Siła, szybkość i skuteczność rosuwastatyny Artykuł przeglądowy
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Abstrakt
Mimo upływu lat statyny nadal stanowią najistotniejszą, choć nie homogenną, grupę leków hipolipemizujących. Największy potencjał wykazuje na tym polu rosuwastatyna. Lek ten wyróżnia się nie tylko siłą i szybkością działania, ale również korzystnym metabolizmem i tym samym – wysokim bezpieczeństwem stosowania. W artykule autorzy omawiają najważniejsze właściwości farmakokinetyczne rosuwastatyny oraz – na podstawie dużych badań klinicznych – wpływ leku na profil lipidowy, hamowanie miażdżycy oraz redukcję incydentów sercowo-naczyniowych.
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Jak cytować
Chruściel, P., & Banach, M. (2015). Siła, szybkość i skuteczność rosuwastatyny . Medycyna Faktów , 8(4(29), 54-60. Pobrano z https://journalsmededu.pl/index.php/jebm/article/view/2283
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Bibliografia
1. Martin P.D., Mitchell P.D., Schneck D.W.: Pharmacodynamic effects and pharmacokinetics of a new HMG-CoA reductase inhibitor, rosuvastatin, after morning or evening administration in healthy subjects. Br. J. Clin. Pharmacol. 2002; 54: 472-477.
2. Banach M., Rizzo M., Toth P.P. 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): 935-955.
3. Martin P.D., Warwick M.J., Dane A.L., et al.: Absolute oral bioavailability of rosuvastatin in healthy white adult male volunteers. Clin. Ther. 2003; 25: 2553-2563.
4. Stein E.A.: New statins and new doses of older statins. Curr. Atheroscler. Rep. 2001; 3(1): 14-8.
5. Martin P.D., Dane A.L., Nwose O.M. et al.: No effect of age or gender on the pharmacokinetics of rosuvastatin: a new HMG-CoA reductase inhibitor. J. Clin. Pharmacol. 2002; 42(10): 1116-1121.
6. Martin P.D., Warwick M.J., Dane A.L. et al.: Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin. Ther. 2003; 25: 2822-2835.
7. Simonson S.G., Martin P.D., Mitchell P. et al.: Pharmacokinetics and pharmacodynamics of rosuvastatin in subjects with hepatic impairment. Eur. J. Clin. Pharmacol. 2003; 58: 669-675.
8. Soran H., Durrington P.: Rosuvastatin efficacy, safety and clinical effectiveness. Expert Opin Pharmacother. 2008; 9(12): 2145-2160.
9. McTaggart F., Buckatt L., Davidson R. et al.: Preclinical and clinical pharmacology of rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am. J. Cardiol. 2001; 87(5A): 28B-32B.
10. Martin P.D., Dane A.L., Schneck D.W. et al.: Disposition of new HMG-CoA reductase inhibitor ZD4522 following dosing in healthy subjects. J. Clin. Pharmacol. 2000; 40: 1056.
11. McCormick A.D., McKillop D., Bulters C.J. et al.: ZD4522: an HMG-CoA reductase inhibitor free of metabolically mediated drug interactions: metabolic studies in human in vitro systems. J. Clin. Pharmacol. 2000; 40: 1055.
12. Smith G., Davidson R., Bloor S. et al.: Pharmacological properties of ZD4522 – a new HMG-CoA reductase inhibitor. Atherosclerosis 2000; 151: 39.
13. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001; 285: 2486-2497.
14. Watanabe M., Koike H., Ishiba T. et al.: Synthesis and biological activity of methanesulfonamide pyrimidine- and N-methanesulfonyl pyrrole-substituted 3,5-dihydroxy-6-heptenoates, a novel series of HMG-CoA reductase inhibitors. Bioorg. Med. Chem. 1997; 5(2): 437-444.
15. Olsson A.G., Pears J., McKellar J. et al:. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am. J. Cardiol. 2001; 88(5): 504-508.
16. White C.M:. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin. Pharmacol. 2002; 42: 963-970.
17. Stalenhoef A.F., Ballantyne C.M., Sarti C. et al.: A comparative study with rosuvastatin in subjects with metabolic syndrome: results of the COMETS study. Eur. Heart. J. 2005; 26(24): 2664-2672.
