VBWG HPS. Lancet. 2003;361: Gæde P et al. N Engl J Med. 2003;348: Recent statin trials: Reduction in primary outcome in patients with diabetes HPSSteno-2 Relative risk reduction (%) P < P = 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
VBWG CARDS: Collaborative AtoRvastatin Diabetes Study design Colhoun HM et al. Diabet Med. 2002;19: Atorvastatin 10 mg Placebo Randomization complete June 2001 Early termination June 2003 Planned completion 2005 Results announced June 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)
VBWG CARDS: Treatment effects on lipids Colhoun HM et al. Lancet. 2004;364: Total-C Average difference 26% 1.4 mmol/L (54 mg/dL) LDL-C Average difference 40% 1.2 mmol/L (46 mg/dL) Years mmol/L Years PlaceboAtorvastatin P <
VBWG CARDS: 37% Reduction in primary outcome Colhoun HM et al. Lancet. 2004;364: Placebo Atorvastatin Years Cumulative hazard (%) 4.75 Placebo 127 events Atorvastatin 83 events Relative risk reduction 37% 95% CI, 17%–52% P = 0.001
VBWG CARDS: Consistent statin effects on components of primary outcome Colhoun HM et al. Lancet. 2004;364: EventPlaceboAtorvastatin Hazard ratio Risk reduction (95% CI) Favors atorvastatin Favors placebo Primary outcome (9.0)83 (5.8) 37% (17–52) P = Acute coronary events 77 (5.5)51 (3.6)36% (9–55) Coronary revascularization 34 (2.4)24 (1.7)31% ( – 16–59) Stroke 39 (2.8)21 (1.5)48% (11–69) n (% randomized)
VBWG 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.