Register of patients with familial hypercholesterolemia and patients of very high cardiovascular risk with lipid-lowering therapy underperformance (RENESSANS)
M. V. Yezhov,
S. A. Bliznyuk,
N. A. Tmoyan,
T. A. Rozhkova,
D. V. Duplyakov,
V. A. Salchenko,
M. A. Kachkovsky,
I. I. Shaposhnik,
V. V. Genkel,
V. S. Gurevich,
S. А. Urazgildeeva,
A. V. Tregubov,
M. V. Muzalevskaya,
S. S. Bazhan,
O. V. Timoshchenko,
I. A. Urvantseva,
K. G. Kozhokar,
A. A. Sokolov,
V. V. Tishko,
O. I. Boyeva,
E. V. Bolotova,
A. M. Namitokov,
Yu. B. Kushnaryova,
T. Yu. Kuznetsova,
V. A. Korneva,
D. Yu. Bogdanov,
E. E. Chichina,
V. M. Solovyov,
A. I. Ershova,
A. N. Meshkov,
V. I. Makogonenko,
A. S. Galyavich,
D. I. Sadykova,
B. V. Pomogaybo,
O. L. Barbarash,
V. V. Kashtalap,
E. A. Shutemova,
I. G. Isaeva,
R. A. Khokhlov,
V. E. Oleynikov,
I. V. Avdeeva,
V. V. Malakhov,
U. V. Chubykina,
V. O. Konstantinov,
A. S. Aliyeva,
V. V. Ovsyannikova,
G. I. Furmenko,
T. M. Chernykh,
O. E. Abashina,
A. R. Dzhanibekova,
E. S. Slastnikova,
L. F. Galimova,
P. D. Duplyakova,
M. I. Voyevoda https://doi.org/10.15829/1560-4071-2019-5-7-13
Abstract
Aim. Russian multicenter register of familial hypercholesterolemia (FH) was transformed into Register of patients with FH and very high cardiovascular risk with insufficient effect of hypolipidemic therapy (RENESSANS Registry) in 2017 The aim of RENESSANS was maximal inclusion of patients not only with FH, but also those with atherosclerotic cardiovascular diseases (CVD), who did not achieve targeted level of low density lipoprotein cholesterol (LDL-C) using hypolipidemic drug therapy.
Material and methods. The RENESSANS Registry is an open, national, observing study that includes patients with definite and probable (according to Dutch lipid clinic network and Simon Broome Registry criteria) heterozygous and homozygous FH, as well as patients of very high cardiovascular risk. There were designed two register forms: for patients with FH and for very high cardiovascular risk patients. Doctors filled out forms in paper and electronic variants. They took into consideration the risk factors of atherosclerosis and anamnesis of CVD, adherence to diet and hypolipidemic therapy. Concentrations of total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C) were measured in blood serum in all centers. LDL-C level was defined according to Friedewald formula: LDL-C=TC-HDL-C-TG/2,2 (mmol/l).
Results. The Registry consisted of 1208 FH patients and 497 patients with very high risk (average age 54±13 and 61±8, respectively, 37% men). Baseline levels of lipids were 9,4±2,3 and 6,9±1,5 mmol/l for TC, 6,6±2,1 and 4,5±1,3 mmol/l for LDL-C, respectively. The frequency of hypolipidemic therapy in both groups is 70%, while targeted level of LDL-C was achieved extremely rarely.
Conclusion. The results show insufficient adherence and low effectiveness of standard hypolipidemic therapy both in patients with FH and very high cardiovascular risk. PCSK9 inhibitors are recommended for resistant hypercholesterolemia treatment. The RENESSANS Registry allows to improve FH diagnostics, to assess treatment effectiveness and choose patients who need treatment with PCSK9 inhibitors.
