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1.
HemaSphere ; 6:2640-2641, 2022.
Article in English | EMBASE | ID: covidwho-2032107

ABSTRACT

Background: The EMA-approved, erythroid maturation agent, luspatercept, has been shown to decrease transfusion burden in patients with transfusion-dependent thalassemia (TDT). Aims: In this multicenter, retrospective cross-sectional study, real-world data from the use of luspatercept in TDT patients, managed in 5 major Thalassemia Centers in Greece are presented. Methods: Inclusion criteria included TDT patients, having received luspatercept as per approved indications for at least 3 months. Data cut-off date was 31/1/2022. We estimated the quantity of blood (in cc of Packed Red Blood Cells -PRBC) received over 12 weeks for the intervals: 12 weeks before starting treatment (baseline);1-12 weeks;5-16 weeks and 13-24 weeks post starting therapy. Changes in mean pre-transfusion hemoglobin (Hb), uric acid, creatinine, lactic acid dehydrogenase (LDH), white blood cells (WBC) and platelets counts were analyzed for these same respective periods. Adverse events (AE) were recorded. Statistical analysis performed with RStudio v.3.6.2. Results: Main results of the study are shown in Table 1. Forty-nine patients (median age: 46 years range:15-64, sex: M:F/33:16) received Luspatercept every 21 days. Data for weeks 5-16 and 13-24 were available for 30 and 16 patients, respectively. The initial dose of luspatercept was 1 mg/kg and increased selectively up to 1.25mg/kg based on tolerability and efficacy and according to guidelines. A statistically significant (p<0.005) decrease in PRBC transfused in all 12-weeks' intervals analyzed compared to baseline was observed. No statistically significant decrease of PRBC transfused was found between the intervals 5-16weeks and 13-24 weeks compared to the initial interval of 1-12 weeks. There was not a significant change for the mean pre-transfusion Hb compared to baseline. A statistically significant (p<0.005) increase in uric acid, creatinine, LDH , WBC and platelets was observed for the interval 1-12 weeks in comparison with baseline (mean: 6.42±1.64mg/dl vs 5.48±1.6mg/dl, 0.87±0.16mg/dl vs 0.83±0.18mg/dl, 352±205mg/dl vs 204±62mg/dl, 11.78x109 ±5.29x109/L vs 10.36x109±4.35x109/L, and 450x109±221x109/L vs 415x109±202x109/L, respectively. Similar difference was observed between the 13-24 weeks interval and baseline only for uric acid, LDH and platelets (mean: 6.28±1.41mg/dl vs 5.48±1.6mg/dl p=0.003, 406±301mg/dl vs 204±62mg/dl p=0.014, 467x109±226x109/L vs 415x109±202x109/L p<0.008 respectively). Twenty five out of 49 patients reported AE. The most common AE included bone pain 16/49 (32.6%) and fatigue 7/49 (14.2%). Frequent urination, headache, swelling at injection site, blurry vision, tearing, libido decrease, tachycardia, periorbital oedema, dizziness, and exacerbation of manic-depressive episodes were also reported. Twelve patients discontinued treatment. Reasons for discontinuation included: non-response to treatment (7 patients), adverse events (3 patients), non-compliance (1 patient), death due to COVID19 infection (1 patient). Summary/Conclusion: Real world data on the use of luspatercept in TDT parallel results from the trial, showing heterogeneous and lasting efficacy and acceptable toxicity. Longer follow up and increased number of patients are required to validate these initial observations. (Table Presented).

