Reporting of Acute Inflammatory Neuropathies with COVID-19 Vaccines: Subgroup Disproportionality Analyses in VigiBase

Since marketing authorization, cases of neuralgic amyotrophy (NA), facial paralysis/Bell’s palsy (FP/BP), and Guillain-Barré syndrome (GBS) were reported with COVID-19 vaccines of different technologies. This study aimed to assess whether NA, FP/BP, and GBS were more frequently reported in VigiBase with COVID-19 vaccines (of any technologies) than with other viral vaccines, over the full database and across potential risk groups by sex and age. The reporting odds ratio (ROR) with 95% confidence interval (95% CI) was used as the measure of disproportionality and subgroup disproportionality analyses were performed by sex and age. Out of 808,906 safety reports with COVID-19 vaccines, 57 (0.01%) reported NA, 3320 (0.4%) FP/BP, and 632 (0.1%) GBS. There were not signals of disproportionate reporting for NA and GBS with COVID-19 vaccines against other viral vaccines. FP/BP was disproportionately more frequently reported with COVID-19 vaccines than with other viral vaccines over the full database (ROR 1.12, 95%CI 1.07–1.17), in males (ROR 1.65, 95%CI 1.54–1.78) and in age subgroups 65–74 years (ROR 1.21, 95%CI 1.05–1.39) and ≥75 years (ROR 1.84, 95%CI 1.52–2.22). Albeit not proving causation, these findings might support clinicians in decision-making for patients potentially at risk for developing an acute inflammatory neuropathy with COVID-19 vaccines.

Download Full-text

Thrombocytopenia with Tedizolid and Linezolid

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01453-17 ◽

2017 ◽

Vol 62 (1) ◽

Cited By ~ 15

Author(s):

Erica Yookyung Lee ◽

Aisling R. Caffrey

Keyword(s):

Adverse Event ◽

Confidence Interval ◽

Drug Administration ◽

Odds Ratio ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Event Reporting ◽

Using Data

ABSTRACT Several studies have suggested the risk of thrombocytopenia with tedizolid, a second-in-class oxazolidinone antibiotic (approved June 2014), is less than that observed with linezolid (first-in-class oxazolidinone). Using data from the Food and Drug Administration adverse event reporting system (July 2014 through December 2016), we observed significantly increased risks of thrombocytopenia of similar magnitudes with both antibiotics: linezolid reporting odds ratio [ROR], 37.9 (95% confidence interval [CI], 20.78 to 69.17); tedizolid ROR, 34.0 (95% CI, 4.67 to 247.30).

Download Full-text

Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004−2016

SAGE Open Medicine ◽

10.1177/2050312118777953 ◽

2018 ◽

Vol 6 ◽

pp. 205031211877795 ◽

Cited By ~ 11

Author(s):

Yumi Motooka ◽

Toshinobu Matsui ◽

Rachel M Slaton ◽

Ryogo Umetsu ◽

Akiho Fukuda ◽

...

Keyword(s):

