ALLHAT RENAL DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED INTO 4 GROUPS BY BASELINE GLOMERULAR FILTRATION RATE (GFR)
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1 1 RENAL DISEASE OUTCOMES IN HYPERTENSIVE PATIENTS STRATIFIED INTO 4 GROUPS BY BASELINE GLOMERULAR FILTRATION RATE (GFR) 6 / 5 /
2 2 Introduction Hypertension is the second most common cause of end-stage renal disease (ESRD) in the US Hypertension is a key factor contributing to progression of chronic kidney disease Successful treatment of hypertension is important in slowing down progression of renal disease 6 / 5 /
3 3 Background In diabetic (DM) and nondiabetic (NDM) hypertensive patients with established chronic renal insufficiency and proteinuria, inhibition of the renin angiotensin axis is suggested to be superior to conventional therapy in slowing decline in renal function Few studies directly compared effects of different classes of antihypertensive drug therapy on decline in renal function in hypertensive patients with mild reduction in glomerular filtration rate (GFR). 6 / 5 /
4 4 Overall Results Renal Outcomes In the study population as a whole, no difference was noted in the risk of ESRD with chlorthalidone compared to amlodipine and lisinopril Estimated GFR was higher at the end of the study in patients randomized to amlodipine compared to chlorthalidone. 6 / 5 /
5 5 Objective Post-hoc analysis of the study to determine whether treatment with a calcium channel blocker or an ACE inhibitor, each versus a diuretic, lowers incidence of renal outcomes in high risk hypertensive patients stratified by baseline GFR. 6 / 5 /
6 6 Baseline Characteristics Stratified By Estimated GFR* Normal GFR ( 90) Mild GFR (60-89) Moderate GFR (30-59) Severe GFR (<30) N 8,126 18,109 5, Mean age, y ** 70.7** 70.3** Black non-hisp, % ** 24.9** 42.9 Women, % ** 52.1** 58.8** Mean SBP ** 150.0** Mean DBP ** 84.1** 83.7 Type 2 diabetes, % ** 33.1** 41.8 History of CHD***, % ** 30.6** 28.0** *Estimated (egfr) (ml/min/1.73 m 2 ) calculated by simplified MDRD equation (Levey et al., J Am Soc Nephrol 11, A ) ** p<.05 compared with normal GFR ***p<0.022, amlodipine (28%) vs. chlorthalidone (31%) in participants with GFR / 5 /
7 7 egfr during the course of the study (Baseline egfr 90) * * * * * 70 Baseline (n=8126) 1 Year (n=5282) 2 Year (n=5188) 4 Year (n=4409) Chlorthalidone Amlodipine Lisinopril * p<0.05 vs. Chlorthalidone Estimated GFR (egfr) calculated from the simplified MDRD equation 6 / 5 /
8 8 egfr During the Course of the Study (Baseline egfr 60-89) * * * Baseline (n=18109) 1 Year (n=12264) 2 Year (n=12011) 4 Year (n=10262) Chlorthalidone Amlodipine Lisinopril * p<0.05 vs. Chlorthalidone Estimated GFR (egfr) calculated from the simplified MDRD equation 6 / 5 /
9 9 egfr During the Course of the Study (Baseline egfr 30-59) * * * 45.0 Baseline (n=5480) 1 Year (n=3498) 2 Year (n=3350) 4 Year (n=2679) Chlorthalidone Amlodipine Lisinopril * p<0.05 vs. Chlorthalidone Estimated GFR (egfr) calculated from the simplified MDRD equation 6 / 5 /
10 10 egfr During the Course of the Study (Baseline egfr <30) Baseline (n=182) 1 Year (n=85) 2 Year (n=71) 4 Year (n=39) Chlorthalidone Amlodipine Lisinopril Estimated GFR (egfr) calculated from the simplified MDRD equation 6 / 5 /
