scholarly journals Infections Deaths in the PLATO Trial

TH Open ◽  
2021 ◽  
Vol 05 (04) ◽  
pp. e503-e506
Author(s):  
Victor Serebruany ◽  
Jean-Francois Tanguay
Keyword(s):  
Antiplatelet Therapy ◽  
Drug Administration ◽  
Dual Antiplatelet Therapy ◽  
Food And Drug Administration ◽  
Platelet Inhibition ◽  
Public Domain ◽  
The Public ◽  
Local Evidence ◽  
Local Site ◽  
Therapeutic Outcomes

Abstract Background Cardiovascular benefits of aggressive dual antiplatelet therapy may be associated with extra risks including bleeding, cancer, and infections discovered first for prasugrel in the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel (TRITON) trial. Ticagrelor in PLATO also caused slightly more infections but surprisingly less sepsis-related deaths (SRD) than clopidogrel. However, verified infection fatalities in PLATO were lacking from the public domain. We obtained the complete Food and Drug Administration (FDA)-issued primary causes death list, matched it with the few local site records dataset and analyzed the patterns of infections and deaths reported in PLATO. Methods Among infections, the FDA spreadsheet contains only two primary death codes for pneumonia (12–2) and SRD (12–8). We obtained local evidence for two pneumonia and two SRD and matched those with the FDA records. We assessed how SRD patterns were reported among nonvascular death's dataset. Results The FDA PLATO records indicate that clopidogrel caused numerically less (n = 8) primary pneumonia deaths than ticagrelor (n = 10) but over three times more SRD (n = 23/7). Among matched verifiable outcomes, both pneumonia deaths were correct, but two clopidogrel SRD were incorrect. Of the remaining 21 clopidogrel SRD, 6 were reported as two separate closed paired entries in Brazil (lines 76 and 78 and 86 and 88) and India (lines 436 and 440), suggesting last minute addition of potentially incorrect SRD reports. Four ticagrelor SRD (lines 24,193,467 and 650) were “compensated” with close or next in line clopidogrel SRD entries (lines 22,195,468 and 651). Conclusion The FDA-issued evidence suggests no benefit of ticagrelor in preventing deaths from infections with slightly more pneumonia deaths, with possible misreporting of SRD in PLATO. These findings require an in-depth precise review of sepsis deaths in this trial.

scholarly journals KEWENANGAN BADAN PENGAWAS OBAT DAN MAKANAN TERHADAP PERDA PROVINSI BALI NO 5 TAHUN 2012 TENTANG PENGENDALIAN PEREDARAN MINUMAN BERALKOHOL

2013 ◽  
Vol 2 (3) ◽  
Author(s):  
I Putu Mahentoro
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Alcoholic Beverage ◽  
Provincial Government ◽  
Alcoholic Beverages ◽  
Ministry Of Health ◽  
The Public ◽  
The Republic ◽  
The Government ◽  
Imported Foods

ABSTRACTThe research was conducted based on the same authority which is ownedby the two institutions, namely Food and Drug Administration of the Republic ofIndonesia and Bali Provicial Government in monitoring and controlling ofalcoholic beverages in Bali.The results of this study demonstrate the Food and Drug Administrationand the Provincial Government of Bali have the same authority to supervise andcontrol alcoholic beverages in Bali. Bali Local Government Regulation Number 5of 2012 on the Circulation of Alcoholic Beverage Control only requires each hasa label on alcoholic beverages issued by the Government of Bali has to bedistributed to the public, while the authority of the Food and Drug Administrationis regulated in the Regulation of Minister of Health of the Republic of IndonesiaNumber 382/MENKES/PER/VI/1989 on Registration of Food that requires allfood produced both by local producers and imported foods are required to beregistered to the Ministry of Health through the Food and Drug Administration.In the Regulation Number 5 Year 2012 did not include the authority of theFood and Drug Administration (the Empty Norms) so that the Food and DrugAdministration can not perform optimally the law enforcement againstmanufacturers, distributors and sellers of alcoholic beverages in violation. Tocope with the condition it should be a amendment in the Bali ProvincialRegulation Number 5 of 2012 by stating firmly and clearly the authority of theFood and Drug Administration related to the registration of food, which requiresthat for all foods and beverages that will be distributed to the public must beregistered to the Ministry of Health through the Food and Drug Administration.

scholarly journals Thromboelastography for monitoring platelet function in unruptured intracranial aneurysm patients undergoing stent placement

2015 ◽  
Vol 21 (1) ◽  
pp. 61-68 ◽  
Author(s):  
Hongchao Yang ◽  
Youxiang Li ◽  
Yuhua Jiang ◽  
Xianli Lv
Keyword(s):  
Intracranial Aneurysm ◽  
Antiplatelet Therapy ◽  
Platelet Function ◽  
Dual Antiplatelet Therapy ◽  
Platelet Inhibition ◽  
Acute Ischemia ◽  
Unruptured Intracranial Aneurysm ◽  
Anterior Circulation ◽  
Permanent Disability ◽  
Significant Difference

