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Edeltraut Garbe - One of the best experts on this subject based on the ideXlab platform.
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herb induced liver injury in the berlin case control Surveillance Study
International Journal of Molecular Sciences, 2016Co-Authors: Antonios Douros, Frank Andersohn, Elisabeth Bronder, Andreas Klimpel, Reinhold Kreutz, Edeltraut Garbe, Juliane BolbrinkerAbstract:Herb-induced liver injury (HILI) has recently attracted attention due to increasing reports of hepatotoxicity associated with use of phytotherapeutics. Here, we present data on HILI from the Berlin Case-Control Surveillance Study. The Study was initiated in 2000 to investigate the serious toxicity of drugs including herbal medicines. Potential cases of liver injury were ascertained in more than 180 Departments of all 51 Berlin hospitals from October 2002 to December 2011. Drug or herb intake was assessed through a standardized face-to-face interview. Drug or herbal aetiology was assessed based on the updated Council for International Organizations of Medical Sciences scale. In ten of all 198 cases of hepatotoxicity included in the Study, herbal aetiology was assessed as probable (once ayurvedic herb) or possible (Valeriana five times, Mentha piperita once, Pelargonium sidoides once, Hypericum perforatum once, Eucalyptus globulus once). Mean age was 56.4 ± 9.7 years, and the predominant pattern of liver injury was hepatocellular. No cases of acute liver failure or death were observed. This case series corroborates known risks for ayurvedic herbs, supports the suspected association between Valeriana use and liver injury, and indicates a hepatotoxic potential for herbs such as Pelargonium sidoides, Hypericum perforatum or Mentha piperita that were rarely associated with liver injury before. However, given that possible causality does not prove clinical significance, further studies in this field are needed.
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drug induced liver injury results from the hospital based berlin case control Surveillance Study
British Journal of Clinical Pharmacology, 2015Co-Authors: Frank Andersohn, Giselle Sarganas, Elisabeth Bronder, Andreas Klimpel, Michael Thomae, Reinhold Kreutz, Edeltraut Garbe, Antonios DourosAbstract:Aim Drug-induced liver injury (DILI) is often responsible for acute liver failure, drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a case–control Study to determine the hepatotoxic risk of a wide range of drugs. Methods The Berlin Case–Control Surveillance Study FAKOS included all 51 Berlin hospitals in a hospital network. Between 2002 and 2011, 198 patients with acute idiopathic hepatitis, 377 inpatient controls and 708 outpatient controls were ascertained. Case patients were thoroughly validated using anamnestic, clinical, laboratory and histological data. Drug exposure was obtained in a face-to-face interview. A possible drug aetiology was assessed in individual patients by applying the updated Council for International Organizations of Medical Sciences (CIOMS) scale. Drug risks were further quantified [odds ratios (OR) with 95% confidence intervals (CI)] in a case–control design with unconditional logistic regression analysis. Drug intake in the last 28 days before index date was considered for the analysis. Results The Study corroborated hepatotoxic risks for a number of drugs, including phenprocoumon (OR 3.3, 95% CI 1.5, 6.7), amiodarone (OR 5.5, 95% CI 1.3, 21.2), clozapine (OR 34.6, 95% CI 2.8, 824.9) and flupirtine (OR 40.2, 95% CI 5.5, 856.9). Increased risks were also suggested for less commonly reported substances such as angiotensin II receptor blockers, atypical antipsychotics and for biperiden, a drug never before reported to be hepatotoxic. Conclusions Our Study identified a large number of drugs as possible causes of hepatotoxicity. The observed risk for seldom reported substances highlights the need for further post-authorization safety studies not exclusively focusing on drugs already labelled as potentially hepatotoxic.
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metamizole induced agranulocytosis revisited results from the prospective berlin case control Surveillance Study
European Journal of Clinical Pharmacology, 2015Co-Authors: Matthias Huber, Frank Andersohn, Giselle Sarganas, Elisabeth Bronder, Andreas Klimpel, Michael Thomae, Christine Konzen, Reinhold Kreutz, Edeltraut GarbeAbstract:Purpose Treatment with metamizole (dipyrone) has steadily increased in Germany over the last decade. The consequences of this increase for metamizole-induced agranulocytosis (MIA) are unclear. The present Study addressed this topic using data from the Berlin Case–Control Surveillance Study.
