METHODS: Sixty-four patients-21 exertional angina; 17 unstable angina/non-ST elevation myocardial infarction (NSTEMI); 26 ST elevation myocardial infarction (STEMI)-provided 188 diseased segments on conventional angiography. All underwent MDCTA within a week of angiography. ROI was mapped out from maximum intensity projections of diseased segments in planar view.
RESULTS: One hundred seventy-four segments were evaluated. Patients who presented with ACS (STEMI and unstable angina/non-ST elevation myocardial infarction) had lower mean VDR compared to patients with exertional angina (0.58 vs. 0.66 vs. 0.81; P < 0.001). Culprit lesions in ACS patients also had the lowest mean VDR when compared to nonculprit lesions and lesions in patients without ACS (0.51 vs. 0.68 vs. 0.81; P < 0.001).
CONCLUSIONS: VDR is a new, convenient, and standardized approach in identifying "culprit" lesions by MDCTA.
MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.