Smoking Cessation ◽

Adverse Event ◽

Adverse Events ◽

Confidence Interval ◽

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Odds Ratio ◽

Electronic Cigarettes ◽

Reporting Odds Ratio ◽

Nicotine Replacement

Objectives: Several smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes are widely used. We evaluated the adverse events related to smoking cessation treatments and electronic cigarettes in the US Food and Drug Administration Adverse Event Reporting System database. Methods: We analyzed reports of adverse events associated with smoking cessation treatment and electronic cigarettes terms dated between January 2004 and December 2016. We used the reporting odds ratio with 95% confidence intervals to detect a signal for each adverse event. Results: In total, 8,867,135 reports in the Food and Drug Administration Adverse Event Reporting System database were analyzed. The numbers of adverse events for nicotine replacement therapy (transdermal, buccal, oral, and respiratory administration) were 1673, 1016, 425, and 56, respectively. Nicotine replacement therapy (transdermal, buccal, and oral) demonstrated adverse events of nausea, nicotine dependence, and dizziness. For nicotine (transdermal) exposure, the top 5 adverse events reported were nausea (149 cases, reporting odds ratio: 2.28 (95% confidence interval: 1.92–2.69)), dizziness (132 cases, reporting odds ratio: 3.04 (95% confidence interval: 2.54–3.63)), application site erythema (108 cases, reporting odds ratio: 32.52 (95% confidence interval: 26.74–39.55)), headache (98 cases, reporting odds ratio: 1.84 (95% confidence interval: 1.50–2.25)), and dyspnea (94 cases, reporting odds ratio: 1.93 (95% confidence interval: 1.57–2.38)). Many cases of improper use of nicotine replacement therapies were reported. Nausea, depression, abnormal dreams, insomnia, and other adverse events were reported for varenicline. Insomnia, rash, anxiety, and dizziness were reported for bupropion. We observed electronic cigarettes–related adverse events such as dizziness, dyspnea, nausea, heart rate increased, and tremor. Conclusion: Our findings suggest that an association exists between nicotine-related adverse events and nicotine replacement therapy. Healthcare professionals should closely monitor smokers trying to quit nicotine use for the misuse of nicotine replacement therapy. These findings may be informative to healthcare professionals in order to improve the management of smoking cessation treatment.

Download Full-text

Ratio Format Shapes Health Decisions: The Practical Significance of the “1-in-X” Effect

Medical Decision Making ◽

10.1177/0272989x18814256 ◽

2018 ◽

Vol 39 (1) ◽

pp. 32-40 ◽

Cited By ~ 1

Author(s):

Miroslav Sirota ◽

Marie Juanchich

Keyword(s):

Decision Making ◽

Side Effects ◽

Confidence Interval ◽

Odds Ratio ◽

Practical Significance ◽

Medical Communication ◽

Health Decisions ◽

Gender And Education ◽

High Prevalence ◽

Perceived Probability

Prior research found that “1-in-X” ratios led to higher and less accurate subjective probability than “N-in-X*N” ratios or other formats, even though they featured the same mathematical information. It is unclear, however, whether the effect transfers into health decisions, and the practical significance of the effect is undetermined. Based on previous findings and risk communication theories, we hypothesized that the 1-in-X effect would occur and transfer into relevant decisions. We also tested whether age, gender, and education differences would moderate the 1-in-X effect on decision making. We conducted 3 well-powered experiments ( n = 1912) using a sample from the general adult UK population to test our hypotheses, estimated the effect, and excluded a possible methodological explanation for such a transfer. In hypothetical scenarios, participants decided whether to travel to Kenya given the chance of contracting malaria (experiment 1) and whether to take recommended steroids given the side effects (experiments 2 and 3). Across the experiments, we replicated a small to medium 1-in-X effect on the perceived probability (Hedge’s g = −0.36; 95% confidence interval [CI], −0.47 to −0.24; z = −6.18; P < 0.001) and found a small effect on subsequent decisions (odds ratio = 1.32; 95% CI, 1.10−1.59; z = 2.99; P = 0.003). The perceived probability fully mediated the effect of the ratio format on decision. Age, gender, and education did not moderate the 1-in-X effect on decision. We argue that a high prevalence of 1-in-X ratios in medical communication makes these small changes clinically relevant. Therefore, to communicate information accurately, 1-in-X ratios should not be used or at least used cautiously in medical communication.

Download Full-text

Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database

Cephalalgia ◽

10.1177/0333102420983292 ◽

2021 ◽

pp. 033310242098329

Author(s):

Roberta Noseda ◽

Francesca Bedussi ◽

Claudio Gobbi ◽

Chiara Zecca ◽

Alessandro Ceschi

Keyword(s):

