Characterization of agomelatine-induced liver injury, incidence and risk factors: A pooled analysis of 7605 treated patients

2016 ◽  
Vol 33 (S1) ◽  
pp. s229-s229
Author(s):  
G. Perlemuter ◽  
P. Cacoub ◽  
D. Valla ◽  
D. Guyader ◽  
B. Saba ◽  
...  

Introduction/objectiveThe hepatic safety of agomelatine was assessed in 49 phase II and III studies. The aim was to analyze the characteristics of patients who developed an increase in transaminases whilst taking agomelatine.MethodA retrospective pooled analysis of changes in serum transaminase in 7605 patients treated with agomelatine (25 mg or 50 mg/day) from 49 completed studies was undertaken. A significant increase in serum transaminase was defined as > 3-fold the upper limit of normal (> 3 ULN). Final causality was determined in a case-by-case review by five academic experts.ResultsTransaminase increased to > 3 ULN in 1.3% and 2.5% of patients treated with 25 mg and 50 mg of agomelatine respectively, compared to 0.5% for placebo. The onset of increased transaminases occurred at < 12 weeks in 64% of patients. The median time to recovery (to ≤ 2ULN) was 14 days following treatment withdrawal. Liver function tests recovered in 36.1% patients despite the continuation of agomelatine, suggesting the presence of a liver adaptive mechanism. Patients with elevated transaminases at baseline, secondary to obesity and fatty liver disease (NAFLD), had an equally increased risk of developing further elevations of transaminases with agomelatine and placebo. This reflects the widespread fluctuations of serum transaminases in patients with NAFLD.ConclusionsThe overall incidence of abnormal transaminases was low and dose dependent. No specific population was identified regarding potential risk factors. Withdrawal of agomelatine led to rapid recovery, and some patients exhibited an adaptive phenomenon. The liver profile of agomelatine seems safe when serum transaminases are monitored.Disclosure of interestThe authors have not supplied their declaration of competing interest.

2017 ◽  
Vol 5 (12) ◽  
pp. 232596711774526 ◽  
Author(s):  
Mirwais Mehrab ◽  
Robert-Jan de Vos ◽  
Gerald A. Kraan ◽  
Nina M.C. Mathijssen

Background: CrossFit is a strength and conditioning program that has gained widespread recognition, with 11,000 affiliated gyms worldwide. The incidence of injuries during CrossFit training is poorly analyzed. Purpose: To investigate the incidence of injuries for persons participating in CrossFit. Risk factors for injury and injury mechanisms were also explored through athlete demographics and characteristics. Study Design: Descriptive epidemiology study. Methods: A questionnaire that focused on injury incidence in CrossFit in the past year and included data on athlete demographics and characteristics was distributed to all 130 CrossFit gyms in the Netherlands and was also available online in active Facebook groups. Data were collected from July 2015 to January 2016. Inclusion criteria consisted of age ≥18 years and training at a registered CrossFit gym in the Netherlands. A total of 553 participants completed the survey. Univariable and multivariable generalized linear mixed models were used to identify potential risk factors for injury. Results: A total of 449 participants met the inclusion criteria. Of all respondents, 252 athletes (56.1%) sustained an injury in the preceding 12 months. The most injured body parts were the shoulder (n = 87, 28.7%), lower back (n = 48, 15.8%), and knee (n = 25, 8.3%). The duration of participation in CrossFit significantly affected the injury incidence rates (<6 months vs ≥24 months; odds ratio, 3.687 [95% CI, 2.091-6.502]; P < .001). The majority of injuries were caused by overuse (n = 148, 58.7%). Conclusion: The injury incidence for athletes participating in CrossFit was 56.1%. The most frequent injury locations were the shoulder, lower back, and knee. A short duration of participation (<6 months) was significantly associated with an increased risk for injury.


2021 ◽  
Vol 10 (11) ◽  
pp. 2462
Author(s):  
Barbara Ruaro ◽  
Paola Confalonieri ◽  
Mario Santagiuliana ◽  
Barbara Wade ◽  
Elisa Baratella ◽  
...  