18. Strandberg T.E., Feely J., Sigurdsson E.L.; DISCOVERY study group: Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study. Clin. Ther. 2004; 26(11): 1821-1833.
19. Faergeman O., Hill L., Windler E. et al.: ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology 2008; 111(4): 219-228.
20. Pitt B., Loscalzo J., Monyak J. et al.: Comparison of lipid-modifying efficacy of rosuvastatin versus atorvastatin in patients with acute coronary syndrome (from the LUNAR study). Am. J. Cardiol. 2012; 109(9): 1239-1246.
21. Schuster H., Barter P.J., Stender S. et al.: Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin Therapy (MERCURY I) study. Am. Heart J. 2004; 147(4): 705-713.
22. Leiter L.A., Rosenson R.S., Stein E. et al.: Efficacy and safety of rosuvastatin 40 mg versus atorvastatin 80 mg in high-risk patients with hypercholesterolemia: results of the POLARIS study. Atherosclerosis 2007; 194(2): e154-164.
23. Clearfield M.B., Amerena J., Bassand J.P. et al.: Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR). Trials 2006; 7: 35.
24. Jukema J.W., Liem A.H., Dunselman P.H. et al.: LDL-C/HDL-C ratio in subjects with cardiovascular disease and a low HDL-C: results of the RADAR (Rosuvastatin and Atorvastatin in different Dosages And Reverse cholesterol transport) study. Curr. Med. Res. Opin. 2005; 21: 1865-1874.
25. Nissen S.E., Nicholls S.J., Sipahi I. et al.; ASTEROID Investigators: Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 2006; 295(13): 1556-1565.
26. Underhill H.R., Yuan C., Zhao X.Q. et al.: Effect of rosuvastatin therapy on carotid plaque morphology and composition in moderately hypercholesterolemic patients: a high-resolution magnetic resonance imaging trial. Am. Heart J. 2008; 155(3): 584.e1-8.
27. Nicholls S.J., Ballantyne C.M., Barter P.J. et al.: Effect of two intensive statin regimens on progression of coronary disease. N. Engl. J. Med. 2011; 365(22): 2078-2087.
28. Fellström B., Zannad F., Schmieder R. et al.: Effect of rosuvastatin on outcomes in chronic haemodialysis patients – design and rationale of the AURORA study. Curr. Control Trials Cardiovasc. Med. 2005; 6(1): 9.
29. Ridker P.M., Danielson E., Fonseca F.A. et al.; JUPITER Trial Study Group: Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet 2009; 373(9670): 1175-1182.
2. Banach M., Rizzo M., Toth P.P. 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): 935-955.
3. Martin P.D., Warwick M.J., Dane A.L., et al.: Absolute oral bioavailability of rosuvastatin in healthy white adult male volunteers. Clin. Ther. 2003; 25: 2553-2563.
4. Stein E.A.: New statins and new doses of older statins. Curr. Atheroscler. Rep. 2001; 3(1): 14-8.
5. Martin P.D., Dane A.L., Nwose O.M. et al.: No effect of age or gender on the pharmacokinetics of rosuvastatin: a new HMG-CoA reductase inhibitor. J. Clin. Pharmacol. 2002; 42(10): 1116-1121.
6. Martin P.D., Warwick M.J., Dane A.L. et al.: Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin. Ther. 2003; 25: 2822-2835.
7. Simonson S.G., Martin P.D., Mitchell P. et al.: Pharmacokinetics and pharmacodynamics of rosuvastatin in subjects with hepatic impairment. Eur. J. Clin. Pharmacol. 2003; 58: 669-675.
8. Soran H., Durrington P.: Rosuvastatin efficacy, safety and clinical effectiveness. Expert Opin Pharmacother. 2008; 9(12): 2145-2160.
9. McTaggart F., Buckatt L., Davidson R. et al.: Preclinical and clinical pharmacology of rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am. J. Cardiol. 2001; 87(5A): 28B-32B.
