ALLHAT. ALLHAT Antihypertensive Trial Results by Baseline Diabetic & Fasting Glucose Status
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1 ALLHAT Antihypertensive Trial Results by Baseline Diabetic & Fasting Glucose Status 1
2 Introduction and Background Clinical trials have reported reduction in CV events with diuretics, CCBs, ACE inhibitors, β-blockers, and ARBs. JNC7 guidelines indicate all these classes are acceptable. Nevertheless, concerns have been raised regarding effects of some classes in diabetic patients. 2
3 U.S. Department of Health and Human Services National Institutes of Health ALLHAT Major Outcomes in High Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic The Antihypertensive and Lipid-Lowering Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) National Heart, Lung, and Blood Institute The ALLHAT Collaborative Research Group Sponsored by the National Heart, Lung, and Blood Institute (NHLBI) JAMA 2002;288:2981 JAMA 2002;288:
4 Introduction and Background 15,297 ALLHAT participants had diabetes (by history) at baseline. This represents 36% of the study cohort. Clearly makes ALLHAT the largest antihypertensive drug comparison trial in hypertensive diabetic patients. 4
5 Randomized Design of ALLHAT BP Trial High-risk hypertensive patients Consent / Randomize Amlodipine Lisinopril Doxazosin Chlorthalidone Follow for CHD and other outcomes until death or end of study (up to 8 yr; mean 4.9 yrs). 5
6 Participants with DM in AHT Drug Trials ALLHAT 15,297 ASCOT 5,145 VALUE 4,891 HOPE 3,577 (43.6% hypertensive) CONVINCE 3,266 HOT 1,501 LIFE 1,195 UKPDS 1,148 SHEP 583 Syst-Eur 492 ABCD 470 ANBP
7 Results Based On Diabetes by History Only JAMA 2002;288:
8 Biochemical Results Fasting Glucose mg/dl Total Chlorthalidone Amlodipine Among baseline nondiabetics with baseline FG <126 mg/dl Lisinopril Baseline Years Baseline 4 Years * Diabetes Incidence (follow-up fasting glucose 126 mg/dl dl) 4 Years * % 9.8%* 8.1%* *p<.05 compared to chlorthalidone 8 JAMA 2002;288:
9 Diabetes Incidence - 4 Years (follow-up FBS 126 mg/dl for those <126 mg/dl at baseline) 30.0 Diabetes Incidence (%) Chlor Amlod Lisin * 9.8 * * p<.05 compared to chlorthalidone 9 JAMA 2002;288:
10 Diabetics & Nondiabetics (History) Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals Diabetics Nondiabetics CHD 0.99 (0.87, 1.13) Mortality 0.96 (0.87, 1.07) Stroke 0.90 (0.75, 1.08) Heart Failure 1.42 (1.23, 1.64) Combined CVD 1.06 (0.98, 1.15) ESRD 1.30 (0.98, 1.73) 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) Favors Favors Amlodipine Chlorthal Favors Favors Amlodipine Chlorthal 10 JAMA 2002;288:
11 Diabetics & Nondiabetics (History) Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals Diabetics Nondiabetics CHD 1.00 (0.87, 1.14) Mortality 1.02 (0.91, 1.13) Stroke 1.07 (0.90, 1.28) Heart Failure 1.22 (1.05, 1.42) Combined CVD 1.08 (1.00, 1.17) ESRD 1.17 (0.87, 1.57) 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 (1.04, 1.19) 1.05 (0.74, 1.48) Favors Favors Lisinopril Chlorthal Favors Favors Lisinopril Chlorthal 11 JAMA 2002;288:
12 Results Based On Diabetes by History and Baseline Glucose Measurements Arch Intern Med. 2005;165:
