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1 ALLHAT Antihypertensive Trial Results by Baseline Diabetic Status January 28, 2004.

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Presentation on theme: "1 ALLHAT Antihypertensive Trial Results by Baseline Diabetic Status January 28, 2004."— Presentation transcript:

1 1 ALLHAT Antihypertensive Trial Results by Baseline Diabetic Status January 28, 2004

2 2 Introduction and Background Clinical trials have reported reduction in CV events with diuretics, CCBs, ACE inhibitors,  -blockers, and ARBs. Clinical trials have reported reduction in CV events with diuretics, CCBs, ACE inhibitors,  -blockers, and ARBs. Concerns have been raised regarding effects of some classes in diabetes. Concerns have been raised regarding effects of some classes in diabetes. JNC7 guidelines indicate all these classes are acceptable. JNC7 guidelines indicate all these classes are acceptable. ALLHAT

3 3 History of Diabetes at Baseline Medical record evidence in the past 2 years (1 or more of the following):Medical record evidence in the past 2 years (1 or more of the following): –Fasting glucose >140 mg/dl –Non-fasting glucose >200 mg/dl –On insulin or oral hypoglycemic agents

4 4 Baseline Characteristics Diabetic and Nondiabetic Participants* AgeDiabeticNondiabetic N12,06321,294 Age – mean66.667.1 Women (%)50.045.1 Black (%)39.333.1 SBP – mean146.5146.2 DBP – mean82.884.7 Current smokers (%)12.327.3 ASCVD (%)33.861.6 *Randomized to chlorthalidone, amlodipine, or lisinopril.

5 5 BP Results by Treatment Group and Baseline Diabetic Status Diabetic-ChlorDiabetic–AmlodDiabetic–Lisin Nondiab–ChlorNondiab–AmlodNondiab–Lisin BL6M1Y3Y5Y D–C146.4139.3137.8135.7135.2 D–A146.3141.5139.7136.9136.6 D-L146.7142.3141.1138.2138.0 ND-C146.2137.6136.0134.0133.6 ND-A146.2139.2137.5134.5134.0 ND-L146.2141.0139.0135.5135.0 BL6M1Y3Y5Y D–C82.879.478.476.274.3 D–A82.679.077.675.373.3 D-L82.979.978.976.274.3 ND-C84.780.579.677.676.0 ND-A84.780.179.076.675.1 ND-L84.881.380.277.775.9

6 6 Blood Pressure at 5 Years by Baseline Diabetic Status ChlorAmlodLisin SBP -Diabetic135.1 (15.7)136.3 (16.1)138.1 (19.2)* mean (sd)Nondiabetic133.3 (14.9)133.8 (14.1)134.7 (17.1)* DBP – mean (sd) Diabetic74.4 (9.8)73.5 (10.2)*74.5 (11.1) Nondiabetic76.0 (9.8)75.2 (9.6)*75.9 (10.5) SBP/DBP difference compared with chlorthalidone Diabetic---+1.2 / -0.9*+3.0* / +0.1 Nondiabetic+0.5 / -0.8*+1.3* / -0.1 * p<0.05 compared with chlorthalidone The SBP difference between lisinopril and chlorthalidone was larger in diabetic (+3.0 mm Hg) than for nondiabetic participants (1.3 mm Hg) (p=0.04).

7 7 Biochemical Measures at 4 Years in Participants with Diabetes ChlorAmlodLisin Chol - mg/dL Mean N 195.0 2855 195.0 1664 192.8* 1574 Fasting Glucose – mg/dl Mean % 126+ N 164.0 68.8% 1627 162.1 67.9% 952 161.5 67.1% 855 Potassium – mmol/L Mean N 4.2 2795 4.5* 1618 4.6* 1528 * p<0.05 compared with chlorthalidone

8 8 Biochemical Measures at 4 Years in Participants without Diabetes ChlorAmlodLisin Chol - mg/dL Mean N 198.3 5640 195.8* 3361 196.1* 3137 Fasting Glucose – mg/dl Mean % 126+ N 108.0 15.2% 3345 105.5* 12.8%* 2002 103.2* 11.1%* 1876 Potassium – mmol/L Mean N 4.1 5520 4.4* 3301 4.5* 3088 * p<0.05 compared with chlorthalidone

9 9 Potassium Supplementation at 4 Years in Participants with and without Diabetes at Baseline ChlorAmlodLisin Diabetic participants N3,9312,1972,227 On K suppl – n (%) 545 (13.9%) 163 (6.9%)* 122 (5.5%)* Nondiabetic participants N7,2414,3074,227 On K suppl – n (%) 1,170 (16.2%) 319 (7.4%)* 212 (5.0%)*