2.
Annals of the Rheumatic Diseases ; 81:1130, 2022.
Article in English | EMBASE | ID: covidwho-2009115

ABSTRACT

Background: Patient's (pts) adherence is a EULAR important recommendation for an optimal disease course and outcome. COVID-19 pandemic has globally challenged the issue of adherence. As relevant Greek data are lacking, the Pan-Hellenic Federation 'Rheumazein' (i.e., co-living with a Rheumatic Disease) conducted a survey among their members to assess adherence and a possible COVID-related negative impact. Objectives: The main endpoint of the study aimed to capture the degree of pt adherence to treatment, either with conventional synthetic or/and biologic DMARDS (csDMARDS, bDMARDS). The secondary endpoints were: a. To record pts'-physicians' interactive communication to assess the level of shared disease making (SDM). b. The emerged barriers to medication access during the pandemic and consequent restrictive measures. c. To record pt perceptions on the usefulness of mobile reminder applications towards an uninterrupted regimen. Methods: A 29-item quantitative questionnaire was uploaded in the social media of the Federation and its associations, in order to register pts' responses on the aforementioned sections. The questionnaire was accessible for a 58-day period (21/09/2021-17/11/2021). Results: Participants' characteristics: The responses of 303 adults with RD (M:F 63:240), aged (in yrs) 18-44: 35%, 45-54: 26%, >55: 38% respectively, were available for analysis. The RD types were RA 33%, AS 18%, PsA 13%, SLE 18%, Juvenile Arthritis 5% and Other RD 13%, respectively. Τhe education level was low/moderate 39%, high 30%, post-graduate 31%, respectively. Receivers of a monotherapy with either cs-or bDMARDS were 93(31%) and 83(27%), of a combined regimen cs+bDMARDs 114(38%) and off treatment 13 (4%). BDMARD receivers were mostly AS pts (93%) while the least, SLE pts (48%). The route of bDMARD administration (sc vs iv did not signifcantly differ (57% vs. 43%). Since diagnosis, the mean disease trajectory was 7. 6 yrs, the mean time on medication 6.9 yrs, while the mean duration on the current regimen 3 yrs, respectively. Adherence: At least one skipped dose during the last trimester was reported, signifcantly more often by pts under csDMARDs than by those under bDMARDs, (60% vs. 40%, p<0.001) with a mean number of 2.7 vs. 1. 8 skipped doses, respectively. Additionally, the main reasons of non-adherence under csDMARDs and bDMARDs signifcantly differed only in respect to pt responsibility (56% vs.19% p<0.001), but not for COVID-related reasons, namely fear either of getting infected, or due to a performed COVID vaccination (35% vs 42%), or due to physician recommendations (22% vs. 32%). Regarding the pt-physician interactive discussions on emerging new treatments, 90% of the pts reported this policy, but only 40% of them in a rather frequent to more frequent rate. In respect to satisfaction, 67% expressed a moderate to high satisfaction regarding the level of provided information, while the degree of their satisfaction was positively related with the frequency of these discussions. The main topics focused on the route and frequency of the medication, especially with bDMARD receivers. Of note, 80% of the bDMARD group participated in the SDM before commencing this therapy, but just 20% in the selection of the brand name. Only a minority of pts (17%) were aware of the existence of mobile applications, reminding the scheduled drug administration;however, they rated these programs as very useful (4.3 according to a 0-5 scale). Despite the difference source of supply of cs and bDMARDs on pt access to treatment, the impact of COVID-19 and consequent restrictive measures had not impaired it (1.5/5 and 1.7/5 by the above scale, respectively). Conclusion: A signifcant percentage of pts skip scheduled DMARD administrations, especially those (60%) under csDMARDs. The relationship with the physician was considered relatively satisfactory. Most of the pts did not have any mobile phone reminder application regarding their dose. Finally, the COVID-19 pandemic appeared to have had little effect on pts' access to both cs-and bDMARDs and co sequently, adherence to their treatments.

