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Sinem Ezgi Gulmez

Sinem Ezgi Gulmez
Koç University School of Medicine · Medical Pharmacology

Professor of clinical pharmacology, pharmacoepidemiology, MD, PhD

About

60
Publications
6,102
Reads
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1,005
Citations
Citations since 2017
12 Research Items
450 Citations
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2017201820192020202120222023020406080
2017201820192020202120222023020406080
2017201820192020202120222023020406080
Introduction
Currently working at Koç University School of Medicine, Department of Medical Pharmacology as full-time professor since September 2018 and as Head of the Department since September 2021. Research areas are pharmacoepidemiology (observational studies), clinical pharmacology, pharmacovigilance.
Additional affiliations
April 2007 - August 2017
University of Bordeaux
Position
  • Professor
April 2005 - March 2007
University of Southern Denmark
Position
  • PostDoc Position
June 2001 - March 2005
Ankara University Faculty of Medicine
Position
  • Ankara University
Education
October 1994 - June 2000
Ankara University Faculty of Medicine
Field of study
  • Medicine

Publications

Publications (60)
Article
Full-text available
Recently, the use of proton pump inhibitors (PPIs) has been associated with an increased risk of pneumonia. We aimed to confirm this association and to identify the risk factors. We conducted a population-based case-control study using data from the County of Funen, Denmark. Cases (n=7642) were defined as all patients with a first-discharge diagnos...
Article
Background Several methods have been proposed to assess causality in drug-induced liver injury but none have been tested in the specific context of acute liver failure leading to transplantation (ALFT). Objective We took advantage of the Study of Acute Liver Transplant (SALT), a European case-population study of ALFT, to test different causality sc...
Article
Full-text available
AimsAcute drug overdose, especially with paracetamol, may cause acute liver failure leading to registration for transplantation (ALFT). Population statistics and between-country differences for ALFT related to overdose have been poorly described. The aim of the present study was to evaluate overdose ALFT in the multi-country Study of Acute Liver Tr...
Article
Introduction Acute liver injury (ALI) is a major reason for stopping drug development or removing drugs from the market. Hospitalisation for ALI is relatively rare for marketed drugs, justifying studies in large-scale databases such as the nationwide Système National des Données de Santé (SNDS), which covers 99% of the French population. Methods S...
Article
Clinical pharmacology is an interdisciplinary field that encompasses all components of the relationship between drugs and humans. All clinical pharmacology professionals aim to support an improved quality of drug-oriented health services by providing teaching, research, and routine health care services that ensure more tolerable and more effective,...
Article
Purpose: Current nonspecific causality assessment tools lack the assessment of drug-induced acute kidney injury (DIAKI). We recently published an editorial letter for developing a specific causality assessment tool for DIAKI. The purpose of the present review was to suggest the possible required parameters and outline the path to developing a kidn...
Article
Full-text available
Objective: Irrational use of antibacterials is a concern during the COVID-19 pandemic. Hospital pharmacoepidemiology studies are important for evaluating the rational use of medicines, especially antibacterials, during pandemics. Defined daily doses (DDD) and drug utilization 90% (DU90%) are established methods for the evaluation of drug utilizatio...
Article
Full-text available
ABSTRACT Objective: Irrational use of antibacterials is a concern during the COVID-19 pandemic. Hospital pharmacoepidemiology studies are important for evaluating the rational use of medicines, especially antibacterials, during pandemics. Defined daily doses (DDD) and drug utilization 90% (DU90%) are established methods for the evaluation of drug u...
Article
Objectifs Quantifier l’exposition aux principales classes médicamenteuses précédant une hospitalisation pour hépatite aiguë à partir des données du Système national des données de santé (SNDS). Méthode Toutes les hospitalisations pour hépatite aiguë (codes diagnostiques CIM-10 K71.1, 71.2, 71.6, 71.9 et K72.0) survenues de 2010 à 2014 ont été iden...
Article
Objectifs Quantifier l’exposition aux antibiotiques et aux antimycobactériens précédant une hospitalisation pour hépatite aiguë à partir des données du Système national des données de santé (SNDS). Méthode Toutes les hospitalisations pour hépatite aiguë (codes diagnostiques CIM-10 K71.1, 71.2, 71.6, 71.9 et K72.0) de 2010 à 2014 ont été identifiée...
Article
Objectifs Quantifier l’exposition aux antidépresseurs et aux benzodiazépines précédant une hospitalisation pour hépatite aiguë à partir des données du Système national des données de santé (SNDS) et son échantillon à1/97 (EGB). Méthode Toutes les hospitalisations pour hépatite aiguë (codes diagnostiques CIM-10 K71.1, 71.2, 71.6, 71.9 et K72.0) de...
Article