10. Martin P.D., Dane A.L., Schneck D.W. et al.: Disposition of new HMG-CoA reductase inhibitor ZD4522 following dosing in healthy subjects. J. Clin. Pharmacol. 2000; 40: 1056.
11. McCormick A.D., McKillop D., Bulters C.J. et al.: ZD4522: an HMG-CoA reductase inhibitor free of metabolically mediated drug interactions: metabolic studies in human in vitro systems. J. Clin. Pharmacol. 2000; 40: 1055.
12. Smith G., Davidson R., Bloor S. et al.: Pharmacological properties of ZD4522 – a new HMG-CoA reductase inhibitor. Atherosclerosis 2000; 151: 39.
13. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001; 285: 2486-2497.
14. Watanabe M., Koike H., Ishiba T. et al.: Synthesis and biological activity of methanesulfonamide pyrimidine- and N-methanesulfonyl pyrrole-substituted 3,5-dihydroxy-6-heptenoates, a novel series of HMG-CoA reductase inhibitors. Bioorg. Med. Chem. 1997; 5(2): 437-444.
15. Olsson A.G., Pears J., McKellar J. et al:. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am. J. Cardiol. 2001; 88(5): 504-508.
16. White C.M:. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin. Pharmacol. 2002; 42: 963-970.
17. Stalenhoef A.F., Ballantyne C.M., Sarti C. et al.: A comparative study with rosuvastatin in subjects with metabolic syndrome: results of the COMETS study. Eur. Heart. J. 2005; 26(24): 2664-2672.
18. Strandberg T.E., Feely J., Sigurdsson E.L.; DISCOVERY study group: Twelve-week, multicenter, randomized, open-label comparison of the effects of rosuvastatin 10 mg/d and atorvastatin 10 mg/d in high-risk adults: a DISCOVERY study. Clin. Ther. 2004; 26(11): 1821-1833.
19. Faergeman O., Hill L., Windler E. et al.: ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology 2008; 111(4): 219-228.
20. Pitt B., Loscalzo J., Monyak J. et al.: Comparison of lipid-modifying efficacy of rosuvastatin versus atorvastatin in patients with acute coronary syndrome (from the LUNAR study). Am. J. Cardiol. 2012; 109(9): 1239-1246.
21. Schuster H., Barter P.J., Stender S. et al.: Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin Therapy (MERCURY I) study. Am. Heart J. 2004; 147(4): 705-713.
22. Leiter L.A., Rosenson R.S., Stein E. et al.: Efficacy and safety of rosuvastatin 40 mg versus atorvastatin 80 mg in high-risk patients with hypercholesterolemia: results of the POLARIS study. Atherosclerosis 2007; 194(2): e154-164.
23. Clearfield M.B., Amerena J., Bassand J.P. et al.: Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR). Trials 2006; 7: 35.
24. Jukema J.W., Liem A.H., Dunselman P.H. et al.: LDL-C/HDL-C ratio in subjects with cardiovascular disease and a low HDL-C: results of the RADAR (Rosuvastatin and Atorvastatin in different Dosages And Reverse cholesterol transport) study. Curr. Med. Res. Opin. 2005; 21: 1865-1874.
25. Nissen S.E., Nicholls S.J., Sipahi I. et al.; ASTEROID Investigators: Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 2006; 295(13): 1556-1565.
26. Underhill H.R., Yuan C., Zhao X.Q. et al.: Effect of rosuvastatin therapy on carotid plaque morphology and composition in moderately hypercholesterolemic patients: a high-resolution magnetic resonance imaging trial. Am. Heart J. 2008; 155(3): 584.e1-8.
27. Nicholls S.J., Ballantyne C.M., Barter P.J. et al.: Effect of two intensive statin regimens on progression of coronary disease. N. Engl. J. Med. 2011; 365(22): 2078-2087.
28. Fellström B., Zannad F., Schmieder R. et al.: Effect of rosuvastatin on outcomes in chronic haemodialysis patients – design and rationale of the AURORA study. Curr. Control Trials Cardiovasc. Med. 2005; 6(1): 9.
29. Ridker P.M., Danielson E., Fonseca F.A. et al.; JUPITER Trial Study Group: Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet 2009; 373(9670): 1175-1182.