ABSTRACT
Background@#This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. @*Methods@#The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex® . @*Results@#A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. @*Conclusion@#Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.
ABSTRACT
As per guidelines for treating dyslipidemia, the recommended low-density lipoprotein cholesterol (LDL-C) level in extremely high-risk patients, including those with coronary artery diseases is 6 months of follow-up, those with a sample size of ≥150 were selected as the final literature for analysis. Risk ratios (RR) using random effects were represented with 95% confidence intervals (CI) for the reliability of the results. Results: An LDL-C level of <55 mg/dL was related to significantly reduced events of major CVDs (RR: 0.88; 95% CI: 0.80-0.98) and myocardial infarction (RR: 0.81; 95% CI: 0.73-0.90) and a reduced risk of ischemic stroke (RR 0.79; 95% CI 0.69-0.89, mean follow-up=2 years). However, an LDL-C level below 55 mg/dL did not reduce the incidence of CVD in intensive therapy in East Asian patients. Conclusions: A goal LDL-C value below 55 mg/dL was identified to be related to a decreased risk of developing CVD. However, the relation to LDL-C below 55 mg/dL with a decreased risk of CVD was not observed in East Asian patients.