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Reduction in high-sensitivity C-reactive protein by pitavastatin was associated with improved outcomes in Japanese patients with stable coronary artery disease: results from REAL-CAD study

Session Poster Session 6

Speaker Hiroshi Iwata

Congress : ESC Congress 2019

  • Topic : preventive cardiology
  • Sub-topic : Lipids: Drug therapy
  • Session type : Poster Session
  • FP Number : P5320

Authors : H Iwata (Tokyo,JP), S Iimuro (Tokyo,JP), A Inoue (Mibu,JP), K Miyauchi (Tokyo,JP), I Taguchi (Koshigaya City,JP), T Hiro (Tokyo,JP), Y Nakagawa (Otsu,JP), Y Ozaki (Toyoake,JP), Y Ohashi (Tokyo,JP), H Daida (Tokyo,JP), H Shimokawa (Sendai,JP), T Kimura (Kyoto,JP), R Nagai (Shimotsuke,JP)

H Iwata1 , S Iimuro2 , A Inoue3 , K Miyauchi1 , I Taguchi4 , T Hiro5 , Y Nakagawa6 , Y Ozaki7 , Y Ohashi8 , H Daida1 , H Shimokawa9 , T Kimura10 , R Nagai11 , 1Juntendo University School of Medicine - Tokyo - Japan , 2Teikyo University, Teikyo Academic Research Center - Tokyo - Japan , 3Dokkyo Medical University - Mibu - Japan , 4Dokkyo Medical University Koshigya Hospital - Koshigaya City - Japan , 5Nihon University - Tokyo - Japan , 6Shiga University of Medical Science - Otsu - Japan , 7Fujita Health University School of Medicine - Toyoake - Japan , 8Chuo University, Department of Integrated Science and Technology for Sustainable Society - Tokyo - Japan , 9Tohoku University Graduate School of Medicine - Sendai - Japan , 10Kyoto University Graduate School of Medicine - Kyoto - Japan , 11Jichi Medical University - Shimotsuke - Japan ,

On behalf: REAL-CAD


Background: The effect of statins on lowering high sensitivity C-reactive protein (hs-CRP) as well as low density lipoprotein cholesterol (LDL-C) has been associated with reduced risk for cardiovascular events in patients with elevated hs-CRP. However, it remains unclear whether this statin effect applies to low-risk patients with stable coronary artery disease (CAD). In this pre-specified sub-study within the REAL-CAD trial, we explored the association between achieved LDL-C/hs-CRP levels and cardiovascular events in Japanese patients with stable CAD who were treated with pitavastatin 1 mg or 4 mg/day.

Methods: The REAL-CAD trial randomly allocated 13,054 patients with stable CAD to pitavastatin 1 mg or 4 mg/day. LDL-C and hs-CRP were measured at baseline and at 6 months after randomization. We excluded those patients without 6-month data and those with endpoint events before 6 months (N=1915). The primary endpoint of the study was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or unstable angina requiring emergency hospitalization. Outcomes were assessed by landmark analysis beyond 6 months among 4 groups that were configured based on LDL-C (median) and hs-CRP (median) targets: achieving neither target, achieving LDL-C target only, achieving hs-CRP target only, and achieving both targets. Data were adjusted for baseline characteristics including age, gender, diabetes and baseline values of LDL-C and hs-CRP.

Results— Median LDL-C and hs-CRP levels were 88 mg/dL and 0.52 mg/L at baseline and 80 mg/dL and 0.48 mg/L after 6 months, respectively. There was no correlation between the change in LDL-C and hs-CRP levels from baseline to 6 months (correlation coefficient: 0.009, P=0.331). Of the 11,677 patients included in the study, 25.1% (N=2799) achieved both LDL-C and hs-CRP targets, 25.3% (N=2282) met neither target, 24.8% (N=2765) met only the hs-CRP target, and 24.7% (N=2753) met only the LDL-C target. Risk of primary endpoint occurrence was significantly lower in those achieving either or both targets than in those meeting neither target (Figure A). In the subgroup analysis stratified by the randomized dose of pitavastatin, the risk for the primary endpoint was significantly lower in patients achieving both targets in both the 1mg and 4 mg arms, and in patients achieving only hs-CRP target in the 1 mg arm (Figure B, C).

Conclusions—In this subanalysis of the REAL-CAD trial, the hs-CRP lowering effect of pitavastatin was independent from LDL-C lowering. Lower achieved hs-CRP was associated with lower risk for cardiovascular events in Japanese patients with stable CAD.

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