Safety profile of oxcarbazepine: results from a prescription-event monitoring study

Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM. Exposure data were obtained from dispensed British National Health Service prescriptions issued by general practitioners (GPs) March 2000–July 2003. Demographic, drug utilization, and clinical event data were collected from questionnaires posted to GPs at least 6 months after first prescription date for each patient. Incidence densities (IDs) (number of first reports per 1,000 patient-months of treatment) were calculated and differences for events reported in month 1 (ID1) and months 2–6 (ID2–6) (99% confidence intervals) were examined for changes in event rates. Follow-up and causality assessment of medically significant events were undertaken. Results: The cohort comprised 2,243 patients [mean age 40.4 years; range 2–99 years; standard deviation (SD) 18.8; 46.3% (n = 1,038) male]. Most frequently reported primary indications were epilepsy, convulsion (n = 1,111; 49.5%, n = 209; 9.3%, respectively). GPs recorded 932 reasons for stopping medication in 698 (31.1%) patients; most frequent clinical reason “drowsiness/sedation” (n = 57; 2.5% of cohort). Clinical events (excluding indication) associated with starting treatment (lower 99% CI > 0) included: “drowsiness/sedation” (ID1-ID2–6 = 14.2), “nausea/vomiting” (ID1-ID2–6 = 13.0), and dizziness (ID1-ID2–6 = 11.6). Events followed up and assessed as probably related to oxcarbazepine use included rash (7 of 11) and hyponatremia (15 of 38). Discussion:  There were no serious adverse drug reactions reported during this study. Results of the study should be taken in context with other epidemiologic studies

Modern innovative solutions to improve outcomes in severe asthma : Protocol for a mixed methods observational comparison of clinical outcomes in mission versus current care delivery

Background: Asthma that is poorly controlled and undertreated can progress to more severe disease that is associated with high levels of unscheduled care that requires high-cost therapy, leading to a significant health economic burden. The identification and appropriate referral to a specialist asthma service is also often delayed by several months or years because of poor recognition and understanding of symptom severity. Current severe asthma services may take several months to provide a comprehensive multidisciplinary assessment, often necessitating multiple hospital visits and costing up to £5000 per patient. Objective: This study aims to evaluate whether a new service model could identify poorly controlled and potentially severe asthma much earlier in the patient pathway, and then compare clinical outcomes between this new care model with standard care. Methods: Modern Innovative Solutions to Improve Outcomes in (MISSION) Severe Asthma is a novel service model developed by asthma specialists from Portsmouth and Southampton severe asthma services. MISSION Severe Asthma identified patients with poorly controlled disease from general practice databases who had not been under secondary outpatient care in the last 12 months or who were not known to secondary care. In 1- or 2-stop assessments, a thorough review of diagnosis, disease phenotype, and control is undertaken, and clinical outcomes collected at baseline. Results: A variety of clinical outcomes will be collected to assess the service model. The results will be reported in February 2020. Conclusions: This protocol outlines a mixed methods study to assess the impact on disease control, unscheduled health care usage, and quality of life in patients seen in the MISSION clinic compared with a closely matched cohort who declined to attend

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Safety of Atrovent® CFC-free inhaler:respiratory events reported from an observational cohort study in England

ObjectivesThe aim of the study was to identify any unexpected clinical events associated with starting the new CFC‐free formulation of Atrovent® MDI in general practice in England.MethodsAn active surveillance cohort study was conducted with a focus on selected clinical events, including respiratory symptoms, in past users of Atrovent® CFC MDI (‘switchers’) and Atrovent® naïve users. Incidence density rate ratios (with 99% confidence intervals) for events occurring in the first 3 months of exposure (risk period‐ID1‐3) compared to 3 months prior to starting treatment (reference period‐IDR) were calculated.ResultsThe cohort consisted of 13 211 patients (median age 70 years, 50.1% female; 63.5% prior users of Atrovent® CFC MDI (‘switchers’)). Common respiratory events occurred at higher rates after starting treatment than before for switchers, for example lower respiratory tract infection (LRTI) [ID1/IDR = 1.45 (99% CI: 1.17, 1.81)] and worsening asthma [ID1/IDR = 1.58 (99% CI: 1.00, 2.51)]. Of these events only LRTI was significant for Atrovent® naïve patients [ID1/IDR = 1.42 (99% CI: 1.04, 1.95)].ConclusionsThe results of this study suggest effect modification of risk as a result of prior Atrovent® CFC MDI use. Overall, Atrovent® CFC‐free MDI appeared to be reasonably well tolerated in the immediate postmarketing period and the safety profile appeared similar to that of the CFC formulation