Background. Some studies with inconclusive results have reported a link between sarcoidosis and an increased risk of pulmonary embolism (PE). This study aimed at assessing a possible correlation between potential risk factors and PE in sarcoidosis patients. Methods. A total of 256 sarcoidosis patients (84 males and 172 females; mean age at diagnosis 49 ± 13) were enrolled after giving written informed consent. Clinical evaluations, laboratory and radiology tests were performed to evaluate the presence of pulmonary embolism. Results. Fifteen sarcoidosis patients with PE (4 males and 11 females; mean age at diagnosis 50 ± 11), diagnosed by lung scintigraphy and 241 sarcoidosis patients without PE (80 males and 161 females; mean age at diagnosis 47 ± 13), were observed. There was a statistically significant increase of the presence of antiphospholipid antibodies in the sarcoidosis group with pulmonary embolism. There was no statistically significant difference between the two groups as to smoking habit, obesity or hereditary thrombophilia frequency (p > 0.05, respectively). Conclusions. This study demonstrates a significant correlation between the presence of antiphospholipid antibody positivity and the pulmonary embolism events in our sarcoidosis patients. Furthermore, we propose screening for these antibodies and monitoring, aimed at timely treatment.


2020 ◽  
Vol 41 (1) ◽  
pp. 59-71 ◽  
Author(s):  
Torsten Schlosshauer ◽  
Marcus Kiehlmann ◽  
Diana Jung ◽  
Robert Sader ◽  
Ulrich M Rieger

Abstract Background Post-bariatric patients present a surgical challenge within abdominoplasty because of residual obesity and major comorbidities. In this study, we analyzed complications following abdominoplasty in post-bariatric patients and evaluated potential risk factors associated with these complications. Objectives The authors sought to determine the complications and risk factors following abdominoplasty in post-bariatric patients. Methods A retrospective study of patients who underwent abdominoplasty was performed from January 2009 to December 2018 at our institution. Variables analyzed were sex, age, body mass index (BMI), smoking, surgical technique, operative time, resection weight, drain output, and complications. Results A total of 406 patients were included in this study (320 female and 86 male) with a mean age of 44.4 years and a BMI of 30.6 kg/m2. Abdominoplasty techniques consisted of traditional (64.3%), fleur-de-lis technique (27.3%), and panniculectomy without umbilical displacement (8.4%). Overall complications recorded were 41.9%, the majority of these being wound-healing problems (32%). Minor and major complications were found in 29.1% and 12.8% of patients, respectively. A BMI value of ≥30 kg/m2 was associated with an increased risk for wound-healing problems (P = 0.001). The frequency of total complications was significantly related to age (P = 0.007), BMI (P = 0.004), and resection weight (P = 0.001). Abdominoplasty technique tended to influence total complications. Conclusions This study demonstrates in a fairly large sample of post-bariatric patients (n = 406) that abdominoplasty alone can be performed safely, with an acceptable complication rate. Age, BMI, and resection weight are shown to be significant risk factors for total complications. The role of surgical technique needs to be evaluated further. Level of Evidence: 4


2020 ◽  
Vol 73 (6) ◽  
pp. 542-549
Author(s):  
Taeha Ryu ◽  
Baek Jin Kim ◽  
Seong Jun Woo ◽  
So Young Lee ◽  
Jung A Lim ◽  
...  

Background: Hypotensive bradycardic events (HBEs) are a frequent adverse event in patients who underwent shoulder arthroscopic surgery under interscalene block (ISB) in the sitting position. This retrospective study was conducted to investigate the independent risk factors of HBEs in shoulder arthroscopic surgery under ISB in the sitting position. Methods: A total of 2549 patients who underwent shoulder arthroscopic surgery under ISB and had complete clinical data were included in the study. The 357 patients who developed HBEs were included in the HBEs group, and the remaining 2192 in the non-HBEs group. The potential risk factors for HBEs, such as age, sex, past medical history, anesthetic characteristics, and intraoperative medications were collected and compared between the groups. Statistically significant variables were included in a logistic regression model to further evaluate the independent risk factors for HBEs in shoulder arthroscopic surgery under ISB. Results: The incidence of HBEs was 14.0% (357/2549). Logistic regression analysis revealed that the intraoperative use of hydralazine (odds ratio [OR] 4.2; 95% confidence interval [CI] 2.9–6.3), propofol (OR 2.1; 95% CI 1.3–3.6), and dexmedetomidine (OR 3.9; 95% CI 1.9–7.8) before HBEs were independent risk factors for HBEs in patients who received shoulder arthroscopic surgery under ISB. Conclusions: The intraoperative use of antihypertensives such as hydralazine and sedatives such as propofol or dexmedetomidine leads to increased risk of HBEs during shoulder arthroscopic surgery under ISB in the sitting position.


Author(s):  
Koen B Pouwels ◽  
Thomas House ◽  
Julie V Robotham ◽  
Paul Birrell ◽  
Andrew B Gelman ◽  
...  

