Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial.

BACKGROUND: A manufacturer of atorvastatin is seeking marketing approval in Korea of a generic product for adult patients with primary hypercholesterolemia. OBJECTIVE: The objective of this study was to compare the efficacy and tolerability of a new generic formulation of atorvastatin (test) with those of an original formulation of atorvastatin (reference) to satisfy regulatory requirements for marketing of the generic product in Korea. METHODS: Patients enrolled were aged 20 to 79 years with documented primary hypercholesterolemia who did not respond adequately to therapeutic lifestyle changes and with a LDL-C level >100 mg/dL from a high-risk group of coronary artery disease patients. Eligible patients were randomized to receive 1 of the 2 formulations of atorvastatin 20 mg per day for 8 weeks. The primary end point was the percent change in LDL-C level from baseline to week 8. Secondary end points included the percent change in total cholesterol, triglycerides, HDL-C level, apolipoprotein B:apolipoprotein A-I ratio, LDL:HDL ratio, LDL-C particle size, high-sensitivity C-reactive protein from baseline to week 8, and achievement rate of the LDL-C goal. RESULTS: A total of 298 patients (141 men and 157 women; 149 patients in each group; mean [SD] age, 62.4 [9.2] in the test group vs 60.3 [8.9] years in the reference group) were included. LDL-C levels were significantly decreased from baseline to week 8 in both groups, and there was no significant difference in the percent change in LDL-C level between groups (-44.0% [17.2%] in the test group, -45.4% [16.9%] in the reference group; P = 0.49). The between-group differences in the percent changes in total cholesterol and triglyceride levels were not statistically significant. In addition, there was no significant difference between the 2 groups in percent changes in HDL-C, apolipoprotein B:apolipoprotein A-I ratio, LDL-C:HDL-C ratio, LDL-C particle size, high-sensitivity C-reactive protein, and the achievement rate of the LDL-C goal. Two (1.3%) patients in the reference group (N = 150) experienced treatment-related serious adverse events (AEs): toxic hepatitis and aggravation of chest pain. Common AEs were cough (4.1%), myalgia (2.1%), and indigestion (1.4%) in the test formulation group and cough (5.3%), creatine kinase elevation (2.7%), and edema (0.7%) in the reference formulation group; however, the differences in overall prevalence of AEs between the 2 treatment groups was not significant (P = 0.88). CONCLUSIONS: There were no significant differences observed in the efficacy and tolerability between the test and reference formulations of atorvastatin in these Korean adult patients with primary hypercholesterolemia.

Hospital discharge risk score system for the assessment of clinical outcomes in patients with acute myocardial infarction (Korea Acute Myocardial Infarction Registry [KAMIR] score).

Assessment of risk at time of discharge could be a useful tool for guiding postdischarge management. The aim of this study was to develop a novel and simple assessment tool for better hospital discharge risk stratification. The study included 3,997 hospital-discharged patients with acute myocardial infarction who were enrolled in the nationwide prospective Korea Acute Myocardial Infarction Registry-1 (KAMIR-1) from November 2005 through December 2006. The new risk score system was tested in 1,461 hospital-discharged patients who were admitted from January 2007 through January 2008 (KAMIR-2). The new risk score system was compared to the Global Registry of Acute Coronary Events (GRACE) postdischarge risk model during a 12-month clinical follow-up. During 1-year follow-up, all-cause death occurred in 228 patients (5.7%) and 81 patients (5.5%) in the development and validation cohorts, respectively. The new risk score (KAMIR score) was constructed using 6 independent variables related to the primary end point using a multivariable Cox regression analysis: age, Killip class, serum creatinine, no in-hospital percutaneous coronary intervention, left ventricular ejection fraction, and admission glucose based on multivariate-adjusted risk relation. The KAMIR score demonstrated significant differences in its predictive accuracy for 1-year mortality compared to the GRACE score for the developmental and validation cohorts. In conclusion, the KAMIR score for patients with acute myocardial infarction is a simpler and better risk scoring system than the GRACE hospital discharge risk model in prediction of 1-year mortality.

Gender differences in clinical features and in-hospital outcomes in ST-segment elevation acute myocardial infarction: from the Korean Acute Myocardial Infarction Registry (KAMIR) study.

