Efficiency and safety of Vortioxetine in the treatment of depressive disorders in cardiac patients
https://doi.org/10.31363/2313-7053-2023-817
Abstract
Importance of the problem. Diseases of the cardiovascular system are in the first place among the causes of death and disability in most industrialized countries, which is undoubtedly an urgent medical and social problem and causes significant economic damage. The prevalence of depressive disorders in modern society, according to WHO estimates, is quite high, and the causes of depressive disorders and methods for their correction in patients with various somatic diseases have been the subject of study by specialists around the world for many decades. The comorbidity of depressive disorders with cardiac pathology is beyond doubt, and the bidirectional relationship of these disorders significantly aggravates the condition of patients, worsens their quality of life and reduces adherence to treatment. The most important conditions for the use of antidepressants in cardiology practice are good tolerability, absence of toxic effect, minimal interaction with other drugs, and relative safety in case of overdose. Vortioxetine, being a modern multimodal antidepressant, demonstrates not only a sufficiently high antidepressant and anti-anxiety activity, but also has a procognitive effect, as well as minimal side effects and undesirable cross-interactions with other drugs, which is confirmed by international randomized placebo-controlled trials. The aim of this work was to evaluate the efficacy and safety of Vortioxetine in the treatment of concomitant depressive disorders in patients with coronary heart disease (CHD), angina pectoris 2-3 functional class (FC) (I 20.8 according to ICD-10), receiving complex therapy for the main (cardiological) diseases at the inpatient and outpatient stages of therapy. Materials and methods. The study included patients with a diagnosis of coronary artery disease, angina pectoris FC 2-3, hypertension 2-3, aged 45 to 66 years (mean age 57.1±1.1 years), receiving complex therapy for the underlying cardiac disease and Vortioxetine at a dose of 10-15 mg/day. within 8 weeks. Anxiety and depressive manifestations were assessed on the HADS scale, the level of cognitive impairment on the PDQ questionnaire, social functioning on the SF-36 questionnaire, the general clinical impression on the CGI-C scale, and the main indicators of the functioning of the cardiovascular system upon admission to the hospital, after 4 weeks of hospitalization. treatment and another 4 weeks after discharge during the period of outpatient observation.
The result of the combined therapy of patients with cardiac pathology and concomitant depressive disorder (basic therapy for CVD and Vortioxetine) was not only an improvement in the cardiovascular system (decrease in heart rate, blood pressure, the frequency of anginal pain, an increase in exercise tolerance), but also the relief of depressive manifestations, which contributed to an increase in the adherence of cardiological patients to the implementation of medical recommendations, and, in turn, led to a decrease in the level of end points—mortality, hospitalization rates, progression of chronic heart failure and disability. Conclusions. Appointment of Vortioxetine to cardiac patients with concomitant depressive disorder of moderate severity is quite effective not only in terms of relief of painful manifestations of the CVS, but also leads to a reduction in anxiety-depressive disorders and an improvement in cognitive and social functioning. The good tolerability of the drug makes it possible to recommend it for the treatment of depressive disorders in cardiological patients in a hospital setting and in outpatient practice.
