scholarly journals An objective systematic comparison of the most common adverse events of COVID-19 vaccines

2021 ◽  
Author(s):  
Claudia Behrens ◽  
Tatiana Gasperazzo ◽  
Maria Samii-Moghadam ◽  
Johannes B. Lampe
Keyword(s):  
Adverse Events ◽  
Public Awareness ◽  
Safety Data ◽  
Dose Schedule ◽  
Safety Outcome ◽  
Awareness Campaigns ◽  
Sql Database ◽  
The Absolute ◽  
Country Specific ◽  
The Eu

Background: Vaccination is an important tool in the fight against pandemics. However, the associated adverse events (AEs) may negatively impact the public perception of vaccines, therefore leading to decreased vaccination willingness. Interestingly, pharmacovigilance data of the three COVID-19 vaccines with a two-dose schedule approved in the EU (AstraZeneca, BioNTech and Moderna) already revealed country-specific differences in their safety profile early on (as of February 2021), at a time when the accumulated occurrence of specific AEs was not yet known. In the safety outcome assessment presented here, we aimed to establish whether these country-specific differences in pharmacovigilance data could be explained by differences in the frequency of AEs as reported in the respective approval studies of each vaccine. Methods: A systematic search was performed to identify all publications regarding the randomized controlled trials (RCTs) of two-dose vaccines approved in the EU (AstraZeneca, BioNTech and Moderna), including regulatory reports and journal articles. All obtained safety data was manually entered into an SQL database. In order to enable the comparability among the data, the solicited AEs for all vaccines (i.e. those AEs actively sought after vaccination) were investigated. The data was standardized to promote comparability and overcome data heterogeneity and complexity. Findings: Twelve documents regarding the RCTs for the three COVID-19 vaccines with a two-dose schedule approved in the EU (AstraZeneca, BioNTech and Moderna) were included in the safety outcome analysis. The entire safety data compiled in the SQL database amounted to 66 different study arms. The data structure revealed 13 different age thresholds or ranges and three different data sets regarding doses (first dose vs. second dose vs. all doses). After standardization and identification of subgroups, the analyses demonstrated that the highest rates of AEs occur after the first dose with the AstraZeneca vaccine, whereas with Moderna and BioNTech most AEs occur after the second dose. Astonishingly, the absolute frequencies of each AE after the first AstraZeneca dose correspond to those of the second dose of the mRNA vaccines (BioNTech and Moderna). Reversely, the absolute frequencies of the same AEs after the second AstraZeneca dose correspond to those of the first dose with the mRNA vaccines. The most common AEs with any vaccine were fatigue, headache and myalgia. Moreover, middle-aged subjects (18 to 55 years) had more side effects than older individuals (> 55 years), an observation that persisted among vaccines. Interpretation: This is the first indirect comparison of these vaccines that uses all available RCT data. The absolute frequency of each AE is similar between the first AstraZeneca dose and the second dose of BioNTech or Moderna; their occurrence was thus independent of platform (vector or mRNA) or the vaccine itself. This assessment demonstrates that the varying frequencies of AEs reported in early pharmacovigilance data for the vaccines in distinct countries, at a time when the accumulated occurrence of specific AEs with certain vaccines was not yet known, cannot be explained by different frequencies being reported in the respective RCTs. Conclusion: The approach presented here could help to objectify future discussions on vaccine preferences. Therefore, it may serve as basis for future public awareness campaigns and may also allow the comparison of vaccine performance in different subgroups (e.g. virus variants, high-risk patients). This approach may also be applied to a broad range of other challenges across the R&D process and various disease categories.

Correlation Between the Tyrozinkinazine Inhibitor Sunitinib - Dose, Schedule of Administration and Adverse Events

2017 ◽  
Vol 68 (7) ◽  
pp. 1652-1659
Author(s):  
Dana Lucia Stanculeanu ◽  
Raluca Ioana Mihaila ◽  
Daniela Zob ◽  
Oana Catalina Toma ◽  
Raluca Ioana Mihaila ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Dose Reduction ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Kinase Inhibitor ◽  
Dose Schedule ◽  
Prophylactic Measures ◽  
Hand Foot Syndrome