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flupirtine induced liver injury seven cases from the berlin case control Surveillance Study and review of the german spontaneous adverse drug reaction reporting database
European Journal of Clinical Pharmacology, 2014Co-Authors: Antonios Douros, Frank Andersohn, Elisabeth Bronder, Andreas Klimpel, Michael Thomae, Reinhold Kreutz, Edeltraut Garbe, Hansdieter OrzechowskiAbstract:The hepatotoxic potential of the analgesic flupirtine has attracted increased attention over the past years. Recently, risk minimisation measures such as maximum treatment duration of 2 weeks have been requested by the European Medicines Agency (EMA). This Study was conducted to further elucidate the clinical pattern of flupirtine-induced liver injury (FILI). Seven FILI patients were ascertained in all Berlin hospitals in the Berlin Case–control Surveillance Study (FAKOS) between 2002 and 2011. Furthermore, we reviewed the severe cases of flupirtine-associated hepatotoxicity included in the adverse drug reaction database of the Federal Institute for Drugs and Medical Devices (BfArM) in Germany from between 1991 and 2012. All seven FILI patients of FAKOS were hospitalised. Six of them were female, mean age was 55 years, and the most common symptoms were fatigue and jaundice. Three patients developed acute liver failure (ALF). Discontinuation of flupirtine invariably led to clinical and laboratory improvement. Review of the BfArM cases (n = 248) showed female sex predominance and high prevalence of jaundice and ALF. Time to onset of symptoms was less than 2 weeks in 9 % of the patients with respective data. Our results corroborate previous findings on FILI’s clinical pattern and on its potentially severe course. Although the hepatotoxic risk might be higher after the first 2 weeks of treatment, earlier onset of severe FILI cannot be ruled out. Postauthorisation safety studies are needed to evaluate EMA’s risk minimisation measures and to quantify flupirtine’s risk according to its duration of use.
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drug induced immune haemolytic anaemia in the berlin case control Surveillance Study
British Journal of Haematology, 2011Co-Authors: Frank Andersohn, Elisabeth Bronder, Andreas Klimpel, Michael Thomae, Edeltraut Garbe, Hubert Schrezenmeier, Martin Hildebrandt, E Spathschwalbe, Andreas GruneisenAbstract:Drug-induced immune haemolytic anaemia is a rare but serious condition. This Study investigated the possibility of drug aetiology of immune haemolytic anaemia (IHA) in 134 patients with new onset of IHA who were identified in the Berlin Case-Control Surveillance Study between 2000 and 2009. Single drugs related to IHA in three or more patients and assessed more than once as a certain or probable cause of IHA in a standardized causality assessment included diclofenac, fludarabine, oxaliplatin, ceftriaxone and piperacillin. In a case-control Study including all 124 IHA cases developed in outpatient care and 731 controls, significantly increased odds ratios (OR) were observed for beta-lactam antibiotics (OR=8·8; 95% confidence interval [CI] 3·2-25·2), cotrimoxazole (OR=6·5; CI 1·1-37·9), ciprofloxacin (OR=6·9, CI 1·3-38·5), fludarabine (OR=22·2; CI: 2·8-454·5) and lorazepam (OR=5·3; CI: 1·2-21·2). Excluding new onset cases with a chronic IHA disease course, an increased risk became also apparent for diclofenac with an OR of 3·1 (CI 1·3-7·0). This is the first case-control Study investigating drugs as risk factors for IHA. It corroborates an increased risk for several drugs that have been implicated as a cause of IHA in the standardized causality assessment of individual cases.
D Felmingham - One of the best experts on this subject based on the ideXlab platform.
