Announcements

Seminar in Medicine, 26.01.2018 , Sinem Ezgi GULMEZ, MD, PhD

Author: KUSOM
Time: 15:00
Location: RF / MED 176

 

To risk or not to risk?  Sinem Ezgi Gülmez 
 
No medicine is without risk. After marketing, continuous monitoring of drug utilization and drug safety is essential. Adverse drug events (ADEs) are the most common iatrogenic causes of patient injuries. For ethical or logistics reasons, ADEs can usually not be studied by randomized clinical trials (RCTs). Pharmacoepidemiology is the study of the effects and the use of drugs in a large population setting using the principles of epidemiology. The Study of Acute Liver Transplantation (SALT) is one of the exhaustive examples of such. Because of clusters of spontaneous reports of suspected hepatotoxicity risk with nimesulide, the European Medicines Agency’s (EMA) Committee on Human Medicinal Products (CHMP) required an epidemiological study. The objective of the SALT study was to assess the population rates of acute liver failure leading to registration for transplantation (ALFT) without identified clinical aetiology in patients exposed to NSAIDs or paracetamol. It was a case-population study in 52 participating liver transplant centres in seven European countries; France, Greece, Ireland, Italy, the Netherlands, Portugal and the UK. Cases were all adults registered from 2005-2007 with ALFT without identified clinical aetiology, exposed to an NSAID or paracetamol within 30 days before the onset of clinical symptoms. NSAID and paracetamol population exposures were assessed using national sales data from Intercontinental Marketing Services (IMS). Risk was estimated as the rate of ALFT per million treatment-years. The SALT concluded that ALFT after exposure to an NSAID was rare, with no major difference between NSAIDs. The event rate of ALFT exposed to non-overdose paracetamol was more than two-fold higher than for all NSAIDs pooled, and higher than most individual NSAIDs.  Quantifying rare ADEs is one of the strengths of pharmacoepidemiology over RCTs. Although the detection of rare ADEs can arise from RCTs, results may be inconclusive and are less likely to be productive, mostly because of lack of adequate power. A real-world unique setting with a superior methodology is needed, and the answers are often obtained quickly.  

KOÇ UNIVERSITY

SCHOOL OF MEDICINE

 

 

SEMINAR IN MEDICINE
Friday, January 26th
, 2018

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Speaker           : Sinem Ezgi GULMEZ, MD, PhD / Bordeaux Segalen University / Department of  Pharmacology

Title                : To risk or not to risk?  

Time               : 15:00 (Refresment will served at 14:45)

Place              : RF/ MED 176

TelePresence  :  AH Dean's Room / KUH 9th Meeting Room

The role of minimally invasive endoscopic techniques for the 
early stage gastrointestinal system cancersThe role of minimally invasive endoscopic techniques for the early stage gastrointestinal system cancers

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To risk or not to risk? 

    No medicine is without risk. After marketing, continuous monitoring of drug utilization and drug safety is essential. Adverse drug events (ADEs) are the most common iatrogenic causes of patient injuries. For ethical or logistics reasons, ADEs can usually not be studied by randomized clinical trials (RCTs). Pharmacoepidemiology is the study of the effects and the use of drugs in a large population setting using the principles of epidemiology. The Study of Acute Liver Transplantation (SALT) is one of the exhaustive examples of such. Because of clusters of spontaneous reports of suspected hepatotoxicity risk with nimesulide, the European Medicines Agency’s (EMA) Committee on Human Medicinal Products (CHMP) required an epidemiological study. The objective of the SALT study was to assess the population rates of acute liver failure leading to registration for transplantation (ALFT) without identified clinical aetiology in patients exposed to NSAIDs or paracetamol. It was a case-population study in 52 participating liver transplant centres in seven European countries; France, Greece, Ireland, Italy, the Netherlands, Portugal and the UK. Cases were all adults registered from 2005-2007 with ALFT without identified clinical aetiology, exposed to an NSAID or paracetamol within 30 days before the onset of clinical symptoms. NSAID and paracetamol population exposures were assessed using national sales data from Intercontinental Marketing Services (IMS). Risk was estimated as the rate of ALFT per million treatment-years. The SALT concluded that ALFT after exposure to an NSAID was rare, with no major difference between NSAIDs. The event rate of ALFT exposed to non-overdose paracetamol was more than two-fold higher than for all NSAIDs pooled, and higher than most individual NSAIDs.  Quantifying rare ADEs is one of the strengths of pharmacoepidemiology over RCTs. Although the detection of rare ADEs can arise from RCTs, results may be inconclusive and are less likely to be productive, mostly because of lack of adequate power. A real-world unique setting with a superior methodology is needed, and the answers are often obtained quickly.