Standard-Dose Statin Therapy Provides Incremental Clinical Benefits in Normocholesterolemic Diabetic Patients
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Key result
Standard-dose statin therapy significantly reduced the risk of major adverse cardiovascular and cerebrovascular events by 67% (HR 0.30) compared to no statin therapy in normocholesterolemic diabetic patients with coronary heart disease.
Why the study?
Does standard-dose statin therapy reduce subsequent cardiovascular events in normocholesterolemic patients with coronary heart disease, particularly those with diabetes?
Population
1,016 patients with coronary heart disease and serum total cholesterol levels of 180-240 mg/dl, including…
Comparison
Standard-dose statin therapy vs Non-statin treatment
Design
RCT, randomly divided, open, blinded-endpoint
Authors
Discussion
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Implication
Supports statin use in normocholesterolemic diabetic patients with CHD; extends evidence beyond hypercholesterolemia.
Study Design
Type
RCT (n=1,016)
Blinding
Open-label, blinded-endpoint
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does standard-dose statin therapy reduce subsequent cardiovascular events in normocholesterolemic patients with coronary heart disease, particularly those with diabetes?
P
Population
1,016 Japanese patients with coronary heart disease and normal cholesterol levels (180-240 mg/dl), including 301 with type 2 diabetes, followed for a mean of 547 days.
I
Intervention
Standard-dose statin therapy
C
Comparator
Non-statin treatment
O
Outcome
Subsequent cardiovascular eventscomposite
Main Result
Hazard Ratio: 0.3 (95% CI 0.14–0.63)
Absolute Event Rate: 6% vs 18%
Number Needed to Treat: 8
p-value: p=0.002
Standard-dose statin therapy provides pronounced incremental clinical benefits in normocholesterolemic diabetic patients with CHD, suggesting significant pleiotropic effects independent of LDL-lowering.
Limitations
- Subanalysis of the MUSASHI database
- Limited to the Japanese population
- Period prevalence of DM, type of antidiabetic agents used, and control of blood glucose or HbA1c were not investigated
- Potential biases in the data setting
Cite This Study
Kojima et al. (2010) conducted an RCT in Coronary heart disease with normal cholesterol levels (n=1,016). Standard-dose statin therapy vs. Non-statin therapy was evaluated on Major adverse cardiovascular and cerebrovascular events (MACCE) in the diabetic subgroup (HR 0.30, 95% CI 0.14-0.63, p=0.002). Standard-dose statin therapy significantly reduced the risk of major adverse cardiovascular and cerebrovascular events by 67% (HR 0.30) compared to no statin therapy in normocholesterolemic diabetic patients with coronary heart disease.
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