Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine
   Position   Associate Professor
Language English
Title HIJ-PROPER - LDL cholesterol targeting with pitavastatin + ezetimibe for patients with acute coronary syndrome and dyslipidemia
Conference ESC Congress 2016
Promoters European Society of Cardiology
Conference Type International society and overseas society
Presentation Type Speech
Lecture Type General
Publisher and common publisher◎HAGIWARA Nobuhisa, WATANABE Erisa, KOYANAGI Ryo, ARASHI Hiroyuki, YAMAGUCHI Junichi, NAKAO Koichi, TOBARU Tetsuya, TANAKA Hiroyuki, Matsui Kunihiko, OGAWA Hiroshi
Date 2016/08/29
(city and name of the country)
Summary This study included 1734 patients(aged ≥ 20 years) with ACS and dyslipidemia who were hospitalized for STEMI, NSTEMI, or unstable angina (UA) within the 10 days prior to randomization. Patients randomized to combination therapy received 2 mg of pitavastatin and 10 mg of ezetimibe as a starting dose, targeting an LDL-C level of < 70mg/dL while the monotherapy group targeted a LDL-C level of 90-100 mg/dL with 2 mg of pitavastatin (patients already receiving a statin discontinued their current medication and were switched to 2 mg of pitavastatin (patients already receiving a statin discontinued their current medication and were switched to 2 mg of pitavastatin as a starting dose). In both groups, the pitavastatin dose was adjusted daily to produce the appropriate LDL-C target level.
The composite primary endpoint consisted of all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke, UA, or revascularization with either percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG). Secondary endpoints included CV events (nonfatal MI, nonfatal stroke, UA, ischemia-driven revas-cularization with either PCI or CABG), all-cause death, heart failure, inflammatory markers, and adverse events (including new occurrence of malignant tumor). Patients were followed for a minimum of 3 years.
At baseline, participants were a mean age of 65.6 years and had a mean body mass index of 24.3 kg/ m2; 75.5% were men and 83.3 % were statin naïve. Index ACS events were STEMI (51.0%), NSTEMI (10.5%), and UA (38.5%). Hypertension was present in 68% of patients and diabetes in 30%. The mean LDL-C at study entry was 135 mg/dL (SD ± 30) and mean sitosterol (a cholesterol absorption marker) was 2.50 μg/mL. The index revascularization for ACS was PCI in 94.5 % of individuals.
Patients treated with pitavastatin and ezetimibe had significantly lower LDL-C (67.5 mg/dL vs 87.2 mg/dL; P < .001), total cholesterol (142.7 mg/dL vs 165.3 mng/dL; P < .001), and triglyceride values (125.2 mg/dL vs 144.2 mg/dL; P < .001) after 1 year compared with those receiving pitavastatin monotherapy. However, the reduction in the composite primary endpoint events among patients receiving intensive LDL-C lowering with the combination of pitavastatin and ezetimibe was not significantly differently from the reductions achieved with pitavastatin alone in patients with ACS and dyslip-idemia at 3 years (32.8% vs 36.9; HR, 0.89; 95% CI, 0.76 to 1.04; P=.152).
There were no significant differences between groups for the secondary outcomes (CV death, nonfatal MI, or nonfatal stroke) and safety outcomes were similar between the 2 arms.
There were no differences between the 2 therapeutic approaches for the major pre-specified subgroups of age, diabetes status, prior lipid-lowering therapy, or median LDL-C mg/dL.