AimsTo elucidate the effects of intensive LDL-C lowering treatment with a standard dose of statin and ezetimibe in patients with dyslipidaemia and high risk of coronary events, targeting LDL-C less than 70 mg/dL (1.8 mmol/L), compared with standard LDL-C lowering lipid monotherapy targeting less than 100 mg/dL (2.6 mmol/L).Methods and resultsThe HIJ-PROPER study is a prospective, randomized, open-label trial to assess whether intensive LDL-C lowering with standard-dose pitavastatin plus ezetimibe reduces cardiovascular events more than standard LDL-C lowering with pitavastatin monotherapy in patients with acute coronary syndrome (ACS) and dyslipidaemia. Patients were randomized to intensive lowering (target LDL-C < 70 mg/dL [1.8 mmol/L]; pitavastatin plus ezetimibe) or standard lowering (target LDL-C 90 mg/dL to 100 mg/dL [2.3–2.6 mmol/L]; pitavastatin monotherapy). The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, and ischaemia-driven revascularization. Between January 2010 and April 2013, 1734 patients were enroled at 19 hospitals in Japan. Patients were followed for at least 36 months. Median follow-up was 3.86 years. Mean follow-up LDL-C was 65.1 mg/dL (1.68 mmol/L) for pitavastatin plus ezetimibe and 84.6 mg/dL (2.19 mmol/L) for pitavastatin monotherapy. LDL-C lowering with statin plus ezetimibe did not reduce primary endpoint occurrence in comparison with standard statin monotherapy (283/864, 32.8% vs. 316/857, 36.9%; HR 0.89, 95% CI 0.76–1.04, P = 0.152). In, ACS patients with higher cholesterol absorption, represented by elevated pre-treatment sitosterol, was associated with significantly lower incidence of the primary endpoint in the statin plus ezetimibe group (HR 0.71, 95% CI 0.56–0.91).ConclusionAlthough intensive lowering with standard pitavastatin plus ezetimibe showed no more cardiovascular benefit than standard pitavastatin monotherapy in ACS patients with dyslipidaemia, statin plus ezetimibe may be more effective than statin monotherapy in patients with higher cholesterol absorption; further confirmation is needed.Trial NoUMIN000002742, registered as an International Standard Randomized Controlled Trial.

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The results suggest that the combination of amlodipine and candesartan is more beneficial in reducing MACE in hypertensive patients with CAD compared to non-amlodipine-DHP-CCBs in combination therapy with candesartan. Further investigation in larger-scale prospective randomized studies is required to reach any conclusion as to the superiority of combination therapy of candesartan with amlodipine.

This study aimed to determine whether different systolic blood pressure (SBP) measurements achieved with antihypertensive therapy impact clinical outcomes by age in patients with hypertension and coronary artery disease (CAD). This post hoc analysis from the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Heart Disease (HIJ‐CREATE) trial included 2048 patients with hypertension and angiographically documented CAD. Participants were divided into three groups based on age at enrollment: middle‐aged (<60 years, n = 570), pre‐elderly (≥60‐<70 years, n = 730), and elderly (≥70 years, n = 748). Among the 2,048 patients, 1695 (82.7%) underwent percutaneous coronary intervention. The primary end point was the time to first occurrence of a major adverse cardiac event (MACE). During a median follow‐up of 4.2 years, the MACE rate was 19.8%, 28.1%, and 31.1% in the middle‐aged, pre‐elderly, and elderly groups, respectively. Achieved BP was defined as the mean BP during scheduled visits. Patients with higher achieved SBP had a higher occurrence of MACE in all age groups. An unadjusted quadratic proportional hazard model was used to evaluate the relationship between achieved BP during follow‐up and risk for MACE. In each age group, participants were divided into quartiles based on the achieved BP during follow‐up. The relationship between achieved SBP and the incidence of MACE did not follow a J‐shaped curve in any age group. In conclusion, in the contemporary era of aggressive coronary revascularization, a lower SBP target may be appropriate even in elderly patients with hypertension and CAD.