BMC pharmacology & toxicology
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BMC Pharmacol Toxicol · Apr 2019
Multicenter Study Observational StudyCharacterization and preventability of adverse drug events as cause of emergency department visits: a prospective 1-year observational study.
Adverse drug events (ADEs) are a significant cause of emergency department (ED) visits, with a major impact on healthcare resource utilization. A multicentre observational study, aimed to describe frequency, seriousness and preventability of ADEs reported in four EDs, was performed in Sicily (Italy) over a 1-year period. ⋯ ADEs are a frequent cause of ED visits. The commonly used antibiotics and anti-inflammatory drugs should be carefully managed, as they are widely involved in mild to severe ADEs. Polytherapy is associated with the occurrence of serious, as well as certainly preventable ADEs, while older age only with serious events. A greater sensitivity to drug monitoring programs among health professionals is needed.
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BMC Pharmacol Toxicol · Jun 2018
Multicenter Study Observational StudyCausality and preventability assessment of adverse drug events of antibiotics among inpatients having different lengths of hospital stay: a multicenter, cross-sectional study in Lahore, Pakistan.
A large number of hospital admissions are attributed to adverse drug reactions (ADRs) and they are the fifth leading cause of death worldwide. The present study aimed to assess the causality and preventability of adverse drug events (ADEs) of antibiotics among inpatients having different lengths of hospital stay. ⋯ Antibiotics associated definitely preventable ADEs were more commonly found in patients having long LOS in the inpatient departments because of MEs and lack of proper pharmacovigilance system. The ADRs showed a probable and possible causal association with both β-lactams and non β-lactams antibiotics.
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BMC Pharmacol Toxicol · Apr 2016
Randomized Controlled Trial Multicenter Study Comparative StudyDesign of a randomized controlled trial of extended-release naltrexone versus daily buprenorphine-naloxone for opioid dependence in Norway (NTX-SBX).
Current guidelines for opioid dependence recommend daily maintenance of physical dependence with methadone or buprenorphine, and discourage abstinence due to the high risk of relapse and overdose. Extended-release formulations of the opioid antagonist naltrexone (XR-NTX) block heroin and other opioid agonists competitively for around 4 weeks per administration. XR-NTX thus enables opioid users to experience abstinence from opioid agonists with greatly reduced risk of overdose compared to medication-free abstinence. While XR-NTX has shown promise compared to placebo and daily naltrexone tablets, there is limited information on long-term safety and its performance compared to daily maintenance treatment. ⋯ Despite minor implementation problems, the protocol appears sufficiently robust to generate results of high interest to patients, clinicians and policy makers.
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BMC Pharmacol Toxicol · Jan 2014
Randomized Controlled Trial Multicenter StudyPalonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: a randomized, multicenter, open-label study.
This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis. ⋯ Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0-72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.
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BMC Pharmacol Toxicol · Sep 2013
Multicenter StudyActive post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers.
After several exploratory and confirmatory clinical trials, the intralesional administration of human recombinant epidermal growth factor (hrEGF) has been approved for the treatment of advanced diabetic foot ulcers (DFU). The aim of this work was to evaluate the effectiveness and safety of this procedure in medical practice. ⋯ The favorable benefit/risk balance, confirms the beneficial clinical profile of intralesional hrEGF in the treatment of DFUs.