Version 1
: Received: 30 August 2024 / Approved: 30 August 2024 / Online: 2 September 2024 (03:31:18 CEST)
How to cite:
Mitkova, Z.; Dimova, A.; Petrova, G.; Dimitrova, M. Adverse Drug Reactions of Cardiovascular Classes of Medicines – Data for the Bulgarian Population. Preprints2024, 2024090004. https://doi.org/10.20944/preprints202409.0004.v1
Mitkova, Z.; Dimova, A.; Petrova, G.; Dimitrova, M. Adverse Drug Reactions of Cardiovascular Classes of Medicines – Data for the Bulgarian Population. Preprints 2024, 2024090004. https://doi.org/10.20944/preprints202409.0004.v1
Mitkova, Z.; Dimova, A.; Petrova, G.; Dimitrova, M. Adverse Drug Reactions of Cardiovascular Classes of Medicines – Data for the Bulgarian Population. Preprints2024, 2024090004. https://doi.org/10.20944/preprints202409.0004.v1
APA Style
Mitkova, Z., Dimova, A., Petrova, G., & Dimitrova, M. (2024). Adverse Drug Reactions of Cardiovascular Classes of Medicines – Data for the Bulgarian Population. Preprints. https://doi.org/10.20944/preprints202409.0004.v1
Chicago/Turabian Style
Mitkova, Z., Guenka Petrova and Maria Dimitrova. 2024 "Adverse Drug Reactions of Cardiovascular Classes of Medicines – Data for the Bulgarian Population" Preprints. https://doi.org/10.20944/preprints202409.0004.v1
Abstract
Objective Hypertension is one of the most common chronic diseases, affecting more than 20 % of the population. The side effects experienced due to antihypertensive medications such as tired-ness, muscle pain, and insomnia are often a significant predictor of poor adherence to therapy. The goal of the current study is to present the frequency, type, seriousness, and severity of adverse drug reactions reported to the BDA via Individual Case Safety Reports (ICSR) and following differentiation of messages found in more than one patient. Methods We conducted a retrospective analysis of the reported adverse drug reactions (ADR) reported in the Bulgarian Drug Agency database after treatment with antihyperlipidemic medicines, angiotensin-converting enzyme (ACE) - inhibitors, and sartans for the period 2017-2021. Each ICSR form was observed and data for suspected medicine and type of adverse reaction was analyzed. Results The total number of processed notifications for adverse drug reactions (ADR) included in the database is 142. The highest number of ADRs was reported for ARB (58), followed by antihyperlipidemic medicines (55) and ACE inhibitors (29.) Most of the assessed adverse events experienced by more than one patient fall into the probable and related categories based on Global Introspection method classification. Therefore, they have been investigated and are consistent with exposure in the population. Conclusion Cardiovascular medicines from the groups of ACE inhibitors, sartans and statins are with high share of reported ADRs in the BDA system. Some of them are severe and need further investigation.
Keywords
drug-related side effects and adverse reactions; antihyperlipidemic medicines; angiotensin-converting enzyme (ACE) - inhibitors; sartans
Subject
Medicine and Pharmacology, Cardiac and Cardiovascular Systems
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
