LIPITOR^® Provides Significant CV Risk Reduction in Patients with Diabetes¹

Hypertension + Diabetes + ≥2 Additional Risk Factors

In an ASCOT-LLA post hoc subgroup analysis in patients with hypertension, diabetes, and ≥2 additional risk factors, LIPITOR^® 10 mg reduced the risk of total CV events and procedures by 23% compared with placebo²

Adapted from Sever PS et al. Diabetes Care. 2005.

ASCOT-LLA Study Design²

• Double-blind, placebo-controlled study including 10,305 hypertensive patients treated with antihypertensive therapy and without a previous MI with TC ≤250 mg/dL (6.5 mmol/L)
• Patients also had ≥3 additional CV risk factors
• Randomized to LIPITOR^® 10 mg (n=5168) or placebo (n=5137)
• Trial was terminated early (after a median follow-up of 3.3 years) on the recommendation of the data safety monitoring board, due to the significant early difference between groups in the primary endpoint.
• Analysis includes the 2532 patients with diabetes randomized to LIPITOR^® (n=1258) or placebo (n=1274)

Diabetes + ≥1 Additional Risk Factor

In the CARDS trial in patients with type 2 diabetes and ≥1 other CHD risk factor, LIPITOR^® 10 mg reduced the risk of major CV events by 37% compared with placebo¹

*Major CV events: MI (including silent MI), unstable angina, acute CHD death, resuscitated cardiac arrest, coronary revascularization, and stroke.⁴

• LIPITOR^®10 mg also reduced the risk of MI by 42% (P=0.007)³

In the CARDS trial in patients with type 2 diabetes and ≥1 risk factor, LIPITOR^® 10 mg reduced the risk of stroke by nearly half compared with placebo⁴

*Major CV events: MI (including silent MI), unstable angina, acute CHD death, resuscitated cardiac arrest, coronary revascularization, and stroke.⁴

• The lowest mean LDL-C level reached with LIPITOR^® in this study was 68 mg/dL (1.8 mmol/L)¹

CARDS Study Design^1,4,5

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG ≤600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years—2 years earlier than planned—due to highly significant benefits of atorvastatin

Diabetes + CKD,

In the CARDS post hoc subgroup analysis in high-risk patients with type 2 diabetes and CKD*, LIPITOR^® 10 mg significantly reduced the risk of stroke compared with placebo⁵

• In the CARDS post hoc subgroup analysis, LIPITOR^® 10 mg (n=482) reduced mean LDL-C from baseline 120 mg/dL to 71 mg/dL⁵

CARDS Study design^1,4,5

• Double-blind, prospective study in which 2838 patients aged 40 to 75 years were randomized to LIPITOR^® 10 mg (n=1428) or placebo (n=1410)
• Patients had type 2 diabetes, no documented history of CVD, LDL-C ≤160 mg/dL, TG ≤600 mg/dL, and ≥1 of the following: hypertension, retinopathy, albuminuria, or current smoking
• The primary endpoint was time to first occurrence of acute CHD events, coronary revascularization, or stroke
• Median duration of follow-up was 4.0 years (IQR 3.0-4.7) in the atorvastatin group; the CARDS trial was terminated at 3.9 years—2 years earlier than planned—due to highly significant benefits of atorvastatin

ASCOT-LLA: Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm; CARDS: Collaborative AtoRvastatin Diabetes Study; CHD: coronary heart disease; CV: cardiovascular; CVD: cardiovascular disease; CKD: chronic kidney disease; HDL-C: high-density lipoprotein cholesterol; IQR: interquartile range; LDL-C: low-density lipoprotein cholesterol; MI: myocardial infarction; RRR: relative risk reduction; TC: total cholesterol; TG: triglycerides.