 1.20 (1.08 – 1.33) 0.001 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Heart Failure by Baseline GFR & Treatment - Lisinopril vs Chlorthalidone

22 ALLHAT 6/5/2006 - 22 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneAmlodipine GFR  90 6.5 (0.8) 87 / 1667 8.0 (1.1) 65 / 1026 1.23 (0.88 – 1.71) 0.22 GFR 60-899.9 (0.7) 203 / 2755 13.4 (1.0) 177 / 1626 1.54 (1.24 – 1.90) <0.001 GFR <6015.6 (1.6) 104 / 881 22.0 (2.4) 87 / 506 1.55 (1.14 – 2.11) 0.005 Total9.7 (0.5) 410 / 5528 13.1 (0.7) 347 / 3323 1.46 (1.25 – 1.69) <0.001 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Heart Failure by Baseline GFR & Treatment in Diabetic Participants - Amlodipine vs Chlorthalidone

23 ALLHAT 6/5/2006 - 23 6-year rates per 100 (se) & total events / N Relative Risk (A/C) (95% CI) p value ChlorthalidoneLisinopril GFR  90 6.5 (0.8) 87 / 1667 8.1 (1.0) 68 / 981 1.35 (0.97 – 1.88) 0.07 GFR 60-899.9 (0.7) 203 / 2755 9.1 (0.9) 119 / 1563 1.04 (0.82 – 1.31) 0.77 GFR <6015.6 (1.6) 104 / 881 20.5 (2.2) 81 / 501 1.44 (1.05 – 1.97) 0.02 Total9.7 (0.5) 410 / 5528 10.9 (0.7) 284 / 3212 1.21 (1.03 – 1.42) 0.02 Differences among treatment group effects by baseline GFR group are not statistically significant. ALLHAT Heart Failure by Baseline GFR & Treatment in Diabetic Participants - Lisinopril vs Chlorthalidone

24 ALLHAT 6/5/2006 - 24 Discussion ALLHAT confirms increased risk for CVD in patients with reduced GFR. The overall study results of no difference in the primary outcome for the lisinopril vs. chlorthalidone and amlodipine vs. chlorthalidone comparisons was consistent across diabetes, GFR, and diabetes-GFR subgroups. ALLHAT

25 6/5/2006 - 25 Conclusion Amlodipine and lisinopril are not superior to chlorthalidone in preventing fatal CHD/non fatal MI Chlorthalidone and amlodipine are similar but chlorthalidone is superior to lisinopril in reducing combined CVD events independent of level of renal function. ALLHAT In high risk hypertensive patients with impaired renal function:

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