11 Evaluating Treatment Effects by Subgroup Significant treatment difference within 1 or more subgroups? Significant Test for Treatment x Subgroup Interaction? Yes No Yes Interaction No interaction No Interaction No interaction Interaction Use subgroup estimates of treatment effects No interaction Use estimate of treatment effect in total population
12 12 End Stage Renal Disease by Baseline Diabetes & Treatment Amlodipine vs Chlorthalidone Diabetic participants Nondiabetic participants 6-year rates per 100 (se) & total events / N Chlorthalidone 2.7 (0.3) 109 / 5, (0.2) 84 / 9,727 Total 1.8 (0.1) 193 / 15,255 Amlodipine 3.6 (0.4) 86 / 3, (0.1) 43 / 5, (0.2) 129 / 9,048 Relative Risk (A/C) (95% CI) p value 1.30 ( ) p = ( ) p = ( ) P = 0.33 Differences among treatment group effects by baseline history of diabetes are not statistically significant. 6 / 5 /
13 13 End Stage Renal Disease by Baseline GFR & Treatment Amlodipine vs Chlorthalidone 6-year rates per 100 (se) & total events / N Chlorthalidone GFR (0.10) 11 / 3648 Amlodipine 0.60 (0.22) 9 / 2274 Relative Risk (A/C) (95% CI) p value 1.31 ( ) p = 0.54 GFR (0.14) 47 / 8360 GFR (0.56) 91 / 2530 GFR < (7.15) 33 / (0.21) 41 / (0.74) 52 / (7.68) 13 / ( ) p = ( ) p = ( ) p = 0.23 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
14 14 End Stage Renal Disease by Baseline GFR & Treatment Amlodipine vs Chlorthalidone Diabetic Participants 6-year rates per 100 (se) & total events / N Chlorthalidone GFR (0.21) 8 / 1,667 GFR (0.30) 26 / 2,755 GFR (1.18) 49 / 848 GFR < (9.76) 19 / 33 Amlodipine 0.76 (0.39) 5 / 1, (0.54) 27 / 1, (1.83) 37 / (11.44) 7 / 20 Relative Risk (A/C) (95% CI) p value 1.03 ( ) p = ( ) p = ( ) p = ( ) p = 0.06 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
15 15 End Stage Renal Disease by Baseline Diabetes & Treatment Lisinopril vs Chlorthalidone Diabetic participants Nondiabetic participants 6-year rates per 100 (se) & total events / N Chlorthalidone 2.7 (0.3) 109 / 5, (0.2) 84 / 9,727 Total 1.8 (0.1) 193 / 15,255 Lisinopril 3.3 (0.4) 73 / 3, (0.2) 53 / 5, (0.2) 126 / 9,054 Relative Risk (95% CI) p value 1.17 ( ) p = ( ) p = ( ) P = 0.38 Differences among treatment group effects by baseline history of diabetes are not statistically significant. 6 / 5 /
16 16 End Stage Renal Disease by Baseline GFR & Treatment Lisinopril vs Chlorthalidone 6-year rates per 100 (se) & total events / N Chlorthalidone GFR (0.10) 11 / 3,648 GFR (0.14) 47 / 8,360 GFR (0.56) 91 / 2,530 GFR < (7.15) 33 / 83 Lisinopril 0.40 (0.15) 7 / 2, (0.18) 37 / 4, (0.73) 55 / 1, (7.59) 15 / 54 Relative Risk (95% CI) p value 1.08 ( ) p = ( ) p = ( ) p = ( ) p = 0.23 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
17 17 End Stage Renal Disease by Baseline GFR & Treatment Lisinopril vs Chlorthalidone Diabetic Participants 6-year rates per 100 (se) & total events / N Chlorthalidone GFR (0.21) 8 / 1,667 GFR (0.30) 26 / 2,755 GFR (1.18) 49 / 848 GFR < (9.76) 19 / 33 Lisinopril 0.27 (0.19) 2 / (0.49) 25 / 1, (1.76) 33 / (10.61) 8 / 23 Relative Risk (95% CI) p value 0.43 ( ) p = ( ) p = ( ) p = ( ) p = 0.14 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
18 18 End Stage Renal Disease or 50% or Greater Decline in GFR by Baseline Diabetes & Treatment Amlodipine vs Chlorthalidone Diabetic participants Events per 100 & total events / N Chlorthalidone / 5,528 Amlodipine / 3,323 Relative Risk (A/C) p value 0.98 p = 0.82 Nondiabetic participants / 9, / 5, p = 0.01 Total / 15, / 9, p = 0.08 Differences among treatment group effects by baseline history of diabetes are not statistically significant. 6 / 5 /
