Atrial fibrillation in patients treated with intravenous zoledronic or pamidronic acid: a pharmacoepidemiological study

Objective Atrial fibrillation (AF) may be triggered by intravenous bisphosphonates (IVBPs) such as zoledronic acid or pamidronic acid. Our objective was to confirm the association between AF and IVBPs in a real-life large pharmacovigilance database. Design A systematic analysis of VigiBase, the World Health Organization's pharmacovigilance database. Methods Analysis of adverse events reported as ‘atrial fibrillation’ (according to the Medical Dictionary for Drug Regulatory Activities) associated with the use of zoledronic acid or pamidronic acid, in VigiBase, the World Health Organization's global Individual Case Safety Report (ICSR) database. All ICSRs reporting AF associated with zoledronic acid or pamidronic acid were included in a disproportionality analysis determining the lower end of the 95% credibility interval for the information component (IC025), showing a statistical association when >0. Results 530 ICSRs reporting on the association between AF and IVBPs were extracted. Bayesian disproportionality analysis detected a significant association between AF and use of zoledronic acid (IC025 = 1.83) and pamidronic acid (IC025 = 2.16). Further analysis of these ICSRs determined that AF was severe in 85.0% of cases and with a mortality of 17.7%. The risk of severe AF was increased (OR: 2.98 (95% CI: 1.17–7.57), P = 0.02) following zoledronic acid vs pamidronic acid, after adjustment for age and gender. Conclusions This is the first VigiBase pharmacoepidemiological study confirming the association between IVBPs and AF. Most AF were severe, with a high frequency of lethal outcome. The risk of severe AF was increased following zoledronic acid use compared to pamidronic acid, advocating for a cautious use of IVBPs.

PREVALENCE AND RISK FACTORS OF POTENTIALLY PRESCRIBING OMISSIONS IN ELDERLY AND SENILE PATIENTS: CLINICAL PRACTICE IN RUSSIAN HOSPITALS

Ретроспективное фармакоэпидемиологическое исследование включало данные медицинской документации 401 пациента 65 лет и старше, проходившего стационарное лечение, и имело целью определить распространенность потенциально упущенных назначений лекарственных средств (ПУНЛС) с использованием критериев START-2 (2015 г.) и выявить ассоциированные факторы риска. Статистический анализ включал методы параметрической и непараметрической статистики, многофакторный анализ. Сравнивали пациентов с упущенными назначениями лекарственных средств и без таковых. Обнаружено, что для пациентов с ПУНЛС были более характерны гипертензия, сахарный диабет, большее число сопутствующих заболеваний, большее число лекарственных назначений. Значимых возрастных и гендерных отличий в указанных группах не было обнаружено. Полипрагмазию наблюдали у 36,7 % пациентов. Использование критериев START-2 позволило выявить 633 эпизода ПУНЛС (67,3 % пациентов). 94,7 % ПУНЛС были связаны с недостаточным использованием статинов, аспирина, β-блокаторов и ингибиторов ангиотензин-превращающего фермента. Многомерный регрессионный анализ обнаружил выраженную ассоциацию между распространенностью ПУНЛС и числом назначенных лекарственных средств, коморбидностью, в особенности ИБС и гипертензией. Сердечнососудистые лекарственные средства были наиболее типичными при ПУНЛС. A retrospective pharmacoepidemiological study (included data from medical records of 401 patients ≥65 years of age who received treatment in hospitals) was aimed to measure prevalence of potentially prescribing omissions (PPOs) among older people using Screening Tool to Alert doctors to Right Treatment 2 (START-2) criteria (2015) and to investigate associated risk factors. Statistical analysis includes methods of parametric and nonparametric statistics. We compared patients who had PPOs with those had not PPOs. It was found that hypertension, diabetes mellitus and high levels of concomitant diseases were more characteristic for people with PPOs, and they received more medications. There were no signifi cantly differences in terms of age and gender. Polypharmacy was observed in 36,7% of patients. Using the START-2 criteria, 633 episodes of PPOs were indicated (67,3% of patients). 94,7% PPOs were mainly associated with under-use of statins, aspirin, b-blockers and angiotensin-converting enzyme inhibitors. Multivariate analyses revealed strong association of PPOs prevalence with the number of prescribed medications and comorbidities, especially, ischaemic heart disease and hypertension. Cardiovascular medications were the most common among PPOs.

Pharmacotherapy and other aspects of senior medical students’ knowledge in community-acquired pneumonia: the final results of the KNOCAP II project

Introduction: Community-acquired pneumonia (CAP) remains an extensive medical and social problem. It is the most common human disease and one of the leading causes of death from infectious diseases. Increasing the level of senior medical students’ knowledge of the diagnosis, treatment and prevention of CAP will improve the level of medical care to the population. The aim of the study: to determine the level of senior medical students’ basic knowledge of CAP prevention, diagnosis and treatment with the help of a pharmacoepidemiological study. Materials and methods: The multicenter study “KNOCAP” (the full name of the project “The Assessment of Physicians’ and Students’ Knowledge of Community-acquired Pneumonia Basics”) presents the results of an anonymous prospective survey aimed at assessing the knowledge and preferences of senior medical students in terms of the CAP pharmacotherapy. In the second stage of the project (2017–2019). The results from 394 senior students from 8 centers of Russia, Ukraine and Kyrgyzstan were received and analyzed. An original questionnaire was developed for this study on the basis of the current clinical guidelines. Conclusion: The final results of a prospective survey revealed an insufficient level of students’ basic knowledge of diagnosis, treatment and prevention of CAP. The study revealed a statistically significant heterogeneity of knowledge levels in different centers, which indicates the need for the introduction of unified and in-depth training programs in this area.