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increasing prevalence of antimicrobial resistance among isolates of streptococcus pneumoniae from the protekt Surveillance Study and compatative in vitro activity of the ketolide telithromycin
Journal of Antimicrobial Chemotherapy, 2002Co-Authors: D Felmingham, Ralf Rene Reinert, Yoichi Hirakata, Arne C. RodloffAbstract:The prevalence of resistance to a range of antimicrobials was determined for isolates of Strepto- coccus pneumoniae examined in the PROTEKT (Prospective Resistant Organism Tracking and Epidemiology for the Ketolide Telithromycin) Surveillance Study (1999-2000) using NCCLS testing methods and interpretative criteria. Of 3362 pneumococcal isolates collected from 69 centres in 25 countries, 22.1% overall were resistant to penicillin G, with the highest rates of resistance found among isolates from Asia (53.4%), France (46.2%) and Spain (42.1%). Erythro- mycin A resistance occurred in 31.1% of isolates overall with the highest rates found in Asia (79.6%), France (57.6%), Hungary (55.6%) and Italy (42.9%). Marked geographical differences in the prevalence of both penicillin G (the Netherlands 0%; South Korea 71.5%) and erythromycin A (Sweden 4.7%; South Korea 87.6%) resistance were observed. Asia was characterized by the highest prevalence of resistance, overall, with only eight of 19 antimicrobials (co-amoxiclav, linezolid, vancomycin, teicoplanin, quinupristin/dalfopristin, levofloxacin, moxifloxacin and telithromycin) retaining high activity against isolates of S. pneumoniae from this region. Notable rates of resistance to clarithromycin, azithromycin, co-trimoxazole and tetracycline were observed in the majority of countries submitting isolates of S. pneumoniae to the PROTEKT Surveillance Study. Fluoroquinolone resistance was low (1%), overall, although 14.3% of 70 isolates from Hong Kong were resistant to levofloxacin and moxifloxacin, all but one of these isolates belonging to a single clone of the 23F serotype. Although, at present, apparently limited to pockets of clonal spread, continued vigilance with regard to the evolution of fluoroquinolone resistance is indicated. Telithromycin (MIC 90 0.12 mg/L; 99.9% of isolates susceptible) and lin- ezolid (MIC 90 2 mg/L; 100% of isolates susceptible) were the two most active oral agents tested, both compounds retaining activity against isolates of fluoroquinolone-resistant S. pneumoniae. The results of the PROTEKT Surveillance Study 1999-2000 emphasize the widespread evolution of resistance to a variety of antimicrobials amongst isolates of S. pneumoniae and demonstrate the potential of telithromycin as a therapeutic option for the treatment of community-acquired respiratory tract infections caused by this organism.
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the protekt Surveillance Study antimicrobial susceptibility of haemophilus influenzae and moraxella catarrhalis from community acquired respiratory tract infections
Journal of Antimicrobial Chemotherapy, 2002Co-Authors: Daryl J. Hoban, D FelminghamAbstract:This paper presents data relating to Haemophilus influenzae and Moraxella catarrhalis from PROTEKT (1999-2000), a Surveillance Study that examined the susceptibility of respiratory pathogens to current and new antibacterials. Beta-lactamase production is the principal mechanism of resistance to ampicillin and other beta-lactam antibacterials in H. influenzae and M. catarrhalis. The PROTEKT Study showed that globally, the prevalence of beta-lactamase production in H. influenzae varied considerably: of 2948 isolates, 489 (16.6%) were beta-lactamase-positive [range: 1.8% (Italy) to 65% (South Korea)]. Beta-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae were uncommon (<0.1%) but their very detection highlights the need for continued vigilance. Overall, few isolates of H. influenzae showed resistance to either macrolides or telithromycin. The emergence of clarithromycin-resistant strains is worrying, however, as such isolates may also show resistance to other macrolides. There was a geographical correlation between beta-lactamase production and the prevalence of resistance to chloramphenicol and tetracycline among the H. influenzae isolates. Of 1131 M. catarrhalis isolates, 92% were beta-lactamase-positive. Most isolates, however, were fully susceptible to nearly all the antibacterials tested, except ampicillin. The most active were ciprofloxacin and levofloxacin (both having MIC(90) values of 0.03 mg/L), moxifloxacin (MIC(90) 0.06 mg/L), azithromycin (MIC(90) < or = 0.06 mg/L) and telithromycin (MIC(90) 0.12 mg/L). Overall, there were no concerns in terms of resistance to fluoroquinolones for both H. influenzae and M. catarrhalis. In summary, the PROTEKT Surveillance Study confirmed the problem of widespread prevalence of beta-lactamase-producing strains of H. influenzae and M. catarrhalis, although these pathogens generally remain susceptible to macrolides, fluoroquinolones and the new ketolide telithromycin.