Sunitinib, a multi-targeted receptor tyrosine kinase inhibitor, has demonstrated survival benefit in patients with metastatic renal cell carcinoma (mRCC) and is generally well tolerated with most adverse events, manifesting as mild to moderate in severity. The most frequent related adverse events include hand-foot syndrome (HFS), hypertension, proteinuria, cardiac toxicities, myelosuppression, fatigue/asthenia, hypothyroidism, diarrhea and hepatotoxicity. The study aims to determine incidence of adverse events among patients with metastatic renal cell carcinoma (mRCC) treated Sunitinib within five years from 2010 to 2015 and comparing the results with data from literature. The study included a total of 56 patients treated with Sunitinib, with a dose of 50 mg (Schedule 4/2). Due to adverse events and individual safety and tolerability, at the indication of the personal clinician, 11 patients needed dose reduction, with a continuous dose of 37.5 mg, daily and 28 patients continued the dose of 50 mg taken daily, on a different schedule (2/1 schedule). The most important toxicities were anemia, leukopenia, thrombocytopenia, gastrointestinal effects (diarrhea), fatigue and hypertension. After dose reduction or modified schedule the incidence of the most frequent toxicities (HFS, leukopenia, thrombocytopenia and fatigue) decreased, but hypertension was still observed in 30% of patients. The results are similar with data from literature. Early identification of individuals at risk and monitoring patients during Sunitinib treatment is very important and it can facilitate early intervention with prophylactic measures or supportive treatment, thus increasing quality of life and adherence to treatment. Further studies need to establish which targeted population can benefit the most from adjusted regimens and to correlate them with prognostic factors for survival.

Naldemedine: Peripherally Acting Opioid Receptor Antagonist for Treating Opioid-induced Adverse Effects

2020 ◽  
Vol 20 (31) ◽  
pp. 2830-2842
Author(s):  
Masanao Inagaki ◽  
Toshiyuki Kanemasa ◽  
Takaaki Yokota
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Severe Pain ◽  
Lead Compound ◽  
Inhibitory Effects ◽  
Pharmacokinetic Profiles ◽  
Structure Activity ◽  
The Usa ◽  
Relationship Study ◽  
The Eu

Opioids are widely used for pain management in moderate-to-severe pain. However, opioids are associated with adverse events, such as constipation and emesis/vomiting. To reduce these undesired effects, a structure–activity relationship study of morphinan derivatives was conducted, and a promising lead compound with inhibitory effects on opioid receptors was obtained. Further improvement in the potency and pharmacokinetic profiles of the lead compound led to the discovery of naldemedine, which showed anti-constipation and anti-emetic effects against these adverse events that were induced by morphine without influencing morphine’s analgesic effect. Naldemedine was launched in Japan and the USA in 2017 and in the EU in 2019, for treating opioid-induced constipation.

Environmental Degradation in the Ikorodu Sub-Urban Lagos - Lagoon Coastal Environment, Nigeria

2018 ◽  
Vol 10 (1) ◽  
pp. 16-33 ◽  
Author(s):  
Shakirudeen Odunuga ◽  
Samuel Udofia ◽  
Opeyemi Esther Osho ◽  
Olubunmi Adegun
Keyword(s):  
Anthropogenic Activities ◽  
Public Awareness ◽  
Biodiversity Loss ◽  
Policy Formulation ◽  
Coastal Environment ◽  
Resource Exploitation ◽  
Average Growth ◽  
Awareness Campaigns ◽  
The Government ◽  
State Of The Environment

Introduction:Human activities exert great pressures on the environment which in turn cause environmental stresses of various intensities depending on the factors involved and the sensitivity of the receiving environment.Objective:This study examines the effects of anthropogenic activities along the sub-urban lagoon fragile coastal ecosystem using DPSIR framework.Results:The results show that the study area has undergone a tremendous change between 1964 and 2015 with the built up area increasing to about 1,080 ha (17.87%) in 2015 from 224 ha (1.32%) in 1964 at an average growth rate of 16.78ha per annum. The nature of the degradation includes an increasing fragility of the ecosystem through the emergence and expansion of wetlands, flooding and erosion as well as a reduction in the benefits from the ecosystem services. Population growth, between 2006 and 2015 for Ikorodu LGA, estimated at 8.84% per annum serves as the most important driving force in reducing the quality of the environment. This is in addition to Pressures emanating from anthropogenic activities. The state of the environment shows continuous resource exploitation (fishing and sand mining) with the impacts of the pressures coming from water pollution, bank erosion, biodiversity loss and flooding. Although there has been a strong policy formulation response from the government, weak implementation is a major challenge.Recommendation:The study recommends public awareness campaigns and the implementation of existing policies to ensure a sustainable sub-urban lagoon coastal environment..

