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