This study evaluated patients’ preoperative platelet function and the relation between acute embolic or hemorrhagic complications in unruptured intracranial aneurysm patients undergoing stent treatment. From September 2013 to December 2013 we prospectively collected clinical data in all unruptured intracranial aneurysm patients undergoing stent-assisted coiling. All patients received a dual antiplatelet therapy (aspirin and clopidogrel) protocol. Diffusion-weighted 3-T MRI was performed for cerebral aneurysm patients within 24 hours after treatment. Platelet function was tested by thromboelastography. Forty-six patients with 50 intracranial aneurysms treated by stent-assisted coiling were included. Fifty-three stents were deployed in 46 procedures, including 39 Enterprise stents and 14 Solitaire stents. Acute ischemia was detected in the territory of the stented vessel in 25 of 46 patients (54.3%), but did not cause permanent disability. There was a significant difference between groups with and without thromboembolism in terms of percentage platelet inhibition and ADP-induced clot strength (MAADP) for clopidogrel, but no significant difference with aspirin. MAADP had a predictive value yielding an area under the ROC curve of 0.67 (95% CI: 0.57–0.81, P < 0.05). Anterior circulation aneurysms were also associated with ischemic events (P = 0.034). Silent acute embolism may be frequent in unruptured intracranial aneurysm treated with stent-assisted coiling even when dual antiplatelet therapy is given. The antiplatelet inhibition parameter (MAADP) was a predictor for acute thromboembolism in unruptured intracranial aneurysm patients treated by stent-assisted coiling.

scholarly journals Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System

2019 ◽  
pp. 1-7
Author(s):  
Adrian Wong ◽  
Angela Li ◽  
Kane Gill ◽  
Matthew P. Gray ◽  
Pamela L. Smithburger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Public Knowledge ◽  
Future Studies ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult patients with underlying comorbidities. However, numerous case reports have described drugs with a lower suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and understanding. Study Design: Retrospective pharmacovigilance evaluation. Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1) known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most frequently reported drugs were analyzed in reporting odds ratios (ROR). Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3, CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs (n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI 2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin (ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2). Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide post-marketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management of causal agents.

Sulfites—A Food and Drug Administration Review of Recalls and Reported Adverse Events

2004 ◽  
Vol 67 (8) ◽  
pp. 1806-1811 ◽  
Author(s):  
BABGALEH TIMBO ◽  
KATHLEEN M. KOEHLER ◽  
CECILIA WOLYNIAK ◽  
KARL C. KLONTZ
Keyword(s):  
Drug Administration ◽  
Fruits And Vegetables ◽  
Adverse Reactions ◽  
Food And Drug Administration ◽  
Study Data ◽  
Current Status ◽  
Food Labels ◽  
Passive Surveillance ◽  
The Public ◽  
Passive Surveillance System

Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested ≥10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

Abstract 1032: High Clopidogrel Maintenance Dosing in Patients with Inadequate Platelet Inhibition: Functional Insights on Thienopyridine Usage According to Updated ACC/AHA/SCAI 2005 Guidelines for Percutaneous Coronary Interventions

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Dominick J Angiolillo ◽  
Marco A Costa ◽  
Steven B Shoemaker ◽  
Bhaloo Desai ◽  
Yuan Hang ◽  
...  
Keyword(s):  
Steady State ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Platelet Function ◽  
Maintenance Dose ◽  
Dual Antiplatelet Therapy ◽  
Platelet Inhibition ◽  
Percutaneous Coronary Interventions ◽  
Percutaneous Coronary ◽  
Risk Patients

Background: Clopidogrel under-dosing is a cause of inadequate platelet inhibition. Inadequate clopidogrel-induced antiplatelet effects have been associated with an increased risk of stent thrombosis. Updated guidelines for percutaneous coronary interventions (PCI) recommend to increase the dose of clopidogrel to 150mg in high risk patients if <50% platelet inhibition is demonstrated. However, to date there are no studies which have evaluated the functional impact of this recommendation. The aim of this study was determine the functional impact of a 150mg maintenance dose of clopidogrel in patients with 50% platelet inhibition while in their steady state phase of dual antiplatelet therapy. Methods: Platelet inhibition was screened by means of the VerifyNow P2Y 12 assay in patients in a steady state phase of dual antiplatelet therapy. Patients with <50% platelet inhibition were treated with 150mg of clopidogrel for one-month. Adenosine diphosphate-induced aggregation using light transmittance aggregometry and P2Y 12 reactivity ratio determined by vasodilator-stimulated phosphoprotein-phosphorylation analysis were also performed. Results: A total of 32 patients were screened to identify 20 with <50% platelet inhibition. Platelet inhibition increased from 28.3±12% to 43.2±18% in patients treated with 150mg of clopidogrel (p=0.004; primary endpoint). All other functional measures also showed that a high maintenance dose of clopidogrel reduces platelet function (Table ) . The degree of platelet inhibition achieved following one-month treatment with high dose clopidogrel broadly varied and only eight (40%) patients yielded a degree of platelet inhibition ≥50%. Conclusions: The use of a 150mg maintenance dose of clopidogrel in high risk patients with <50% platelet inhibition increases platelet inhibition. However, the antiplatelet effects achieved are non-uniform and a considerable number of patients persist with elevated platelet function. Platelet function analysis pre and post high clopidogrel maintenance dose therapy

COMMITTEE ON NUTRITION

PEDIATRICS ◽  
1960 ◽  
Vol 25 (1) ◽  
pp. 164-167
Author(s):  
Keyword(s):  
Child Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Food Additives ◽  
The Public ◽  
Infant And Child Health ◽  
And Child Health

The above discussion may be summarized by stating that the Food and Drug Administration is actively protecting the public from chemicals which constitute almost an indigenous part of our civilization. From the standpoint of the physician, this does not require immediate concern, but knowledge of the multitude of food additives, the extent to which insecticides are used, and the constant vigilance of the Administration are factors to be recognized. Continuous vigilance on the part of everyone concerned with infant and child health is a necessity for continuous health.

Smoking promotes clopidogrel-mediated platelet inhibition in patients receiving dual antiplatelet therapy

2009 ◽  
Vol 124 (5) ◽  
pp. 588-591 ◽  
Author(s):  
Thomas Gremmel ◽  
Sabine Steiner ◽  
Daniela Seidinger ◽  
Renate Koppensteiner ◽  
Simon Panzer ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Platelet Inhibition
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