Advance care planning: the future

2020 ◽  
pp. bmjspcare-2020-002304
Author(s):  
Judith Rietjens ◽  
Ida Korfage ◽  
Mark Taubert
Keyword(s):  
Advance Care Planning ◽  
Public Awareness ◽  
Care Planning ◽  
Decisional Capacity ◽  
Best Interest ◽  
Awareness Campaigns ◽  
People With Dementia ◽  
Future Care ◽  
Advance Care ◽  
Improve Patient

ObjectivesThere is increased global focus on advance care planning (ACP) with attention from policymakers, more education programmes, laws and public awareness campaigns.MethodsWe provide a summary of the evidence about what ACP is, and how it should be conducted. We also address its barriers and facilitators and discuss current and future models of ACP, including a wider look at how to best integrate those who have diminished decisional capacity.ResultsDifferent models are analysed, including new work in Wales (future care planning which includes best interest decision-making for those without decisional capacity), Asia and in people with dementia.ConclusionsACP practices are evolving. While ACP is a joint responsibility of patients, relatives and healthcare professionals, more clarity on how to apply best ACP practices to include people with diminished capacity will further improve patient-centred care.

scholarly journals 1288. Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial Infections

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S659-S659
Author(s):  
Angela Talley ◽  
Archie Thurston ◽  
Grayson Moore ◽  
Myriah M Satterfield ◽  
Erika L Manyak ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthy Volunteers ◽  
Controlled Trial ◽  
Phase 1 ◽  
Safety Data ◽  
Elderly Subjects ◽  
Independent Contractor ◽  
Serious Adverse Events ◽  
Healthy Elderly ◽  
Dose Proportional

Abstract Background SPR720 (phosphate pro-drug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for non-tuberculous mycobacterial lung disease (NTM-LD) and pulmonary tuberculosis. SPR719 has broad-spectrum activity versus clinically relevant mycobacteria in vitro and in murine and hollow fiber (HF) infection models. In this first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) study, the safety, tolerability and pharmacokinetics (PK) of SPR720/SPR719 were evaluated in healthy volunteers. Methods This was a Phase 1 randomized, double-blind, placebo-controlled trial with 7 SAD cohorts (including a food effect cohort) and 5 MAD cohorts. Healthy volunteers (n=8/cohort, 3:1 randomization) received SPR720 or placebo in single oral doses of ranging from 100 mg to 2000 mg or repeat total daily doses ranging from 500 mg to 1500 mg for 7 or 14 days. Safety monitoring and PK sampling occurred throughout the trial. Plasma and urine concentrations of SPR720/SPR719 were measured by validated LC-MS/MS methods. PK parameters were calculated using non-compartmental analysis. Results A total of 96 subjects (including 8 healthy elderly subjects, age ≥ 65 years) were randomized and received study drug. SPR720 was well-tolerated at daily doses up to 1000 mg for up to 14 days. Across SAD/MAD cohorts, the most common adverse events were gastrointestinal (nausea, vomiting and diarrhea) and headache, all of mild or moderate severity and dose dependent. No serious adverse events were reported. Across SAD cohorts, a dose proportional and greater-than-dose proportional increase in SPR719 plasma Cmax and AUC0-24, respectively were observed. SPR720 was rapidly absorbed with a mean SPR719 t1/2 of 2.9-4.5 h. Dosing with food decreased SPR719 plasma AUC by ~20%. No clinically meaningful effect of age on plasma AUC was observed. In the MAD cohorts, SPR719 plasma exposure declined approximately 40% between Day 1 and Day 7, suggesting induction of an elimination pathway. However, plasma AUC0-24 was similar at Days 7 and 14. Conclusion Together with HF pharmacodynamic data, human PK and safety data for SPR720 suggest that predicted therapeutic exposures can be attained with a well-tolerated once-daily dose. Further evaluation in a Phase 2 NTM-LD trial is planned. Disclosures Angela Talley, MD, Spero Therapeutics (Employee, Shareholder) Archie Thurston, Jr., PhD, Spero Therapeutics (Consultant) Grayson Moore, BA, RN, Spero Therapeutics, Inc. (Shareholder, Independent Contractor) Vipul Kumar, PhD, Spero Therapeutics (Employee, Shareholder) Suzanne Stokes, PhD, Spero Therapeutics (Employee, Shareholder) Aaron Dane, MSc, Spero theraputics (Consultant) David Melnick, MD, Spero Therapeutics (Employee)Spero Therapeutics (Employee)

scholarly journals Medical dispatchers’ perception of the interaction with the caller during emergency calls - a qualitative study

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Thea Palsgaard Møller ◽  
Hejdi Gamst Jensen ◽  
Søren Viereck ◽  
Freddy Lippert ◽  
Doris Østergaaard
Keyword(s):  
Public Awareness ◽  
Emergency Call ◽  
Awareness Campaigns ◽  
Emergency Calls ◽  
Modifiable Factors ◽  
Qualitative Interview Study ◽  
Call Process ◽  
Complex Procedure ◽  
Call Handling ◽  
Emergency Medical Dispatchers

