Safety of Lipid-Lowering Therapy with Statins according to a Regional Pharmacovigilance Centre

Scientific relevance. Since statins are widely used to prevent cardiovascular diseases, the control of statin-related complications is essential from both medical and social perspectives.Aim. The study aimed to analyse unsolicited reports on adverse drug reactions (ADRs) to control the safety of statin therapy.Materials and methods. The study analysed information on ADRs observed during statin treatment from the reporting forms submitted by medical organisations in Irkutsk to the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2022. The causal relationship between ADRs and statin therapy was assessed using the Naranjo scale.Results. The database contained 1068 ADR reporting forms; 12 (1.1%) were spontaneous reports of statin-related complications, including 4 cases (33.4%) of myalgia, 7 cases (58.3%) of myalgia with moderately elevated transaminase levels (3–5 times the upper limit of normal), and 1 case of rhabdomyolysis that required statin discontinuation. In all cases, a reduction in the statin dose resulted in a regression in the clinical symptoms of ADRs. Most ADRs were observed in women with comorbidities (diabetes mellitus, obesity, and hypothyroidism), but the small sample size prevented the authors from testing the identified differences for statistical significance.Conclusions. According to the study results, statins have a reliable safety profile. Adequate and patient-specific selection of statin doses and ADR prevention are important responsibilities of clinical practitioners

Structural and textural properties of pillared montmorillonite at intercalation of large Al- and Al/Ce-polyhydroxocomplexes

© 2015, Pleiades Publishing, Ltd. The possibility of adjusting the separation of silicate layers in montmorillonite in a broad range of basal distances d001 (1.3–2.4 nm) at the intercalation of large (0.7–1.8 nm) polyhydroxocomplexes of aluminum ([Al13O4(OH)24(H2O)12]7+, [Al30O8(OH)56(H2O)24]18+) and aluminum/cerium synthesized through the combined hydrolysis of aluminum and cerium salts in a reactor under pressure is shown. The formation of polyhydroxocomplexes was controlled by the methods of 27Al NMR and photon correlation and fluorescent spectroscopy at different concentrations of Al3+ ions (2.5–5.1 M) in solution. Textural properties (specific surface area, total pore volume, and mesoporosity) and fractal dimensionality of the samples of intercalated montmorillonite obtained by annealing at 300°C have been determined using the method of low-temperature nitrogen adsorption–desorption

Our experience of monitoring of drugs safety in gerontological practice

The analysis of work on identification and registration of complications of medicinal therapy in medical institutions of the Irkutsk region showed that the frequency of undesirable medicinal reactions at inpatients is more senior than 60 years makes from 10 % to 25 %. At advanced age the special place is taken by dysfunction of a digestive tract and allergic reactions at purpose of cardiovascular medicines, and also antibacterial and the antiglaucomous medicines. The number of cases of absence of therapeutic effect of PM in this age group made 18,9 %, reactions from the digestive tract - 15,5 % of cases, thus in 6,5 % pseudomembranous colitis was registered. It is established that risk factors of emergency of such reaction were the background pain or depressive syndrome, accompanying application of more than three drugs and absence of the scheme of a titration of dosages

Calcium Signaling Initiated by Agonists in Mesenchymal Stromal Cells from the Human Adipose Tissue

Mesenchymal stromal cells (MSCs) from different sources represent a heterogeneous population of proliferating non-differentiated cells that contain multipotent stem cells capable of originating a variety of mesenchymal cell lineages. By using Ca2+ imaging and the Ca2+ dye Fluo-4, we studied MSCs from the human adipose tissue and examined Ca2+ signaling initiated by a variety of GPCR ligands, focusing primarily on adrenergic and purinergic agonists. Being characterized by a relative change of Fluo-4 fluorescence, agonist-induced Ca2+ responses were generated in an “all-or-nothing” fashion. Specifically, at relatively low doses, agonists elicited undetectable responses but initiated quite similar Ca2+ transients at all concentrations above the threshold. The inhibitory analysis and Ca2+/IP3 uncaging pointed at the phosphoinositide cascade as a pivotal pathway responsible for agonist transduction and implicated Ca2+-induced Ca2+ release (CICR) in shaping agonists-dependent Ca2+ signals. Altogether, our data suggest that agonist transduction in MSCs includes two fundamentally different stages: an agonist initially triggers a local, gradual, and relatively small Ca2+ signal, which next stimulates CICR to accomplish transduction with a large and global Ca2+ transient. By involving the trigger-like mechanism CICR, a cell is capable of generating Ca2+ responses of virtually universal shape and magnitude at different agonist concentrations above the threshold

MONITORING OF DRUG SAFETY IN CLINICAL PRACTICE

The results of work on identification and registration of complications of medicinal therapy in medical institutions of the Irkutsk region showed that that the frequency of undesirable medicinal reactions in patients made from 10 to 30 %. The standard scheme of antibacterial therapy results in resistance of pathogenetic flora. Hospital patients have great possibility of being infected with microorganisms, the so-called hospital strains (bacteria). The drug safety monitoring showed the necessity of the policing of prescribing of cardiovascular, antibacterial and antiglaucoma drugs

Off-Label Prescribing in Paediatric Cardiology: Regulatory Aspects and Safety Assessment by Spontaneous Reporting

