Skip to main content
Top
Published in: Advances in Therapy 3/2019

Open Access 01-03-2019 | Statins | Original Research

Clinical Management of High and Very High Risk Patients with Hyperlipidaemia in Central and Eastern Europe: An Observational Study

Authors: Ivo Petrov, Andreea Dumitrescu, Michaela Snejdrlova, Barak Zafrir, Beata Wożakowska-Kapłon, Lubomira Fabryova, Hrvoje Pintarić, Ian Bridges, Reneta Petkova

Published in: Advances in Therapy | Issue 3/2019

Login to get access

Abstract

Introduction

A retrospective/prospective observational study was conducted to explore the current management of hyperlipidaemia in high-risk (HR) and very high risk (VHR) patients in central/eastern Europe and Israel.

Methods

The study enrolled adult patients who were receiving lipid-lowering therapy and attending a specialist (cardiologist/diabetologist/lipidologist) or internist for a routine visit at 57 sites (including academic/specialist/internal medicine centres) across Bulgaria, Croatia, Czech Republic, Israel, Poland, Romania and Slovakia. Data were collected from medical records, for the 12 months before enrolment, with/without ≤ 6 months’ additional prospective follow-up.

Results

A total of 1244 patients, mean (SD) age 63.3 (11.3) years were included (307 with familial hypercholesterolaemia (FH), 943 secondary prevention patients). Almost all patients (98.1%) were receiving statins (76.7% monotherapy/21.4% combined therapy), with 53.1% receiving high-intensity statin therapy: 127 patients (10.2%) had adverse events attributed to statin intolerance. Mean (SD) low density lipoprotein cholesterol (LDL-C) levels were 3.3 (1.7) mmol/L at the first, and 2.7 (1.3) mmol/L at the last, visit of the retrospective phase of observation, with little change during the prospective phase. Less than one-quarter (23.8%; 95% CI 17.29–31.45%) of HR patients and less than half (42.0%; 39.05–44.98%) of VHR patients achieved their risk-based LDL-C targets of < 2.5 and < 1.8 mmol/L, respectively. Less than 15% of FH patients reached these targets (10.9% (5.6–18.7%) of HR and 12.1% (8.0–17.4%) of VHR patients). The revised 2016 ESC/EAS target for HR patients (2.6 mmol/L) was met by 28.5% (21.44–36.38%) of HR patients overall. Almost one-half of patients (42.1%) experienced one or more cardiovascular events during observation.

Conclusion

Our findings confirm that, despite widespread statin use, a substantial proportion of patients treated for hyperlipidaemia in central/eastern Europe and Israel, particularly those with FH, do not reach recommended LDL-C targets, thus remaining at risk of cardiovascular events.

Funding

Amgen (Europe) GmbH.
Appendix
Available only for authorised users
Literature
2.
go back to reference Tolonen H, Keil U, Ferrario M, Evans A. Prevalence, awareness and treatment of hypercholesterolaemia in 32 populations: results from the WHO MONICA Project. Int J Epidemiol. 2005;34(1):181–92.CrossRefPubMed Tolonen H, Keil U, Ferrario M, Evans A. Prevalence, awareness and treatment of hypercholesterolaemia in 32 populations: results from the WHO MONICA Project. Int J Epidemiol. 2005;34(1):181–92.CrossRefPubMed
3.
go back to reference Kannel WB. The Framingham Study: an epidemiological investigation of cardiovascular disease, Section 30. Some characteristics related to the incidence of cardiovascular disease and death: the Framingham Study. 18-year follow-up. Washington, D.C.: Dept. of Health, Education, and Welfare, Publication No. (NIH) 74-599; 1974. Kannel WB. The Framingham Study: an epidemiological investigation of cardiovascular disease, Section 30. Some characteristics related to the incidence of cardiovascular disease and death: the Framingham Study. 18-year follow-up. Washington, D.C.: Dept. of Health, Education, and Welfare, Publication No. (NIH) 74-599; 1974.
4.
go back to reference Kannel WB. Range of serum cholesterol values in the population developing coronary artery disease. Am J Cardiol. 1995;76(9 Suppl. 1):69C–77C.CrossRefPubMed Kannel WB. Range of serum cholesterol values in the population developing coronary artery disease. Am J Cardiol. 1995;76(9 Suppl. 1):69C–77C.CrossRefPubMed
5.
go back to reference Kannel WB, Castelli WP, Gordon T. Cholesterol in the prediction of atherosclerotic disease: new perspectives based on the Framingham study. Ann Intern Med. 1979;90(1):85–91.CrossRefPubMed Kannel WB, Castelli WP, Gordon T. Cholesterol in the prediction of atherosclerotic disease: new perspectives based on the Framingham study. Ann Intern Med. 1979;90(1):85–91.CrossRefPubMed
6.
go back to reference Cholesterol Treatment Trialists Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670–81.CrossRef Cholesterol Treatment Trialists Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670–81.CrossRef
7.
go back to reference Reiner Z, Catapano AL, De Backer G, et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32(14):1769–818.CrossRefPubMed Reiner Z, Catapano AL, De Backer G, et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32(14):1769–818.CrossRefPubMed
8.
go back to reference Catapano AL, Graham I, De Backer G, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) developed with the special contribution of the European Association for Cardiovascular Prevention and Rehabilitation (EACPR). Atherosclerosis. 2016;253:281–344.CrossRefPubMed Catapano AL, Graham I, De Backer G, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) developed with the special contribution of the European Association for Cardiovascular Prevention and Rehabilitation (EACPR). Atherosclerosis. 2016;253:281–344.CrossRefPubMed
9.
go back to reference Pajak A, Kozela M. Cardiovascular disease in central and east Europe. Public Health Rev. 2012;33:416–35.CrossRef Pajak A, Kozela M. Cardiovascular disease in central and east Europe. Public Health Rev. 2012;33:416–35.CrossRef
11.
go back to reference Banach M, Rizzo M, Toth PP, et al. Statin intolerance—an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Expert Opin Drug Saf. 2015;14(6):935–55.CrossRefPubMed Banach M, Rizzo M, Toth PP, et al. Statin intolerance—an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Expert Opin Drug Saf. 2015;14(6):935–55.CrossRefPubMed
12.
go back to reference Hovingh GK, Davidson MH, Kastelein JJ, O’Connor AM. Diagnosis and treatment of familial hypercholesterolaemia. Eur Heart J. 2013;34(13):962–71.CrossRefPubMed Hovingh GK, Davidson MH, Kastelein JJ, O’Connor AM. Diagnosis and treatment of familial hypercholesterolaemia. Eur Heart J. 2013;34(13):962–71.CrossRefPubMed
13.
go back to reference Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015;36(17):1012–22.CrossRefPubMedPubMedCentral Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015;36(17):1012–22.CrossRefPubMedPubMedCentral
14.
go back to reference Reiner Ž, De Backer G, Fras Z, et al. Lipid lowering drug therapy in patients with coronary heart disease from 24 European countries—findings from the EUROASPIRE IV survey. Atherosclerosis. 2016;246:243–50.CrossRefPubMed Reiner Ž, De Backer G, Fras Z, et al. Lipid lowering drug therapy in patients with coronary heart disease from 24 European countries—findings from the EUROASPIRE IV survey. Atherosclerosis. 2016;246:243–50.CrossRefPubMed
15.
go back to reference Gitt AK, Lautsch D, Ferrieres J, et al. Low-density lipoprotein cholesterol in a global cohort of 57,885 statin-treated patients. Atherosclerosis. 2016;255:200–9.CrossRefPubMed Gitt AK, Lautsch D, Ferrieres J, et al. Low-density lipoprotein cholesterol in a global cohort of 57,885 statin-treated patients. Atherosclerosis. 2016;255:200–9.CrossRefPubMed
16.
go back to reference Zafrir B, Jubran A, Lavie G, Halon DA, Flugelman MY, Shapira C. Clinical determinants and treatment gaps in familial hypercholesterolemia: data from a multi-ethnic regional health service. Eur J Prev Cardiol. 2017;24(8):867–75.CrossRefPubMed Zafrir B, Jubran A, Lavie G, Halon DA, Flugelman MY, Shapira C. Clinical determinants and treatment gaps in familial hypercholesterolemia: data from a multi-ethnic regional health service. Eur J Prev Cardiol. 2017;24(8):867–75.CrossRefPubMed
17.
go back to reference Perez de Isla L, Alonso R, Watts GF, et al. Attainment of LDL-cholesterol treatment goals in patients with familial hypercholesterolemia: 5-year SAFEHEART Registry follow-up. J Am Coll Cardiol. 2016;67(11):1278–85.CrossRefPubMed Perez de Isla L, Alonso R, Watts GF, et al. Attainment of LDL-cholesterol treatment goals in patients with familial hypercholesterolemia: 5-year SAFEHEART Registry follow-up. J Am Coll Cardiol. 2016;67(11):1278–85.CrossRefPubMed
18.
go back to reference Marks D, Thorogood M, Neil HA, Humphries SE. A review on the diagnosis, natural history, and treatment of familial hypercholesterolaemia. Atherosclerosis. 2003;168(1):1–14.CrossRefPubMed Marks D, Thorogood M, Neil HA, Humphries SE. A review on the diagnosis, natural history, and treatment of familial hypercholesterolaemia. Atherosclerosis. 2003;168(1):1–14.CrossRefPubMed
19.
go back to reference Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease Consensus Statement of the European Atherosclerosis Society. Eur Heart J. 2013;34(45):3478–90.CrossRefPubMedPubMedCentral Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease Consensus Statement of the European Atherosclerosis Society. Eur Heart J. 2013;34(45):3478–90.CrossRefPubMedPubMedCentral
20.
go back to reference Benn M, Watts GF, Tybjaerg-Hansen A, Nordestgaard BG. Familial hypercholesterolemia in the Danish general population: prevalence, coronary artery disease, and cholesterol-lowering medication. J Clin Endocrinol Metab. 2012;97(11):3956–64.CrossRefPubMed Benn M, Watts GF, Tybjaerg-Hansen A, Nordestgaard BG. Familial hypercholesterolemia in the Danish general population: prevalence, coronary artery disease, and cholesterol-lowering medication. J Clin Endocrinol Metab. 2012;97(11):3956–64.CrossRefPubMed
21.
go back to reference Banach M, Stulc T, Dent R, Toth PP. Statin non-adherence and residual cardiovascular risk: there is need for substantial improvement. Int J Cardiol. 2016;225:184–96.CrossRefPubMed Banach M, Stulc T, Dent R, Toth PP. Statin non-adherence and residual cardiovascular risk: there is need for substantial improvement. Int J Cardiol. 2016;225:184–96.CrossRefPubMed
22.
go back to reference Perreault S, Blais L, Dragomir A, et al. Persistence and determinants of statin therapy among middle-aged patients free of cardiovascular disease. Eur J Clin Pharmacol. 2005;61(9):667–74.CrossRefPubMed Perreault S, Blais L, Dragomir A, et al. Persistence and determinants of statin therapy among middle-aged patients free of cardiovascular disease. Eur J Clin Pharmacol. 2005;61(9):667–74.CrossRefPubMed
23.
go back to reference Blackburn DF, Dobson RT, Blackburn JL, Wilson TW, Stang MR, Semchuk WM. Adherence to statins, beta-blockers and angiotensin-converting enzyme inhibitors following a first cardiovascular event: a retrospective cohort study. Can J Cardiol. 2005;21(6):485–8.PubMed Blackburn DF, Dobson RT, Blackburn JL, Wilson TW, Stang MR, Semchuk WM. Adherence to statins, beta-blockers and angiotensin-converting enzyme inhibitors following a first cardiovascular event: a retrospective cohort study. Can J Cardiol. 2005;21(6):485–8.PubMed
24.
go back to reference Seidah NG, Awan Z, Chrétien M, Mbikay M. PCSK9: a key modulator of cardiovascular health. Circ Res. 2014;114(6):1022–36.CrossRefPubMed Seidah NG, Awan Z, Chrétien M, Mbikay M. PCSK9: a key modulator of cardiovascular health. Circ Res. 2014;114(6):1022–36.CrossRefPubMed
25.
go back to reference Lipinski MJ, Benedetto U, Escarcega RO, et al. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary hypercholesterolaemia: a network meta-analysis. Eur Heart J. 2016;37(6):536–45.CrossRefPubMed Lipinski MJ, Benedetto U, Escarcega RO, et al. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary hypercholesterolaemia: a network meta-analysis. Eur Heart J. 2016;37(6):536–45.CrossRefPubMed
26.
go back to reference Navarese EP, Kolodziejczak M, Schulze V, et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: a systematic review and meta-analysis. Ann Intern Med. 2015;163(1):40–51.CrossRefPubMed Navarese EP, Kolodziejczak M, Schulze V, et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: a systematic review and meta-analysis. Ann Intern Med. 2015;163(1):40–51.CrossRefPubMed
27.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
28.
go back to reference Sabatine MS, Giugliano RP, Pedersen TR. Evolocumab in patients with cardiovascular disease. N Engl J Med. 2017;377(8):787–8.PubMed Sabatine MS, Giugliano RP, Pedersen TR. Evolocumab in patients with cardiovascular disease. N Engl J Med. 2017;377(8):787–8.PubMed
29.
go back to reference Sabatine MS, Giugliano RP, Wiviott SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1500–9.CrossRefPubMed Sabatine MS, Giugliano RP, Wiviott SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1500–9.CrossRefPubMed
30.
go back to reference Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1489–99.CrossRefPubMed Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1489–99.CrossRefPubMed
31.
go back to reference Landmesser U, Chapman MJ, Stock JK, et al. 2017 update of ESC/EAS Task Force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia. Eur Heart J. 2018;39:1131–43.CrossRefPubMed Landmesser U, Chapman MJ, Stock JK, et al. 2017 update of ESC/EAS Task Force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia. Eur Heart J. 2018;39:1131–43.CrossRefPubMed
Metadata
Title
Clinical Management of High and Very High Risk Patients with Hyperlipidaemia in Central and Eastern Europe: An Observational Study
Authors
Ivo Petrov
Andreea Dumitrescu
Michaela Snejdrlova
Barak Zafrir
Beata Wożakowska-Kapłon
Lubomira Fabryova
Hrvoje Pintarić
Ian Bridges
Reneta Petkova
Publication date
01-03-2019
Publisher
Springer Healthcare
Keywords
Statins
Ezetimibe
Published in
Advances in Therapy / Issue 3/2019
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-019-0879-1

Other articles of this Issue 3/2019

Advances in Therapy 3/2019 Go to the issue