3.
Gastroenterology ; 162(7):S-1006-S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967394

ABSTRACT

Introduction Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients. Aims and Methods Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AE. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AE were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders). Results A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35-55) years, Crohn's disease 64.3%, history of COVID-19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1. More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5-43) days. There were no serious AE leading to emergency room visit or hospitalization. Total AE were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P<0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)]. In the multiple regression analysis AE occurrence was positively associated with young age, female gender and blood type AB rhesus positiveafter both doses, whereas inactive disease was negatively associated with AE only in D1 (p= 0.044) No association with the use of medications including advanced therapy was found (p>0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions (Table 2). Conclusions The presence of SARs-CoV-2 vaccination AE in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses. (Table Presented) (Table Presented)

4.
European Journal of Clinical Pharmacology ; 78:S130, 2022.
Article in English | EMBASE | ID: covidwho-1955961

ABSTRACT

Introduction: Zolpidem and zopiclone are widely used for sleep disorders, yet their abuse and dependence potential has been underestimated. The electronic prescription of zolpidem/zopiclone became mandatory on 17.07.2019 in Greece. Objectives: To investigate descriptive characteristics of zolpidem/ zopiclone prescriptions and the impact of the mandatory electronic prescription mandate. Methods: Anonymized prescriptions of zopiclone (ATC: N05CF01) and/or zolpidem (ATC: NC05CF02) that were executed in pharmacies between 01.10.2018 and 01.10.2021 were obtained from the Greek nationwide prescription database. The database covers almost the entire Greek population and it is administrated by IDIKA of the Greek Ministry of Health. We investigated descriptive characteristics of prescriptions, and calculated themonthly number of prescriptions taking into consideration dates with potential impact, i.e., the date of the mandatory electronic prescription mandate (on 17.07.2019) and the date of the first case of COVID-19 in Greece (on 26.02.2020). Results and Conclusion: During the investigated period of three years, there were 1229842 executed prescriptions of zolpidem (89.4%), zopiclone (10.4%) or both (0.3%), considering 156554 unique patients. The patients weremainly elderly (73.1%were ≥ 65 years old) andwomen (64.5%). The majority of the prescription physicians (69.9%) were general practitioners or internists, followed by 17% psychiatrists or neurologists, 5.3% cardiologists, 4.5% physicians in specialty training, 1% nephrologists and 2.4% of physicians with another specialty. After the mandatory electronic prescription mandate and before COVID- 19 in Greece, i.e., between 08.2019 to 03.2020, there was a notable increase of prescriptions in comparison to the previous period from 10.2018 to 07.2019 (median 37267 vs median 34106;Mann-Whitney U=9, p-value=0.009). After COVID-19, the median monthly number of prescriptions was 36363, yet there were variations ranging from 16963 to 39956. In conclusion, the mandatory electronic prescription system could increase the surveillance of drugs with abuse potential such as zolpidem and zopiclone. Nevertheless, the large number of prescriptions in elderly patients and prescribed by primary care physicians is worrisome and warrants further investigation.

5.
Review of Clinical Pharmacology and Pharmacokinetics, International Edition ; 35(3):103-109, 2021.
Article in English | EMBASE | ID: covidwho-1766517

ABSTRACT

Masks are essential for COVID-19 prevention, but recently they were suggested to modify cutaneous facial microenvironment and trigger acne, named ''maskne''. We aimed to evaluate the prevalence of maskne and possible risk factors. This prospective, multicenter study that was carried out during the 2nd lockdown from November 2020 to January 2021 through an online questionnaire, was sent to all registered users of the University of West Attica, in Greece and 1854 volunteers were responded. There were 5 types of face masks used by the study population. Most participants reported that they were using more than one type of mask, alternately or at the same time. There were 2 types of masks most frequently used;surgical masks (mean: 3,2 SD =,95) and fabric masks (mean: 3.08, SD = 1.04). Surgical masks were used mainly by Health Care Workers (HCWs) (p<.001) and fabric masks from students and educational staff (p<.001). Onset or ex-acerbation of acne was found in the study population (n: 996, 53.8%). It was more common to HCWs and students (n: 747, 56.4%) and associated with the type of masks, daily use of make-up and moisturizing cream and hours per day of wearing face masks. Previous history of acne vulgaris was reported from 557 participants while 318 (57,1%) (p < .001) mentioned re-appearance of their maskne phenomenon is an important clinical sign to orient clinician's therapeutic protocols during COVID-19 pandemic. To our knowledge, this is the most multitudinous study in Greek population, assessing the impact of prolonged use of face masks with the appearance of maskne.

