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- W2328932600 abstract "Purpose: Statins may reduce cardiovascular (CV) morbidity in patients with mild-to-moderate elevations in liver enzyme levels. This post-hoc analysis of the IDEAL study compared intensive versus moderate statin therapy for the prevention of CV events in coronary heart disease (CHD) patients stratified by serum alanine aminotransferase (ALT) level at baseline. Methods: IDEAL compared intensive (atorvastatin 80 mg/day) versus moderate (simvastatin 20–40 mg/day) statin therapy for the prevention of CV events in 8888 patients with CHD over 4.8 years of follow-up. Here, Cox regression analysis was used to investigate the effect of intensive versus moderate statin therapy on the risk of IDEAL study end points in patients with normal baseline ALT (ALT < ULN [upper limit of normal]) versus elevated baseline ALT (ALT ≥ ULN). Treatment × normal or elevated baseline ALT interactions were tested at the 0.1 significance level. Results: Of 8863 IDEAL patients with non-missing baseline ALT values, 7782 (87.8%) had an ALT < ULN and 1081 (12.2%) had an ALT ≥ ULN. In patients with elevated ALT levels, the rates of major CV events (CHD death, nonfatal acute MI, resuscitated cardiac arrest, or stroke) were 11.5% for simvastatin and 6.5% for atorvastatin, indicating a significant risk reduction with intensive statin therapy (hazard ratio [HR], 0.556; 95% confidence interval [CI], 0.367–0.842; p=0.0056). In patients with normal ALT levels, these rates were 13.9% for simvastatin and 12.7% for atorvastatin (HR, 0.903; 95% CI, 0.799–1.020; p=0.1011). The significant treatment × subgroup interaction for major CV events (interaction p=0.0277) indicated a greater treatment effect in the elevated ALT group versus the normal ALT group. A similar trend towards greater benefit with atorvastatin in the elevated ALT group was observed for the other study end points; interaction p values were statistically significant for cerebrovascular events (HR, 0.391; 95% CI, 0.164–0.929; interaction p=0.0457) and major coronary events (HR, 0.617; 95% CI, 0.396–0.961; interaction p=0.0945). Adjustment for baseline characteristics that showed statistically significant differences between treatment groups did not substantially affect these findings. Conclusions: The CV benefit of intensive lipid lowering with atorvastatin compared with a more moderate regimen with simvastatin was generally greater in patients with elevated baseline ALT than patients with normal baseline ALT. Moderate elevations in liver enzyme levels should not present a barrier to prescribing statins, even at higher doses, in high-risk patients." @default.
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- W2328932600 date "2013-08-02" @default.
- W2328932600 modified "2023-10-16" @default.
- W2328932600 title "Effect of intensive lipid lowering with atorvastatin on cardiovascular outcomes in coronary heart disease patients with baseline elevations in alanine aminotransferase levels" @default.
- W2328932600 doi "https://doi.org/10.1093/eurheartj/eht307.p679" @default.
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