Frontiers in neurogenesis

One of the most intriguing dogmas in neurosciences—the empirical lack of brain neuronal regeneration in adulthood onwards to late life—began to be debunked initially by research groups focused on understanding postnatal (early days/weeks of murine and guinea pigs) neurodevelopmental and neuroplastic events [...

Inibidores selectivos da ciclooxigenase-2 e a hipertensão arterial: análise das notificações espontâneas remetidas à unidade de farmacovigilância do norte

O objectivo deste trabalho foi avaliar a possível relação entre a utilização de Anti Inflamatórios Não Esteróides Inibidores da Ciclooxigenase-2 (ICOX -2) e o aparecimento de Hipertensão Arterial (HTA). Durante o período em análise, foram notificados, à Unidade de Farmacovigilância do Norte (UFN), 11 casos de HTA relacionados com a utilização de ICOX -2 (6 etoricoxib e 5 ao rofecoxib). A HTA foi mais vezes notificada aos ICOX -2 (6,0%) do que aos AINEs não selectivos (1,6%) [RR = 3,8 (1,4-10,2)]. The aim of this study was to evaluate the possible relationship between the use of selective cyclooxygenase-2 inhibitors non-steroidal anti-inflammatory drugs (ICOX -2) and the high blood pressure (HBP). During the period in analysis, 11 cases of HBP related with the use of ICOX -2 (6 etoricoxib and 5 to rofecoxib) had been notified, to the Unidade de Farmacovigilância do Norte. The HBP was more times notified to the ICOX -2 (6.0%) then to the no selective NSAIDs (1.6%) [RR = 3.8 (1.4-10.2)]

Estratégias para aumentar a sensibilidade da farmacovigilância em Portugal

OBJECTIVE: To evaluate the results of an intervention to improve the number and relevance of reports of adverse drug reactions. METHODS: A cluster-randomized controlled trial was conducted with pharmacists working in Northern Portugal, in 2007. After randomization, 364 individuals were placed into the intervention group (261 in telephone interviews and 103 in workshops), while the control group was comprised of 1,103 pharmacists. The following were approached in the educational intervention: the problem of adverse drug reaction, the impact on public health and spontaneous reporting. With regard to relevance, adverse reactions were classified into severe and unexpected. Statistical analysis was performed, based on the intention-to-treat principle; generalized linear mixed models were applied, using the penalized quasi-likelihood method. The pharmacists studied were followed during a period of 20 months. RESULTS: The intervention increased the rate of spontaneous reporting of adverse reactions three times (RR = 3.22; 95% CI 1.33;7.80), when compared to the control group. The relevance of reporting rose, with an increase in severe adverse reactions by approximately four times (RR = 3.87; 95% CI 1.29;11.61) and in unexpected adverse reactions by five times (RR = 5.02; 95% CI 1.33;18.93), compared to the control group. CONCLUSIONS: During a period of up to four months, educational interventions significantly increased the number and relevance of spontaneous reporting of adverse drug reactions by pharmacists in Northern Portugal.OBJETIVO: Evaluar los resultados de intervención para mejoría de la cantidad y relevancia de las notificaciones de reacciones adversas a medicamentos. MÉTODOS: Fue implementado un estudio controlado aleatorio, por agrupaciones de farmacéuticos que ejercen actividad profesional en la región norte de Portugal, en 2007. Posterior a la aleatoriedad, 364 individuos fueron distribuidos en el grupo de intervención (261 en la intervención telefónica y 103 en los workshops); el grupo control fue constituido por 1.103 farmacéuticos. En la intervención educativa fueron abordados la problemática de las reacciones adversas a medicamentos, el impacto en la salud pública y la notificación espontánea. Con relación a la relevancia, las reacciones adversas fueron clasificadas en graves e inesperadas. El análisis estadístico fue efectuado con base en el principio intention-to-treat; se aplicaron modelos lineares generalizados mixtos, utilizando el método penalized quasi-likelihood. Los farmacéuticos estudiados fueron seguidos durante un período de 20 meses. RESULTADOS: La intervención aumentó tres veces la tasa de notificación espontánea de las reacciones adversas (RR=3,22; IC95%:1,33;7,80) con relación al grupo control. Hubo un incremento en la relevancia de las notificaciones con aumento de las reacciones adversas graves en cerca de cuatro veces (RR=3,87; IC95%:1,29;11,61) e inesperadas en cinco veces (RR=5,02; IC 95%: 1,33;18,93), con relación al grupo control. CONCLUSIONES: Las intervenciones educativas aumentan significativamente, en hasta cuatro meses, la cantidad y la relevancia de las notificaciones espontáneas de reacciones adversas a medicamentos por parte de los farmacéuticos de la región Norte de Portugal.OBJETIVO: Avaliar os resultados de intervenção para melhoria da quantidade e relevância das notificações de reacções adversas a medicamentos. MÉTODOS: Foi implementado um estudo controlado aleatorizado, por agrupamentos em farmacêuticos a exercer actividade profissional na região norte de Portugal, em 2007. Após aleatorização, 364 indivíduos foram alocados ao grupo de intervenção (261 na intervenção telefónica e 103 nos workshops); o grupo de controlo foi constituído por 1.103 farmacêuticos. Na intervenção educativa foram abordados a problemática das reacções adversas a medicamentos, o impacto na saúde pública e a notificação espontânea. Quanto à relevância, as reações adversas foram classificadas em graves e inesperadas. A análise estatística foi efectuada com base no princípio intention-to-treat; aplicaram-se modelos lineares generalizados mistos, utilizando o método penalized quasi-likelihood. Os farmacêuticos estudados foram seguidos durante um período de 20 meses. RESULTADOS: A intervenção aumentou três vezes a taxa de notificação espontânea das reações adversas (RR = 3,22; IC 95%: 1,33; 7,80) relativamente ao grupo de controlo. Houve incremento da relevância das notificações com aumento das reações adversas graves em cerca de quatro vezes (RR = 3,87; IC 95%: 1,29;11,61) e inesperadas em cinco vezes (RR = 5,02; IC 95%: 1,33;18,93), relativamente ao grupo de controlo. CONCLUSÕES: As intervenções educativas aumentam significativamente, por até quatro meses, a quantidade e a relevância das notificações espontâneas de reacções adversas a medicamentos por parte dos farmacêuticos da região norte de Portugal