Confidence Interval ◽

Spontaneous Abortion ◽

Adverse Drug Reactions ◽

Birth Defects ◽

Odds Ratio ◽

Drug Exposure ◽

Reporting Odds Ratio ◽

Drug Reactions ◽

Pregnancy And Lactation ◽

In Pregnancy

Objective To assess the safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation. Methods Safety reports of suspected adverse drug reactions were retrieved from VigiBase as of 31 December 2019, for a case-by-case assessment and disproportionality analysis using the reporting odds ratio (ROR). Results There were 94 safety reports: 50 (53.2%) on erenumab, 31 (33.0%) on galcanezumab, and 13 (13.8%) on fremanezumab. In five (5.3%) safety reports, drug exposure occurred prior to pregnancy, in 85 (90.4%) during pregnancy, in one (1.1%) during lactation, in one (1.1%) via paternal exposure, and in two (2.1%) the exposure time was unknown. Out of 94 safety reports, 51 (54.3%) consisted only of drug exposure, while 43 (45.7%) additionally reported 47 adverse drug reactions including maternal toxicities (n = 18), poor breastfeeding (n = 1), spontaneous abortion (n = 23), preterm birth/prematurity (n = 3), and birth defects (n = 2). There was no signal of disproportionate reporting for spontaneous abortion compared to the full database (reporting odds ratio 1.46, 95% confidence interval 0.97–2.20). When triptans were used as a comparator group, a signal of disproportionate reporting for spontaneous abortion was detected in association with erenumab, galcanezumab, and fremanezumab (reporting odds ratio 1.86, 95% confidence interval 1.12–3.13), which was not statistically significant after excluding confounded safety reports (reporting odds ratio 1.21, 95% confidence interval 0.67–2.21). Conclusions No specific maternal toxicities, patterns of major birth defects, or increased reporting of spontaneous abortion were found. However, because of the relatively limited number of adverse drug reactions reported and the lack of long-term safety data, continuous surveillance is required in pregnant and lactating women exposed to these drugs.

Download Full-text

Sex modulates the association of radial artery augmentation index with renal function decline in individuals without chronic kidney disease

International Urology and Nephrology ◽

10.1007/s11255-020-02776-5 ◽

2021 ◽

Author(s):

Qiao Qin ◽

Fangfang Fan ◽

Jia Jia ◽

Yan Zhang ◽

Bo Zheng

Keyword(s):

Chronic Kidney Disease ◽

Renal Function ◽

Kidney Disease ◽

Arterial Stiffness ◽

Confidence Interval ◽

Odds Ratio ◽

Adjusted Odds Ratio ◽

Augmentation Index ◽

Renal Function Decline

Abstract Purpose An increase in arterial stiffness is associated with rapid renal function decline (RFD) in patients with chronic kidney disease (CKD). The aim of this study was to investigate whether the radial augmentation index (rAI), a surrogate marker of arterial stiffness, affects RFD in individuals without CKD. Methods A total of 3165 Chinese participants from an atherosclerosis cohort with estimated glomerular filtration rates (eGFR) of ≥ 60 mL/min/1.73 m2 were included in this study. The baseline rAI normalized to a heart rate of 75 beats/min (rAIp75) was obtained using an arterial applanation tonometry probe. The eGFRs at both baseline and follow-up were calculated using the equation derived from the Chronic Kidney Disease Epidemiology Collaboration. The association of the rAIp75 with RFD (defined as a drop in the eGFR category accompanied by a ≥ 25% drop in eGFR from baseline or a sustained decline in eGFR of > 5 mL/min/1.73 m2/year) was evaluated using the multivariate regression model. Results During the 2.35-year follow-up, the incidence of RFD was 7.30%. The rAIp75 had no statistically independent association with RFD after adjustment for possible confounders (adjusted odds ratio = 1.12, 95% confidence interval: 0.99–1.27, p = 0.074). When stratified according to sex, the rAIp75 was significantly associated with RFD in women, but not in men (adjusted odds ratio and 95% confidence interval: 1.23[1.06–1.43], p = 0.007 for women, 0.94[0.76–1.16], p = 0.542 for men; p for interaction = 0.038). Conclusion The rAI might help screen for those at high risk of early rapid RFD in women without CKD.

Download Full-text

Plasma acylcarnitines and risk of lower-extremity functional impairment in older adults: a nested case–control study

Scientific Reports ◽

10.1038/s41598-021-82912-y ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Francisco Félix Caballero ◽

Ellen A. Struijk ◽

Alberto Lana ◽

Antonio Buño ◽

Fernando Rodríguez-Artalejo ◽

...