Keywords
Supporting agencies: This study was supported by Amgen and Sanofi-Aventis Group
About the Authors
M. V. Yezhov
National Medical Research Center of Cardiology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest S. A. Bliznyuk
National Medical Research Center of Cardiology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest N. A. Tmoyan
National Medical Research Center of Cardiology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest T. A. Rozhkova
National Medical Research Center of Cardiology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest D. V. Duplyakov
Samara Region Clinical Cardiology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest V. A. Salchenko
Samara Region Clinical Cardiology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest M. A. Kachkovsky
Medical University “Reaviz”
Russian Federation
Competing Interests:
Russian Federation
Samara
Competing Interests:
no conflict of interest I. I. Shaposhnik
South-Ural State Medical University
Russian Federation
Competing Interests:
Russian Federation
Chelyabinsk
Competing Interests:
no conflict of interest V. V. Genkel
South-Ural State Medical University
Russian Federation
Competing Interests:
Russian Federation
Chelyabinsk
Competing Interests:
no conflict of interest V. S. Gurevich
Center of Atherosclerosis and Disorders of Lipid Metabolism, St. Petersburg State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest S. А. Urazgildeeva
Center of Atherosclerosis and Disorders of Lipid Metabolism, St. Petersburg State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest A. V. Tregubov
Center of Atherosclerosis and Disorders of Lipid Metabolism, St. Petersburg State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest M. V. Muzalevskaya
Center of Atherosclerosis and Disorders of Lipid Metabolism, St. Petersburg State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest S. S. Bazhan
Research Institute for treatment and preventive medicine
Russian Federation
Competing Interests:
Russian Federation
Novosibirsk
Competing Interests:
no conflict of interest O. V. Timoshchenko
Research Institute for treatment and preventive medicine
Russian Federation
Competing Interests:
Russian Federation
Novosibirsk
Competing Interests:
no conflict of interest I. A. Urvantseva
District Cardiac Dispensary, Center for Diagnostic and Cardiovascular Surgery
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest K. G. Kozhokar
District Cardiac Dispensary, Center for Diagnostic and Cardiovascular Surgery
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest A. A. Sokolov
Military medical academy of S.M. Kirov
Russian Federation
Competing Interests:
Russian Federation
St. Petersburg
Competing Interests:
no conflict of interest V. V. Tishko
Military medical academy of S.M. Kirov
Russian Federation
Competing Interests:
Russian Federation
St. Petersburg
Competing Interests:
no conflict of interest O. I. Boyeva
Stavropol State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest E. V. Bolotova
SRI — S. V. Ochapovsky Regional Clinical Hospital № 1, Ministry of Health of Krasnodarsky Krai
Russian Federation
Competing Interests:
Russian Federation
Krasnodar
Competing Interests:
no conflict of interest A. M. Namitokov
SRI — S. V. Ochapovsky Regional Clinical Hospital № 1, Ministry of Health of Krasnodarsky Krai
Russian Federation
Competing Interests:
Russian Federation
Krasnodar
Competing Interests:
no conflict of interest Yu. B. Kushnaryova
A.A. Vishnevsky Central Military Clinical Hospital № 3
Russian Federation
Competing Interests:
Russian Federation
Moscow Region
Competing Interests:
no conflict of interest T. Yu. Kuznetsova
Petrozavodsk State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest V. A. Korneva
Petrozavodsk State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest D. Yu. Bogdanov
Vladivostok Clinical Hospital № 1
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest E. E. Chichina
Sakhalin Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
Yuzhno-Sakhalinsk
Competing Interests:
no conflict of interest V. M. Solovyov
Yu.E. Veltischev Research and Clinical Institute for Pediatrics, N. I. Pirogov Russian National Research Medical University (RNRMU)
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest A. I. Ershova
National Medical Research Center for Preventive Medicine
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest A. N. Meshkov
National Medical Research Center for Preventive Medicine
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest V. I. Makogonenko
National Medical Research Center for Preventive Medicine