10 10 Cumulative CHD Event Rate Years to CHD Event 01234567 0.04.08.12.16.2 CHD by Antihypertensive Treatment Group In Participants With Diabetes at Baseline HR (95% CI)p value A/C0.99 (0.87-1.13)0.93 L/C1.00 (0.87-1.14)0.97 Chlorthalidone Amlodipine Lisinopril

11 11 Cumulative CHD Event Rate Years to CHD Event 01234567 0.04.08.12.16.2 CHD by Antihypertensive Treatment Group In Participants Without Diabetes at Baseline HR (95% CI)p value A/C0.97 (0.86-1.09)0.56 L/C0.99 (0.88-1.11)0.85 Chlorthalidone Amlodipine Lisinopril

12 12 Cumulative Mortality Rate Years to Death 01234567 0.04.08.12.16.2.24.28 All-Cause Mortality by Antihypertensive Treatment Group In Participants With Diabetes at Baseline HR (95% CI)p value A/C0.96 (0.87-1.07)0.48 L/C1.02 (0.91-1.13)0.77 Chlorthalidone Amlodipine Lisinopril

13 13 Cumulative Mortality Rate Years to Death 01234567 0.04.08.12.16.2.24.28 All-Cause Mortality by Antihypertensive Treatment Group In Participants Without Diabetes at Baseline HR (95% CI)p value A/C0.95 (0.87-1.04)0.26 L/C1.00 (0.91-1.09)1.00 Chlorthalidone Amlodipine Lisinopril

14 14 Cumulative Stroke Rate Years to Stroke 01234567 0.04.08.12 Stroke by Antihypertensive Treatment Group In Participants With Diabetes at Baseline HR (95% CI)p value A/C0.90 (0.75-1.08)0.26 L/C1.07 (0.90-1.28)0.45 Chlorthalidone Amlodipine Lisinopril

15 15 Cumulative Stroke Rate Years to Stroke 01234567 0.04.08.12 Stroke by Antihypertensive Treatment Group In Participants Without Diabetes at Baseline HR (95% CI)p value A/C0.96 (0.81-1.14)0.63 L/C1.23 (1.05-1.44)0.01 Chlorthalidone Amlodipine Lisinopril

16 16 Cumulative HF Rate Years to HF 01234567 0.04.08.12.16.2 Heart Failure by Antihypertensive Treatment Group In Participants With Diabetes at Baseline HR (95% CI)p value A/C1.42 (1.23-1.64)<0.001 L/C1.22 (1.05-1.42)0.009 Chlorthalidone Amlodipine Lisinopril

17 17 Cumulative HF Rate Years to HF 01234567 0.04.08.12.16.2 Heart Failure by Antihypertensive Treatment Group In Participants Without Diabetes at Baseline HR (95% CI)p value A/C1.33 (1.16-1.52)<0.001 L/C1.20 (1.04-1.38)0.01 Chlorthalidone Amlodipine Lisinopril

18 18 Cumulative Combined CVD Event Rate Years to Combined CVD Event 01234567 0.1.2.3.4 Combined CVD by Antihypertensive Treatment Group In Participants With Diabetes at Baseline HR (95% CI)p value A/C1.06 (0.98-1.15)0.12 L/C1.08 (1.00-1.17)0.05 Chlorthalidone Amlodipine Lisinopril

19 19 Cumulative Combined CVD Event Rate Years to Combined CVD Event 01234567 0.1.2.3.4 Combined CVD by Antihypertensive Treatment Group In Participants Without Diabetes at Baseline HR (95% CI)p value A/C1.02 (0.96-1.09)0.51 L/C1.12 (1.05-1.19)0.001 Chlorthalidone Amlodipine Lisinopril

20 20 End Stage Renal Disease by Antihypertensive Treatment Group In Participants With Diabetes at Baseline HR (95% CI)p value A/C1.30 (0.98, 1.73)0.07 L/C1.17 (0.87, 1.57)0.31 0.00 0.01 0.02 0.03 0.04 0.05 Cumulative ESRD Rate 01234567 Years to ESRD 0.05 0.04 0.03 0.02 0.01

21 21 End Stage Renal Disease by Antihypertensive Treatment Group In Participants Without Diabetes at Baseline HR (95% CI)p value A/C0.86 (0.60, 1.25)0.43 L/C1.05 (0.73, 1.48)0.78 Chlorthalidone Amlodipine Lisinopril 0.00 0.01 0.02 0.03 0.04 0.05 Cumulative ESRD Rate 01234567 Years to ESRD 0.05 0.04 0.03 0.02 0.01

22 22 Diabetics & Nondiabetics Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals CHD0.99 (0.87, 1.13) Mortality0.96 (0.87, 1.07) Stroke0.90 (0.75, 1.08) Heart Failure1.42 (1.23, 1.64) Combined CVD1.06 (0.98, 1.15) ESRD1.30 (0.98, 1.73) Favors Amlodipine Chlorthal 0.50 12 0.97 (0.86,1.09) 0.95 (0.87, 1.04) 0.96 (0.81, 1.14) 1.33 (1.16, 1.52) 1.02 (0.96, 1.09) 0.86 (0.60, 1.25) 0.5012 Favors Amlodipine Chlorthal DiabeticsNondiabetics There is no difference in treatment group effect by baseline history of diabetes.

