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Drug safety

A Perutelli, C Tascini, L Domenici, S Garibaldi, C Baroni, E Cecchi, M G Salerno
OBJECTIVE: Tigecycline is a glycylcycline antimicrobial structurally related to minocycline, with a wide spectrum of activity that includes anaerobes and typical and atypical microorganisms causing pelvic inflammatory disease (PID). This study aimed to evaluate efficacy and safety of tigecycline in complicated PID and un-complicated PID after the failure of first-line antibiotic therapy. PATIENTS AND METHODS: Between May 2014 and April 2016 at the 2nd Unit of Obstetrics and Gynecology, Santa Chiara Hospital of Pisa a pilot study on 20 women with mild/moderate PID after the failure of first-line antibiotic therapy and on 8 women with complicated PID was conducted...
June 2018: European Review for Medical and Pharmacological Sciences
Sara M Pires, Ana Sofia Duarte, Tine Hald
Source attribution and microbial risk assessment methods have been widely applied for the control of several foodborne pathogens worldwide by identifying (i) the most important pathogen sources and (ii) the risk represented by specific foods and the critical points in these foods' production chains for microbial control. Such evidence has proved crucial for risk managers to identify and prioritize effective food safety and public health strategies. In the context of antimicrobial resistance (AMR) from livestock and pets, the utility of these methods is recognized, but a number of challenges have largely prevented their application and routine use...
May 2018: Microbiology Spectrum
Dirk Woitalla, Antoine Dunac, Ali Safavi, Maria-Gabriella Ceravolo, Juan Carlos Gomez Esteban, Nicola Pavese, Mahnaz Asgharnejad, Lars Joeres, Jan-Christof Schuller, K Ray Chaudhuri
BACKGROUND: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson's disease (PD) patients. METHODS: Patients previously received levodopa for ≥6 months as monotherapy/in combination with another dopamine-agonist (DA). Primary variable: Unified PD Rating Scale (UPDRS) Part-II change from baseline to end-of-observation-period (EOP)...
June 19, 2018: Expert Opinion on Pharmacotherapy
Brian A Baldo
Drugs may cause serotonin toxicity by a number of different mechanisms including inhibition of serotonin uptake and metabolism, increased serotonin synthesis and release, activation of serotonin receptors, and inhibition of cytochrome P450 oxidases. Some drug interactions involving opioids can increase intrasynaptic levels of serotonin, and opioid analgesic drugs are now recognized as being involved in some cases of serotonin toxicity especially if administered in conjunction with other serotonergic medications including monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants...
June 18, 2018: Archives of Toxicology
Chao Xu, Patanjali Ravva, Jun Steve Dang, Johann Laurent, Céline Adessi, Christine McIntyre, Georgina Meneses-Lorente, François Mercier
PURPOSE: To inform lumretuzumab and pertuzumab dose modifications in order to decrease the incidence, severity, and duration of the diarrhea events in metastatic breast cancer patients treated with a combination therapy of lumretuzumab (anti-HER3) in combination with pertuzumab (anti-HER2) and paclitaxel using quantitative clinical pharmacology modeling approaches. METHODS: The safety and pharmacokinetic (PK) data from three clinical trials (lumretuzumab monotherapy n = 47, pertuzumab monotherapy n = 78, and the combination therapy of lumretuzumab, pertuzumab and paclitaxel n = 35) were pooled together to develop a continuous-time discrete states Markov model describing the dynamics of the diarrhea events...
June 18, 2018: Cancer Chemotherapy and Pharmacology
Martine W F T Verhees, Janne Houben, Eva Ceulemans, Marian J Bakermans-Kranenburg, Marinus H van IJzendoorn, Guy Bosmans
BACKGROUND: Despite growing interest in the (therapeutic) use of intranasal oxytocin administration in children, the potential side-effects of intranasal oxytocin have remained largely unclear to date. The current study is the first double-blind randomized controlled trial to examine side-effects following single administration of oxytocin nasal spray in elementary school-aged children. METHODS: One hundred children (8-12 years old) were randomly assigned to receive oxytocin or placebo nasal spray...
June 18, 2018: Psychopharmacology
Sylvie Hall, Diana Isaacs, Jennifer N Clements
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) came to market in the year 2005, as a new therapeutic classification, for clinical use in the management of type 2 diabetes mellitus (T2DM). Since 2005, there have been six approved products on the market, with the newest product being semaglutide (Novo Nordisk). Several studies have been conducted and completed evaluating its pharmacokinetics as a once-weekly subcutaneous injection. As a dose of 0.5 or 1 mg, semaglutide has a half-life of 7 days; therefore, it would reach steady state in 4-5 weeks...