Objective: To estimate the percentage of individuals infected with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) over time in the community in England and to quantify risk factors. Design: Repeated cross-sectional surveys of population-representative households with longitudinal follow-up if consent given. Setting: England. Participants: 34,992 Individuals aged 2 years and over from 16,722 private residential households. Data were collected in a pilot phase of the survey between 26 April and 28 June 2020. Main outcome measures: Percentage of individuals in the community testing positive for SARS-CoV-2 RNA using throat and nose swabs. Individuals were asked about any symptoms and potential risk factors. Results: The percentage of people in private-residential households testing positive for SARS-CoV-2 reduced from 0.32% (95% credible interval (CrI) 0.19% to 0.52%) on 26 April to 0.08% (95% CrI 0.05% to 0.12%) on 28 June, although the prevalence stabilised near the end of the pilot. Factors associated with an increased risk of testing positive included having a job with direct patient contact (relative exposure (RE) 4.06, 95% CrI 2.42 to 6.77)), working outside the home (RE 2.49, 95% CrI 1.39 to 4.45), and having had contact with a hospital (RE 2.20, 95% CrI 1.09 to 4.16 for having been to a hospital individually and RE 1.95, 95% CrI 0.81 to 4.09 for a household member having been to a hospital). In 133 visits where individuals tested positive, 82 (61%, 95% CrI 53% to 69%) reported no symptoms, stably over time. Conclusion: The percentage of SARS-CoV-2 positive individuals declined between 26 April and 28 June 2020. Positive tests commonly occurred without symptoms being reported. Working outside your home was an important risk factor, indicating that continued monitoring for SARS-CoV-2 in the community will be essential for early detection of increases in infections following return to work and other relaxations of control measures.


PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0244330
Author(s):  
Thomas Hummel ◽  
Saskia Hannah Meves ◽  
Andreas Breuer-Kaiser ◽  
Jan-Ole Düsterwald ◽  
Dominic Mühlberger ◽  
...  

Introduction Reduced antiplatelet activity of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic events. The reported prevalence data for low-responders vary widely and there have been few investigations in vascular surgery patients even though they are at high risk for thromb-embolic complications. The aim of this prospective observational monocentric study was to elucidate possible changes in ALR or CLR after common vascular procedures. Methods Activity of aspirin and clopidogrel was measured by impedance aggregometry using a multiple electrode aggregometer (Multiplate®). Possible risk factors for ALR or CLR were identified by demographical, clinical data and laboratory parameters. In addition, a follow-up aggregometry was performed after completion of the vascular procedure to identify changes in antiplatelet response. Results A total of 176 patients taking antiplatelet medications aspirin and/or clopidogrel with peripheral artery disease (PAD) and/or carotid stenosis (CS) were included in the study. The prevalence of ALR was 13.1% and the prevalence of CLR was 32% in the aggregometry before vascular treatment. Potential risk factors identified in the aspirin group were concomitant insulin medication (p = 0.0006) and elevated C-reactive protein (CRP) (p = 0.0021). The overall ALR increased significantly postoperatively to 27.5% (p = 0.0006); however, there was no significant change in CLR that was detected. In a subgroup analysis elevation of the platelet count was associated with a post-procedure increase of ALR incidence. Conclusion The incidence of ALR in vascular surgery patients increases after vascular procedures. An elevated platelet count was detected as a risk factor. Further studies are necessary to analyse this potential influence on patency rates of vascular reconstructions.


2018 ◽  
Vol 6 (7_suppl4) ◽  
pp. 2325967118S0012
Author(s):  
Tetsuya Matsuura ◽  
Toshiyuki Iwame ◽  
Koichi Sairyo

