Tom 11, Nr 5 (2016)
Artykuł przeglądowy
Opublikowany online: 2016-09-23
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Farmakoterapia skojarzona w heterozygotycznej rodzinnej hipercholesterolemii
Folia Cardiologica 2016;11(5):401-408.
Streszczenie
Rodzinna hipercholesterolemia (FH) charakteryzuje się wysokim stężeniem cholesterolu frakcji LDL (LDL-C) w osoczu
i dużym ryzykiem przedwczesnej choroby wieńcowej (CHD). Heterozygotyczna rodzinna hipercholesterolemia jest najczęściej występującą chorobą genetyczną. Jej częstość ocenia się na 1/200–1/500 w populacji generalnej (w polskiej dorosłej populacji 1/250). Większość przypadków FH jest nadal niezdiagnozowana i nieleczona lub niewłaściwie leczona. Wczesne wykrycie FH i wczesne rozpoczęcie terapii mogą zmniejszyć ryzyko sercowo-naczyniowe. Intensywna terapia statyną powinna być standardem postępowania w FH. Osoby, które stosując maksymalną tolerowaną dawkę statyny, nie mogą osiągnąć docelowego stężenia LDL-C lub które nie tolerują statyn, mogą potrzebować dodatkowych lub alternatywnych leków zmniejszających stężenie lipidów. W takich sytuacjach należy rozważyć stosowanie ezetimibu i/lub inhibitorów PCSK9 jako leków dodatkowych lub w monoterapii. Wykazano, że ezetimib dodany do statyny może dodatkowo zmniejszyć ryzyko chorób sercowo-naczyniowych. Ostatnie badania z inhibitorami PCSK9, łącznie z metaanalizami, wiążą się z oczekiwaniami redukcji ryzyka epizodów sercowo-naczyniowych i zgonów. W artykule dokonano przeglądu literatury i opinii ekspertów na temat skojarzonej terapii lekowej w FH.
Słowa kluczowe: rodzinna hipercholesterolemiaryzyko sercowo-naczyniowefarmakoterapia skojarzonastatynyezetimibinhibitory PCSK9
Referencje
- Myśliwiec M, Walczak M, Małecka-Tendera E, et al. Postępowanie w rodzinnej hipercholesterolemii u dzieci i młodzieży. Stanowisko Forum Ekspertów Lipidowych. Kardiologia Polska. 2013; 71(10): 1099–1105.
- Cybulska B, Gaciong Z, Hoffman P, et al. Ciężka hipercholesterolemia — kiedy stosować inhibitory proproteinowej konwertazy subtilizyny/kexiny 9 (inhibitory PCSK9)? Stanowisko grupy ekspertów Polskiego Towarzystwa Kardiologicznego. Kardiologia Polska. 2016; 74(4): 394–398.
- Myśliwiec M, Walczak M, Małecka-Tendera E, et al. Management of familial hypercholesterolemia in children and adolescents. Position paper of the Polish Lipid Expert Forum. J Clin Lipidol. 2014; 8(2): 173–180.
- Nordestgaard BG, Chapman MJ, Humphres SE, et al. European Atherosclerosis Society consensus panel. Familial hypercholesterolemia is underdiagnosed and undertreatment in the general population: guidance for clinicians to prevent coronary artery disease. Eur. Heart J. 2013; 34: 3478–3490.
- Wiegman A, Gidding SS, Watts GF, et al. European Atherosclerosis Society Consensus Panel. Familial hypercholesterolaemia in children and adolescents: gaining decades of life by optimizing detection and treatment. Eur Heart J. 2015; 36(36): 2425–2437.
- Santos RD, Gidding SS, Hegele RA, et al. International Atherosclerosis Society Severe Familial Hypercholesterolemia Panel. Defining severe familial hypercholesterolaemia and the implications for clinical management: a consensus statement from the International Atherosclerosis Society Severe Familial Hypercholesterolemia Panel. Lancet Diabetes Endocrinol. 2016; 4(10): 850–861.
- Onorato A, Sturm A. Heterozygous Familial Hypercholesterolemia. Circulation. 2016; 133(14): e587–e589.