Abstract Background Medical dispatching is a highly complex procedure and has an impact upon patient outcome. It includes call-taking and triage, prioritization of resources and the provision of guidance and instructions to callers. Whilst emergency medical dispatchers play a key role in the process, their perception of the process is rarely reported. We explored medical dispatchers’ perception of the interaction with the caller during emergency calls. Secondly, we aimed to develop a model for emergency call handling based on these findings. Methods To provide an in-depth understanding of the dispatching process, an explorative qualitative interview study was designed. A grounded theory design and thematic analysis were applied. Results A total of 5 paramedics and 6 registered nurses were interviewed. The emerging themes derived from dispatchers’ perception of the emergency call process were related to both the callers and the medical dispatchers themselves, from which four and three themes were identified, respectively. Dispatchers reported that for callers, the motive for calling, the situation, the perception and presentation of the problem was influencing factors. For the dispatchers the expertise, teamwork and organization influenced the process. Based on the medical dispatchers´ perception, a model of the workflow and interaction between the caller and the dispatcher was developed based on themes related to the caller and the dispatcher. Conclusions According to medical dispatchers, the callers seem to lack knowledge about best utilization of the emergency number and the medical dispatching process, which can be improved by public awareness campaigns and incorporating information into first aid courses. For medical dispatchers the most potent modifiable factors were based upon the continuous professional development of the medical dispatchers and the system that supports them. The model of call handling underlines the complexity of medical dispatching that embraces the context of the call beyond clinical presentation of the problem.

scholarly journals Immunotherapy in hepatocellular carcinoma: evaluation and management of adverse events associated with atezolizumab plus bevacizumab

2021 ◽  
Vol 13 ◽  
pp. 175883592110311
Author(s):  
Chiun Hsu ◽  
Lorenza Rimassa ◽  
Hui-Chuan Sun ◽  
Arndt Vogel ◽  
Ahmed O. Kaseb
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Safety Data ◽  
Standard Of Care ◽  
Antiangiogenic Agents ◽  
Efficacy And Safety ◽  
First Line

In light of positive efficacy and safety findings from the IMbrave150 trial of atezolizumab plus bevacizumab, this novel combination has become the preferred first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). Several additional trials are ongoing that combine an immune checkpoint inhibitor with another agent such as a multiple kinase inhibitor or antiangiogenic agent. Therefore, the range of first-line treatment options for unresectable HCC is likely to increase, and healthcare providers need succinct information about the use of such combinations, including their efficacy and key aspects of their safety profiles. Here, we review efficacy and safety data on combination immunotherapies and offer guidance on monitoring and managing adverse events, especially those associated with atezolizumab plus bevacizumab. Because of their underlying liver disease and high likelihood of portal hypertension, patients with unresectable HCC are at particular risk of gastrointestinal bleeding, and this risk may be exacerbated by treatments that include antiangiogenic agents. Healthcare providers also need to be alert to the risks of proteinuria and hypertension, colitis, hepatitis, and reactivation of hepatitis B or C virus infection. They should also be aware of the possibility of rarer but potentially life-threatening adverse events such as pneumonitis and cardiovascular events. Awareness of the risks associated with these therapies and knowledge of adverse event monitoring and management will become increasingly important as the therapeutic range broadens in unresectable HCC.

Sentiments expressed in YouTube public awareness campaigns: stroke

2021 ◽  
Vol 51 (6) ◽  
pp. 971-974
Author(s):  
Thanh G. Phan ◽  
Richard Beare ◽  
Velandai Srikanth ◽  
Henry Ma
Keyword(s):  
Public Awareness ◽  
Awareness Campaigns

Cardiovascular, Dermatological, Gastrointestinal, Hematological, Hormonal, and Immunosuppressant Agents

2002 ◽  
Vol 37 (10) ◽  
pp. 1113-1126 ◽  
Author(s):  
Joyce A. Generali
Keyword(s):  
At Risk ◽  
Adverse Events ◽  
Drug Interactions ◽  
Prescription Drugs ◽  
Hospital Pharmacy ◽  
Safety Data ◽  
Black Box ◽  
Information Monitoring ◽  
Black Box Warnings ◽  
Wall Chart

“Black-box” warnings report valuable postmarketing safety data about prescription drugs, keeping practitioners informed about potential adverse events, drug interactions, key dosing information, monitoring and administration requirements, and at-risk patient populations. They are especially crucial for newly approved agents. A list of agents with black-box warnings does not currently exist; however Hospital Pharmacy will be publishing comprehensive lists by drug category in this column until November 2002. At that time, a complete list in wall chart form will be released. Hospital Pharmacy will update the data as salient information becomes available.

Improved quality of reporting safety data of medication in paediatric randomised controlled trials

2021 ◽  
pp. archdischild-2020-321197
Author(s):  
Taco Jan Prins ◽  
Corine Rollema ◽  
Eric van Roon ◽  
Tjalling de Vries
Keyword(s):  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Safety Data ◽  
Drug Event ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Event Reporting ◽  
The Past ◽  
Randomised Controlled

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event reporting.Main outcome measuresQuality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient.ResultsWe reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05).ConclusionsReporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

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