Acetic acid guided biopsies in Barrett’s surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol):a feasibility study for a randomised tandem endoscopy trial. The ABBA study.

<div><p>MiRNAs function in post-transcriptional regulation of gene expression and play very important roles in plant development. <i>Lonicera japonica</i> is one of the important medicinal plants in China. However, few studies on the discovery of conserved and novel miRNAs from <i>L</i>. <i>japonica</i> were reported. In this study, we employed deep sequencing technology to identify miRNAs in leaf and flower tissues of <i>L</i>. <i>japonica</i>. A total of 22.97 million clean reads from flower and leaf tissues were obtained, which generated 146 conserved miRNAs distributed in 20 families and 110 novel miRNAs. Accordingly, 72 differentially expressed miRNAs (P≤0.001) between leaves and flowers and their potential target genes were identified and validated. The qRT-PCR validation showed that majority of the differentially expressed miRNAs showed significant tissue-specific expression in <i>L</i>. <i>japonica</i>. Furthermore, the miRNA-mRNA and mRNA-mRNA regulatory networks were constructed using Cytoscape software. Taken together, this study identified a large number of miRNAs and target genes in <i>L</i>. <i>japonica</i>, which not only provides the first global miRNA expression profiles, but also sheds light on functional genomics research on <i>L</i>. <i>japonica</i> in the future.</p></div

Acetic acid guided biopsies in Barrett’s surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol):a feasibility study for a randomised tandem endoscopy trial. The ABBA study.

Background and study aims - Barrett’s esophagus is a potentially pre-cancerous condition, affecting 375,000 people in the UK. Patients receive a 2-yearly endoscopy to detect cancerous changes, as early detection and treatment results in better outcomes. Current treatment requires random mapping biopsies along the length of Barrett’s, in addition to biopsy of visible abnormalities. As only 13 % of precancerous changes appear as visible nodules or abnormalities, areas of dysplasia are often missed. Acetic acid chromoendoscopy (AAC) has been shown to improve detection of pre-cancerous and cancerous tissue in observational studies, but no randomized controlled trials (RCTs) have been performed to date. Patients and methods - A “tandem” endoscopy cross-overdesign. Participants will be randomized to endoscopy usingmapping biopsies or AAC, in which dilute acetic acid issprayed onto the surface of the esophagus, highlighting tissuethrough an whitening reaction and enhancing visibilityof areas with cellular changes for biopsy. After 4 to 10weeks, participants will undergo a repeat endoscopy, usingthe second method. Rates of recruitment and retention willbe assessed, in addition to the estimated dysplasia detectionrate, effectiveness of the endoscopist training program,and rates of adverse events (AEs). Qualitative interviewswill explore participant and endoscopist acceptabilityof study design and delivery, and the acceptability ofswitching endoscopic techniques for Barrett's surveillance. Results - Endoscopists’ ability to diagnose dysplasia in Barrett’sesophagus can be improved. AAC may offer a simple,universally applicable, easily-acquired technique to improvedetection, affording patients earlier diagnosis and treatment,reducing endoscopy time and pathology costs. TheABBA study will determine whether a crossover “tandem”endoscopy design is feasible and acceptable to patientsand clinicians and gather outcome data to power a definitivetrial