About the Authors
N. V. FilippovaRussian Federation
Natal’a V. Filippova
Yu. B. Barylnik
Russian Federation
Yulia B. Barylnik
T. M. Bogdanova
Russian Federation
Tatyana M. Bogdanova
V. V. Blinova
Russian Federation
Victoria V. Blinova
A. A. Shchelchkova
Russian Federation
Anastasia A. Shchelchkova
E. S. Mozgacheva
Russian Federation
Ekaterina S. Mozgacheva
References
1. World Health Organization. Depression. (in Rus.). https://www.who.int/ru/news-room/fact-sheets/detail/depression
2. Ilyina ES, Filippova NV, Barylnik YuB. Pharmacogenetics of antidepressants (from history to the present). Vestnik nevrologii, psikhiatrii i neyrokhirurgii. 2021;9:713-729. (in Rus.). https://doi.org/10.33920/med-01-2109-06
3. Piña IL, Di Palo KE, Ventura HO. Psychopharmacology and Cardiovascular Disease. J Am Coll Cardiol. 2018;71(20):2346-2359. https://doi.org/10.1016/j.jacc.2018.03.458
4. Ariyo AA, Haan М, Tangen СМ, Rutledge JC, Cushman M, Dobs A, Furberg CD. Depressive symptoms and risks of coronary heart disease and mortality in elderly Americans. Circulation. 2000;102:1773-1779. https://doi.org/10.1161/01.cir.102.15.1773
5. Cardiovascular prevention 2017. Russian national guidelines. Rossiyskiy kardiologicheskiy zhurnal. 2018;(6):7-122. (in Rus.). https://doi. org/10.15829/1560-4071-2018-6-7-122
6. Drapkina OM, Fedin AI, Dorofeyeva OA, Medvedev VE, Kareva YeN, Dzhioyeva ON, Kuklin SG, Solov›yeva EYu., Abdulganiyeva DI., Kim ZF, Grigorovich MS, Shaposhnik II, Koryagina NA, Seredenin SB. Influence of psychosocial risk factors on the course and prognosis of cardiovascular diseases. Kardiovaskulyarnaya terapiya i profilaktika. 2022;21(5):3280. (in Rus.). https://doi. org/10.15829/1728-8800-2022-3280
7. Tang M, Li X. Adverse reactions of antidepressant drugs and their application in patients with cardiovascular diseases. Zhong Nan Da Xue Xue Bao Yi Xue Ban 2020; 45(10):1228-1233. https://doi.org/10.11817/j.issn.16727347.2020.190160.
8. Kotov AM, Stotsky AD, Kolesnikov DB. Antidepressants in cardiology. Klinicheskaya meditsina. 2012;10:11-16. (in Rus.).
9. Richelson E. Multi-modality: a new approach for the treatment of major depressive disorder. Int J Neuropsychopharmacol. 2013;16(6):1433-1442. https://doi.org/10.1017/s1461145712001605
10. Lundbeck H. Brintellix™ (vortioxetine hydrobromide tablets): US prescribing information. 2013. https://www.accessdata.fda.gov/drugsatfda_docs/ label/2013/204447s000lbl.pdf
11. Lundbeck H. Brintellix™ (vortioxetine tablets): EU summary of product characteristics. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002717/WC500159449.pdf
12. Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetinereferenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012;27(4):215-223. https://doi.org/10.1097/yic.0b013e3283542457
13. Mahableshwarkar A, Zajecka J, Jacobson W, Chen Y, Keefe RSE. A Randomized, Placebo-Controlled, Active-Reference, Double-Blind, FlexibleDose Study of the Efficacy of Vortioxetine on Cognitive Function in Major Depressive Disorder. Neuropsychopharmacology. 2016; 41 (12): 2961. https://doi.org/10.1038/npp.2016.181
14. McIntyre RS, Lophaven S, Olsen CK. A randomized, doubleblind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int J Neuropsychopharmacol. 2014;17(10):1557-1567. https://doi.org/10.1017/s1461145714000546
15. Theunissen EL, Street D, Hojer AM, Vermeeren A, van Oers A, Ramaekers JG. A randomized trial on the acute and steady-state effects of a new antidepressant, vortioxetine (LuAA21004), on actual driving and cognition. Clin Pharmacol Ther. 2013;93(6):493-501. https://doi.org/10.1038/clpt.2013.39
16. Alam MY, Jacobsen PL, Chen Y, Serenko M, Mahableshwarkar AR. Safety, tolerability, and efficacy of vortioxetine (Lu AA21004) in major depressive disorder: results of an open-label, flexible-dose, 52-week extension study. Int Clin Psychopharmacol. 2013;29(1):36-44. https://doi.org/10.1097/yic.0000000000000010
17. Montgomery SA, Nielsen RZ, Poulsen LH, Häggström L. A randomized, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotoninnoradrenalin reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum Psychopharmacol. 2014;29(5):470-482. https://doi.org/10.1002/hup.2424
18. Takeda. Efficacy and safety study of vortioxetine (Lu AA21004) for treatment of major depressive disorder [ClinicalTrials.gov identifier NCT 01255787]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov
19. Wang G, Gislum M, Filippov G, Montgomery S. Randomized, double-blind study of vortioxetine versus venlafaxine in adults with major depressive disorder (MDD). Current Medical Research and Opinion. 2015;31(4):785-794. https://doi.org/10.1185/03007995.2015.1014028
20. Barylnik YuB, Parashchenko AF, Filippova NV, Abrosimova YuS, Bachilo EV, Deeva MA, Vorontsov OV, Shebaldova NS. Experience with the use of the drug Vortioxetine (Brintellix) in outpatient psychiatric practice. Psikhicheskoye zdorov’ye. 2018;16(7):40-47. (in Rus.). https://doi.org/10.25557/2074-014X.2018.07.40-47
21. МКБ-10—Международная классификация болезней 10 пересмотра. Болезни системы кровообращения. https://mkb-10.com/index.php?pid=8001
22. Churkin AA, Martyushov AN. Brief guide to the use of the ICD-10 in psychiatry and narcology. Moscow:Triada-X, 1999. 232 p. (in Rus.).
