HPS. Lancet. 2003;361:2005-16.

1
Recent statin trials Reduction in
primaryoutcome in patients with diabetes
HPS
Steno-2
0
10
22
20
Relativeriskreduction()
P lt 0.0001
30
40
53
50
P 0.007
60
HPS major coronary event, stroke, or
revascularization Steno-2 CV death, nonfatal MI,
CABG, PCI, nonfatal stroke,amputation for
ischemia, or vascular surgery for PAD
HPS. Lancet. 20033612005-16. Gæde P et al. N
Engl J Med. 2003348383-93.
2
CARDS Collaborative AtoRvastatin Diabetes Study
design
High-risk patients with type 2 diabetes (N
2838)
Atorvastatin 10 mg
Placebo
Randomization completeJune 2001
Early termination June 2003
Plannedcompletion2005
ResultsannouncedJune 2004
Primary outcome Composite of major coronary
events, revascularizations, unstable angina,
resuscitated cardiac arrest, and stroke
Colhoun HM et al. Diabet Med. 200219201-11.
3
CARDS Treatment effects on lipids
Total-CAverage difference 261.4 mmol/L (54
mg/dL)
LDL-CAverage difference 401.2 mmol/L (46 mg/dL)
6
4
3
4
2
mmol/L
2
1
P lt 0.0001
P lt 0.0001
0
0
0
1
2
3
4.5
4
0
1
2
3
4.5
4
Years
Years
Placebo
Atorvastatin
Colhoun HM et al. Lancet. 2004364685-96.
4
CARDS 37 Reduction in primary outcome
Colhoun HM et al. Lancet. 2004364685-96.
5
CARDS Consistent statin effects on components
of primary outcome
n ( randomized)
Risk reduction (95 CI)
Favorsatorvastatin
Favorsplacebo
Event
Placebo
Atorvastatin
37 (1752)P 0.001
Primary outcome
127 (9.0)
83 (5.8)
Acute coronary events
77 (5.5)
51 (3.6)
36 (955)
Coronaryrevascularization
34 (2.4)
24 (1.7)
31 (1659)
Stroke
39 (2.8)
21 (1.5)
48 (1169)
0.2
0.4
0.6
0.8
1.0
1.2
Hazard ratio
Colhoun HM et al. Lancet. 2004364685-96.
6
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. 2004140644-9.