ANICHKOV study: the effect of combined hypotensive and lipid-lowering therapy on cardiovascular complications in patients of high and very high risk

Abstract


Reducing the risk of cardiovascular complications include lifestyle changes, drug therapy for achieving target blood pressure levels, normalizing the lipid profile, and correcting other risk factors. Adherence to therapy is of particular role, especially in primary prevention, which determines the need to implement the concept of fixed combinations. Approximately 70% of patients with AH have elevated levels of total cholesterol (TCh) and LDL-C, which determines the feasibility of using a FC containing a statin with two antihypertensive drugs. Aim. The aim of the study was to assess cardiovascular risk in patients with elevated levels of total cholesterol and LDL-C and concomitant AH, a comparative analysis of adherence, efficacy and safety of various forms of combined therapy in outpatient practice, including promising lisinopril/amlodipine/rosuvastatin FC (Ekvamer®). Materials and methods. The ANICHKOV study included 702 patients in Moscow and the Moscow region over 18 years old with a cholesterol level ≥7.5 mmol/l and/or LDL-C ≥4.9 mmol/l from March 2017 to December 2018 based on 2 federal centers. According to the results of visit I, patients were prescribed with one of three therapy schemes. In the absence of AH, patients received scheme I (Mertenil® at initial dosage of 10 mg/day). When history of AH existed or AH detected at visit I, patients were randomized to scheme II (Ekvamer® 5/10/10 mg/day) or III (Mertenil® 10 mg/day + Ekvator® 5/10 mg/day). During the observation, the treatment scheme remained unchanged, however, if the target levels of LDL-C and/or BP were not reached, the doses could be increased. The analysis of the main effects of the prescribed therapy were carried out for 12 months, and the frequency of MACE (CVD, ACS, stroke, or hospitalization to perform PCI) was also evaluated Results and discussion. Following the visit I, scheme I was assigned to 390 patients (55.6%), scheme II - 190 (27.1%), scheme III - 122 (17.4%). In 147 patients (20.9%), TG level was >2.3 mmol/l, which required additional fenofibrate intake in a dose of 145 mg/day. Adherence level was 89.5%, including scheme I - 91.7%, scheme II - 90.5%, scheme III - only 81.8%. In general, among compliant patients (n = 590), the decrease in TCh level was 41.0%, LDL-C - 47.4%. 16.6% of patients reached target levels of LDL-C <2.5 mmol/l, 5.6% - <1.8 mmol/l. In the fenofibrate subgroup, TG level decrease was 34.6%. During the follow-up period, 47 cases of side effects were observed in 27 patients (4.6%), that did not require modification of therapy. Systolic BP reduction in compliant patients of schemes II and III was 20 mm. Hg (13.1%), diastolic BP - 12 mm. Hg (13.6%), target BP levels (<140/90 mm. Hg) reached 83.7% and 80.8% of patients, respectively, target levels of BP and LDL-C <2.5 mmol/l reached 14.5% and 13.1% of patients, respectively, <1.8 mmol/l - 5.8% and 5.1%, respectively. During the observation period no deaths were recorded, other components of MACE were observed in 38 patients (5.8%), including 27 among compliant patients (4.6%) and 11 among non-compliant (15.9%, p<0.01). In 19 out of 38 patients (50%), hospitalization for routine PCI was the end point, ACS - in 12 (31.6%), and stroke - in 7 (18.4%). Conclusion. The results of the study demonstrated a sufficient hypolipidemic effect and high safety of Mertenil® and Ekvamer®. A higher adherence to the combined preparation than to two monodrugs was noted. Achieving target levels of BP and LDL-C is problematic, which dictates the expediency of using fixed combinations of drugs, especially in primary prevention.

Full Text

Restricted Access

About the authors

I V Sergienko

National Medical Research Center of Cardiology of the Ministry of Health of Russian Federation

Moscow, Russia

A A Ansheles

National Medical Research Center of Cardiology of the Ministry of Health of Russian Federation

Email: a.ansheles@gmail.com
Moscow, Russia

O M Drapkina

National Research Center for Preventive Medicine of the Ministry of Health of Russian Federation

Moscow, Russia

N B Gornyakova

National Medical Research Center of Cardiology of the Ministry of Health of Russian Federation

Moscow, Russia

M Yu Zubareva

National Medical Research Center of Cardiology of the Ministry of Health of Russian Federation

Moscow, Russia

R N Shepel

National Research Center for Preventive Medicine of the Ministry of Health of Russian Federation

Moscow, Russia

V V Kuharchuk

National Medical Research Center of Cardiology of the Ministry of Health of Russian Federation

Moscow, Russia

S A Boytsov

National Medical Research Center of Cardiology of the Ministry of Health of Russian Federation