23 23 Favors Lisinopril Chlorthal 0.501 2 CHD1.00 (0.87, 1.14) Mortality1.02 (0.91, 1.13) Stroke1.07 (0.90, 1.28) Heart Failure1.22 (1.05, 1.42) Combined CVD1.08 (1.00, 1.17) ESRD1.17 (0.87, 1.57) Diabetics & Nondiabetics Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals DiabeticsNondiabetics 0.50 12 0.99 (0.88, 1.11) 1.00 (0.91, 1.09) 1.23 (1.05, 1.44) 1.20 (1.04, 1.38) 1.12 (1.05, 1.19) 1.05 (0.74, 1.48) Favors Lisinopril Chlorthal There is no difference in treatment group effect by baseline history of diabetes.

24 24 ESRD Events and Estimated GFR by Baseline Diabetes Status ChlorAmlodLisin Participants with a History of Diabetes ESRD events 6-yr/100 (se) RR (p) 2.6 (0.3)3.6 (0.4) 1.30 (p=0.07) 3.2 (0.4) 1.17 (p=0.31) Est 4-yr GFR Mean (N)70.0 (2796)75.8* (1620)70.7 (1530) Participants without a History of Diabetes ESRD events 6-yr/100 (se) RR (p) 1.2 (0.2)1.0 (0.2) 0.86 (p=0.43) 1.2 (0.9) 1.05 (p=0.78) Est 4-yr GFR Mean (N)70.1 (5520)74.7* (3304)70.7 (3091) * p<0.05 compared with chlorthalidone

25 25 ALLHAT Results by Baseline Diabetic Status - Conclusions Treatment group comparison results were similar in diabetic and nondiabetic participants For both diabetic and nondiabetic participants, there were significant advantages for the diuretic arm –Compared with the ACEI and CCB arms, there was less HF –Compared with the ACEI arm, there was less stroke and less combined CVD

26 26 ALLHAT Results - Overall Because of the superiority of thiazide-type diuretics in preventing one or more major forms of CVD and their lower cost, they should be the drugs of choice for first- step antihypertensive drug therapy in both diabetic and nondiabetic participants.

27 27 Additional Slides

28 28 BP Results – Amlodipine vs Chlorthalidone and Baseline Diabetic Status Diabetic-ChlorDiabetic–Amlod Nondiabetic–ChlorNondiabetic–Amlod BL6M1Y3Y5Y D – C146.4139.3137.8135.7135.2 D – A146.3141.5139.7136.9136.6 ND – C146.2137.6136.0134.0133.6 ND – A146.2139.2137.5134.5134.0 BL6M1Y3Y5Y D – C82.879.478.476.274.3 D – A82.679.077.675.373.3 ND – C84.780.579.677.676.0 ND – A84.780.179.076.675.1

29 29 BP Results – Lisinopril vs Chlorthalidone and Baseline Diabetic Status Diabetic-ChlorDiabetic–Lisin Nondiabetic–ChlorNondiabetic–Lisin BL6M1Y3Y5Y D – C146.4139.3137.8135.7135.2 D – L146.7142.3141.1138.2138.0 ND – C146.2137.6136.0134.0133.6 ND – L146.2141.0139.0135.5135.0 BL6M1Y3Y5Y D – C82.879.478.476.274.3 D – L82.979.978.976.274.3 ND – C84.780.579.677.676.0 ND – L84.881.380.277.775.9

30 30 Outcomes in Participants with Diabetes – Amlodipine Compared With Chlorthalidone 6-Year Rates per 100 (se) RR (95% CI) p ChlorAmlAml/Chl CHD13.5 (0.6) 592 13.8 (0.8) 358 0.99 (0.87, 1.13) 0.93 Mortality19.0 (0.6) 926 19.0 (0.8) 541 0.96 (0.87, 1.07) 0.48 Stroke7.1 (0.4) 314 6.6 (0.5) 172 0.90 (0.75, 1.08) 0.26 Heart Failure9.7 (0.5) 410 13.0 (0.7) 347 1.42 (1.23, 1.64) <0.001 Combined CVD 33.9 (0.8) 1,609 36.2 (1.0) 1,030 1.06 (0.98, 1.15) 0.12 ESRD2.6 (0.3) 109 3.6 (0.4) 86 1.30 (0.98, 1.73) 0.07