June 19, 2018: Clinical Pharmacokinetics
Harmanjit Singh, Avinash Chakrawarti, Harjit Singh, P Guruprasad, Yogendra Kumar Gupta
Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are attractive agents to be used in the elderly patients with Type 2 diabetes mellitus (T2DM) because of their beneficial effects. Methods: In this cross-sectional, observational study, we evaluated and compared the treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ) in two groups (i.e., regimens containing DPP4 inhibitors vs. other regimens). Efficacy was evaluated by assessing and comparing the glycosylated hemoglobin (HbA1c) values and the percentage of patients who achieved the glycemic control (HbA1c <7%)...
January 2018: Journal of Family Medicine and Primary Care
Raghu Durvasula, Janet Kelly, Anneliese Schleyer, Bradley D Anawalt, Shabir Somani, Timothy H Dellit
Background: As healthcare costs rise and reimbursements decrease, healthcare organization leadership and clinical providers must collaborate to provide high-value healthcare. Medications are a key driver of the increasing cost of healthcare, largely as a result of the proliferation of expensive specialty drugs, including biologic agents. Such medications contribute significantly to the inpatient diagnosis-related group payment system, often with minimal or unproved benefit over less-expensive therapies...
April 2018: American Health & Drug Benefits
Anna Marie Jilla, Carole E Johnson, Jeffrey L Danhauer
Recently, President Trump signed into law the Food and Drug Administration (FDA) Reauthorization Act of 2017, which included the Over-the-Counter Hearing Aid Act designed to provide greater public accessibility to and affordability of amplification for individuals with self-identified mild and moderate hearing loss through the provision of over-the-counter (OTC) hearing aids (HAs) with a direct-to-consumer (DTC) delivery model. American Speech-Language-Hearing Association and American Academy of Audiology Position Statements on OTC HAs state that these devices should only be used for adults with mild hearing losses...
May 2018: Seminars in Hearing
Harsha R Mittakanti, Christopher S Elliott
Male enhancement and erectile dysfunction supplements are typically non-Food and Drug Administration (FDA) approved and readily available for purchase by anyone. Longstanding priapism is a significant potential side effect. A 25-year-old man presented with a 48-h priapism after taking Rhino 7 Platinum 3000. He required bilateral corpo-glanular shunting to alleviate his priapism. On initial 2-week follow-up, he had significant fibrosis of the corporal bodies bilaterally and had been unable to achieve an erection...
June 19, 2018: International Journal of Impotence Research
Chanel F Whittaker, Margaret A Miklich, Roshni S Patel, Jeffrey C Fink
Ensuring patient safety is a priority of medical care because iatrogenic injury has been a primary concern. Medications are an important source of medical errors, and kidney disease is a thoroughfare of factors threatening safe administration of medicines. Principal among these is reduced kidney function because almost half of all medications used are eliminated via the kidney. Additionally, kidney patients often suffer from multimorbidity, including diabetes, hypertension, and heart failure, with a range of prescribers who often do not coordinate treatments...
June 18, 2018: Clinical Journal of the American Society of Nephrology: CJASN
Elizabeth G Rhee, Matthew L Rizk, Nicole Calder, Marcela Nefliu, Steven J Warrington, Michael S Schwartz, Eric Mangin, Keith Boundy, Pratik Bhagunde, Francheska Colon-Gonzalez, Patricia Jumes, Yang Liu, Joan R Butterton
Relebactam is a novel class A and C β-lactamase inhibitor that is being developed in combination with imipenem/cilastatin for the treatment of serious gram-negative bacterial infections. Here we report on 2 phase 1 randomized, double-blind, placebo-controlled, pharmacokinetics, safety, and tolerability studies of relebactam administered with or without imipenem/cilastatin in healthy participants: 1) a single dose (25 to 1150 mg) and multiple dose (50 to 625 mg every 6 hours [q6h] for 7 to 14 days) escalation study in men and 2) a single dose (125 mg) study in women and elderly...
