Table 10Placebo-controlled trials in patients with diabetes

Study/Duration of follow-upPatients (N, mean baseline LDL-C, other risk factors)Drug, dosePrimary outcome (CHD endpoints)CHD endpoints relative risk (95% CI)All-cause mortalitya relative risk (95% CI)
CARDS125
3.9 years
2838
<107 mg/dL
At least 1: Retinopathy, albuminuria, current smoking, or hypertension
Atorvastatin 10 mgComposite of acute CHD event (MI, unstable angina, acute CHD death, resuscitated cardiac arrest), coronary revascularization, or stroke.0.63 (0.48 to 0.83)−27% (−48 to 1.0)b
Heart Protection Study (HPS) (Subgroup analysis)178
4.8 years
5963
125 mg/dL
Vascular disease (51%), treated hypertension (40%), current smoking (13%)
Simvastatin 40 mgMI, stroke, vascular procedure, cancer or other serious adverse experience, and about the main reasons for all other hospital admissions0.73 (0.62 to 0.85)Not evaluated
ASCOT-LLA (Subgroup analysis)184
3.3 years
2532
127.4 mg/dL
No history of CHD
Smoking (20%)
Atorvastatin 10 mgTotal CV events (CV deaths, nonfatal MI, unstable or stable angina, life- threatening arrhythmias, nonfatal HF, nonfatal stroke, PAD, retinal vasc thrombosis, revascularization, TIA, and reversible ischemic neuro deficits0.77 (0.61 to 0.96)Not evaluated
ASPEN142
4 years
2411
113.5 mg/dL
CVD history (34%), hypertension (55%), BP 133/76, smokers (12.5%)
Atorvastatin 10 mgComposite of CV death (fatal MI, fatal stroke, sudden cardiac death, HF, or arrhythmic nonsudden cardiac death), nonfatal or silent MI, nonfatal stroke, recanalization, CABG, resusc cardiac arrest, worsening or unstable angina requiring hospitalizationHR 0.90 (0.73 to 1.12)Not evaluated
LIPS (Subgroup analysis)183
3–4 years
202
126 mg/dL
Post-percutaneous coronary intervention
Fluvastatin 80 mgComposite of cardiac death (all deaths except those related to a noncardiac cause), nonfatal MI, and reinterventions (CABG, revascularization, or PCI for a new lesion)0.49 (0.29 to 0.84)Not evaluated
Xu, Kai 2007145
1.8 years
648
125 mg/dL
Percutaneous coronary intervention, prior MI (42.5%), bare metal stent (81%)
Atorvastatin 20 mgFatal and nonfatal MI, revascularization0.63 (0.50 to 0.79)0.63 (0.34 to 1.1)c
4D134
4 years
1255
121 mg/dL
Undergoing maintenance hemodialysis
Atorvastatin 20 mgComposite of death from cardiac causes, fatal stroke, nonfatal MI, or nonfatal stroke0.92 (0.77 to 1.10)0.93 (0.79 to 1.08)
a

All-cause mortality was a secondary outcome.

b

P=0.059.

c

P=0.196.

From: Adults

Cover of Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin
Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin: Final Report Update 5 [Internet].
Smith MEB, Lee NJ, Haney E, et al.
Portland (OR): Oregon Health & Science University; 2009 Nov.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.