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Presenter Disclosure Information. Barry R. Davis, MD, PhD Clinical Outcomes in Participants with Dysmetabolic Syndrome in ALLHAT. FINANCIAL DISCLOSURE: DSMB’s: Merck, Takeda. UNLABELED / UNAPPROVED USES DISCLOSURE: None. ALLHAT.

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  1. Presenter Disclosure Information Barry R. Davis, MD, PhD Clinical Outcomes in Participants with Dysmetabolic Syndrome in ALLHAT FINANCIAL DISCLOSURE: DSMB’s: Merck, Takeda UNLABELED / UNAPPROVED USES DISCLOSURE: None

  2. ALLHAT Clinical Outcomes in Participants with Dysmetabolic Syndrome in ALLHAT Barry R. Davis, MD, PhD & Henry R. Black, MD for the ALLHAT Collaborative Research Group Presented at the American Heart Association Meeting November 8, 2004

  3. ALLHAT Randomized Designof ALLHAT Amlodipine Chlorthalidone Doxazosin Lisinopril High-risk hypertensive patients Consent / Randomize (42,418) Eligible for lipid-lowering Not eligible for lipid-lowering Consent / Randomize (10,355) Pravastatin Usual care Follow for CHD and other outcomes until death or end of study (up to 8 yr).

  4. ALLHAT Dysmetabolic Syndrome • ALLHAT reported overall superiority of thiazide-type treatment for first-step therapy of hypertension • Patients with dysmetabolic syndrome (DS) are at especially high risk for many hypertensive complications • Post hoc analyses from ALLHAT regarding treatment of hypertension in patients with and without DS are of interest • Definitions of DS vary (WHO, ATP III, etc.)

  5. ALLHAT Dysmetabolic Syndrome (DS) Any 3 or more of the following items: • Glycemic disorder • History of diabetes • Baseline glucose • BMI ≥30 • Fasting triglycerides 150+ • HDL cholesterol <40 in men, <50 in women • High BP (“yes” for all ALLHAT participants) • DS missing: # yes <3 and # yes + # missing ≥ 3

  6. ALLHAT Glycemic Disorder

  7. ALLHAT Definitions ofDysmetabolic Syndrome

  8. ALLHAT Definitions of Dysmetabolic Syndrome (continued) * UA = Urinary albumin excretion rate ** A/C = Albumin:creatinine ratio + Family history of type 2 diabetes, hypertension or CVD; polycystic ovary syndrome; sedentary lifestyle; advancing age; ethnic groups having high risk for type 2 diabetes or CVD

  9. ALLHAT Dysmetabolic Syndrome –Classification & Missing Values

  10. ALLHAT Baseline Characteristics - Participants* With and Without DS *Randomized to chlorthalidone, amlodipine, or lisinopril. ** p<.05

  11. ALLHAT Baseline Characteristics - Participants* With and Without DS *Randomized to chlorthalidone, amlodipine, or lisinopril. ** p<.05

  12. ALLHAT Blood Pressure at 5 Yearsby Baseline DS Status

  13. ALLHAT Biochemical Measures at 4 Yearsin Participants with Dysmetabolic Syndrome

  14. ALLHAT Biochemical Measures at 4 Yearsin Participants without Dysmetabolic Syndrome

  15. ALLHAT 14 12 10 08 Cumulative CHD Event Rate, % 6 4 2 0 0 1 2 3 4 5 6 Years to CHD CHD by Treatment Group In Participants With DS at Baseline Chlorthalidone Amlodipine Lisinopril

  16. ALLHAT 14 12 10 8 Cumulative CHD Event Rate, % 6 4 2 0 0 1 2 3 4 5 6 Years to CHD CHD by Treatment Group In Participants Without DS at Baseline Chlorthalidone Amlodipine Lisinopril

  17. ALLHAT Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals With Dysmetabolic Syndrome Without Dysmetabolic Syndrome 0.95 (0.84 - 1.07) 1.05 (0.90 - 1.22) 0.97 (0.88 - 1.06) 0.93 (0.83 - 1.04) 0.87 (0.74 - 1.04) 1.04 (0.83 - 1.29) 1.32 (1.15 - 1.51) 1.45 (1.20 - 1.75) 1.05 (0.98 - 1.12) 1.05 (0.96 - 1.15) 1.27 (0.96 - 1.68) 0.81 (0.51 - 1.26) 0.50 1 2 0.50 1 2 Favors Amlodipine Favors Chlorthalidone Favors Amlodipine Favors Chlorthalidone

  18. ALLHAT Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals With Dysmetabolic Syndrome Without Dysmetabolic Syndrome 1.01 (0.90 - 1.13) 1.02 (0.88 - 1.20) 1.01 (0.93 - 1.12) 1.02 (0.91 - 1.14) 1.09 (0.93 - 1.28) 1.20 (0.97 - 1.48) 1.28 (1.12 - 1.47) 1.02 (0.83 - 1.25) 1.14 (1.06 - 1.21) 1.07 (0.98 - 1.17) 1.22 (0.92 - 1.63) 0.76 (0.48 - 1.21) 0.50 1 2 0.50 1 2 Favors Lisinopril Favors Chlorthalidone Favors Lisinopril Favors Chlorthalidone

  19. ALLHAT Results by Baseline Dysmetabolic Syndrome - Conclusions • Treatment group comparison results were similar in participants with and without DS at baseline (i.e., there were no significant interactions) • For both DS and non-DS participants, neither the CCB nor ACEI arms were superior to the diuretic arm • For HF, diuretic was superior to CCB • Results were similar with DS definition similar to ATP III

  20. 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 patients with and without dysmetabolic syndrome.