Objectifs Quantifier l’exposition aux anti-inflammatoires non stéroïdiens (AINS) et aux analgésiques précédant une hospitalisation pour hépatite aiguë à partir des données du Système national des données de santé (SNDS). Méthode Toutes les hospitalisations pour hépatite aiguë (codes diagnostiques CIM-10 K71.1, 71.2, 71.6, 71.9 et K72.0) de 2010 à...
Article
Non-steroidal anti-inflammatory drugs (NSAIDs) are reversible inhibitors of cyclo-oxygenase (COX), mainly used for the symptomatic relief of pain, whether traumatic, infectious, episodic or rheumatologic. Use for the long-term relief of inflammation is waning with the emergence of specific biotherapies. Their effects are related to potency, dosage,...
Article
Purpose The SALT study found similar per‐user risks of acute liver failure (ALF) leading to transplantation (ALFT) between NSAIDs and a threefold higher risk in nonoverdose paracetamol (NOP) users. The objective of EPIHAM was to identify the risks of hospital admission for acute liver injury (ALI) associated with NSAIDs and NOP. Methods Case‐popul...
Article
Objectifs Les résultats d’une étude multinationale récente (SALT) ont montré que le risque individuel par utilisateur d’insuffisance hépatique aiguë ayant entraîné une transplantation hépatique (IHAT) était similaire quel que soit l’anti-inflammatoire non stéroïdien (AINS), et trois à quatre fois plus élevés chez les utilisateurs de paracétamol à d...
Article
Aims: The aim of the present study was to describe the real-life usage patterns of paracetamol. Methods: The Echantillon Généraliste de Bénéficiaires (EGB) database, the permanent 1/97 representative sample from the French national healthcare insurance system, was searched in 2011 to identify usage patterns, concomitant chronic diseases and use...
Chapter
In Turkey, the Drug Safety Monitoring and Evaluation Department – Turkish Pharmacovigilance Center (TÜFAM) of the General Directorate of Pharmaceuticals and Pharmacy of the Ministry of Health is responsible for national pharmacovigilance activities. Pharmacovigilance contact points (PCPs) were established in 2005 within the national pharmacovigilan...
Article
Full-text available
Purpose The effect of denominator options on event rates was tested on the French part of the Study of Acute Liver Transplant (SALT). Methods SALT is a case population study of acute liver failure registered for transplantation (ALFT), exposed to non-steroidal anti-inflammatory drugs (NSAIDs) or non-overdose paracetamol, from 2005 to 2007. Populati...
Article
Background: After the publication of the Regulation (EU) No 1235/2010 and Directive 2010/84/EU on 31st of December 2010, the new legislation on pharmacovigilance came into operation for the better protection of public health through a further strengthened EU system for medicines safety. REMARKS: The main changes include the new definition of advers...
Article
The effect of denominator options on event rates was tested on the French part of the Study of Acute Liver Transplant (SALT). SALT is a case population study of acute liver failure registered for transplantation (ALFT), exposed to non-steroidal anti-inflammatory drugs (NSAIDs) or non-overdose paracetamol, from 2005 to 2007. Population exposure was...
Article
Full-text available
Background: Most NSAIDs are thought to be able to cause hepatic injury and acute liver failure (ALF), but the event rates of those leading to transplantation (ALFT) remain uncertain. Objectives: The aim of the study was to estimate population event rates for NSAID-associated ALFT METHODS: This was a case-population study of ALFT in 57 eligible l...
Article
Purpose: The European Committee for Human Medicinal Products (CHMP) requested a multinational study with the aim to investigate the risk of acute liver failure (ALF) leading to registration for transplantation in patients exposed to non-steroidal anti-inflammatory drugs (NSAIDs). The method of this multinational, multicentre, retrospective case-po...
Article
For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is certainly not the case. The study was...
Article
Full-text available
Objective: Use of drugs that may lead to abuse or dependence are subject to controlled prescriptions (CPs) in many countries, and these are closely monitored by health authorities. According to national regulations in Turkey, CPs may be red coloured (RCPs) or green coloured (GCPs). The aim of this study was to evaluate the use of such drugs in Ista...
Conference Paper
Introduction The risk of acute liver failure (ALF) related to NSAIDs is still discussed and the European Medicines Agency requested a study investigating this. University Bordeaux Segalen conducted the study independently. Aim To estimate the incidence rates of ALF leading to registration for liver transplantation (LT) in patients exposed to NSAID...
Article
Full-text available
To describe the inappropriate use of traditional non-steroidal anti-inflammatory drugs (tNSAIDs) in elderly subjects in the CADEUS cohort using the Beers 2003 criteria modified by recommendations from the French Medicines Agency. Of the 23,217 subjects in the CADEUS cohort, 1,851 were ≥65 years old, had bee diagnosed with osteoarthritis (OA), and h...
Article