In paediatrics, it is a common practice to use pharmaceuticals outside the approved Summary of Product Characteristics (i.e. off-label). According to the literature, up to 45% of inpatient paediatric prescriptions and 10–20% of outpatient ones are for off-label uses. It is essential to analyse such uses, as it helps medical practitioners act reasonably and professionally.The aim of the study was to explore the possibility of using spontaneous reports to assess the risks of the off-label use of cardiac medicinal products in children in the Irkutsk region.Materials and methods. The authors analysed 25 reporting forms on adverse drug reactions (ADRs) in paediatric cardiac patients from the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region and regional data from the Automated Information System (AIS) of the Federal Service for Surveillance in Healthcare of the Russian Federation (Roszdravnadzor) submitted in 2009–2020. The inclusion criterion for reporting forms was a causal relationship between the off-label use of a medicinal product and the ADR that was scored as “possible” or higher on the Naranjo probability scale.Results. According to the reporting forms, the off-label use of cardiac medicinal products in children was associated with ADRs, such as angiooedema, cutaneous symptoms, and bronchospasm. The majority of ADRs (84%) were considered severe. The medicinal products were prescribed for heart failure, arterial hypertension, and cardiac arrhythmias. The majority of ADR reports (75%) were submitted by inpatient medical organisations.Conclusions. The analysis of spontaneous ADR reporting databases is a simple and informative method for studying the safety of medicinal products. It is necessary to raise awareness of ADRs associated with off-label prescribing amongst paediatric cardiologists in order to reduce the incidence of ADRs. The following contributions will improve the quality of medical care: all parties involved with pharmaceuticals should adhere to good pharmacovigilance practices, medical practitioners should be actively involved in treatment safety monitoring, and the professional training curricula of paediatric cardiologists and paediatricians should include specific units on the practical functioning of pharmacovigilance

Analysis of Data on Adverse Drug Reactions and Functional Flaws of the Pharmacovigilance System Associated with Self-Treatment with Antibiotics

In the Russian Federation, a substantial proportion of the population (39.3–75.7%) opts for self-treatment. Self-administration of prescription medicinal products, particularly antibiotics, can lead to serious adverse drug reactions (ADRs). The safety of medicines in circulation relies upon the proper functioning of the pharmacovigilance system, both in general and in the case of self-medication ADRs.The aim of the study was to analyse data on the serious ADRs attributed to self-treatment with antibiotics and reported to the Regional Centre for Drug Safety Monitoring of the Irkutsk Region, as well as on the pharmacovigilance problems associated with self-treatment.Materials and methods: the study analysed the suspected ADR reporting forms from the database accumulated by the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2019. The inclusion criteria for the reporting forms were full completion and a Naranjo probability score categorising antibiotic–ADR causality at least as “possible”.Results: of the total 2325 reports in the database, 790 (34%) were on the ADRs associated with the use of antibiotics. Of these, 222 reported serious ADRs caused by self-medication. The largest number of ADRs (126) was recorded in patients aged 40–70 years; the proportion of women (60.32%) was significantly higher than the proportion of men (39.68%). Hospitalisation was required for 23 patients with serious adverse events. In 80% of the studied cases, patients justified the need for self-prescription of antibiotics with cough (which they regarded as acute bronchitis), but their presumptive diagnosis coincided with that established in the hospital only in 47.83% of the cases. The reports of ADRs during self-treatment with antibiotics were mainly received from hospitals (205 cases), and much less often from outpatient clinics and directly from patients (9 and 8 cases, respectively). There were no reports from pharmacy organisations; and it may be assumed that their employees did not take active part in reporting.Conclusions: the use of antibiotics for self-medication can lead to serious ADRs; therefore, the medicinal products of this class should be used only as directed by a doctor. To reduce the incidence of ADRs, it is necessary to raise awareness of the population and medical specialists conducting antibiotic therapy. The quality of medical care will benefit from proper performance of pharmacovigilance activities by all parties to the circulation of medicines, active involvement of patients in treatment safety monitoring, inclusion of specific sections on practical functioning of the pharmacovigilance system into the training curricula of pharmaceutical professionals, and creation of a feedback system connecting pharmacovigilance organisations to medical ones and other subjects of the circulation of medicines

SYNTHESIS AND DEPOSITION OF AG NANOPARTICLES ONTO POLYPROPTLENE FILM BY ATMOSPHERIC PRESSURE GLOW DISCHARGE TREATMENT

This report presents a one-step method of silver nanoparticles synthesis and deposition of it onto polypropylene surface by use of an atmospheric pressure glow discharge. Obtained data of UV-vis spectroscopy and Zetasizer indicate that Ag nanoparticles are polydispersed. The polypropylene film surface is modified during gas discharge treatment219-21

Clinical and pharmacological monitoring of drug safety in pediatrics

The 95 cases of adverse drug reactions in children were registered in the Centre of Drug Safety Monitoring of Irkutsk Region from 2009 to 2015. In 21.4 % of cases, the coexistent affections developed. Children were allergic three times more often than adults. In 14.7 % of cases severe allergic reactions were registered. Most often allergies occurred after taking immunotropic (62.2 %), antimicrobial (16.2 %) and nonsteroidal anti-inflammatory drugs (10.8 %). 10.5 % of cases concerned inefficient drug use in children under 3 years; and 36.8 % of cases concerned children aged 3 to 18 years. The following risk factors of inefficient antibiotic therapy in children with urinary system infections were determined: the duration of the disease up to 5 years, isolation of two or more infectious agents and concomitant infections of upper and lower urinary tract. Adverse drug reaction occurred more often when more than three drugs were prescribed at the same time. Such cases were generally registered in patients with infectious diseases and epilepsy. Risk of adverse reaction increased with the off-label drug use. Introduction of monitoring methods and prediction algorithms allowing to reveal with high probability and to prevent adverse drug reactions in children improved efficiency and quality of pharmacotherap