  21. ALLHAT Additional Slides (Not presented at AHA)

  22. ALLHAT BP Results by Treatment Group and Baseline DS

  23. ALLHAT BP Results by Treatment Group and Baseline DSAmlodipine vs Chlorthalidone

  24. ALLHAT BP Results by Treatment Group and Baseline DSLisinopril vs Chlorthalidone

  25. ALLHAT Outcomes in Participants with DS –Amlodipine Compared With Chlorthalidone

  26. ALLHAT Outcomes in Participants with DS –Lisinopril Compared with Chlorthalidone

  27. ALLHAT Outcomes in Participants without DS –Amlodipine Compared with Chlorthalidone

  28. ALLHAT Outcomes in Participants without DS –Lisinopril Compared with Chlorthalidone

  29. ALLHAT 20 16 12 Cumulative Death Event Rate, % 8 4 0 0 1 2 3 4 5 6 Years to Death All-Cause Mortality by Treatment Group In Participants With DS at Baseline Chlorthalidone Amlodipine Lisinopril

  30. ALLHAT 20 16 12 Cumulative Death Event Rate, % 8 4 0 0 1 2 3 4 5 6 Years to Death All-Cause Mortality by Treatment Group In Participants Without DS at Baseline Chlorthalidone Amlodipine Lisinopril

  31. ALLHAT 7 6 5 4 Cumulative Stroke Event Rate, % 3 2 1 0 0 1 2 3 4 5 6 Years to Stroke Stroke by Treatment Group In Participants With DS at Baseline Chlorthalidone Amlodipine Lisinopril

  32. ALLHAT 7 6 5 4 Cumulative Stroke Event Rate, % 3 2 1 0 0 1 2 3 4 5 6 Years to Stroke Stroke by Treatment Group In Participants Without DS at Baseline Chlorthalidone Amlodipine Lisinopril

  33. ALLHAT 12 10 8 Cumulative HF Event Rate, % 6 4 2 0 0 1 2 3 4 5 6 Years to HF Heart Failure by Treatment Group In Participants With DS at Baseline Chlorthalidone Amlodipine Lisinopril

  34. ALLHAT 12 10 8 Cumulative HF Event Rate, % 6 4 2 0 0 1 2 3 4 5 6 Years to HF Heart Failure by Treatment Group In Participants Without DS at Baseline Chlorthalidone Amlodipine Lisinopril

  35. ALLHAT 35 30 25 20 Cumulative CCVD Event Rate, % 15 10 5 0 0 1 2 3 4 5 6 Years to CCVD Combined CVD by Treatment Group In Participants With DS at Baseline Chlorthalidone Amlodipine Lisinopril

  36. ALLHAT 35 30 25 20 Cumulative CCVD Event Rate, % 15 10 5 0 0 1 2 3 4 5 6 Years to CCVD Combined CVD by Treatment Group In Participants Without DS at Baseline Chlorthalidone Amlodipine Lisinopril

  37. ALLHAT 3 2 Cumulative ESRD Event Rate, % 1 0 0 1 2 3 4 5 6 Years to ESRD End Stage Renal Disease by Treatment Group In Participants With DS at Baseline Chlorthalidone Amlodipine Lisinopril

  38. ALLHAT 3 2 Cumulative ESRD Event Rate, % 1 0 0 1 2 3 4 5 6 Years to ESRD End Stage Renal Disease by Treatment Group In Participants Without DS at Baseline Chlorthalidone Amlodipine Lisinopril

  39. ALLHAT Outcomes in Participants With Dysmetabolic Syndrome- Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals 0.95 (0.84 - 1.07) 0.97 (0.88 - 1.06) 0.87 (0.74 - 1.04) 1.32 (1.15 - 1.51) 1.05 (0.98 - 1.12) 1.27 (0.96 - 1.68) 0.50 1 2 Favors Chlorthalidone Favors Amlodipine

  40. ALLHAT Outcomes in Participants Without Dysmetabolic Syndrome Amlodipine/Chlorthalidone Relative Risk and 95% Confidence Intervals 1.05 (0.90 - 1.22) 0.93 (0.83 - 1.04) 1.04 (0.83 - 1.29) 1.45 (1.20 - 1.75) 1.05 (0.96 - 1.15) 0.81 (0.51 - 1.26) 0.50 1 2 Favors Chlorthalidone Favors Amlodipine

  41. ALLHAT Outcomes in Participants With Dysmetabolic Syndrome Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals CHD 1.01 (0.90 - 1.13) All-cause mortality 1.01 (0.93 - 1.12) Stroke 1.09 (0.93 - 1.28) Heart Failure 1.28 (1.12 - 1.47) Combined CVD 1.14 (1.06 - 1.21) ESRD 1.22 (0.92 - 1.63) 0.50 1 2 Favors Chlorthalidone Favors Lisinopril

  42. ALLHAT Outcomes in Participants Without Dysmetabolic Syndrome Lisinopril/Chlorthalidone Relative Risk and 95% Confidence Intervals 1.02 (0.88 - 1.20) 1.02 (0.91 - 1.14) 1.20 (0.97 - 1.48) 1.02 (0.83 - 1.25) 1.07 (0.98 - 1.17) 0.76 (0.48 - 1.21) 0.50 1 2 Favors Chlorthalidone Favors Lisinopril

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