Type B adverse drug reactions reported by an immunoallergology department

Objective: Characterization of the adverse drug reactions (ADR) reported by the immunoallergology department (IAD), Centro Hospitalar de São João (Porto), to the Northern Pharmacovigilance Centre (NPC). Methods: An observational, descriptive and retrospective study was conducted, based in a spontaneous report system. Participants were all the patients from the IAD, with suspected ADR, reported to NPC by specialists after the study was completed. Results: Studied population had a median age of 41 years, with the predominance of the female gender (73.2%). Allergic rhinitis and asthma were the most frequent comorbidities. All studied ADR were type B, 89.6% were serious, 86.4% unexpected and 2.6% associated with drugs that presented less than 2 years in the market. The most represented drug classes were the non-steroidal anti-inflammatory drugs (NSAIDs) (52.6%) and antibiotics (25.2%). Skin symptoms represented 61.2% of the reported complaints. About 52.9% of these ADR occurred in less than one hour after intake. The most frequent ADR treatment at the time of the reaction was drug interruption (86.2%), followed by the prescription of anti-histamines (42.2%). Conclusions: Reported ADR to NPC by the Drug Alert Unit were mainly serious, unexpected, associated with NSAIDs and antibiotics and related with marketing authorization medicines older than two years. These results could be very useful to develop strategies to prevent the clinical and economic consequences of ADR.publishe

Characterization of 2-year progression of different phenotypes of nonproliferative diabetic retinopathy

The aim of the study was to characterize the 2-year progression of risk phenotypes of nonproliferative diabetic retinopathy (NPDR) in type 2 diabetes (T2D) phenotype C, or ischemic phenotype, identified by decreased skeletonized retinal vessel density (VD), ≥2 SD over normal values, and phenotype B, or edema phenotype, identified by increased retinal thickness, i.e., subclinical macular edema, and no significant decrease in VD. A prospective longitudinal cohort study (CORDIS, NCT03696810) was conducted with 4 visits (baseline, 6 months, 1 year, and 2 years). Ophthalmological examinations included best-corrected visual acuity, color fundus photography (CFP), and optical coherence tomography (OCT) and OCT angiography. Early Treatment Diabetic Retinopathy Study grading was performed at the baseline and last visits based on 7-field CFP. Results: One hundred and twenty-two eyes from T2D individuals with NPDR fitted in the categories of phenotypes B and C and completed the 2-year follow-up. Sixty-five (53%) of the eyes were classified as phenotype B and 57 (47%) eyes as phenotype C. Neurodegeneration represented by thinning of the ganglion cell layer and inner plexiform layer was present in both phenotypes and showed significant progression over the 2-year period (p < 0.001). In phenotype C, significant progression in the 2-year period was identified in decreased skeletonized VD (p = 0.01), whereas in phenotype B microvascular changes involved preferentially decrease in perfusion density (PD, p = 0.012). Phenotype B with changes in VD and PD (flow) and preferential involvement of the deep capillary plexus (p < 0.001) is associated with development of center-involved macular edema. In the 2-year period of follow-up, both phenotypes B and C showed progression in retinal neurodegeneration, with changes at the microvascular level characterized by decreases in PD in phenotype B and decreases in VD in phenotype C.info:eu-repo/semantics/publishedVersio

Pharmacovigilance in Older Adults

Polypharmacy and physiological changes inherent to the aging process can cause significant modifications in the pharmacokinetic and dynamic regimens of drugs, making the elderly more susceptible to adverse drug effects. Adverse drug reactions (ADR) in older adults have a significant impact on hospital admissions, increasing hospital stay and healthcare costs. Most common ADR in this population are dose-related and predictable. However, they can be difficult to diagnose as they often have nonspecific symptoms. This could be minimized by decreasing the use and prescription of potentially inappropriate medication and being aware of possible drug interactions. Besides, being older patients underrepresented in clinical trials and due to their physiological modifications, serious or atypical ADR are more common in this age range. To minimize harm in older adults, effective pharmacovigilance must be encouraged

Prevalence and Significance of Antibiotic-Associated Adverse Reactions

The World Health Organization (WHO) defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse drug effects. The aim is to promote the safety and effective use of medicines through an early detection and evaluation of drug safety risks. The pharmacovigilance system is essentially based in spontaneous reports of Adverse Drug Reactions (ADR). ADR can be associated with severe outcomes and significant mortality, besides, most of them are deemed to be preventable events. Globally, antibiotics are among the most widely prescribed medications and their extensive use is linked to antibiotic-associated ADR. This chapter aims to summarize available epidemiological data concerning antibiotic use related ADR and analyze the reports received by the EudraVigilance system regarding the exclusive usage of antibiotics

Characterization of two-year progression of neurodegeneration in different risk phenotypes of diabetic retinopathy

To characterize the two-year progression of neurodegeneration in different diabetic retinopathy (DR) risk phenotypes in type 2 diabetes.info:eu-repo/semantics/publishedVersio