13 Diabetes by History & Baseline Fasting Glucose FG <110 mg/dl NFG <110 mg/dl FG mg/dl FG 126 mg/dl Other/missing History of Diabetes* Diabetic Diabetic Diabetic Diabetic Diabetic No History of Diabetes Nondiabetic Nondiabetic Impaired fasting glucose (IFG) Diabetic Excluded FG = Fasting glucose NFG = Nonfasting glucose *Medical record evidence in the past 2 years: Fasting glucose >140 mg/dl, nonfasting glucose >200 mg/dl, and/or on insulin or oral hypoglycemic agents 13
14 Diabetes by History & Baseline Fasting Glucose* History of Diabetes** No History of Diabetes FG <110 mg/dl 13,456 NFG <110 mg/dl 3,556 FG mg/dl 12,063 1,399 FG 126 mg/dl 1,038 Other/missing 1,845 FG = Fasting glucose NFG = Nonfasting glucose *Randomized to chlorthalidone, amlodipine, or lisinopril **Medical record evidence in the past 2 years: Fasting glucose >140 mg/dl, non-fasting glucose >200 mg/dl, and/or on insulin or oral hypoglycemic agents 14
15 Diabetes by History and Baseline Fasting Glucose by Treatment Group Chlorthalidone Amlodipine Diabetic 5, % 3, % 3,510 Lisinopril IFG % % % Nondiabetic 7, % 4,594 Total 14, % 8,555 Missing % 100.0% 4,627 8, % 54.2% 100.0% 15
16 Baseline Characteristics Diabetic, IFG, and Nondiabetic Participants* Age N Age mean Women (%) Black (%) SBP mean DBP mean Current smokers (%) Diabetic IFG Nondiabetic 13,101 1,399 17, ** 49.3** 38.8** 146.5** 82.9** 13.4** ** ** ASCVD (%) 35.8** *Randomized to chlorthalidone, amlodipine, or lisinopril ** p<.05 compared to nondiabetic participants 16
17 Blood Pressure at 5 Years - Diabetic, Impaired Fasting Glucose, and Nondiabetic Participants SBP - mean (sd( sd) DBP - mean (sd( sd) Chlor Amlod Lisin Diabetic (15.6) (15.9)* (19.0)* Impaired FG (16.1) (13.2) (15.2) Nondiabetic (14.9) (14.1) (17.3)* Diabetic 74.4 (9.7) 73.6 (10.1)* 74.6 (11.1) Impaired FG 74.0 (9.8) 74.4 (9.5) 75.1 (11.2) Nondiabetic 76.2 (9.8) 75.3 (9.6)* 76.1 (10.4) * p<0.05 compared with chlorthalidone 17
18 Cumulative CHD Event Rate CHD in Participants with a History of Diabetes Mellitus or with FG 126+ at Baseline HR (95% CI) p value A/C 0.97 ( ) 0.64 L/C 0.97 ( ) 0.59 Chlorthalidone Amlodipine Lisinopril Years to CHD Event 18
19 CHD in Participants With Impaired Fasting Glucose (No History of Diabetes) Cumulative CHD Event Rate HR (95% CI) p value A/C 1.73 ( ) 0.02 L/C 1.16 ( ) 0.56 Chlorthalidone Amlodipine Lisinopril Years to CHD Event 19
20 CHD in Normoglycemic Participants (No History of Diabetes) Cumulative CHD Event Rate HR (95% CI) p value A/C 0.94 ( ) 0.36 L/C 1.02 ( ) 0.79 Chlorthalidone Amlodipine Lisinopril Years to CHD Event 20
21 Diabetes-Treatment Interactions - CHD Comparison & p for interaction Subgroup RR A/C 0.01 Diab 0.97 ( ) IFG 1.73 ( ) Normo 0.94 ( ) 21
22 Outcomes in the Blood Pressure Component of ALLHAT DIABETIC GROUP Amlodipine / Chlorthalidone Lisinopril / Chlorthalidone CHD 0.97 ( ) All cause mortality 0.95 ( ) Combined CHD 1.02 ( ) 0.97 ( ) 0.99 ( ) 1.03 ( ) Stroke 0.89 ( ) 1.06 ( ) Heart Failure 1.39 ( ) 1.15 ( ) Combined CVD 1.06 ( ) ESRD 1.27 ( ) ( ) 1.09 ( ) Favors Favors Amlodipine Chlorthalidone Favors Favors Lisinopril Chlorthalidone 22
23 Outcomes in the Blood Pressure Component of ALLHAT IMPAIRED FASTING GROUP Amlodipine / Chlorthalidone Lisinopril / Chlorthalidone CHD 1.73 ( ) 1.16 ( ) All cause mortality 0.93 ( ) 1.07 ( ) Combined CHD 1.37 ( ) 1.12 ( ) Stroke 0.68 ( ) 0.91 ( ) Heart Failure 1.66 ( ) 1.20 ( ) Combined CVD 1.13 ( ) 1.09 ( ) ESRD 0.52 ( ) 1.50 ( ) Favors Favors Amlodipine Chlorthalidone Favors Favors Lisinopril Chlorthalidone