Objectives: With the incidence of Little League elbow increasing, pitch limit recommendations for preventing throwing injuries have been developed in the United States and Japan. In 1995, the Japanese Society of Clinical Sports Medicine announced limits of 50 pitches per day and 200 pitches per week to prevent throwing injuries in younger than 12 years old. However the relationship between pitch limit recommendation and elbow injuries among pitchers has not been adequately studied. The aim of our study was to evaluate the association between pitch counts and elbow injuries in youth pitchers. Methods: A total of 149 pitchers without prior elbow pain were observed prospectively for 1 season to study injury incidence in relation to specific risk factors. Average age was 10.1 years (range, 7-11 years). One year later, all pitchers were examined by questionnaire. Subjects were asked whether they had experienced any episodes of elbow pain during the season. The questionnaire was also used to gather data on pitch counts per day and per week, age, number of training days per week, and number of games per year. We investigated the following risk factors for elbow injury: pitch counts, age, position, number of training days per week, and number of games per year. Data were analyzed by multivariate logistic regression models and presented as odds ratio (OR) and profile likelihood 95% confidence interval (CI) values. The likelihood-ratio test was also performed. A two-tailed P value of less than .05 was considered significant. All analysis was done in the SAS software package (version 8.2). Results: Of the 149 subjects, 66 (44.3%) reported episodes of pain in the throwing elbow during the season. 1. Analysis for pitch count per day Univariate analysis showed that elbow pain was significantly associated with more than 50 pitches per day. Multivariate analysis showed that more than 50 pitches per day (OR, 2.44; 95% CI, 1.22-4.94), and more than 70 games per year (OR, 2.47; 95% CI, 1.24-5.02) were risk factors significantly associated with elbow pain. Age and number of training days per week were not significantly associated with elbow pain. 1. Analysis for pitch count per week Univariate analysis showed that elbow pain was significantly associated with more than 200 pitches per week. Multivariate analysis showed that more than 200 pitches per week (OR, 2.04; 95% CI, 1.03-4.10), and more than 70 games per year (OR, 2.41; 95% CI, 1.22-4.87) were risk factors significantly associated with elbow pain. Age was not significantly associated with elbow pain. Conclusion: A total of 44.3% of youth baseball pitchers had elbow pain during the season. Multivariable logistic regression revealed that elbow pain was associated with more than 50 pitches per day, more than 200 pitches per week, and more than 70 games per year. Previous studies have revealed the risk factor with the strongest association to injury is pitcher. Our data suggest that compliance with pitch limit recommendations including limits of 50 pitches per day and 200 pitches per week may be protective against elbow injuries. Those who played more than 70 games per year had a notably increased risk of injury. With increasing demand on youth pitchers to play more, there is less time for repair of bony and soft tissues in the elbow. In conclusion, among youth pitchers, limits of 50 pitches per day, 200 pitches per week, and limits of 70 games per year may protect elbow injuries.


2017 ◽  
Vol 66 (06) ◽  
pp. 517-522
Author(s):  
Simon Sündermann ◽  
Hatem Alkadhi ◽  
Michele Genoni ◽  
Francesco Maisano ◽  
Maximilian Emmert ◽  
...  

Background We aimed to assess asymptomatic patients who had open-heart surgery with median sternotomy for potential sternal anomalies (SA), their related patient-specific risk factors, and treatment options for the prevention of SA. Methods Multiplanar CT scans (CTs) from 131 asymptomatic consecutive patients were analyzed retrospectively. Of these, 83 underwent CABG (63.4%), and 48 had aortic valve (AV) procedures via median sternotomy. Sternal bone healing was analyzed for SA and their exact location. Results In total, 49 SA were identified in 42 (32.1%) patients; 65% SA were found in the manubrium (n = 32). Five hundred thirty-two wires were implanted (4.2 ± 0.5 wires/patient), out of which 96.1% (n = 511) were figure 8 wires. There was no difference between normal and abnormal sterna with regard to the number of wires used for sternal closure (4.2 ± 0.5 vs. 4.3 ± 0.6, p = ns). The distance between wire placement to the proximal edge of the manubrium in normal and abnormal sterna was comparable (11.2 ± 4.2 vs. 10.9 ± 4.8 mm, p = ns). Patients who underwent CABG had a significantly higher risk for SA (OR = 2.4, p ≤ 0.05, 95% CI [1.2–4.9]). The use of BIMA (OR = 4.4, p ≤ 0.05, 95% CI [1.1–17.9]) and body mass index (BMI) > 31 kg/m2 (OR = 3.4, p ≤ 0.01, 95% CI [1.4–8.3]) significantly increased the risk of SA. Conclusion At least 30% of patients were at an increased risk for SA after receiving a median sternotomy. CABG, use of BIMA, and a BMI > 30 kg/m2 were potential risk factors for the development of SA and warrant close clinical follow-up. Sternal plate fixation, particularly in the manubrium, could be beneficial in such patients.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S564-S564
Author(s):  
S García Mateo ◽  
S J Martínez-Domínguez ◽  
M C Aso Gonzalvo ◽  
C J Gargallo-Puyuelo ◽  
B Gallego Llera ◽  
...  

