What question did this study set out to answer?

To assess whether 10 mg of daily atorvastatin reduces cardiovascular disease events compared with placebo in patients with type 2 diabetes and low baseline low-density lipoprotein cholesterol levels.

June 26, 2006Diabetes Care

Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes

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Why the study?

Does atorvastatin 10 mg reduce the composite of cardiovascular events in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets?

Population

2,410 subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets

Comparison

Atorvastatin 10 mg vs Placebo

Design

RCT, randomly assigned, double-blind

Follow-up

4 years

Authors

RKRobert H. KnoppNorthwestern University MDMichael C dʼEmdenThe University of Queensland JSJ. G. SmildeRefaja Ziekenhuis

Discussion

Member takes

Implication

Atorvastatin 10 mg does not reduce cardiovascular events in type 2 diabetes with LDL below targets; challenges routine statin use and extends evidence on treatment thresholds.

Key Points

To assess whether 10 mg of daily atorvastatin reduces cardiovascular disease events compared with placebo in patients with type 2 diabetes and low baseline low-density lipoprotein cholesterol levels.
Randomized, double-blind, parallel-group study (ASPEN) evaluating 2,410 subjects with type 2 diabetes assigned to 10 mg daily atorvastatin or placebo over a 4-year duration.
Tracked a composite primary end point including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, recanalization, coronary artery bypass surgery, resuscitated cardiac arrest, and hospitalization for unstable angina.
Atorvastatin produced a 29% mean reduction in low-density lipoprotein cholesterol over 4 years compared with placebo (P < 0.0001).
The primary composite end point occurred in 13.7% of atorvastatin-treated subjects versus 15.0% of placebo-treated subjects (hazard ratio 0.90, 95% CI 0.73–1.12).
Subgroup primary event rates were 10.4% versus 10.8% without prior myocardial infarction or intervention (HR 0.97, 95% CI 0.74–1.28) and 26.2% versus 30.8% with prior intervention (HR 0.82, 95% CI 0.59–1.15).

Structured PICO

Does atorvastatin 10 mg reduce the composite of cardiovascular events in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets?

Population

2,410 subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets

Intervention

Atorvastatin 10 mg

Comparator

Placebo

Outcome

Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, recanalization, coronary artery bypass surgery, resuscitated cardiac arrest, and worsening or unstable angina requiring hospitalizationcomposite

Atorvastatin 10 mg did not significantly reduce the composite primary cardiovascular endpoint compared to placebo in subjects with type 2 diabetes and baseline LDL cholesterol below contemporary guideline targets.

Limitations

overall study design
types of subjects recruited
nature of the primary end point
protocol changes required because of changing treatment guidelines

Cite This Study

Knopp et al. (2006) studied this question.

synapsesocial.com/papers/6a7ecdf56cdd7a4db3026d9d https://doi.org/10.2337/dc05-2415

Topics

PCSK9 inhibitors Women and heart disease Cardiovascular prevention GLP-1 agonists cardiovascular outcomes

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Implication

Atorvastatin 10 mg does not reduce cardiovascular events in type 2 diabetes with LDL below targets; challenges routine statin use and extends evidence on treatment thresholds.

Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Topics

Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

Topics

Also Consider