June 18, 2018: Antimicrobial Agents and Chemotherapy
Guan-Hui Zhou, Jun Han, Jun-Hui Sun, Yue-Lin Zhang, Tan-Yang Zhou, Chun-Hui Nie, Tong-Yin Zhu, Sheng-Qun Chen, Bao-Quan Wang, Zi-Niu Yu, Hong-Liang Wang, Li-Ming Chen, Wei-Lin Wang, Shu-Sen Zheng
BACKGROUND: This study aimed to investigate the efficacy and safety of drug eluting beads transarterial chemoembolization (DEB-TACE) treatment by CalliSpheres® in Chinese patients with hepatocellular carcinoma (HCC) as well as the predicting factors for response. METHODS: 99 patients with HCC were consecutively enrolled in this study. All participants were treated by CalliSpheres® DEB-TACE. Clinical response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria...
June 8, 2018: BMC Cancer
Taraneh Moini Zanjani, Masoumeh Sabetkasaei, Behnaz Karimian, Farzaneh Labibi, Babak Farokhi, Nariman Mossafa
Background Evidence for a role of immune system in hyperalgesic pain states is increasing. Recent work in neuroimmunology suggests that the immune system does more than simply perform its well known functions of recognizing and removing invading pathogens and tumors. Interest in neuroinflammation and neuroimmune activation has grown rapidly in recent years with the recognition of the role of central nervous system inflammatiom and immune responses in the aetiology of pain states. Among various theories, the role of inflammatory responses of the injured nerve has recently received attention...
December 29, 2017: Scandinavian Journal of Pain
Anna Folkesson, Per Hartvig Honoré, Ole J Bjerrum
A high proportion of patients suffering from neuropathic pain do not receive satisfactory pain relief from their current treatment, due to incomplete efficacy and dose-limiting adverse effects. Hence, one strategy to improve treatment outcome is the use of a combination of analgesic drugs. The potential benefits of such approach include improved and prolonged duration of analgesic effect and fewer or milder adverse effects with lower doses of each drug. Gabapentin is recommended as a first-line drug in the treatment of neuropathic pain, and has recently been demonstrated to act on supraspinal structures to stimulate the descending noradrenergic pain inhibitory system...
December 29, 2017: Scandinavian Journal of Pain
F Petzke, K B Jensen, E Kosek, E Choy, S Carville, P Fransson, S C R Williams, H Marcus, Y Mainguy, M Ingvar, R H Gracely
Background In recent years, the prescription of serotonin-noradrenalin reuptake inhibitors (SNRIs) for treatment of fibromyalgia (FM) has increased with reports of their efficacy. The SNRI milnacipran is approved by the U.S. Food and Drug Administration (FDA) for treatment of FM, yet, the mechanisms by which milnacipran reduces FM symptoms are unknown. A large number of neuroimaging studies have demonstrated altered brain function in patients with FM but the effect of milnacipran on central pain processing has not been investigated...
December 29, 2017: Scandinavian Journal of Pain
Anders Hougaard, Anne Werner Hauge, Song Guo, Peer Tfelt-Hansen
Background and aims NXN-188 is a combined neuronal nitric oxide synthase (nNOS) inhibitor and 5HT-1B/1D receptor agonist which has previously shown efficacy in the acute treatment of migraine. Nitric oxide (NO) is involved in the pathogenesis of migraine pain and is formed after cortical spreading depression. Therefore NXN-188 could perhaps prevent the development of the headache phase in migraine with aura if taken during the aura. The aims of the present study were to evaluate the efficacy and safety of 600mg NXN-188 in the acute treatment of migraine when dosed during the aura...
December 29, 2017: Scandinavian Journal of Pain
Leila Niemi-Murola, Jani Unkuri, Katri Hamunen
Introduction and aim Pain is a frequent symptom in emergency patients and opioids are commonly used to treat it at emergency departments and at pre-hospital settings. The aim of this systematic review is to examine the efficacy and safety of parenteral opioids used for acute pain in emergency medicine. Method Qualitative review of randomized controlled trials (RCTs) on parenteral opioids for acute pain in adult emergency patients. Main outcome measures were: type and dose of the opioid, analgesic efficacy as compared to either placebo or another opioid and adverse effects...
December 29, 2017: Scandinavian Journal of Pain
Lars Arendt-Nielsen, Michele Curatolo
Background Mechanistic, translational, human experimental pain assessment technologies (pain bio markers) can be used for: (1) profiling the responsiveness of various pain mechanisms and pathways in healthy volunteers and pain patients, and (2) profiling the effect of new or existing analgesic drugs or pain management procedures. Translational models, which may link mechanisms in animals to humans, are important to understand pain mechanisms involved in pain patients and as tools for drug development. This is urgently needed as many drugs which are effective in animal models fail to be efficient in patients as neither the mechanisms involved in patients nor the drugs' mechanistic actions are known...
December 29, 2017: Scandinavian Journal of Pain
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