Keyword(s):

Older Adults ◽

Confidence Interval ◽

Lower Extremity ◽

Functional Impairment ◽

Odds Ratio ◽

Case Control Study ◽

Case Control ◽

Community Dwelling ◽

Control Study ◽

Long Chain

AbstractElevated concentrations of acylcarnitines have been associated with higher risk of obesity, type 2 diabetes and cardiovascular disease. The aim of the present study was to assess the association between L-carnitine and acylcarnitine profiles, and 2-year risk of incident lower-extremity functional impairment (LEFI). This case–control study is nested in the Seniors-ENRICA cohort of community-dwelling older adults, which included 43 incident cases of LEFI and 86 age- and sex- matched controls. LEFI was assessed with the Short Physical Performance Battery. Plasma L-carnitine and 28 acylcarnitine species were measured. After adjusting for potential confounders, medium-chain acylcarnitines levels were associated with 2-year incidence of LEFI [odds ratio per 1-SD increase: 1.69; 95% confidence interval: 1.08, 2.64; p = 0.02]. Similar results were observed for long-chain acylcarnitines [odds ratio per 1-SD increase: 1.70; 95% confidence interval: 1.03, 2.80; p = 0.04]. Stratified analyses showed a stronger association between medium- and long-chain acylcarnitines and incidence of LEFI among those with body mass index and energy intake below the median value. In conclusion, higher plasma concentrations of medium- and long-chain acylcarnitines were associated with higher risk of LEFI. Given the role of these molecules on mitochondrial transport of fatty acids, our results suggest that bioenergetics dysbalance contributes to LEFI.

Download Full-text

Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06356-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Marouf Alhalabi ◽

Mohammed Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

First Line ◽

Link Type ◽

Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

Download Full-text

Hispanic/Latino Ethnic Identity and Diabetes: An Examination of Underlying Acculturation Processes and the Hispanic/Latino Health Advantage

Health Education & Behavior ◽

10.1177/10901981211010083 ◽

2021 ◽

Vol 48 (3) ◽

pp. 285-294

Author(s):

Jeannie B. Concha ◽

Kristen Kelly ◽

Briana Mezuk

Keyword(s):

Ethnic Identity ◽

Confidence Interval ◽

Health Outcomes ◽

Physical Health ◽

Odds Ratio ◽

Well Being ◽

The United States ◽

Diabetes Prevalence ◽

Physical Health Outcomes ◽

The Relationship

Background. Hispanics/Latinos in the United States experience both a health advantage and disadvantage in developing diabetes. Ethnic identity, a predictor of psychological well-being, has not been widely applied to physical health outcomes. The objective of this study is to apply what is known regarding ethnic identity and psychological health to physical health outcomes (diabetes) and to explore the moderating effect of education as a possible underlying mechanism of the Hispanic Health Advantage/Disadvantage. Specifically, this study examines (a) the association between ethnic identity and diabetes prevalence among adult Hispanics/Latinos and (b) determines whether education modifies this relationship. Method. Data come from the nationally representative adult U.S. household study, National Latino and Asian American Study (NLAAS), collected in 2001 to 2003 ( N = 1,746). Multiple logistic regression was conducted to examine the relationship between ethnic identity, education, and their interaction with likelihood of diabetes. Results. Hispanics/Latinos with high ethnic identity have a higher odds of reporting diabetes among those with 13 to 15 years of education (odds ratio: 1.84; 95% confidence interval: 1.16–2.92) and a lower odds among those with 16+ years of education (odds ratio: 0.53; 95% confidence interval: 0.34–0.84). Ethnic identity is associated with diabetes prevalence and the relationship is moderated by educational attainment. Conclusion. Given the growth, diversity, and diabetes disparities among Hispanics/Latinos, our buffering and exacerbating findings exemplify the complexity and fluidity of theory in understanding psychological/behavioral processes. The findings highlight the importance of designing targeted health interventions that take into account the diverse psychosocial and educational experiences of Hispanics/Latinos.

Download Full-text

Do Children Who Experience Laryngospasm Have an Increased Risk of Upper Respiratory Tract Infection?