- Pajak A, Szafraniec K, Polak M, et al. Prevalence of familial hypercholesterolemia: a meta-analysis of six large, observational, population-based studies in Poland. Arch Med Sci. 2016; 12(4): 687–696.
- Henderson R, O'Kane M, McGilligan V, et al. The genetics and screening of familial hypercholesterolaemia. J Biomed Sci. 2016; 23: 39.
- Tada H, Kawashiri Ma, Okada H, et al. Assessment of coronary atherosclerosis in patients with familial hypercholesterolemia by coronary computed tomography angiography. Am J Cardiol. 2015; 115(6): 724–729.
- Vuorio A, Watts GF, Kovanen PT. Initiation of PCSK9 inhibition in patients with heterozygous familial hypercholesterolaemia entering adulthood: a new design for living with a high-risk condition? Eur Heart J. 2016; 37(17): 1353–1356.
- Perak AM, Ning H, de Ferranti SD, et al. Long-Term Risk of Atherosclerotic Cardiovascular Disease in US Adults With the Familial Hypercholesterolemia Phenotype. Circulation. 2016; 134(1): 9–19.
- Vuorio AF, Turtola H, Piilahti KM, et al. Familial hypercholesterolemia in the Finnish north Karelia. A molecular, clinical, and genealogical study. Arterioscler Thromb Vasc Biol. 1997; 17(11): 3127–3138.
- Wong B, Kruse G, Kutikova L, et al. Cardiovascular Disease Risk Associated With Familial Hypercholesterolemia: A Systematic Review of the Literature. Clin Ther. 2016; 38(7): 1696–1709.
- De Backer G, Besseling J, Chapman J, et al. EUROASPIRE Investigators. Prevalence and management of familial hypercholesterolaemia in coronary patients: An analysis of EUROASPIRE IV, a study of the European Society of Cardiology. Atherosclerosis. 2015; 241(1): 169–175.
- 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(3): 240–249.
- Safarova MS, Kullo IJ. My Approach to the Patient With Familial Hypercholesterolemia. Mayo Clin Proc. 2016; 91(6): 770–786.
- Versmissen J, Oosterveer DM, Yazdanpanah M, et al. Efficacy of statins in familial hypercholesterolaemia: a long term cohort study. BMJ. 2008; 337: a2423.
- DeMott K, Nherera L, Shaw EJ. Clinical guidelines and evidence review for familial hypercholesterolaemia: the identification and management of adults and children with familial hypercholesterolaemia. National Collaborating Centre for Primary Care and Royal College of General Practitioners, London 2008.
- Mortality in treated heterozygous familial hypercholesterolaemia: implications for clinical management. Atherosclerosis. 1999; 142(1): 105–112.
- Mundal L, Retterstøl K. A systematic review of current studies in patients with familial hypercholesterolemia by use of national familial hypercholesterolemia registries. Curr Opin Lipidol. 2016; 27(4): 388–397.
- Neil A, Cooper J, Betteridge J, et al. Reductions in all-cause, cancer, and coronary mortality in statin-treated patients with heterozygous familial hypercholesterolaemia: a prospective registry study. Eur Heart J. 2008; 29(21): 2625–2633.
- Catapano AL, Graham I, De Ba, 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 Society (EAS) Developed with the special contribution of the European Association for Cardiovascular Prevention and Rehabilitation (EACPR). Atherosclerosis. 2016; 253: 281–344.
- F Piepoli M. 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). Int J Behav Med. 2017 [Epub ahead of print]; 37: 2315–2381.
- Taylor BA, Thompson PD. Statins and Their Effect on PCSK9-Impact and Clinical Relevance. Curr Atheroscler Rep. 2016; 18(8): 46.
- Piltman DG, Chen W, Bowlin S, et al. Adherence to statin, subsequent healthcare costs, and cardiovascular hospitalizations. Am J Cardiol. 2011; 107: 1662–1626.
- Wu NQ, Li JJ. PCSK9 gene mutations and low-density lipoprotein cholesterol. Clin Chim Acta. 2014; 431: 148–153.
- Cai G, Zhang B, Shi G, et al. The associations between proprotein convertase subtilisin/kexin type 9 E670G polymorphism and the risk of coronary artery disease and serum lipid levels: a meta-analysis. Lipids Health Dis. 2015; 14: 149.
- Cohen JC, Boerwinkle E, Mosley TH, et al. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006; 354(12): 1264–1272.
- Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. Writing Committee. 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016; 68(1): 92–125.
- Agarwala A, Kajani Z, Miedema MD, et al. The Role of Ezetimibe in the Treatment of Cardiovascular Disease. Curr Atheroscler Rep. 2016; 18(2): 1–8.
- Starzyk K, Wożakowska-Kapłon B. Gdy statyna to za mało — skojarzenie statyny z ezetimibem w terapii hipercholesterolemii. Folia Cardiologica. 2016; 10(6): 428–437.
- Bays HE, Davidson MH, Massaad R, et al. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011; 108(4): 523–530.
- Pisciotta L, Fasano T, Bellocchio A, et al. Effect of ezetimibe coadministered with statins in genotype-confirmed heterozygous FH patients. Atherosclerosis. 2007; 194(2): e116–e122.
- Avellone G, Di Garbo V, Guarnotta V, et al. Efficacy and safety of long-term ezetimibe/simvastatin treatment in patients with familial hypercholesterolemia. Int Angiol. 2010; 29(6): 514–524.
- Ballantyne CM, Houri J, Notarbartolo A, et al. Ezetimibe Study Group. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation. 2003; 107(19): 2409–2415.
- Baigent C, Landray MJ, Reith C, et al. SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011; 377(9784): 2181–2192.
- Cannon CP, Blazing MA, Giugliano RP, et al. IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015; 372(25): 2387–2397.
- Nakajima N, Miyauchi K, Yokoyama T, et al. Effect of combination of ezetimibe and a statin on coronary plaque regression in patients with acute coronary syndrome. IJC Metabolic & Endocrine. 2014; 3: 8–13.
- Tsujita K, Yamanaga K, Komura N, et al. PRECISE-IVUS Investigators. Lipid profile associated with coronary plaque regression in patients with acute coronary syndrome: Subanalysis of PRECISE-IVUS trial. Atherosclerosis. 2016; 251: 367–372.
- Rossebø AB, Pedersen TR, Boman K, et al. SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008; 359(13): 1343–1356.
- Peto R, Emberson J, Landray M, et al. Analyses of cancer data from three ezetimibe trials. N Engl J Med. 2008; 359(13): 1357–1366.
- Pokharel Y, Virani SS, Ballantyne CM. The promise of proprotein convertase subtilisin/kexin 9 inhibitors for the treatment of familial hypercholesterolemia. Curr Atheroscler Rep. 2015; 17(5): 508.
- Ito MK, Santos RD. PCSK9 Inhibition With Monoclonal Antibodies: Modern Management of Hypercholesterolemia. J Clin Pharmacol. 2017; 57(1): 7–32.
- Latimer J, Batty JA, Neely RD, et al. PCSK9 inhibitors in the prevention of cardiovascular disease. J Thromb Thrombolysis. 2016; 42(3): 405–419.
- Raal F, Scott R, Somaratne R, et al. Low-density lipoprotein cholesterol-lowering effects of AMG 145, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease in patients with heterozygous familial hypercholesterolemia: the Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) randomized trial. Circulation. 2012; 126(20): 2408–2417.
- Raal FJ, Stein EA, Dufour R, et al. RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015; 385(9965): 331–340.
- Sabatine MS, Giugliano RP, Wiviott SD, et al. Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015; 372(16): 1500–1509.
- Kastelein JJP, Ginsberg HN, Langslet G, et al. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015; 36(43): 2996–3003.
- Ginsberg HN, Rader JJ, Raal FJ, et al. ODDYSEY HIGH FH efficacy and safety of alirocumab in patients with severe heterozygous familial hypercholesterolemia [abstract]. Circulation. 2014; 130: 2119.
- Robinson JG, Farnier M, Krempf M, et al. ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015; 372(16): 1489–1499.
- Hassan M. OSLER and ODYSSEY LONG TERM: PCSK9 inhibitors on the right track of reducing cardiovascular events. Glob Cardiol Sci Pract. 2015; 2015(2): 20.
- 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.
- 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): 536–545.
