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@#Introduction: Previous studies reported that a two-week double-dose clopidogrel treatment following percutaneous coronary intervention has no difference in safety compared to standard therapy. This study aimed to determine the all-cause readmission rate and survival after a year of percutaneous coronary intervention (PCI) in patients who were treated with two-week double-dose clopidogrel regimen. Methods: This was a retrospective study on patients who underwent PCI in a state general hospital in Malaysia in 2014. Patients’ one month and one-year survival status were retrieved using the hospital electronic patient management system. Patients who received a two-week course of 150mg clopidogrel and subsequently a one-year course of standard double antiplatelet therapy were included. Results: A total of 381 out of 563 patients who underwent PCI were included in the analysis, while those who were switched to ticagrelor and transferred to other hospitals post-PCI excluded. Patients had a mean age of 56.9 (SD 10.7), with majority male (331, 86.9%) and Malay (144, 37.8%). The PCI was mainly indicated for ST-elevated myocardial infarction (188, 49.3%), non-STEMI (114, 29.9%) and unstable angina (36, 9.4%). A total of 107 (28.1%) patients were readmitted within the one year post-PCI period. Readmissions were mainly due to ACS (55.5%) and bleeding events (2.4%). The 30-day and 1-year all-cause mortality was 33 cases and 43 cases, respectively. Conclusion: The low readmission and bleeding related readmission suggested that the two-week double-dose clopidogrel regimen was safe for the post PCI patients. Future randomised trial to establish the efficacy of this dosing regimen is therefore warranted.
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@#Aim: This study is conducted to compare the pharmacokinetic profiles of two fixed dose combination of metformin/glibenclamide tablets (500mg/5 mg per tablet). 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.