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Effects of Intensive Blood Pressure Control on Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial. William C. Cushman, MD, FACP, FAHA Veterans Affairs Medical Center, Memphis, TN For The ACCORD Study Group.

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Effects of Intensive Blood Pressure Control on Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

William C. Cushman, MD, FACP, FAHA

Veterans Affairs Medical Center, Memphis, TN

For The ACCORD Study Group


Accord sponsor collaborators and contributors

Collaboration & support Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)

National Eye Institute (NEI)

National Institute on Aging (NIA)

Centers for Disease Control and Prevention (CDC)

Contributions

Abbott Laboratories (and Fournier Laboratories)

AstraZeneca Pharmaceuticals LP

Sanofi-Aventis U.S

GlaxoSmithKline Pharmaceuticals

King Pharmaceuticals, Inc.

MediSense Products (division of Abbott Laboratories)

Merck & Company, Inc.

Closer Healthcare Inc.

Novartis Pharmaceuticals. Inc.

Novo Nordisk Pharmaceuticals., Inc.

Omron Healthcare, Inc.

AmylinPharmaceuticals, Inc.

Takeda Pharmaceuticals Inc

ACCORD Sponsor, Collaborators and Contributors

Sponsor: The National Heart, Lung, and Blood Institute (NHLBI)


ACCORD Study Design Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

  • Randomized multi-center clinical trial

  • Conducted in 77 clinical sites in North America (U.S. and Canada)

  • Designed to independently test three medical strategies to reduce CVD in diabetic patients

    • BP question: does a therapeutic strategy targeting systolic blood pressure (SBP) <120 mmHg reduce CVD events compared to a strategy targeting SBP <140 mmHg in patients with type 2 diabetes at high risk for CVD events?


ACCORD Double 2 x 2 Factorial Design Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

Lipid

BP

Placebo Fibrate

Intensive

Standard

Intensive

Glycemic

Control

1383

1374

1178

1193

5128

Standard

Glycemic

Control

1370

1391

1184

1178

5123

2765

2362

2371

10,251

2753

5518

4733*

  • * 94% power for 20% reduction in event rate, assuming standard group rate of 4% / yr and 5.6 yrs follow-up


ACCORD BP Trial Eligibility Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

  • Stable Type 2 Diabetes >3 months

  • HbA1c 7.5% to 11% (or <9% if on more meds)

  • High CVD risk = clinical or subclinical disease or ≥2 risk factors

  • Age (limited to <80 years after Vanguard)

    • ≥ 40 yrs with history of clinical CVD (secondary prevention)

    • ≥ 55 yrs otherwise

  • Systolic blood pressure

    • 130 to 160 mm Hg (if on 0-3 meds)

    • 161 to 170 mm Hg (if on 0-2 meds)

    • 171 to 180 mm Hg (if on 0-1 meds)

  • Urine protein <1.0 gm/24 hours or equivalent

  • Serum Creatinine ≤1.5 mg/dl


Accord bp protocol
ACCORD BP Protocol Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

  • Many drugs/combinations provided to achieve goal BP according to randomized assignment.

  • Intensive Intervention:

    • 2-drug therapy initiated: thiazide-type diuretic + ACEI, ARB, or b-blocker.

    • Drugs added and/or titrated at each visit to achieve SBP <120 mm Hg.

    • At periodic “milepost” visits: addition of another drug “required” if not at goal.

  • Standard Intervention:

    • Intensify therapy if SBP ≥160 mm Hg @ 1 visit or ≥140 mm Hg @ 2 consecutive visits

    • Down-titration if SBP <130 mm Hg @ 1 visit or <135 mm Hg @ 2 consecutive visits


Baseline characteristics
Baseline Characteristics Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

*Median value


Systolic pressures mean 95 ci
Systolic Pressures (mean Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial+ 95% CI)

Mean # Meds

Intensive: 3.2 3.4 3.5 3.4

Standard: 1.9 2.1 2.2 2.3

Average after 1st year: 133.5 Standard vs. 119.3 Intensive, Delta = 14.2


Medications prescribed 12 month visit
Medications Prescribed (12 Month Visit) Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial


Adverse events
Adverse Events Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

  • † Symptom experienced over past 30 days from HRQL sample of

  • N=969 participants assessed at 12, 36, and 48 months post-randomization


Clinical parameters assessed at last clinic visit
Clinical Parameters assessed at last clinic visit Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial


Primary secondary outcomes
Primary & Secondary Outcomes Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

Also examined Fatal/Nonfatal HF (HR=0.94, p=0.67), a composite of fatal coronary events, nonfatal MI and unstable angina (HR=0.94, p=0.50) and a composite of the primary outcome, revascularization and unstable angina

(HR=0.95, p=0.40)


Primary Outcome Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

Nonfatal MI, Nonfatal Stroke or CVD Death

HR = 0.88

95% CI (0.73-1.06)


Nonfatal Stroke Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

Total Stroke

HR = 0.63

95% CI (0.41-0.96)

HR = 0.59

95% CI (0.39-0.89)


Stroke results
Stroke Results Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

  • Intensive BP management reduced the rate of two closely correlated secondary end points: total stroke (p=0.01) and nonfatal stroke (p=0.03).

  • Assuming that this finding was real, the number needed to treat to the lower SBP level to prevent one stroke over 5 years was 89.

  • These effects would be consistent with meta-analyses summarizing the impact of a 10 mm Hg reduction in SBP on strokes from observational studies (relative risk=0.64) and drug treatment trials (relative risk=0.59).


Primary Outcome by Pre-defined Subgroups Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

Also examined DBP tertiles (p=0.70) and number of screening meds (p=0.44)


Conclusions
Conclusions Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

  • The ACCORD BP trial evaluated the effect of targeting a SBP goal of 120 mm Hg, compared to a goal of 140 mm Hg, in patients with type 2 diabetes at increased cardiovascular risk.

  • The results provide no conclusive evidence that the intensive BP control strategy reduces the rate of a composite of major CVD events in such patients.


Published online March 14, 2010 Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial


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