19 19 End Stage Renal Disease or 50% or Greater Decline in GFR by Baseline GFR & Treatment Amlodipine vs Chlorthalidone Events per 100 (se) & total events / N Chlorthalidone GFR % 112 / 3,648 GFR % 190 / 8,360 GFR % 143 / 2,530 GFR < % 37 / 83 Amlodipine 2.0% 46 / 2, % 106 / 4, % 77 / 1, % 13 / 45 Relative Risk (A/C) p value 0.65 p = p = p = p = 0.08 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
20 20 End Stage Renal Disease or 50% or Greater Decline in GFR by Baseline GFR & Treatment Diabetic Participants Amlodipine vs Chlorthalidone Events per 100 (se) & total events / N Chlorthalidone GFR % 77 / 1,667 GFR % 99 / 2,755 GFR % 77 / 848 GFR < % 19 / 33 Amlodipine 2.9% 30 / 1, % 68 / 1, % 49 / % 7 / 20 Relative Risk (A/C) p value 0.62 p= p= p= p=0.11 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
21 21 End Stage Renal Disease or 50% or Greater Decline in GFR by Baseline Diabetes & Treatment Lisinopril vs Chlorthalidone Diabetic participants Events per 100 & total events / N Chlorthalidone / 5,528 Lisinopril / 3,212 Relative Risk (L/C) p value 1.04 p = 0.71 Nondiabetic participants / 9,727 Total / 15, / 5, / 9, p = P = 0.65 Differences among treatment group effects by baseline history of diabetes are not statistically significant. 6 / 5 /
22 22 End Stage Renal Disease or 50% or Greater Decline in GFR by Baseline GFR & Treatment Lisinopril vs Chlorthalidone Events per 100 (se) & total events / N Chlorthalidone GFR % 112 / 3,648 Lisinopril 2.6% 57 / 2,204 Relative Risk (L/C) p value 0.84 p = 0.28 GFR % 190 / 8,360 GFR % 143 / 2,530 GFR < % 37 / % 125 / 4, % 90 / 1, % 16 / p = p = p = 0.08 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
23 23 End Stage Renal Disease or 50% or Greater Decline in GFR by Baseline GFR & Treatment Diabetic Participants Lisinopril vs Chlorthalidone Events per 100 (se) & total events / N Chlorthalidone GFR % 77 / 1,667 Lisinopril 3.6% 35 / 981 Relative Risk (L/C) p value 0.76 p=0.20 GFR % 99 / 2,755 GFR % 77 / 848 GFR < % 19 / % 67 / 1, % 53 / % 8 / p= p= p=0.09 Differences among treatment group effects by baseline GFR group are not statistically significant. 6 / 5 /
24 24 Summary The overall study results of no difference in ESRD and the composite (ESRD/50% decline in GFR) for the lisinopril vs. chlorthalidone and amlodipine vs. chlorthalidone comparisons was consistent across diabetes, GFR, and diabetes-gfr subgroups. 6 / 5 /
25 25 Discussion # events Six year event rate /100 Combined CVD Events ESRD events High risk hypertensive patients are at higher risk for CVD than ESRD Risk of ESRD is higher in diabetic participants, and those with reduced GFR at baseline 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 6 / 5 /
26 26 Strengths & Limitations Strength - The number of patients with moderate reduction in GFR, and the number of patients developing ESRD are higher in compared to any other renal study, including AASK, RENAAL and IDNT Limitation Proteinuria is an independent predictor of decline in renal function. Information about proteinuria was not available in participants. 6 / 5 /
27 27 Conclusion In high risk hypertensive patients with reduced GFR, amlodipine and lisinopril are not superior to chlorthalidone in reducing the rate of development of ESRD and significant decrements in GFR 6 / 5 /
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