6.
Journal of Crohn's and Colitis ; 16:i576-i577, 2022.
Article in English | EMBASE | ID: covidwho-1722358

ABSTRACT

Background: Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients. Methods: Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AEs were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders). Results: A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35-55) years, Crohn's disease 64.3%, history of COVID- 19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1. More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although reluctant/hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5-43) days. There were no serious AEs leading to emergency room visit or hospitalization. Total AEs were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P<0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)]. In the multiple regression analysis AE occurrence was positively associated with young age and female gender after both doses, whereas inactive disease was negatively associated with AE only in D1 (p=0.044). No association with the use of medications including advanced therapy was found (p>0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions. Conclusion: The presence of SARs-CoV-2 vaccination AEs in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses.

7.
European Heart Journal ; 42(SUPPL 1):2410, 2021.
Article in English | EMBASE | ID: covidwho-1554463

ABSTRACT

Background: Various studies suggest a decrease of hospital admissions for acute coronary syndromes (ACS) during COVID-19 outbreak, implying an increase in ACS related pre-hospital-care deaths as a cause of this phenomenon. Purpose: Aim of this study was to investigate the impact of social containment measures on ACS admission and acute coronary deaths (ACDs) rates in Greece, during COVID-19 first pandemic wave in 2020. Methods: Data for this analysis were retrieved by the official records of University Forensic and Cardiology Departments and the Forensic Science Services of the most crowded metropolitan areas of Greece (almost 25% of the entire Greek population ≈ 2.5 million people). The study period was defined as the time between March 15 2020, when the Greek state started to implement strict lock-down measures to contain COVID-19 pandemics, until April 14 2020. To compare admission and SCD rates, a corresponding control period a year earlier was chosen. Incidence rates (IRs) (events over days) of ACSs and ACDs in each time-period were assessed along with IRs ratios (IRRs) and 95% CI intervals. Secondary analysis for nonischemic cardiovascular deaths (CVDs) or violent deaths (VDs) (including road traffic accident deaths) was also performed. Results: There has been a relative 38.9% reduction in ACS admissions in 2020 [1.8, 95% CI (1.35-2.34) in 2019 vs 1.1, 95% CI (0.76-1.54) in 2020, p=0.02], concordant with a 66% relative reduction of total admissions (p<0.005). Overall, 171 deaths in 2020 vs 208 in 2019 were referred for autopsies in the enrolled forensic departments. Gender and age distribution were not significantly different between case and control periods. There were no statistically significant differences in the frequency of deaths between the two periods examined, with the exception of deaths secondary to road traffic accidents [IR 0.13, 95% CI (0.04-0.34) in 2020 vs 0.67, 95% CI (0.41-1.03) in 2019, p=0.001] and CVDs [IR 0.43, 95% CI (0.23-0.74) in 2020 vs 1.03, 95% CI (0.70-1.47) in 2019, p=0.007] which significantly decreased during COVID-19 pandemic wave. Absolute numbers, percentile changes and IRs are demonstrated in Figure 1 and Table 1. Conclusions: Our analysis offers evidence over a significant decrease in ACS-related hospitalization rates during COVID-19 first pandemic wave. This decrease is not linked to an increase in pre-hospital, autopsy defined ACDs, as previously thought, implying that many ACS patients may not ask for help on time due to infection fear, being prone however to lateonset complications. Pre-hospital triage and care services, should be appropriately transformed to facilitate and speed-up access of cardiovascular patients to health-care systems during the pandemic. (Figure Presented).

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