Recently, an apparent protective effect of statins against upper gastrointestinal bleeding (UGB) was postulated in a post hoc analysis of a randomized trial. We aimed to evaluate the effect of statin use on acute nonvariceal UGB alone or in combinations with low-dose aspirin and other antithrombotic drugs. A population-based case-control study was...
Article
Objective: There is an increasing interest to pharmacoeconomy, which is an interdisciplinary branch. However, its concept is open to misuse. In the present study, we aimed to evaluate the curriculum of the Turkish medical schools; whether they have, or are planning any formal pharmacoeconomy lectures. Methods: A questionnaire was prepared to evalua...
Article
Recent studies have suggested an increased risk of upper gastrointestinal bleeding (UGB) in spironolactone users. The aim was to confirm the association, identify the risk factors and quantify the absolute risk. A population based case-control study was conducted in the County of Funen, Denmark. Cases (n = 3652) were all subjects with a first disch...
Article
In replyWe are pleased that our study1 has generated interest, and we appreciate the opportunity to respond to the queries.Kerman and Barkin have pointed out GERD and other risk factors for CAP. Gastroesophageal reflux disease itself might explain an excess in the incidence of CAP among proton pump inhibitor users.2 Reflux is associated with some a...
Article
Full-text available
Findings have shown that dipyrone has a beneficial effect on skin flap survival. A pharmacologic explanation for this effect points to its vascular smooth muscle-relaxing effect. This study evaluated the effect of dipyrone on blood flow and thus survival of rat random dorsal skin flaps. For this study, 27 male Wistar albino rats were randomly assig...
Article
We evaluated the effect of tirofiban hydrochloride on the survival of epigastric island flaps in rats that had had all the veins occluded. Male Wistar Albino rats were randomly assigned to control (treated with sterile saline) and experimental (treated with tirofiban hydrochloride 1 mg/kg intravenously) groups. An epigastric island skin flap 3x6 cm...
Article
While many preclinical models detect the analgesic activity of nonsteroidal antiinflammatory drugs (NSAIDs), the radiant heat tail-flick response has repeatedly been insensitive to this class of drugs. As the tail-flick test involves nociceptive processing at spinal circuits with supraspinal modulation, it seems reasonable to assume that the NSAIDs...
Article
Migraine is a common disorder with a relatively high burden of disease from the perspective of both society and the individual patient. Optimizing the use of prophylactic treatment may decrease the frequency and severity of attacks thus reducing the burden of disease. In this regard, topiramate has been found to be as effective as propranolol in th...
Article
Full-text available
Dipyrone is an analgesic and antipyretic agent with a distinctive spasmolytic effect on smooth muscles. We recently showed that dipyrone significantly relaxed precontracted tracheal smooth muscle in guinea pig. To investigate whether this in vitro observation could be observed in vivo in the respiratory function parameters of asthma patients. Twent...
Article
Nimesulide is available in gel formulation and applied mainly for topical pain management. However, its passage to the synovial fluid is not yet clear. The aim of this study was to evaluate if topical administered nimesulide passes into the synovial fluid and to compare its concentration with the oral nimesulide administration regimen. Synovia and...
Article
Dipyrone (Novalgin) is an effective analgesic, antipyretic agent also with spasmolytic effects on various types of smooth muscles. It has recently been reported that dipyrone relaxes tracheal smooth muscle of guinea pig. In this present study, we aimed to investigate whether this and previously reported in vitro results have any consequences on the...
Article
Full-text available
Background: Dipyrone differs from other nonsteroidal anti-inflammatory drugs with a distinctive spasmolytic effect; however, the mechanism of action is not clear yet. The possible mechanism behind this effect was investigated on airway smooth muscle tone in vitro. The effect of dipyrone on inositol phosphate (IP) accumulation was evaluated on guine...
Article
Dipyrone, an effective analgesic drug, is widely used in the management of headache. However, few studies have evaluated its efficacy and safety in migraine. We aimed to assess the efficacy and safety of 1 g dipyrone (Novalgin, two 500 mg tablets) on pain and related symptoms in acute migraine attacks with or without aura in a double-blind, cross-o...
Article
Septoplasty is one of the most common nasal operations performed in otorhinolaryngological practice. At the end of the operation, most surgeons place nasal packings and remove them after 48–72 hours. The removal of the packings may be very painful. The objective of this study was to evaluate the analgesic effectiveness of dipyrone, when given befor...
Article
was 1.5 (95% confidence interval (CI), 1.3-1.7). No as- sociation was found with histamine2-receptor antago- nists (OR, 1.10; 95% CI, 0.8-1.3) or with past use of PPIs (OR, 1.2; 95% CI, 0.9-1.6). Recent initiation of treat- ment with PPIs (0-7 days before index date) showed a particularly strong association with community- acquired pneumonia (OR, 5...

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