Moscow, Russia

References

  1. Piepoli M.F, Hoes A.W, Agewall S, Albus C, Brotons C, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016;37(29):2315-81. doi: 10.1093/eurheartj/ehw106
  2. Sasich L.D, Wolfe S.M, Pearson C, Swankin D.A, Levin A.A, et al. The National Council on Patient Information and Education. JAMA. 1997;278(18):1491-2.
  3. Ockene I.S, Hayman L.L, Pasternak R.C, Schron E, Dunbar-Jacob J. Task force #4 - adherence issues and behavior changes: achieving a long - term solution. 33rd Bethesda Conference. J Am Coll Cardiol. 2002;40(4):630-40.
  4. Dezii C.M. A retrospective study of persistence with single - pill combination therapy vs. concurrent two - pill therapy in patients with hypertension. Manag Care. 2000;9(9 Suppl):2-6.
  5. Renshaw R.M. Keys to diabetes control? Patience, persistence, and perseverance. Manag Care. 2007;16(5):35-8, 43.
  6. Brinton E.A. Understanding Patient Adherence and Concerns with STatins and MedicatION Discussions with Physicians (ACTION): A Survey on the Patient Perspective of Dialogue with Healthcare Providers Regarding Statin Therapy. Clin Cardiol. 2018;41(6):710-20 doi: 10.1002/clc.22975
  7. Burns K, Turnbull F, Patel A, Peiris D. Opinions of community pharmacists on the value of a cardiovascular polypill as a means of improving medication compliance. Int J Pharm Pract. 2012;20(3):155-63. doi: 10.1111/j.2042-7174.2011.00175.x
  8. Monane M, Bohn R.L, Gurwitz J.H, Glynn R.J, Levin R, et al. The effects of initial drug choice and comorbidity on antihypertensive therapy compliance: results from a population - based study in the elderly. Am J Hypertens. 1997;10(7 Pt 1):697-704.
  9. Chapman R.H, Benner J.S, Petrilla A.A, Tierce J.C, Collins S.R, et al. Predictors of adherence with antihypertensive and lipid - lowering therapy. Arch Intern Med. 2005;165(10):1147-52. doi: 10.1001/archinte.165.10.1147
  10. Castellano J.M, Sanz G, Penalvo J.L, Bansilal S, Fernandez-Ortiz A, et al. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014;64(20):2071-82. doi: 10.1016/j.jacc.2014.08.021
  11. Недогода С.В., Чумачек Е.В., Ледяева А.А., Цома В.В., Саласюк А.С. Сравнительная эффективность фиксированных комбинаций лизиноприла с амлодипином и эналаприла с гидрохлортиазидом. Кардиоваскулярная терапия и профилактика. 2013;12(2):25-9.
  12. Муромцева Г.А., Концевая А.В., Константинов В.В., Артамонова Г.В., Гатагонова Т.М. и др. Распространенность факторов риска неинфекционных заболеваний в российской популяции в 2012-2013 гг. Результаты исследования ЭССЕ-РФ. Кардиоваскулярная терапия и профилактика. 2014;13(6):4-11.
  13. Бойцов С.А., Якушин С.С., Марцевич С.Ю., Лукьянов М.М., Никулина Н.Н. и др. Амбулаторно-поликлинический регистр кардиоваскулярных заболеваний в Рязанской области (РЕКВАЗА): основные задачи, опыт создания и первые результаты. Рациональная фармакотерапия в кардиологии. 2013;9(1):4-14.
  14. Sever P.S, Dahlof B, Poulter N.R, Wedel H, Beevers G, et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower - than - average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial - Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 2003;361(9364):1149-58. doi: 10.1016/S0140-6736(03)12948-0
  15. Карпов Ю.А., Кухарчук В.В., Бойцов С.А. Заключение совета экспертов Национального общества по изучению атеросклероза (НОА). Семейная гиперхолестеринемия в Российской Федерации: нерешенные проблемы диагностики и лечения. Атеросклероз и дислипидемии. 2015;2(19):5-17
  16. Бланкова З.Н., Асланян Н.С., Смолянинова Н.Г., Агеев Ф.Т. Современный подход к лечению больных высокого сердечно - сосудистого риска: возможности комбинированной терапии. Системные гипертензии. 2017;14(1):12-6.

Statistics

Views

Abstract - 64

PDF (Russian) - 6

Cited-By


PlumX

Dimensions

Refbacks

  • There are currently no refbacks.


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
 

Address of the Editorial Office:

  • Novij Zykovskij proezd, 3, 40, Moscow, 125167

Correspondence address:

  • Novoslobodskaya str 31c4., Moscow, 127005, Russian Federation

Managing Editor:

 

© 2018 "Consilium Medicum" Publishing house

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies