A Randomized, Single-Dose, Two-way Crossover, Open-label Study to Evaluate the Pharmacokinetics of Etoricoxib Tablet 120 mg and Arcoxia(R) 120 mg in Healthy Thai Subjects under Fasting Conditions

开始日期2019-07-05

申办/合作机构

Abbott Healthcare Products BV

CTR20170233 / Completed临床1期

中国健康绝经女性受试者单次和多次口服雌二醇0.5 mg/地屈孕酮2.5 mg后17β-雌二醇、地屈孕酮及其代谢产物药代、安全和耐受

主要目的为描述中国健康绝经后女性单次和多次口服含0.5 mg 17β-雌二醇和2.5 mg地屈孕酮的片剂后，雌二醇（E2）、地屈孕酮（D）及其主要代谢产物[雌酮（E1）、硫酸雌酮（E1S）和二氢地屈孕酮（DHD）]的药代动力学（PK）。次要目的为研究单次和重复口服含0.5 mg 17β-雌二醇和2.5 mg地屈孕酮的片剂的安全性和耐受性。

开始日期2017-06-05

申办/合作机构

Abbott Healthcare Products BV

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2023-02-01·Drugs

Risk of COVID-19 Diagnosis and Hospitalisation in Patients with Osteoarthritis or Back Pain Treated with Ibuprofen Compared to Other NSAIDs or Paracetamol: A Network Cohort Study

Article

作者: Xie, Junqing ; Varrassi, Giustino ; Prieto-Alhambra, Daniel ; Driessen, Stefan ; Argyriou, George ; Brash, James T ; Seager, Sarah ; Turkmen, Cigdem ; Reich, Christian

OBJECTIVEWe aimed to investigate whether ibuprofen use, compared with other non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs), cyclooxygenase-2 inhibitors (COX-2i) or paracetamol, increases the risk of coronavirus disease 2019 (COVID-19) diagnosis or hospitalisation.DESIGNA prevalent user and active comparator cohort study.SETTINGTwo US claims databases (Open Claims and PharMetrics Plus) mapped to the Observational Medical Outcomes Partnership Common Data Model.PARTICIPANTSInsured patients with a history of osteoarthritis or back pain and receiving ibuprofen, other ns-NSAIDs, COX-2i or paracetamol between 1 November, 2019 and 31 January, 2020 (study enrolment window 1) or between 1 February, 2020 and 31 October, 2020 (study enrolment window 2).MAIN OUTCOME MEASURESLarge-scale propensity score matching and empirical calibration were used to minimise confounding. Incidence and hazard ratios of COVID-19 diagnosis and hospitalisation according to drug/s use were estimated and pooled in the same study period across data sources using a fixed-effects meta-analysis. Index treatment episode was the primary risk evaluation window, censored at the time of discontinuation.RESULTSA total of 633,562 and 1,063,960 participants were included in periods 1 and 2, respectively, for the ibuprofen versus ns-NSAIDs comparison, 311,669 and 524,470 for ibuprofen versus COX-2i, and 492,002 and 878,598 for ibuprofen versus paracetamol. Meta-analyses of empirically calibrated hazard ratios revealed no significantly differential risk of COVID-19 outcomes in users of ibuprofen versus any of the other studied analgesic classes: hazard ratios were 1.13 (0.96-1.33) for the ibuprofen-ns-NSAIDs comparison, 1.03 (0.83-1.28) for the ibuprofen-COX-2i comparison and 1.13 (0.74-1.73) for ibuprofen-paracetamol comparison on COVID-19 diagnosis in the February 2020-October 2020 window. Similar hazard ratios were found on COVID-19 hospitalisation and across both study periods.CONCLUSIONSIn patients with osteoarthritis or back pain, we found no differential risks of incident COVID-19 diagnosis or COVID-19 hospitalisation for ibuprofen users compared with other ns-NSAIDs, COX-2i or paracetamol. Our findings support regulatory recommendations that NSAIDs, including ibuprofen, should be prescribed as indicated in the same way as before the COVID-19 pandemic, especially for those who rely on ibuprofen or NSAIDs to manage chronic arthritis or musculoskeletal pain symptoms.

2023-01-01·Vaccine

Enhanced passive safety surveillance of Influvac® and Influvac® Tetra: Results from seven consecutive seasons

Article

作者: Nauta, Jos ; Rogoll, Jutta ; Nisslein, Thomas ; de Voogd, Hanka ; van de Witte, Serge ; Moeller-Arendt, Melanie

