HPS. Lancet . 2003;361:2005-16. Gæde P et al. N Engl J Med . 2003;348:383-93.

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VBWG HPS. Lancet. 2003;361:2005-16. Gæde P et al. N Engl J Med. 2003;348:383-93. nt statin trials: Reduction in prim ome in patients with diabetes 60 50 40 30 20 10 0 HPS Steno-2 Relative risk reduction (%) 22 53 P < 0.0001 P = 0.007 : major coronary event, stroke, or revascularization no-2: CV death, nonfatal MI, CABG, PCI, nonfatal stroke, utation for ischemia, or vascular surgery for PAD

description

Recent statin trials: Reduction in primary outcome in patients with diabetes. HPS. Steno-2. 0. 10. 22. 20. Relative risk reduction (%). P < 0.0001. 30. 40. 53. 50. P = 0.007. 60. HPS: major coronary event, stroke, or revascularization - PowerPoint PPT Presentation

Transcript of HPS. Lancet . 2003;361:2005-16. Gæde P et al. N Engl J Med . 2003;348:383-93.

Page 1: HPS.  Lancet . 2003;361:2005-16. Gæde P et al.  N Engl J Med . 2003;348:383-93.

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HPS. Lancet. 2003;361:2005-16.Gæde P et al. N Engl J Med. 2003;348:383-93.

Recent statin trials: Reduction in primaryoutcome in patients with diabetes

60

50

40

30

20

10

0HPS Steno-2

Relativerisk

reduction(%)

22

53

P < 0.0001

P = 0.007

HPS: major coronary event, stroke, or revascularizationSteno-2: CV death, nonfatal MI, CABG, PCI, nonfatal stroke,amputation for ischemia, or vascular surgery for PAD

Page 2: HPS.  Lancet . 2003;361:2005-16. Gæde P et al.  N Engl J Med . 2003;348:383-93.

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CARDS: Collaborative AtoRvastatin Diabetes Study design

Colhoun HM et al. Diabet Med. 2002;19:201-11.

Atorvastatin 10 mg

Placebo

Randomization completeJune 2001

Early termination June 2003

Plannedcompletion

2005

ResultsannouncedJune 2004

Primary outcome: Composite of major coronary events, revascularizations, unstable angina, resuscitated cardiac arrest, and stroke

High-risk patients

with type 2 diabetes (N = 2838)

Page 3: HPS.  Lancet . 2003;361:2005-16. Gæde P et al.  N Engl J Med . 2003;348:383-93.

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CARDS: Treatment effects on lipids

Colhoun HM et al. Lancet. 2004;364:685-96.

Total-CAverage difference 26%1.4 mmol/L (54 mg/dL)

LDL-CAverage difference 40%1.2 mmol/L (46 mg/dL)

6

4

2

0

Years

0 1 2 3 4.54

mmol/L

4

3

1

0

Years

0 1 2 3 4.54

2

Placebo Atorvastatin

P < 0.0001 P < 0.0001

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CARDS: 37% Reduction in primary outcome

Colhoun HM et al. Lancet. 2004;364:685-96.

1410 1351 1306 1022 651 305Placebo

1428 1392 1361 1074 694 328Atorvastatin

15

10

5

0

Years0 1 2 3 4

Cumulativehazard

(%)

4.75

Placebo127 events

Atorvastatin83 events

Relative risk reduction 37%95% CI, 17%–52%P = 0.001

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CARDS: Consistent statin effects on components of primary outcome

Colhoun HM et al. Lancet. 2004;364:685-96.

Event Placebo Atorvastatin

Hazard ratio

Risk reduction(95% CI)

Favorsatorvastatin

Favorsplacebo

Primary outcome

0.2 0.4 0.6 0.8 1.0 1.2

127 (9.0) 83 (5.8)37% (17–52)

P = 0.001

Acute coronaryevents

77 (5.5) 51 (3.6) 36% (9–55)

Coronaryrevascularization

34 (2.4) 24 (1.7) 31% (–16–59)

Stroke39 (2.8) 21 (1.5) 48% (11–69)

n (% randomized)

Page 6: HPS.  Lancet . 2003;361:2005-16. Gæde P et al.  N Engl J Med . 2003;348:383-93.

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ACP recommendations for lipid management in patients with diabetes

• Lipid-lowering therapy is indicated for secondary prevention in all patients with diabetes and known coronary artery disease

• Statins are indicated for primary prevention of macrovascular complications in patients with diabetes and other CV risk factors

• Once statin therapy is initiated, patients should receive at least moderate doses

• Routine monitoring of liver function or muscle enzymes is not recommended for patients receiving statins, except in specific circumstances

Snow V et al. Ann Intern Med. 2004;140:644-9.