24 Outcomes in the Blood Pressure Component of ALLHAT NORMOGLYCEMIC Amlodipine / Chlorthalidone Lisinopril / Chlorthalidone CHD 0.94 ( ) All cause mortality 0.95 ( ) Combined CHD 0.95 ( ) Stroke 1.03 ( ) Heart Failure 1.30 ( ) 1.02 ( ) 1.02 ( ) 1.05 ( ) 1.31 ( ) 1.19 ( ) Combined CVD 1.02 ( ) 1.13 ( ) ESRD 0.85 ( ) 0.99 ( ) Favors Favors Favors Favors Amlodipine Chlorthalidone Lisinopril Chlorthalidone 24
25 Diabetes-Treatment Interactions - CCHD Comparison & p for interaction Subgroup RR (95% CI) A/C 0.03 Diab 1.02 ( ) IFG 1.37 ( ) Normo 0.95 ( ) 25
26 Race-Diabetes-Treatment Interactions Comparison & p for interaction Subgroup RR CHD - L/C 0.04 Total Diab 0.97 Total IFG 1.16 Black IFG 4.35 Nonblack IFG 0.77 Total Nondiab 1.02 Total Mortality - Total Diab 0.95 A/C 0.05 Total IFG 0.93 Black IFG 1.25 Nonblack IFG 0.92 Total Nondiab
27 ALLHAT Results by Baseline Diabetic Status Summary Treatment group comparison results for CVD and ESRD events were similar in diabetic and nondiabetic participants. Compared with chlorthalidone arm Higher risk of HF with amlodipine Higher risk of stroke, HF, and combined CVD with lisinopril 27
28 ALLHAT Results by Baseline Diabetic Status Summary (cont) Results for CVD and ESRD events were also similar in small group of participants with IFG, except for possible excess CHD with amlodipine Post-hoc sub-group May merit further study 28
29 ALLHAT Results by Baseline Diabetic Status Implications For minimizing CVD/renal risk in medium term, thiazide-like diuretics preferred, except: ALLHAT did not address proteinuric nephropathy. Do differences in glycemia translate into long-term advantage for CVD/renal events? Not for CVD death, based on SHEP extended follow-up analyses; post-trial trial ALLHAT FU continues. Ongoing trials testing glycemia-reduction reduction CVD 29
30 The conclusions presented for the ALLHAT diabetes subgroups are entirely consistent with the overall conclusions for the entire study cohort. 30
31 EXTRA SLIDES 31
32 All-Cause Mortality in Participants with a History of Diabetes Mellitus or FG 126+ mg/dl at Baseline.28 HR (95% CI) p value Cumulative Mortality Rate A/C L/C 0.95 ( ) 0.99 ( ) Chlorthalidone Amlodipine Lisinopril Years to Death 32
33 Cumulative Mortality Rate All-Cause Mortality in Participants with Impaired Fasting Glucose (No History of Diabetes) HR (95% CI) p value A/C 0.93 ( ) 0.71 L/C 1.07 ( ) 0.70 Chlorthalidone Amlodipine Lisinopril Years to Death 33
34 All-Cause Mortality in Normoglycemic Participants (No History of Diabetes).28 HR (95% CI) p value Cumulative Mortality Rate A/C L/C 0.95 ( ) 1.02 ( ) Chlorthalidone Amlodipine Lisinopril Years to Death 34
35 Cumulative Combined CHD Event Rate Combined CHD in Participants with a History of Diabetes Mellitus or FG 126+ mg/dl at Baseline HR (95% CI) p value A/C 1.02 ( ) 0.64 L/C 1.03 ( ) 0.56 Chlorthalidone Amlodipine Lisinopril Years to Combined CHD Event 35
36 Cumulative Combined CHD Event Rate Combined CHD in Participants with Impaired Fasting Glucose (No History of Diabetes) HR (95% CI) p value A/C 1.37 ( ) 0.05 L/C 1.12 ( ) 0.47 Chlorthalidone Amlodipine Lisinopril Years to Combined CHD Event 36