Anesthesiology ◽

10.1097/00000542-199609000-00005 ◽

1996 ◽

Vol 85 (3) ◽

pp. 475-480. ◽

Cited By ~ 107

Author(s):

Mark S. Schreiner ◽

Irene O'Hara ◽

Dorothea A. Markakis ◽

George D. Politis

Keyword(s):

Confidence Interval ◽

Respiratory Infection ◽

Odds Ratio ◽

Signs And Symptoms ◽

Control Group ◽

Upper Respiratory Tract ◽

Upper Respiratory Infection ◽

Airway Surgery ◽

Increased Risk ◽

Upper Respiratory

Background Laryngospasm is the most frequently reported respiratory complication associated with upper respiratory infection and general anesthesia in retrospective studies, but prospective studies have failed to demonstrate any increase in risk. Methods A case-control study was performed to examine whether children with laryngospasm were more likely to have an upper respiratory infection on the day of surgery. The parents of all patients (N = 15,183) who were admitted through the day surgery unit were asked if their child had an active or recent (within 2 weeks of surgery) upper respiratory infection and were questioned about specific signs and symptoms to determine if the child met Tait and Knight's definition of an upper respiratory infection. Control subjects were randomly selected from patients whose surgery had occurred within 1 day of the laryngospasm event. Results Patients who developed laryngospasm (N = 123) were 2.05 times (95% confidence interval 1.21-3.45) more likely to have an active upper respiratory infection as defined by their parents than the 492 patients in the control group (P < or = 0.01). The development of laryngospasm was not related to Tait and Knight's definition for an upper respiratory infection or to recent upper respiratory infection. Children with laryngospasm were more likely to be younger (odds ratio = 0.92, 95% confidence interval 0.87-0.99), to be scheduled for airway surgery (odds ratio = 2.08, 95% confidence interval 1.21-3.59), and to have their anesthesia supervised by a less experienced anesthesiologist (odds ratio = 1.69, 95% confidence interval 1.04-2.7) than children in the control group. Conclusion Laryngospasm was more likely to occur in children with an active upper respiratory infection, children who were younger, children who were undergoing airway surgery, and children whose anesthesia were supervised by less experienced anesthesiologists. Understanding the risk factors and the magnitude of the likely risk should help clinicians make the decision as to whether to anesthetize children with upper respiratory infection.

Download Full-text

Parental risk factors for congenital diaphragmatic hernia – a large German case-control study

BMC Pediatrics ◽

10.1186/s12887-021-02748-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Felicitas Schulz ◽

Ekkehart Jenetzky ◽

Nadine Zwink ◽

Charlotte Bendixen ◽

Florian Kipfmueller ◽

...

Keyword(s):

Risk Factors ◽

Confidence Interval ◽

Environmental Risk ◽

Odds Ratio ◽

Alcohol Intake ◽

Case Control Study ◽

Case Control ◽

Parental Risk Factors ◽

Healthy Control ◽

Control Study

Abstract Background Evidence for periconceptional or prenatal environmental risk factors for the development of congenital diaphragmatic hernia (CDH) is still scarce. Here, in a case-control study we investigated potential environmental risk factors in 199 CDH patients compared to 597 healthy control newborns. Methods The following data was collected: time of conception and birth, maternal BMI, parental risk factors such as smoking, alcohol or drug intake, use of hairspray, contact to animals and parental chronic diseases. CDH patients were born between 2001 and 2019, all healthy control newborns were born in 2011. Patients and control newborns were matched in the ratio of three to one. Results Presence of CDH was significantly associated with maternal periconceptional alcohol intake (odds ratio = 1.639, 95% confidence interval 1.101–2.440, p = 0.015) and maternal periconceptional use of hairspray (odds ratio = 2.072, 95% confidence interval 1.330–3.229, p = 0.001). Conclusion Our study suggests an association between CDH and periconceptional maternal alcohol intake and periconceptional maternal use of hairspray. Besides the identification of novel and confirmation of previously described parental risk factors, our study underlines the multifactorial background of isolated CDH.

Download Full-text