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LDL-C Targets in Japanese Patients with Stable Coronary Artery Disease Receiving Statin Therapy: A REAL-CAD Study Sub-analysis

[2022/12/17] A sub-analysis of the REAL-CAD trial showed that LDL-C levels up to 70 mg/dL conferred a reduced risk of cardiovascular events in Japanese patients with stable coronary artery disease, but that lowering LDL-C below that level did not reduce risk, according to Dr.Masashi Sakuma, Dokkyo Medical University School of Medicine, and colleagues reported in the November 14 issue of BMC Medicine.

The REAL-CAD trial was a multicenter, randomized Japanese trial comparing high-dose (4 mg/day) versus low-dose (1 mg/day) pitavastatin in patients with stable coronary artery disease. Dr.Sakuma and colleagues evaluated the association between LDL-C levels 6 months after randomization and 5-year cardiovascular events in 11,105 patients enrolled in the REAL-CAD trial and investigated the LDL-C threshold at which the hazard ratio for cardiovascular events remains constant even if LDL-C levels fall below that threshold.

For the primary endpoints (cardiovascular death, nonfatal MI, nonfatal ischemic stroke, and unstable angina requiring emergency hospitalization), the model evaluated with log likelihood had the best fit when the LDL-C threshold was assumed to be 70 mg/dL. In the model with a threshold of ≧70 mg/dL, the hazard ratio for each 10 mg/dL increase in LDL-C was 1.07 (95% CI 1.01-1.13); the risk of cardiovascular events decreased until the LDL-C level fell to 70 mg/dL, but when it fell below that level the risk was independent of LDL-C values were independent of LDL-C levels.

Dr.Sakuma and colleagues summarize, "Our analytical model suggests that there is a threshold for LDL-C for secondary prevention of cardiovascular events in Japanese patients with coronary artery disease and that the threshold for the primary endpoint may be 70 mg/dL.

Sakuma M, et al. BMC Med. 2022; 20: 441

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