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Safety monitoring of COVID-19 vaccines in multiple European countries: Initial results from the COVID-19 vaccine monitor (CVM)

M. RAETHKE, N. LUXI, G. TRIFIRÒ, N. THURIN, D. MENTZER, E. DE CLERCQ, B. KOVACIC, K. MORTON, F. MARQUES, S. SONDERLICHOVÁ, F. VILLALOBOS, F. RIEFOLO, F. VAN HUNSEL and M. STURKENBOOM
Aten Primaria.2022 Aug; 54(9):102437.doi: PMID:

Myocarditis associated with SARS-CoV-2 vaccines by dose and brand in three European countries using large electronic health care data sources: A self-controlled risk interval study in the COVID-19 vaccine monitor study

C. DURÁN, S. BELITSER, S. BOTS, F. RIEFOLO, D. MESSINA, R. GINI, P. GARCÍA-POZA, M. PÉREZ, J. CARRERAS, E. CORRECHER-MARTÍNEZ, A. URCHUEGUÍA, P. SOUVEREIN, F. VILLALOBOS, J. RIERA-ARNAU, A. SCHULTZE, I. DOUGLAS, O. KLUNGEL and M. STURKENBOOM
Aten Primaria.2022 Aug; 54(9):102437.doi: PMID:

Effect of Lipids on Diabetic Retinopathy in a Large Cohort of Diabetic Patients after 10 Years of Follow-Up

P. ROMERO-AROCA, R. VERGES, J. PASCUAL-FONTANILLES, A. VALLS, J. FRANCH, J. BARROT, X. MUNDET, A. LA TORRE, A. MORENO, R. SAGARRA, J. BASORA, E. GARCIA-CURTO and M. BAGET-BERNALDIZ
Aten Primaria.2022 Aug; 54(9):102437.doi:10.3390/jcm12206674 PMID:37892811

(1) Background: Diabetic retinopathy (DR) remains the leading cause of low vision and blindness in young adults of working age. Although the most important risk factors-such as the duration of diabetes mellitus (DM) and glycemic control measured by HbA1c-are known, the effects of lipids are not as clear. The aim of the present study is to analyze the effects of lipids on the development of DR. (2) Methods: This is a retrospective study of a population of 175,645 DM2 patients, during the period 2010 to 2020, in which the effects of different lipid factors are studied. (3) Results: The variables that most influenced the development of DR in our study, based on significance and cumulative hazard (CH), were arterial hypertension (CH 1.217, p < 0.001), HbA1c levels (CH 1.162, p = 0.001), microalbuminuria (CH 1.012, p < 0.001), LDL-C cholesterol (CH 1.007, p = 0.012), TC/HDL-C index (CH 1.092, p < 0.001), No-HDL-C/HDL-C index (CH 1.065, p = 0.002), the use of statins (CH 1.001, p = 0.005), and body mass index (CH 1.007, p < 0.001). (4) Conclusions: LDL-cholesterol, TC/HDL-C, and No-HDL-C/HDL-C indices are related to the development of DR, and there is a protective effect of HDL-cholesterol and the use of fibrates.

VAC4EU study tracking post-authorization safety of mRNA-1273 in five European countries: How to overcome the methodological challenges

W. AARTS, J. CHOI, D. ROY, C. FRY, S. LANE, R. GINI, A. GIRARDI, O. PAOLETTI, F. VILLALOBOS, C. BISSACCO, E. SEGUNDO, A. LUPATTELLI, J. ZHAO, D. WEIBEL, D. ESPOSITO, D. MARTIN, S. ST LAURENT, M. EMILEBACKER, V. EHRENSTEIN, S. SORUP and B. GOODALE
Aten Primaria.2022 Aug; 54(9):102437.doi: PMID:

Using negative control outcomes to identify unmeasured confounding in a self-controlled risk interval study evaluating the COVID-19 vaccine myocarditis safety signal

S. BOTS, S. BELITSER, C. DURÁN, J. RIERA-ARNAU, A. SCHULTZE, D. MESSINA, E. SEGUNDO, I. DOUGLAS, J. CARRERAS, P. GARCÍA-POZA, R. GINI, C. HUERTA, M. MARTÍN-PEREZ, I. MARTIN, O. PAOLETTI, C. BISSACCO, E. CORRECHER-MARTÍNEZ, P. SOUVEREIN, A. URCHUEGUIA, F. VILLALOBOS, M. STURKENBOOM and O. KLUNGEL
Aten Primaria.2022 Aug; 54(9):102437.doi: PMID:

Incidence of COVID-19 disease severity in a cohort of 4.4 million Italian and Spanish children from six healthcare databases

C. DURÁN, F. RIEFOLO, R. GINI, D. MESSINA, P. GARCÍA-POZA, M. MARTÍN-PEREZ, F. VILLALOBOS, M. PALLEJÀ-MILLÁN, E. BARBIERI, L. STONA, Y. INGRASCIOTTA, J. CARRERAS, E. CORRECHER-MARTÍNEZ, A. URCHUEGUÍA, M. TARI, V. IENTILE and M. STURKENBOOM
Aten Primaria.2022 Aug; 54(9):102437.doi: PMID:

Importance of Maternal Iron Status on the Improvement of Cognitive Function in Children After Prenatal Iron Supplementation.

Iglesias-Vázquez L, Voltas N, Hernández-Martínez C, Canals J, Coronel P, Gimeno M, Basora J and Arija V
Aten Primaria.2022 Aug; 54(9):102437.doi:10.1016/j.amepre.2023.02.006 PMID:36906495

INTRODUCTION: The effectiveness of prenatal iron supplementation improves maternal hematological outcomes, but little research has focused on child outcomes. The objective of this study was to assess whether prenatal iron supplementation adjusted to maternal needs improves children’s cognitive functioning. METHODS: The analyses included a subsample of nonanemic pregnant women recruited in early pregnancy and their children aged 4 years (n=295). Data were collected between 2013 and 2017 in Tarragona (Spain). On the basis of hemoglobin levels before the 12th gestational week, women receive different iron doses: 80 vs 40 mg/d if hemoglobin is 110-130 g/L and 20 vs 40 mg/d if hemoglobin >130 g/L. Children’s cognitive functioning was assessed using the Wechsler Preschool and Primary Scale of Intelligence-IV and Developmental Neuropsychological Assessment-II tests. The analyses were carried out in 2022 after the completion of the study. Multivariate regression models were performed for assessing the association between different doses of prenatal iron supplementation and children’s cognitive functioning. RESULTS: Taking 80 mg/d of iron was positively associated with all the scales of the Wechsler Preschool and Primary Scale of Intelligence-IV and Neuropsychological Assessment-II when mothers had initial serum ferritin <15 µg/L, but it was negatively associated with Verbal Comprehension Index, Working Memory Index, Processing Speed Index, and Vocabulary Acquisition Index from Wechsler Preschool and Primary Scale of Intelligence-IV and verbal fluency index from Neuropsychological Assessment-II when mothers showed initial serum ferritin >65 µg/L. In the other group, taking 20 mg/d of iron was positively associated with Working Memory Index, Intelligence Quotient, verbal fluency, and emotion recognition indices when women had initial serum ferritin >65 µg/L. CONCLUSIONS: Prenatal iron supplementation adjusted to the maternal hemoglobin levels and baseline iron stores improves cognitive functioning in children aged 4 years.

Adjusting prenatal iron supplementation to women’s needs in early pregnancy to improve maternal iron status in late pregnancy

L. IGLESIAS-VÁZQUEZ, N. ARANDA, E. APARICIO, J. BASORA and V. ARIJA
Aten Primaria.2022 Aug; 54(9):102437.doi: PMID:

Injury-induced activation of the endocannabinoid system promotes axon regeneration

S. MARTINEZ-TORRES, F. MESQUIDA-VENY, J. DEL RIO and A. HERVERA
Aten Primaria.2022 Aug; 54(9):102437.doi:10.1016/j.isci.2023.106814 PMID:37235048

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials.

Ahmadizar F, Luxi N, Raethke M, Schmikli S, Riefolo F, Saraswati PW, Bucsa C, Osman A, Liddiard M, Maques FB, Petrelli G, Sonderlichová S, Thurin NH, Villalobos F, Trifirò G and Sturkenboom M
Aten Primaria.2022 Aug; 54(9):102437.doi:10.1007/s40264-023-01304-5 PMID:37103643

BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

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