BACKGROUND: Studies have suggested that women are biologically different and that female gender itself is independently associated with poor clinical outcome after an acute myocardial infarction (AMI). HYPOTHESIS: We analyzed data from the Korean Acute Myocardial Infarction Registry (KAMIR) to assess gender differences in in-hospital outcomes post ST-segment elevation myocardial infarction (STEMI). METHODS: Between November 2005 and July 2007, 4037 patients who were admitted with STEMI to 41 facilities were registered into the KAMIR database; patients admitted within 72 hours of symptom onset were selected and included in this study. RESULTS: The proportion of patients who had reperfusion therapy within 12 hours from chest pain onset was lower in women. Women had higher rates of in-hospital mortality (8.6% vs 3.2%, P < .01), noncardiac death (1.5% vs 0.4%, P < .01), cardiac death (7.1% vs 2.8%, P < .01), and stroke (1.2% vs 0.5%, P < .05) than men. Multivariate logistic regression analysis identified age, previous angina, hypertension, a Killip class > or = II, a left ventricular ejection fraction (LVEF) < 40%, and a thrombolysis in myocardial infarction flow (TIMI) grade < or = 3 after angioplasty as independent risk factors for in-hospital death for all patients; however, female gender itself was not an independent risk factor. CONCLUSIONS: The results of this study show that although women have a higher in-hospital mortality than men, female gender itself is not an independent risk factor for in-hospital mortality.

A new risk score system for the assessment of clinical outcomes in patients with non-ST-segment elevation myocardial infarction.

BACKGROUND AND OBJECTIVES: Prediction for long-term clinical outcomes in patients with non-ST elevation acute coronary syndrome is important as well as early risk stratification. The aim of this study is to develop a simple assessment tool for better early bedside risk stratification for both short- and long-term clinical outcomes. SUBJECTS AND METHODS: 2148 patients with non-ST-segment elevation myocardial infarction (NSTEMI) (64.9±12.2 years, 35.0% females) were enrolled in a nationwide prospective Korea Acute Myocardial Infarction Registry (KAMIR). A new risk score was constructed using the variables related to one year mortality: TIMI risk index (17.5-30: 1 point, >30: 2 points), Killip class (II: 1 point, >II: 2 points) and serum creatinine (≥1.5 mg/dL: 1 point), based on the multivariate-adjusted risk relationship. The new risk score system was compared with the Global Registry of Acute Coronary Events (GRACE) and TIMI risk scores during a 12-month clinical follow-up. RESULTS: During a one year follow-up, all causes of death occurred in 362 patients (14.3%), and 184 (8.6%) patients died in the hospital. The new risk score showed good predictive value for one year mortality. The accuracy for in-hospital and one year post-discharge mortality rates, the new risk score demonstrated significant differences in predictive accuracy when compared with TIMI and GRACE risk scores. CONCLUSION: A new risk score in the present study provides simplicity with accuracy simultaneously for early risk stratification, and also could be a powerful predictive tool for long-term prognosis in NSTEMI.

Assessment of coronary artery bypass graft patency by multislice computed tomography.

The recently developed multislice computed tomography (MSCT) is capable of rapid imaging of cardiac structures, including coronary arteries, during a single breath-hold. We evaluated coronary artery bypass graft (CABG) patency by comparing MSCT results to those of contrast angiography. MSCT and contrast angiography were performed in 39 patients (10 women, 29 men and mean age 60.0 +/- 7.8 years) with a total of 115 bypass grafts including 36 left internal mammary arteries, 4 right internal mammary arteries, 19 radial arteries, 2 gastroepiploic arteries and 54 vein grafts. Patients were investigated for an average of 14 +/- 27 months (range 1 - 108 months) after CABG surgery. Contrast angiography showed a patency rate of 87.0% (100/115). Ninety-nine of these 100 patent grafts by contrast angiography and 14 of the remaining 15 occluded grafts were correctly classified by MSCT (93.3% sensitivity and 99.0% specificity for bypass graft occlusion). The positive and negative predictive values for bypass graft occlusion were 93.3% and 99%, respectively, with an overall diagnostic accuracy of 98.3% (97.2% for left internal mammary artery, 100% for radial artery, 98.1% for vein graft and 100% for other grafts). In conclusion, MSCT is a useful and accurate diagnostic tool for the evaluation of bypass graft patency.