ABSTRACT
BACKGROUND: In the present clinical trial, we compared the efficacy and safety of the generic clopidogrel besylate (CB) with the innovator clopidogrel hydrogen sulfate (CHS) salt in patients eligible to receive clopidogrel. METHODS: A prospective 2-arm, multicenter, open-label, phase 4 clinical trial. Consecutive patients (n = 1864) were screened and 1800 were enrolled in the trial and randomized to CHS or CB. Primary efficacy end point was the composite of myocardial infarction, stroke, or death from vascular causes, and primary safety end point was rate of bleeding events as defined by Bleeding Academic Research Consortium criteria. RESULTS: At 12-month follow-up, no differences were observed between CB (n = 759) and CHS (n = 798) in primary efficacy and safety end points (age, sex, history of percutaneous coronary intervention adjusted odds ratio [OR], 0.70; 95% confidence interval [CI], 0.41-1.21 and OR, 0.81; 95% CI, 0.51-1.29, respectively) between CHS and CB. Analyses of efficacy and safety in subgroups that were defined according to the qualifying diagnosis revealed that there was no difference between CHS and CB. CONCLUSION: The efficacy and safety of CB administered for 12 months for the secondary prevention of atherothrombotic events are similar to that of CHS. (Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence, SCIENCE trial; ClinicalTrials.gov Identifier:NCT02126982).
Subject(s)
Cardiovascular Diseases/drug therapy , Drugs, Generic/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Secondary Prevention/methods , Ticlopidine/analogs & derivatives , Aged , Aged, 80 and over , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/mortality , Clopidogrel , Drug Compounding , Drugs, Generic/adverse effects , Drugs, Generic/chemistry , Female , Greece , Hemorrhage/chemically induced , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/etiology , Odds Ratio , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/chemistry , Prospective Studies , Risk Factors , Stroke/etiology , Therapeutic Equivalency , Ticlopidine/adverse effects , Ticlopidine/chemistry , Ticlopidine/therapeutic use , Time Factors , Treatment OutcomeABSTRACT
This work deals with privacy implications and threats that can emerge with the large-scale use of electronic biometric documents, such the recently introduced electronic passport (e-Passport). A brief introduction to privacy and personal data protection is followed by a presentation of the technical characteristics of the e-Passport. The description includes the digital data structure, and the communication and reading mechanisms of the e-Passport, indicating the possible points and methods of attack.
Subject(s)
Biometry , Computer Security , PrivacyABSTRACT
BACKGROUND AND STUDY AIMS: Acute cholangitis (AC) and especially suppurative cholangitis due to biliary lithiasis is an emergency situation that requires urgent biliary decompression. The aim of the study is to present our policy for the treatment of AC due to choledocholithiasis, endoscopically. METHODS: In a 4-year period, 71 patients presenting AC, due to lithiasis, underwent endoscopic retrograde cholangio-pancreatography and endoscopic sphincterotomy (ES). All patients had fever, jaundice, abdominal pain, and in case of suppurative cholangitis hemodynamic instability. Most of them seemed to be high-risk candidates for surgery. RESULTS: Forty-nine patients had AC and 22 patients had acute obstructive suppurative cholangitis (AOSC). ES (conventional or needle-knife biliary fistulotomy) was successful in 69 out of 71 (97%) patients. Two patients were eventually operated and were excluded from statistical analysis. Fifty of the 69 patients (72%) had a complete bile duct clearance in 1 session. Conventional ES, complete bile duct clearance, and other endoscopic maneuvers (balloon, basket, lithotripsy) were significantly more frequent in the AC group (P<0.001). Needle-knife biliary fistulotomy, and stent insertion were significantly more frequent in the AOSC group (P<0.001). Endoscopical treatment had low morbidity and total hospital stay time. CONCLUSIONS: ES is the procedure of choice for the treatment of AC offering definite treatment with low morbidity and short hospitalization. Urgent biliary decompression with minimal endoscopic maneuvers is crucial for the outcome of patients having AOSC.