BACKGROUND AND OBJECTIVESIn 2014, the European Medicines Agency (EMA) set out requirements for an enhanced safety surveillance for seasonal influenza vaccines. This paper presents data from the yearly Enhanced Passive Safety Surveillance (EPSS) implemented for Influvac® since season 2014/15 and continued for Influvac® Tetra from season 2018/19 onwards.METHODSIn seven consecutive seasons, an EPSS, aiming for at least 1,000 vaccinees (additional target of 100 vaccinees per five predefined age groups), was conducted in Germany, where market characteristics were expected to allow for a quick generation of representative data. Reactogenicity data in terms of reporting rates, severity and duration of pre-specified local and systemic adverse events of interest (AEI) were collected using response cards, which were completed by vaccinees and returned seven days after vaccination via regular mail. In addition, response cards contained a call center number to enhance reporting of other than pre-specified adverse events.RESULTSThe primary target of at least 1,000 vaccinees was surpassed in all seasons, as was the additional target of 100 adults and elderly. Reactogenicity data were in line with known safety profile of Influvac® and Influvac® Tetra. In children, the target was mostly met in seasons when the EPSS was conducted for Influvac®, but not in seasons when it was conducted for Influvac® Tetra. Although the data for Influvac® Tetra are based on a low number of paediatric vaccinees, they do not indicate a different reactogenicity profile of Influvac® Tetra compared with Influvac®. No signals were identified.CONCLUSIONThe EPSS set up for Influvac® and Influvac® Tetra proved a robust and effective methodology to comply with the objectives of EMÁ's guidance on enhanced safety surveillance of seasonal influenza vaccines. Safety data from seven consecutive seasons confirmed the favourable safety profile of both vaccines.

2022-06-29·Human Reproduction

P-615 Lack of analytical interference of dydrogesterone in progesterone immuno-assays: a multi-laboratory spike and recovery study of widespread used assays

作者: Wolthuis, A ; Eggersmann, T ; Griesinger, G ; Van Amsterdam, P

AbstractStudy questionDoes dydrogesterone (DYD) and its active metabolite 20-α-dihydrodydrogesterone (DHD) interfere with routinely used progesterone assays?Summary answerThis multi-laboratory spike-and-recovery study does not indicate any relevant interference of DYD/DHD within routinely used progesterone assays.What is known alreadyProgesterone (P4), a sex steroid, is measured in serum or plasma by competitive immunoassay or Liquid Chromatography mass spectrometry (LC-MS) in a variety of clinical contexts. One potential limitation of steroid hormone immunoassays is interference caused by compounds with structural similarity to the target steroid of the assay. Dydrogesterone, an orally active close stereoisomer of progesterone, is used for various indications in women’s health, including luteal phase support. To date, the potential interference of DYD/DHD with P4 immunoassays has not systematically been studied.Study design, size, durationThe present systematic in-vitro study investigated potential interferences of DYD/DHD in seven widely used, commercially available P4 immunoassays and a LC-MS method over a range of concentrations of DYD/DHD and P4. The study was performed in collaboration with participants in the endocrine section of the Dutch foundation for quality assessments in medical laboratories. For each assay method, each laboratory received a set of nine blinded human plasma samples (containing different P4 and/or DYD/DHD concentrations).Participants/materials, setting, methodsRoutine human plasma samples were anonymized and pooled to create three graded concentration levels of progesterone (P4 high, P4 medium, P4 low). Each pooled P4 plasma sample (6-7 ml) was spiked at high, medium and “none” DYD/DHD concentration and was divided into 0.5 ml aliquots. The blinded aliquots were analyzed by seven different laboratories with their routine progesterone assay (six different immunoassays and LC-MS assay, respectively).Main results and the role of chanceHigh, medium, and low P4 samples had concentrations of approximately 60 nmol/l progesterone, 20 nmol/l progesterone and <10 nmol/l (male plasma), respectively. The immuno- assays tested were Immulite 200XPI (Siemens Healthineers), Advia Centaur (Siemens Healthineers), Atellica (Siemens Healthineers), Architect I2000 (Abbott Diagnostics), Cobas 8000 (Roche Diagnostics), UniCel DxI 800 (Beckman-Coulter) and LC-MS (Agilent). The sample recovery rate (P4 result obtained by the assays tested for sample spiked with DYD/DHD, divided by the result obtained for the corresponding sample with no DYD/DHD x 100) was within a +/-10% window for the medium P4 and high P4 concentrations, but more variable for the low P4 samples. The latter is, however, attributable to high inter- and intra-method variability, especially at low P4 concentrations. The P4 plasma concentrations generally showed considerable inter-assay variability at each concentration level, with Immunlite 2000 at the lower end and Cobas 8000/801 and Dxi at the higher end of the reported results for the High and Medium P4 samples as compared to LC-MS. The study confirms the inherent method variability of P4 immunoassays casting doubts on the clinical use of P4 cut-offs to guide clinical management, especially at low concentrations.Limitations, reasons for cautionOnly one sample per concentration level was provided to the laboratories which didn't allow for a systematic quantification of intra-method variability. The concentrations of DYD/DHD haven't been verified by means of a validated bioanalytical method. Measurement of DYD and DHD is to date only feasible by a highly-selective LC-MS method.Wider implications of the findingsThe present study is strongly indicative that relevant interference of DYD/DHD does not exist. This finding implies that a clinician can reliably distinguish P4 concentrations from DYD/DHD concentrations in a blood sample within a routine care-setting.Trial registration numbernot applicable

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