Background: Intensive low-density lipoprotein cholesterol therapy with ezetimibe/simvastatin in IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) significantly reduced the first primary endpoint (PEP) in patients post-acute coronary syndrome (ACS) compared to placebo/simvastatin.
Objectives: This analysis tested the hypothesis that total events, including those beyond the first event, would also be reduced with ezetimibe/simvastatin therapy.
Methods: All PEP events (cardiovascular [CV] death, myocardial infarction [MI], stroke, unstable angina [UA] leading to hospitalization, coronary revascularization ≥30 days post-randomization) during a median 6-year follow-up were analyzed in patients randomized to receive ezetimibe/simvastatin or placebo/simvastatin in IMPROVE-IT. Negative binomial regression was used for the primary analysis.
Results: Among 18,144 patients, there were 9,545 total PEP events (56% were first events and 44% subsequent events). Total PEP events were significantly reduced by 9% with ezetimibe/simvastatin vs placebo/simvastatin (incidence-rate ratio [RR]: 0.91; 95% confidence interval [CI]: 0.85 to 0.97; p = 0.007), as were the 3 pre-specified secondary composite endpoints and the exploratory composite endpoint of CV death, MI, or stroke (RR: 0.88; 95% CI: 0.81 to 0.96; p = 0.002). The reduction in total events was driven by decreases in total nonfatal MI (RR: 0.87; 95% CI: 0.79 to 0.96; p = 0.004) and total NF stroke (RR: 0.77; 95% CI: 0.65 to 0.93; p = 0.005).
Conclusions: Lipid-lowering therapy with ezetimibe plus simvastatin improved clinical outcomes. Reductions in total PEP events, driven by reductions in MI and stroke, more than doubled the number of events prevented compared with examining only the first event. These data support continuation of intensive combination lipid-lowering therapy after an initial CV event. (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT]; NCT00202878).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jacc.2015.10.077 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Prospective validation and revision of predictive models for post-ERCP pancreatitis: focus on procedure-related factors and a novel risk stratification approach.
Surg Endosc
December 2024
Division of Gastroenterology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea.
Introduction: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP). Although retrospective models to predict PEP have shown promise, their real-world applicability remains uncertain. Thus, we used prospectively derived cohort data to validate current prediction models.
View Article and Find Full Text PDFImpact of major duodenal papilla morphology on the outcomes of primary needle-knife fistulotomy for deep biliary cannulation.
Sci Rep
December 2024
Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
The morphology of the major duodenal papilla (MDP) plays a crucial role in the selection of the cannulation technique. Primary needle-knife fistulotomy (pNKF) is an advanced cannulation technique is getting more popular because of the lower risk of post-ERCP pancreatitis (PEP). However, few studies have explored the impact of MDP morphology on pNKF outcomes.
View Article and Find Full Text PDFEffect of respiration and exercise on seismocardiographic signals.
Comput Biol Med
December 2024
Department of Mechanical and Aerospace Engineering, University of Central Florida, and the Biomedical Acoustics Research Company, 32816, Orlando, FL, USA.
Background: Seismocardiographic signals (SCG) are chest wall vibrations induced by mechanical cardiac activities. This study investigated the morphological changes in the SCG signal due to respiration and exercise.
Methods: Fifteen healthy subjects were recruited, and SCG was acquired before and after exercise.
Predictors of Post-ERCP Pancreatitis: A Comprehensive Systematic Review and Meta-Analysis.
Clin Gastroenterol Hepatol
December 2024
Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN.
Background And Aims: Pancreatitis is the most common serious adverse event associated with endoscopic retrograde cholangiopancreatography (ERCP). This meta-analysis aimed to precisely assess the risk factors for post-ERCP pancreatitis (PEP).
Methods: We searched electronic databases for studies that assessed risk factors for PEP after adjusting for ≥3 risk factors, including at least one pre-specified patient-related and one procedure-related risk factor, and reported the data as adjusted odds ratios (OR) with 95% confidence intervals.
Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study.
J Natl Cancer Inst
December 2024
Department of Gastrointestinal Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Background: Noninferiority (NI) and equivalence trials evaluate whether an experimental therapy's effect on the primary endpoint (PEP) is contained within an acceptable margin compared to standard-of-care. The reliability and impact of this conclusion, however, is largely dependent on the justification for this design, the choice of margin, and the analysis population used.
Methods: A meta-epidemiological study was performed of phase 3 randomized NI and equivalence oncologic trials registered at ClinicalTrials.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!