37 Cumulative Combined CHD Event Rate Combined CHD in Normoglycemic Participants (No History of Diabetes) HR (95% CI) p value A/C 0.95 ( ) 0.33 L/C 1.05 ( ) 0.28 Chlorthalidone Amlodipine Lisinopril Years to Combined CHD Event 37
38 Stroke in Participants with a History of Diabetes Mellitus or with FG 126+ mg/dl at Baseline.12 HR (95% CI) p value Cumulative Stroke Rate A/C L/C 0.89 ( ) 1.06 ( ) Chlorthalidone Amlodipine Lisinopril Years to Stroke 38
39 Cumulative Stroke Rate Stroke in Participants with Impaired Fasting Glucose (No History of Diabetes) HR (95% CI) p value A/C 0.68 ( ) 0.23 L/C 0.91 ( ) 0.75 Chlorthalidone Amlodipine Lisinopril Years to Stroke 39
40 Stroke in Normoglycemic Participants (No History of Diabetes) Cumulative Stroke Rate HR (95% CI) p value A/C 1.03 ( ) 0.77 L/C 1.31 ( ) Chlorthalidone Amlodipine Lisinopril Years to Stroke 40
41 Stroke by Race by Baseline Diabetic Status Amlodipine / Chlorthalidone HR (95% CI) p value Diabetic Black 0.96 ( ) 0.77 Non-Black 0.83 ( ) 0.15 IFG Black 0.74 ( ) 0.55 Non-Black 0.61 ( ) 0.26 Nondiabetic Black 0.95 ( ) 0.79 Non-Black 1.07 ( )
42 Stroke by Race by Baseline Diabetic Status Lisinopril / Chlorthalidone HR (95% CI) p value Diabetic Black 1.36 ( ) 0.02 Non-Black 0.85 ( ) 0.20 IFG Black 1.35 ( ) 0.49 Non-Black 0.68 ( ) 0.34 Nondiabetic Black 1.54 ( ) Non-Black 1.19 ( )
43 Heart Failure in Participants with a History of Diabetes Mellitus or with FG 126+ mg/dl at Baseline Cumulative HF Rate HR (95% CI) p value A/C 1.39 ( ) <0.001 L/C 1.15 ( ) 0.06 Chlorthalidone Amlodipine Lisinopril Years to HF 43
44 Heart Failure in Participants with Impaired Fasting Glucose (No History of Diabetes) Cumulative HF Rate HR (95% CI) p value A/C 1.66 ( ) 0.06 L/C 1.20 ( ) 0.52 Chlorthalidone Amlodipine Lisinopril Years to HF 44
45 Heart Failure in Normoglycemic Participants (No History of Diabetes) Cumulative CHF Rate HR (95% CI) Chlorthalidone Amlodipine Lisinopril p value A/C 1.30 ( ) L/C 1.19 ( ) Years to CHF 45
46 Cumulative Combined CVD Event Rate Combined CVD in Participants with a History of Diabetes Mellitus or with FG 126+ mg/dl at Baseline HR (95% CI) p value A/C 1.06 ( ) 0.13 L/C 1.07 ( ) 0.08 Chlorthalidone Amlodipine Lisinopril Years to Combined CVD Event 46
47 Cumulative Combined CVD Event Rate Combined CVD in Participants with Impaired Fasting Glucose (No History of Diabetes) HR (95% CI) p value A/C 1.13 ( ) 0.34 L/C 1.09 ( ) Years to Combined CVD Event Chlorthalidone Amlodipine Lisinopril 47
48 Cumulative Combined CVD Event Rate Combined CVD in Normoglycemic Participants (No History of Diabetes) HR (95% CI) p value A/C 1.02 ( ) 0.57 L/C 1.13 ( ) Chlorthalidone Amlodipine Lisinopril Years to Combined CVD Event 48
49 ESRD in Participants with a History of Diabetes Mellitus or with FG 126+ mg/dl at Baseline.04 HR (95% CI) p value A/C 1.27 ( ) 0.08 Cumulative ESRD Rate L/C 1.09 ( ) Chlorthalidone Amlodipine Lisinopril Years to ESRD 49
50 Cumulative ESRD Rate ESRD in Participants with Impaired Fasting Glucose (No History of Diabetes) HR (95% CI) p value A/C 0.52 ( ) 0.43 L/C 1.50 ( ) 0.48 Chlorthalidone Amlodipine Lisinopril Years to ESRD 50
51 ESRD in Normoglycemic Participants (No History of Diabetes) Cumulative ESRD Rate HR (95% CI) p value A/C 0.85 ( ) 0.46 L/C 0.99 ( ) 1.00 Chlorthalidone Amlodipine Lisinopril Years to ESRD 51
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