31 31 Outcomes in Participants with Diabetes – Lisinopril Compared with Chlorthalidone 6-Year Rates per 100 (se) RR (95% CI) p ChlorLisinLisin/Chl CHD13.5 (0.6) 592 12.8 (0.7) 339 1.00 (0.87, 1.14) 0.97 Mortality19.0 (0.6) 926 19.5 (0.8) 544 1.02 (0.91, 1.13) 0.77 Stroke7.1 (0.4) 314 7.6 (0.6 193) 1.07 (0.90, 1.28) 0.45 Heart Failure9.7 (0.5) 410 10.8 (0.7) 284 1.22 (1.05, 1.42) 0.009 Combined CVD 33.9 (0.8) 1,609 35.5 (1.0) 985 1.08 (1.00, 1.17) 0.05 ESRD2.6 (0.3) 109 3.2 (0.4) 73 1.17 (0.87, 1.57) 0.31

32 32 Outcomes in Participants without Diabetes – Amlodipine Compared with Chlorthalidone 6-Year Rates per 100 (se) RR (95% CI) p ChlorAmlAml/Chl CHD9.8 (0.4) 770 9.2 (0.5) 440 0.97 (0.86, 1.09) 0.56 Mortality15.4 (0.4) 1,277 14.5 (0.6) 715 0.95 (0.87, 1.04) 0.26 Stroke4.5 (0.3) 361 4.4 (0.3) 205 0.96 (0.81, 1.14) 0.63 Heart Failure6.1 (0.3) 460 7.9 (0.4) 359 1.33 (1.16, 1.52) <0.001 Combined CVD 28.0 (0.6) 2,332 28.4 (0.7) 1,402 1.02 (0.96, 1.09) 0.51 ESRD1.2 (0.2) 84 1.0 (0.2) 43 0.86 (0.60, 1.25) 0.43

33 33 Outcomes in Participants without Diabetes – Lisinopril Compared with Chlorthalidone 6-Year Rates per 100 (se) RR (95% CI) p ChlorLisinLisin/Chl CHD9.8 (0.4) 770 9.9 (0.5) 457 0.99 (0.88, 1.11) 0.85 Mortality15.4 (0.4) 1,277 15.1 (0.6) 770 1.00 (0.91, 1.09) 1.00 Stroke4.5 (0.3) 361 5.4 (0.4) 264 1.23 (1.05, 1.44) 0.01 Heart Failure 6.1 (0.3) 460 7.1 (0.4) 328 1.20 (1.04, 1.38) 0.01 Combined CVD 28.0 (0.6) 2,332 30.9 (0.7) 1,529 1.12 (1.05, 1.19) 0.001 ESRD1.2 (0.2) 84 1.2 (0.9) 53 1.05 (0.74, 1.48) 0.78

34 34 Diabetics Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals CHD0.99 (0.87, 1.13) All-cause mortality0.96 (0.87, 1.07) Stroke0.90 (0.75, 1.08) Heart Failure1.42 (1.23, 1.64) Combined CVD1.06 (0.98, 1.15) ESRD1.30 (0.98, 1.73) Favors Amlodipine Favors Chlorthalidone 0.50 12

35 35 Diabetics Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals CHD1.00 (0.87, 1.14) All-cause mortality1.02 (0.91, 1.13) Stroke1.07 (0.90, 1.28) Heart Failure1.22 (1.05, 1.42) Combined CVD1.08 (1.00, 1.17) ESRD1.17 (0.87, 1.57) Favors Lisinopril Favors Chlorthalidone 0.501 2

36 36 Nondiabetics Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals CHD0.97 (0.86,1.09) All-cause mortality0.95 (0.87, 1.04) Stroke0.96 (0.81, 1.14) Heart Failure1.33 (1.16, 1.52) Combined CVD1.02 (0.96, 1.09) ESRD0.86 (0.60, 1.25) 0.5012 Favors Amlodipine Favors Chlorthalidone

37 37 Nondiabetics Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals CHD0.99 (0.88, 1.11) All-cause mortality1.00 (0.91, 1.09) Stroke1.23 (1.05, 1.44) Heart Failure1.20 (1.04, 1.38) Combined CVD1.12 (1.05, 1.19) ESRD1.05 (0.74, 1.48) Favors Lisinopril Favors Chlorthalidone 0.50 12

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