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest A. S. Galyavich
Kazan State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest D. I. Sadykova
Kazan State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest B. V. Pomogaybo
413 Military hospital
Russian Federation
Competing Interests:
Russian Federation
Volgograd
Competing Interests:
no conflict of interest O. L. Barbarash
Research Institute for Complex Issues of Cardiovascular Diseases
Russian Federation
Competing Interests:
Russian Federation
Kemerovo
Competing Interests:
no conflict of interest V. V. Kashtalap
Research Institute for Complex Issues of Cardiovascular Diseases
Russian Federation
Competing Interests:
Russian Federation
Kemerovo
Competing Interests:
no conflict of interest E. A. Shutemova
Cardiology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Ivanovo
Competing Interests:
no conflict of interest I. G. Isaeva
Cardiology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Ivanovo
Competing Interests:
no conflict of interest R. A. Khokhlov
Voronezh Regional Clinical Consulting and Diagnostic Center
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest V. E. Oleynikov
Penza State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest I. V. Avdeeva
Penza State University
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest V. V. Malakhov
National Medical Research Center of Cardiology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest U. V. Chubykina
National Medical Research Center of Cardiology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Moscow
Competing Interests:
no conflict of interest V. O. Konstantinov
I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
St. Petersburg
Competing Interests:
no conflict of interest A. S. Aliyeva
Almazov National Medical Research Center
Russian Federation
Competing Interests:
Russian Federation
St. Petersburg
Competing Interests:
no conflict of interest V. V. Ovsyannikova
N.N. Burdenko Voronezh State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest G. I. Furmenko
N.N. Burdenko Voronezh State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest T. M. Chernykh
N.N. Burdenko Voronezh State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest O. E. Abashina
V.D. Seredavin Samara Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
Samara
Competing Interests:
no conflict of interest A. R. Dzhanibekova
City Clinical Hospital № 3
Russian Federation
Competing Interests:
Russian Federation
Stavropol
Competing Interests:
no conflict of interest E. S. Slastnikova
Republican Children’s Clinical Hospital, Ministry of Health of Tatarstan
Russian Federation
Competing Interests:
Russian Federation
Kazan
Competing Interests:
no conflict of interest L. F. Galimova
Republican Children’s Clinical Hospital, Ministry of Health of Tatarstan
Russian Federation
Competing Interests:
Russian Federation
Kazan
Competing Interests:
no conflict of interest P. D. Duplyakova
Samara State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Competing Interests:
no conflict of interest M. I. Voyevoda
Research Institute for treatment and preventive medicine
Russian Federation
Competing Interests:
Russian Federation
Novosibirsk
Competing Interests:
no conflict of interest References
1. Metelskaya VA, Shalnova SA, Deev AD, et al. An analysis of the prevalence of indicators characterizing the atherogenicity of the lipoprotein spectrum in residents of the Russian Federation (according to the ESSE-RF study). Prophylactic medicine. 2016;19 (1):15-23. (In Russ.) doi:1017116/profmed201619115-23.
2. Ezhov MV, Bliznyuk SA, Alekseeva IA, et al. Prevalence of hypercholesterolemia and use of statins in outpatient practice in the Russian Federation. The ICEBERG study is the diagnosis of patients with hypercholesterolemia in patients with ambulatory practice at an early stage in order to improve the cardiovascular prognosis. The Journal of Atherosclerosis and Dyslipidemias. 2017;4:5-18. (In Russ.)
3. Ershova AI, Meshkov AN, Bazhan SS, et al. The prevalence of familial hypercholesterolemia in the West Siberian region of the Russian Federation: A substudy of the ESSE-RF. PLoS One. 2017;12 (7): e0181148. doi:10.1371/journal.pone.0181148.
4. Ezhov MV, Sergienko IV, Duplyakov DV, et al. Results of the Russian research program on the diagnosis and treatment of patients with familial hypercholesterolemia. High prevalence, low awareness, poor adherence. The Journal of Atherosclerosis and Dyslipidemias. 2017;2:5-15. (In Russ.)
5. Ezhov MV, Bazhan SS, Ershova AI, et al. Clinical guidelines for familial hypercholesterolemia. The Journal of Atherosclerosis and Dyslipidemias. 2019;1:5-43. (In Russ.)
6. Kotseva K, De Backer G, De Bacquer D, et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol. 2019;26 (8):824-35. doi:10.1177/2047487318825350.
7. Akioyamen LE, Genest J, Shan SD, et al. Estimating the prevalence of heterozygous familial hypercholesterolaemia: a systematic review and meta-analysis. BMJ Open. 2017;7 (9): e016461. doi:10.1136/bmjopen-2017-016461.
8. Sokolov AA, Alexandrova OYu, Kashtalap VV, et al. Methodical recommendations on the organization of medical care for patients with hereditary atherogenic disorders of lipid metabolism in the subjects of the Russian Federation. The Journal of Atherosclerosis and Dyslipidemias. 2016;4:14-20. (In Russ.)
9. Catapano AL, Graham I, De Backer G, et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016;37 (39):2999-3058. doi:101093/eurheartj/ehw272.
10. deGoma EM, Ahmad ZS, O'Brien EC, et al. Treatment Gaps in Adults With Heterozygous Familial Hypercholesterolemia in the United States: Data From the CASCADE-FH Registry. Circ Cardiovasc Genet. 2016;9:240-9. doi:10.1161/CIRCGENETICS.116.001381.
11. Perez de Isla L, Alonso R, Mata N, et al. Coronary Heart Disease, Peripheral Arterial Disease, and Stroke in Familial Hypercholesterolaemia: Insights From the SAFEHEART Registry (Spanish Familial Hypercholesterolaemia Cohort Study). Arterioscler Thromb Vasc Biol. 2016;36:2004-10. doi:10.1161/ATVBAHA.116.307514.
12. Vrablik M, Raslova K, Vohnout B, et al. Real-life LDL-C treatment goals achievement in patients with heterozygous familial hypercholesterolemia in the Czech Republic and Slovakia: Results of the PLANET registry. Atherosclerosis. 2018;277:355-61. doi:10.1016/j.atherosclerosis.2018.08.008.
13. EAS Familial Hypercholesterolaemia Studies Collaboration; EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC) Investigators. Overview of the current status of familial hypercholesterolaemia care in over 60 countries — The EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC). Atherosclerosis. 2018;277:234-55. doi:10.1016/j.atherosclerosis.2018.08.051.
14. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017;376 (18):1713-22. doi:10.1056/NEJMoa1615664.
15. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379 (22):2097-107. doi: 10.1056/NEJMoa1801174.
Review
For citations:
Yezhov M.V., Bliznyuk S.A., Tmoyan N.A., Rozhkova T.A., Duplyakov D.V., Salchenko V.A., Kachkovsky M.A., Shaposhnik I.I., Genkel V.V., Gurevich V.S., Urazgildeeva S.А., Tregubov A.V., Muzalevskaya M.V., Bazhan S.S., Timoshchenko O.V., Urvantseva I.A., Kozhokar K.G., Sokolov A.A., Tishko V.V., Boyeva O.I., Bolotova E.V., Namitokov A.M., Kushnaryova Yu.B., Kuznetsova T.Yu., Korneva V.A., Bogdanov D.Yu., Chichina E.E., Solovyov V.M., Ershova A.I., Meshkov A.N., Makogonenko V.I., Galyavich A.S., Sadykova D.I., Pomogaybo B.V., Barbarash O.L., Kashtalap V.V., Shutemova E.A., Isaeva I.G., Khokhlov R.A., Oleynikov V.E., Avdeeva I.V., Malakhov V.V., Chubykina U.V., Konstantinov V.O., Aliyeva A.S., Ovsyannikova V.V., Furmenko G.I., Chernykh T.M., Abashina O.E., Dzhanibekova A.R., Slastnikova E.S., Galimova L.F., Duplyakova P.D., Voyevoda M.I. Register of patients with familial hypercholesterolemia and patients of very high cardiovascular risk with lipid-lowering therapy underperformance (RENESSANS). Russian Journal of Cardiology. 2019;(5):7-13. (In Russ.) https://doi.org/10.15829/1560-4071-2019-5-7-13
Views:
3556
Email this article 