Dyslipidemia coexists with type 2 diabetes in 34% of Japanese patients. Statins and low-dose aspirin are commonly used to reduce the risk of atherosclerosis in diabetic patients. Dr. Takeshi Morimoto presented results of a trial that explored the burden of dyslipidemia, prevalence and effects of statin use, and the rationale for treatment strategies in Japanese patients with type 2 diabetes.
The Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial was a randomized, controlled, open-label, blinded-endpoint study to examine the efficacy of low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes mellitus. A total of 2,539 patients with no history of cardiovascular disease were randomized to aspirin (N=1,262) or no aspirin (N=1,277). Statins were prescribed by physicians based on clinical judgment. The primary endpoint was the composite of all atherosclerotic events. The median follow-up was 4.4 years.
Dyslipidemia was present in 53% of patients at baseline. Aspirin reduced the risk of atherosclerotic events by 20% (HR=0.8, 95% CI 0.6-1.1, p=0.16). A total of 154 events occurred, most consisting of nonfatal ischemic strokes. There were 59 hemorrhages, 40 in the aspirin group and 19 in the non-aspirin group.
Key findings in relation to LDL levels were:
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Baseline LDL was ≥120 mg/dL in 50% of patients and ≥100 mg/dL in 75% of patients. |
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Statins were received by 25% of patients. |
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Patients with baseline LDL ≥120 mg/dL had a higher risk of atherosclerotic events versus those with LDL <120 mg/dL (HR=1.5, 95% CI 1.1-2.1, p=0.02). Patients with LDL ≥100 mg/dL in the aspirin group had significantly less atherosclerotic events versus the non-aspirin group (HR=0.68, p=0.05). |
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Aspirin use made no difference in atherosclerotic events in patients with LDL <100 mg/dL. |
Statin use at baseline made no difference in risk of atherosclerotic events. Among patients who did not receive statins, those in the aspirin group had significantly fewer atherosclerotic events versus those in the non-aspirin group (HR=0.7, p=0.0047). Aspirin use made no difference in the number of atherosclerotic events in patients receiving statins. Among patients with LDL ≥100 mg/dL, those who did not receive aspirin or statins had a significantly higher risk of atherosclerotic events (p=0.02).
The JPAD trial confirmed that in Japanese patients with type 2 diabetes, baseline LDL is a risk factor for atherosclerotic events. Both aspirin and statins reduced the risk of atherosclerotic events in patients with increased LDL. Cumulative risk factors justify the use of aspirin and statins for primary prevention. Consideration of individual risks is important. Limitations of the trial were that it was a post-hoc analysis with a relatively shorter follow-up, low power, alpha errors due to multiple comparisons, and statins were not randomized.
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