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The safety of antihypertensive drugs. Retrospective analysis of adverse reactions based on a regional database

https://doi.org/10.18705/1607-419X-2021-27-2-216-228

Abstract

Objective. To analyze adverse drug reactions (ADR) occuring in patients taking antihypertensive drugs (AHD).

Design and methods. We have analyzed 459 cases of ADR caused by AHD and recorded in the regional database (register) called ARCADe (Adverse Reactions in Crimea, Autonomic Database) during 2011–2018 years.

Results. Out of all ADR, 304 cases (3,9 4,4 4,9 % of the total number of cases) were associated with AHD affecting renin-angiotensin-aldosterone system,101 (1,2 1,5 1,8 %) — with calcium channel blockers, and 54 cases (0,6 0,8 1,0 %) — with β-blockers. In the majority of cases, the ADRs were attributed to Enalapril (85 cases) and Amlodipine (76 cases). The analysis of the outcomes showed that serious reactions (life-threatening conditions, hospitalization, and disability) occurred in 72 cases. The remaining 387 ADRs were not considered serious. The majority of reported ADRs were unavoidable reactions of mild severity.

About the Authors

A. V. Matveev
National Pharmacovigilance Research Center; S. I. Georgievsky Medical Academy
Russian Federation

Alexander V. Matveev, MD, PhD, Associate Professor, Department of Basic and Clinical Pharmacology, Medical Academy named after S. I. Georgievskiy, Vernadsky Crimean Federal University

Moscow; Simferopol



A. E. Krasheninnikov
National Pharmacovigilance Research Center
Russian Federation

Anatoly E. Krasheninnikov, PhD in Pharmaceutical Sciences, CEO, Autonomous Non-commercial Organization “National Pharmacovigilance Research Center”

Moscow



A. V. Ushakov
S. I. Georgievsky Medical Academy
Russian Federation

Alexey V. Ushakov, MD, PhD, DSc, Professor, Head, Department of Internal Medicine № 1, Medical Academy named after S. I. Georgievskiy, Vernadsky Crimean Federal University

Simferopol



E. A. Egorova
S. I. Georgievsky Medical Academy
Russian Federation

Elena A. Egorova, PhD in Pharmaceutical Sciences, Associate Professor, Department of Basic and Clinical Pharmacology, Medical Academy named after S. I. Georgievskiy, Vernadsky Crimean Federal University

5/7 Lenin boulevard, Simferopol, 295051 Russia



A. G. Dormidor
Center of the Blood Circulation Pathology
Russian Federation

Artur G. Dormidor, Director, Center for Blood Circulation Pathology

Moscow



References

1. Cardiovascular diseases. World Health Organization. [cited 2019 November 5]. [Electronic resource]. URL: https://www.who.int/ru/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

2. Russian Medical Society for Arterial Hypertension. All-russian scientific society of Cardiology. Diagnosis and treatment of arterial hypertension. Russian recommendations. 4 th Version. Moscow, 2010. Cited 2019 March 2. In Russian. Available from: www.scardio.ru/content/Guidelines/recommendation-ag-2010.pdf

3. Aksenov VA, Vlasov VV. Should we treat grade1 hypertension? Therapy. 2016;1(5):58–66. In Russian.

4. Andreeva GF, Deev AD, Gorbunov VM. Effect of Lisinopril and Enalapril on quality of life and blood pressure daily profile in patients with stable arterial hypertension. Ratsionalnaya Farmakoterapiya v Kardiologii = Rational Pharmacotherapy in Cardiology. 2006;2:32–36. In Russian.

5. Waeber B, Burnier M, Brunner HR. How to improve adherence with prescribed treatment in hypertensive patients? J Cardiovasc Pharmacol. 2000;36(3):23–26.

6. Marcevich SYu. The effectiveness and safety of drug therapy in the primary and secondary prevention of cardiovascular diseases. Recommendations of VNOK. M., 2011. 76 p. In Russian.

7. Rawlins M. Spontaneous reporting of adverse drug reactions. I: the data. Br J Clin Pharmacol. 1988;1(26):1–5. doi:10.1111/j.1365–2125.1988.tb03356.x

8. Astahova AV, Lepahin VK. Drugs. Adverse reactions and safety monitoring. Edited by AV Astahova, VK Lepahin. 2 nd edition. M.: ECSMO, 2008. 256 p. In Russian.

9. Structure and principles. WHO Collaboratoring Centre for Drug Statistics Methodology [cited 2019 November 25]. [Electronic resource]. URL: https://www.whocc.no/atc/structure_and_principles/

10. Talbot J, Aronson JK. Stephens’ detection and evaluation of adverse drug reactions: principles and practice. 6 th ed. Oxford: Wiley-Blackwell; 2011. 750 p.

11. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. J Am Med Assoc. 1997;277(4):301–306. doi:10.1001/jama.1997.03540280039031

12. Hartwig SC, Denger SD, Schneider PJ. Severity-indexed, incident report-based medication error-reporting program. Am J Hosp Pharm. 1991;48(12):2611–2616.

13. Petrov AV, Matveyev AV, Krasheninnikov AYe, Yegorova YeA, Konyayeva EI. Analysis of adverse reactions severity in patients receiving non-steroidal anti-inflammatory drugs according to the messages received in 2011–2016 in the Republic of Crimea. Effectivnaya Pharmacotherapiya. Rheumatologiya, Traumatologiya i Orthopedia = Effective Pharmacotherapy. Rheumatology, Traumatology and Orthopedia. 2018;1:6–9. In Russian.

14. Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reaction. Hosp Pharm. 1992;27(6):538.

15. Hallas J, Haghfelt T, Gram LF, Grodum E, Damsbo N. Drug related admissions to a cardiology department: frequency and avoidability. J Intern Med. 1990;228(4):379–384.

16. Zhuravleva MV, Romanov BK, Gorodetskaya GI, Muslimova OV, Krysanova VS, Demchenkova Eu. Topical issues of drug safety, possibilities of improving of pharmacovigilance. Safety Risk Pharmacother. 2019;7(3):109–119. doi:10.30895/2312-7821-2019-7-3-109-119. In Russian.

17. The standard operating procedure for monitoring the effectiveness and safety of drugs in medical organizations of the state healthcare system of the city of Moscow for general practitioners and paramedical personnel. Guidelines. Ed. by MV Zhuravleva. M., 2019. 42 p. In Russian.

18. Stephens’ detection and evaluation of adverse drug reactions: principles and practice. 2011. John Wiley & Sons, Ltd. 732 p.

19. Fitzpatrick S, Scott A. Quick simultaneous confidence interval for multinomial proportions. J Am Statist Associat. 1987;82(399):875–878.

20. Karabayeva AI, Kausova GK, Turlanov KM, Abildayeva GA. Peculiarity of aetiology, pathogenesis and clinical course of arterial hypertension of old patients. Vestnik KazNMU = Bulletin of KazNMU. 2013;4(1):71–74. In Russian.

21. Leonelo E. Bautista, predictors of persistence with anti-hypertensive therapy: results from the NHANES. Am J Hypertens. 2008;21(2):183–188. doi:10.1038/ajh.2007.33

22. Sychev DA. Polypharmacy in clinical practice: problems and solutions. Tutorial. 2 nd ed., corr. and suppl. SPb.: CzOP “Professija”, 2018. 272 p. In Russian.

23. Frolova EF. Hypertension. Russian Family Doctor. 2016;20(2):6–18. In Russian.

24. Matveev AV, Krasheninnikov AE, Kiseleva NM, Egorova EA, Dormidor AG. Analysis of spontaneous reports of adverse reactions in patients with coronary artery disease in the Republic of Crimea. Complex Issues Cardiovasc Diseas. 2018;7(4):26–32. doi:10.17802/2306-1278-2018-7-4-26-32. In Russian.

25. Leonova MV, Belousov DYu, Galitskiy AA, Amagzaeva VYu, Burdelova NN. Side effects of angiotensin-converting enzyme inhibitors in hypertensive patients. Arterial’naya Gipertenziya = Arterial Hypertension. 2010;16(4):412–417. doi:10.18705/1607-419X-2010-16-4-412-417. In Russian.

26. Alhawassi TM, Krass I, Pont LG. Antihypertensive-related adverse drug reactions among older hospitalized adults. Int J Clin Pharm. 2018;40(2):428–435. doi:10.1007/s11096-017-0583-7

27. Olowofela AO, Isah AO. A profile of adverse effects of antihypertensive medicines in a tertiary care clinic in Nigeria. Ann Afr Med. 2017;16(3):114–119. doi:10.4103/aam.aam_6_17

28. Umerova AR, Dement’eva VV. Monitoring of harmful adverse reactions od medicinal products. Astrakhanskiy Med J. 2009;4(2):52–56. In Russian.


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For citations:


Matveev A.V., Krasheninnikov A.E., Ushakov A.V., Egorova E.A., Dormidor A.G. The safety of antihypertensive drugs. Retrospective analysis of adverse reactions based on a regional database. "Arterial’naya Gipertenziya" ("Arterial Hypertension"). 2021;27(2):216-228. (In Russ.) https://doi.org/10.18705/1607-419X-2021-27-2-216-228

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