Abstract Background Patients with Inflammatory Bowel Disease (IBD) suffer from a chronic illness and many of them need immunosuppressive therapy throughout the course of the disease. Consequently, COVID-19 pandemic has caused uncertainty about the possible increased risk of suffering SARS-CoV-2 infection that could confer IBD or its treatments. The aim of this study is to assess SARS-CoV-2 seroprevalence in patients with IBD as well as the existence of potential risk factors for its development. Methods This is a unicentric cross-sectional study developed in IBD unit of University Hospital “Lozano Blesa” of Zaragoza. Patients older than 18 years with established diagnosis of Crohn′s Disease (CD), Ulcerative Colitis (UC) or Indeterminate Colitis (IC) have been included. A blood sample has been drawn from each patient to detect IgG against SARS-CoV-2 (ELISA method) and each patient has completed a questionnaire to know symptoms related to infection and previous comorbidity. We have performed a descriptive analysis and a univariate analysis to study relationship between potential risk factors and seroconversion against SARS-CoV-2. Results 431 patients have been included, with a mean age of 50.2 ± 14.1 years and a 51.3% of women. Of them, 49.7% suffer from UC, 49.2% CD and 1.2% IC. Related to the treatment, 23.5% receive anti-TNF biologic agents, 13.1% other kind of biologic agents, 9.3% immunomodulators, 7.7% combined treatment (biologic agent and immunomodulator), 33.1% other treatment and 13.3% no treatment. According to World Health Organization (WHO) definitions, 85.6% had not suffered the infection, 7.7% were confirmed cases (only 3 admitted patients) and 6.7% were probable cases. The seroprevalence of SARS-CoV-2 obtained is 8.8%, being significantly higher among confirmed cases than among probable cases (71.0% in confirmed vs 6.9% in probable; RR 10.3; p&lt;0.001). A higher risk of seroconversion has been detected among patients without biologic agents (11.8% in patients without biologic agents vs 5.3% in patients with biologic agents; RR 2.2; p=0.021). No differences have been observed in the seroprevalence of patients with other treatments for IBD or in terms of age, active smoking, level of inflammation markers, the presence of symptoms of infection or hospital admission. Conclusion The seroprevalence of SARS-CoV-2 of Aragon′s patients with IBD is similar to that described in national seroprevalence study of Ministry of Health for the region (8.8%). The treatment with biologic agents is associated with a lower risk of seroconversion


PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241908
Author(s):  
Amélia Nkutxi Vueba ◽  
Clarissa Perez Faria ◽  
Ricardo Almendra ◽  
Paula Santana ◽  
Maria do Céu Sousa

We report a study on toxoplasmosis in pregnant women in Luanda, Angola, determining the seroprevalence, geospatial distribution and its association with socio-economic features, dietary habits and hygiene and health conditions. Anti-Toxoplasma gondii IgG and IgM were quantified in serum samples of women attended at the Lucrecia Paim Maternity Hospital between May 2016 and August 2017. The IgG avidity test and qPCR assay were used for dating the primary infection. Data were collected by questionnaire after written consent, and spatial distribution was assessed through a Kernel Density Function. The potential risk factors associated with Toxoplasma infection were evaluated using bivariate and multivariate binomial logistic regression analysis. Anti-T. gondii antibodies were quantified in 878 pregnant women, and 346 (39.4%) samples were IgG positive, 2 (0.2%) positive for IgM and IgG, and 530 (60.4%) negative for both immunoglobulins. The longitudinal study showed that none of the seronegative women seroconverted during the survey. Regarding other infections, 226 (25.7%) were positive for hepatitis B, while 118 (13.4%) were HIV-positive. The seroprevalence of toxoplasmosis was similar in most municipalities: 43.8% in Cazenga (28 of 64); 42.5% in Viana (88 of 207); 42.3% in Cacuaco (22 of 52); and 41.1% in Luanda ((179 of 435). In contrast, the seroprevalence in municipality of Belas was lower (25.8%; 31 of 120) and bivariate and multivariate analysis has shown a lower risk for toxoplasmosis in this area (OR 0.479, CI: 0.305–0.737; OR 0.471, CI: 0.299–0.728). The multivariate analysis has shown a significant increased risk for toxoplasmosis in women in the last trimester of pregnancy (OR 1.457, CI: 1.011–2.102), suffering spontaneous abortion (OR 1.863, CI: 1.014–3.465) and having pets at home (OR 1.658, CI: 1.212–2.269). Also, women who tested positive for hepatitis B (OR 1.375, CI: 1.008–1.874) and HIV (OR 1.833, CI: 1.233–2.730) had a significant increased risk for T. gondii infection. In conclusion, our study showed that a large number of pregnant women are not immunized for toxoplasmosis and identified the risk factors for this infection in Luanda. It is crucial to establish the diagnosis of primary maternal infection as well as the diagnosis of congenital toxoplasmosis. Our results underlined the need for diagnostic and clinical follow-up of toxoplasmosis, HIV and hepatitis B during pregnancy.


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