Analysis of adverse reactions of antihypertensive drugs registered in the Republic of Crimea for the period 2011-2016

The aim of study was to analyze and investigate the severity of adverse reactions (AR) on drugs used for arterial hypertension treatment in patients living in the Republic of Crimea for the period 2011—2016.

Materials and methods. We studied notification cards about AR registered in the regional database of spontaneous messages ARCADe. We analyzed 211 notification cards about AR in patients with proven arterial hypertension diagnosis (ICD code П0—П5).

Results. Drugs from the groups of angiotensin-converting enzyme inhibitors and slow calcium channel blockers most often cause AR, among them enalapril and amlodipine are the absolute leaders. AR occurred less frequently in application of drugs from the groups of в-blockers and angiotensin IIreceptor blockers. The study of the clinical manifestations of AR showed that most of them were allergic reactions of varying severity (skin itch, urticaria, swelling of lips, eyelids, tongue). The number of such cases was 70 (33.2 %) from all registered cases of AR on antihypertensive drugs. Examination of the outcomes of AR in patients taking antihypertensive drugs showed that the development of temporary disability was observed in 19 (9 %) cases, the hospitalization of outpatients as a result of AR development on drugs was required in 7 (3.3 %) cases, and in 2 cases patients had to prolong hospitalization. Life-threatening conditions in the form of Quincke’s edema were reported in 13patients. In the remaining 170 (80.6 %) cases AR were not serious and did not cause the above consequences. Assessment of AR severity revealed that mild AR were most common, much less often antihypertensive drugs caused severe AR (the incidence ranged from 5 to 13 %, depending on the method for severity assessment).

Conclusion. The obtained results confirm our previously published data that in the structure of AR on antihypertensive drugs, bulk of the reports associated with angiotensin-converting enzyme inhibitors. Most often antihypertensive drugs caused mild AR.

1. Shalnova S. A. Hypertension: prevalence, awareness, antihypertensive drugs and treatment efficacy among the population of the Russian Federation. Rossijskij kardiologicheskij zhurnal = Russian Journal of Cardiology 2006;(4):45—50. (In Russ.).

2. Aksenov V. A., Vlasov V. V. Is it necessary to treat arterial hypertension of 1 degree? Terapiya = Therapy 2016;1(5):58—66. (In Russ.).

3. Russian recommendations (4th revision). The section of arterial hypertension of the all-Russian scientific society of cardiologists. Diagnosis and treatment of arterial hypertension. Moscow, 2010. 34 р. (In Russ.). URL: http://www.scardio.ru/content/Guidelines/recommendation-ag-2010.pdf.

4. Clinical guidelines. Hypertension in adults. Russian Medical Society for Arterial Hypertension, 2016. 70 s. (In Russ.). URL: http://webmed.irkutsk.ru/doc/pdf/fedhypert.pdf.

5. European Society of Hypertension-European Society of Cardiology Guidelines Committee. 2003 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003;21(6):1011—53. PMID: 12777938. DOI: 10.1097/01.hjh.0000059051.65882.32.

6. Sturov N. V., Kuznetsov V. I. Antihypertensive drugs: brief information for the general practitioner. Zemskij vrach = Zemskiy Doctor 2010;(1):15—8. (In Russ.).

7. Zhyvylo I. O., Radchenko G. D., Sirenko Yu. M. Is national registry of patients with pulmonary arterial hypertension currently required? Ukrains’kij kardiologichnij zhurnal = Ukrainian Cardiology Journal 2016;(1):41—6.(In Ukrainian).

8. Federal Law from 12.04.2010 № 61-FL(revision from 04.06.2018) “About circulation of medicines”. (In Russ.). URL: http://legalacts.ru/doc/federalnyi-zakon-ot-12042010-n-61-fz-ob.

9. Talbot J. Stephens’ detection and evaluation of adverse drug reactions: principles and practice. John Wiley & Sons, Ltd., 2011. 752 p.

10. Classen D. C., Pestotnik S. L., Evans R. S. et al. Adverse drug events in hospitalized patients. Excess length of stay, extra costs and attributable mortality. JAMA 1997;277(4):301—6. PMID: 9002492.

11. Hartwig S. C., Denger S. D., Schneider P. J. Severity-indexed, incident report-based medication error-reporting program. Am J Hosp Pharm 1991;48(12):2611-6. PMID: 1814201.

12. Petrov A. V., Matveev A. V., Krasheninnikov A. E. et al. Analysis of the severity of adverse reactions in patients receiving nonsteroidal antiinflammatory drugs according to reports received in 2011-2016 in the Republic of Crimea. Effektivnaya farmakoterapiya. Revmatologiya, travmatologiya i ortopediya = Effective Pharmaco‑ therapy. Rheumatology, Traumatology and Orthopedics 2018;(4):6–9. (In Russ.).

13. Matvieiev O. V., Matvieieva N.V. Example of introduction of database in pharmaco vigilance department practice (Abstract 662). Pharmacoepidemiol Drug Saf 2012;21(Suppl 3):309.

14. Matvieiev O., Konyaeva O., Koval O. Adverse reactions in Crimea in 2010(Abstract P81). Basic Clin Pharmacol Toxicol 2011;109(Suppl 1):81.

15. Khurshid F., Aqil M., Alam M. S. et al. Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi. Daru 2012;20(1):34. DOI: 10.1186/2008-2231-20-34.