23. Kobalava ZhD, Konradi AO, Nedogoda SV, Shlyakhto EV, Arutyunov GP, Baranova EI, Barbarash OL, Boitsov SA Vavilova TV, Villevalde SV, Galyavich AS, Glezer MG, Grineva EN, Grinshtein YuI, Drapkina OM, Zhernakova YuV, Zvartau N E, Kislyak OA, Koziolova NA, Kosmacheva ED, Kotovskaya YuV, Libis RA, Lopatin YuM, Nebieridze DV, Nedoshivin AO , Ostroumova OD, Oshchepkova EV, Ratova LG, Skibitsky VV, Tkacheva ON, Chazova IE, Chesnikova AI, Chumakova GA, Shalnova SA, Shestakova MV, Yakushin SS, Yanishevsky SN. Arterial hypertension in adults. Clinical guidelines 2020. Rossiyskiy kardiologicheskiy zhurnal 2020;25(3):3786 (in Rus.). https://doi.org/10.15829/1560-4071-2020-3-3786
24. Russian Society of Cardiology (RCS). Stable ischemic heart disease. Clinical guidelines 2020. Rossiyskiy kardiologicheskiy zhurnal 2020;25(11):4076 (in Rus.) https://doi.org/10.15829/29/1560-4071-2020-4076
25. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361-370.
26. Sullivan MJL; Edgley K, Dehoux E. Perceived Deficits Questionnaire (PDQ). Basic description. https://eprovide.mapi-trust.org/instruments/perceived-deficits-questionnaire#online_distribution
27. Peto V, Jenkinson C, Fitzpatrick R, Greenhall R. The development and validation of a short measure of functioning and well-being for individuals with Parkinson’s disease. Qual Life Res. 1995;4:241-248.
28. Spearing MK, Post RM, Leverich GS, et al. Modification of the Clinical Global Impression (CGI) scale for use in bipolar illness (BP): the CGIBP. Psychiatr Res. 1997;5;73 (3): 159-171. https://doi.org/10.1016/s0165-1781(97)00123-6
29. Novik A.A., Ionova T.I. Manual on evaluation of quality of life in medicine. Ed by.: Yu.L. Shevchenko, 2nd ed. M.: Olma Mediagrup, 2007 (in Rus.).
30. Lawrence C, Roy A, Harikrishnan V, Yu S, Dabbous O. Association between severity of depression and self-perceived cognitive difficulties among full-time employees. Primary Care Companion CNS Disord. 2013; 15 (3). https://doi.org/10.4088/pcc.12m01469
Review
For citations:
Filippova N.V., Barylnik Yu.B., Bogdanova T.M., Blinova V.V., Shchelchkova A.A., Mozgacheva E.S. Efficiency and safety of Vortioxetine in the treatment of depressive disorders in cardiac patients. V.M. BEKHTEREV REVIEW OF PSYCHIATRY AND MEDICAL PSYCHOLOGY. 2023;57(2):105-115. (In Russ.) https://doi.org/10.31363/2313-7053-2023-817