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evolving resistance patterns in community acquired respiratory tract pathogens first results from the protekt global Surveillance Study prospective resistant organism tracking and epidemiology for the ketolide telithromycin
Journal of Infection, 2002Co-Authors: D FelminghamAbstract:In recent years, antibacterial resistance among respiratory pathogens implicated in community-acquired respiratory tract infections (RTIs) has spread worldwide at an alarming rate. Thus, there is a pressing need for new antibacterials that retain activity against resistant organisms, have a low potential to select for resistance and do not induce cross-resistance. Telithromycin is the first of a new class of antibacterials - the ketolides - that have been designed specifically to overcome resistance among respiratory tract pathogens. This paper presents the first results of the PROTEKT Study (Prospective Resistant Organism Tracking and Epidemiology for the Ketolide Telithromycin), a worldwide Surveillance Study initiated to chart the prevalence of important resistance phenotypes and genotypes and the comparative activity of telithromycin against such strains. Analysis of over 7,000 bacterial isolates by April 2001 has confirmed the notable prevalence of strains resistant to commonly prescribed RTI antibacterials for all the pathogens studied. Telithromycin demonstrates high activity against isolates of Streptococcus pneumoniae, irrespective of penicillin G, macrolide or fluoroquinolone resistance. Telithromycin is also highly active against other respiratory tract pathogens, including Streptococcus pyogenes and beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis. These data justify the assertion that telithromycin is a promising new candidate for the empirical treatment of community-acquired RTIs, particularly in the face of increasing antibacterial resistance.
Kimihiko Kichikawa - One of the best experts on this subject based on the ideXlab platform.
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zilver ptx post market Surveillance Study of paclitaxel eluting stents for treating femoropopliteal artery disease in japan 2 year results
CardioVascular and Interventional Radiology, 2019Co-Authors: Kimihiko Kichikawa, Erin E Oleary, Aaron E Lottes, Hiroyoshi Yokoi, Takao Ohki, Shinsuke Nanto, Kimihiro Komori, Masato Nakamura, Shigeo Ichihashi, Scott A SnyderAbstract:Purpose A prospective, multicenter post-market Surveillance Study in Japan evaluated the 2-year safety and effectiveness of the DES in real-world patients with complex femoropopliteal artery lesions.
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zilver ptx post market Surveillance Study of paclitaxel eluting stents for treating femoropopliteal artery disease in japan 12 month results
Jacc-cardiovascular Interventions, 2016Co-Authors: Hiroyoshi Yokoi, Erin E Oleary, Aaron E Lottes, Takao Ohki, Shinsuke Nanto, Kimihiko Kichikawa, Kimihiro Komori, Masato Nakamura, Michael D DakeAbstract:Abstract Objectives This multicenter, prospective, post-market Surveillance Study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. Background The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized Study and a complementary, large single-arm Study supported the safety and effectiveness of the DES. Methods There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the Study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. Results In this Study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Conclusions Despite more challenging lesions, results from the current Study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837 )
Hiroyoshi Yokoi - One of the best experts on this subject based on the ideXlab platform.
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zilver ptx post market Surveillance Study of paclitaxel eluting stents for treating femoropopliteal artery disease in japan 2 year results
CardioVascular and Interventional Radiology, 2019Co-Authors: Kimihiko Kichikawa, Erin E Oleary, Aaron E Lottes, Hiroyoshi Yokoi, Takao Ohki, Shinsuke Nanto, Kimihiro Komori, Masato Nakamura, Shigeo Ichihashi, Scott A SnyderAbstract:Purpose A prospective, multicenter post-market Surveillance Study in Japan evaluated the 2-year safety and effectiveness of the DES in real-world patients with complex femoropopliteal artery lesions.
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zilver ptx post market Surveillance Study of paclitaxel eluting stents for treating femoropopliteal artery disease in japan 12 month results
Jacc-cardiovascular Interventions, 2016Co-Authors: Hiroyoshi Yokoi, Erin E Oleary, Aaron E Lottes, Takao Ohki, Shinsuke Nanto, Kimihiko Kichikawa, Kimihiro Komori, Masato Nakamura, Michael D DakeAbstract:Abstract Objectives This multicenter, prospective, post-market Surveillance Study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. Background The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized Study and a complementary, large single-arm Study supported the safety and effectiveness of the DES. Methods There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the Study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. Results In this Study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Conclusions Despite more challenging lesions, results from the current Study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837 )
Scott A Snyder - One of the best experts on this subject based on the ideXlab platform.
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zilver ptx post market Surveillance Study of paclitaxel eluting stents for treating femoropopliteal artery disease in japan 2 year results
CardioVascular and Interventional Radiology, 2019Co-Authors: Kimihiko Kichikawa, Erin E Oleary, Aaron E Lottes, Hiroyoshi Yokoi, Takao Ohki, Shinsuke Nanto, Kimihiro Komori, Masato Nakamura, Shigeo Ichihashi, Scott A SnyderAbstract:Purpose A prospective, multicenter post-market Surveillance Study in Japan evaluated the 2-year safety and effectiveness of the DES in real-world patients with complex femoropopliteal artery lesions.
