Pitavastatin: a distinctive lipid-lowering drug

Bibliography

• Di Angelantonio E, Sarwar N, Perry P et al.; Emerging Risk Factors Collaboration: Major lipids, apolipoproteins, and risk of vascular disease. JAMA 302, 1993–2000 (2009).
   Google Scholar
• Baigent C, Keech A, Kearney PM et al.; Cholesterol Treatment Trialists’ (CTT) Collaborators: Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 366, 1267–1278 (2005).
   Google Scholar
• ▪ Risk reduction benefits associated with LDL-C decline.
   Google Scholar
• Graham DJ, Staffa JA, Shatin D et al.: Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 292, 2585–2590 (2004).
   Google Scholar
• Cziraky MJ, Willey VJ, McKenney JM et al.: Statin safety: an assessment using an administrative claims database. Am. J. Cardiol. 97, 61C–68C (2006).
   Google Scholar
• Beaird SL: HMG-CoA reductase inhibitors: assessing differences in drug interactions and safety profiles. J. Am. Pharm. Assoc. 40, 637–644 (2000).
   Google Scholar
• Liem AH, van de Woestijne AP, Roeters van Lennep HW, Zwinderman AH, van der Steeg WA, Jukema JW: ApoB/A1 and LDL-C/ HDL-C and the prediction of cardiovascular risk in statin-treated patients. Curr. Med. Res. Opin. 24, 359–364 (2008).
   Google Scholar
• Panayiotou A, Griffin M, Georgiou N et al.: ApoB/ApoA1 ratio and subclinical atherosclerosis. Int. Angiol. 27, 74–80 (2008).
   Google Scholar
• Foley KA, Simpson RJ Jr, Crouse JR III, Weiss TW, Markson LE, Alexander CM: Effectiveness of statin titration on low-density lipoprotein cholesterol goal attainment in patients at high risk of atherogenic events. Am. J. Cardiol. 92, 79–81 (2003).
   Google Scholar
• Phatak H, Wentworth C, Sazonov V, Burke T: Prevalence and predictors of lipid abnormalities in patients treated with statins in the UK general practice. Atherosclerosis 202, 225–233 (2009).
   Google Scholar
• Kurihara Y, Douzono T, Kawakita K, Nagasaki Y: A large-scale, long-term, prospective post-marketing surveillance of pitavastatin (LIVALO Tablet): LIVALO Effectiveness and Safety (LIVES) study. Jpn Pharmacol. Ther. 36, 709–731 (2008).
   Google Scholar
• ▪Long-term post-marketing surveillance study of pitavastatin.
   Google Scholar
• Corsini A, Bellosta S, Baetta R, Fumagalli R, Paoletti R, Bernini F: New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol. Ther. 84, 413–428 (1999).
   Google Scholar
• Corsini A, Maggi FM, Catapano AL: Pharmacology of competitive inhibitors of HMG-CoA reductase. Pharmacol. Res. 31, 9–27 (1995).
   Google Scholar
• Shitara Y, Sugiyama Y: Pharmacokinetic and pharmacodynamic alterations of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors: drug–drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol. Ther. 112, 71–105 (2006).
   Google Scholar
• Ho RH, Tirona RG, Leake BF et al.: Drug and bile acid transporters in rosuvastatin hepatic uptake: function, expression, and pharmacogenetics. Gastroenterology 130, 1793–1806 (2006).
   Google Scholar
• Hsiang B, Zhu Y, Wang Z et al.: A novel human hepatic organic anion transporting polypeptide (OATP2) Identification of a liver-specific human organic anion transporting polypeptide and identification of rat and human hydroxymethylglutaryl-CoA reductase inhibitor transporters. J. Biol. Chem. 274, 37161–37168 (1999).
   Google Scholar
• Noé J, Portmann R, Brun ME, Funk C: Substrate-dependent drug–drug interactions between gemfibrozil, fluvastatin and other organic anion-transporting peptide (OATP) substrates on OATP1B1, OATP2B1, and OATP1B3. Drug Metab. Dispos. 35, 1308–1314 (2007).
   Google Scholar
• Aoki T, Nishimura H, Nakagawa S et al.: Pharmacological profile of a novel synthetic inhibitor of 3-hydroxy-3-methylglutarylcoenzyme A reductase. Arzneimittelforschung 47, 904–909 (1997).
   Google Scholar
• Morikawa S, Umetani M, Nakagawa S et al.: Relative induction of mRNA for HMG CoA reductase and LDL receptor by five different HMG-CoA reductase inhibitors in cultured human cells. J. Atheroscler. Thromb. 7, 138–144 (2000).
   Google Scholar
• Saiki A, Murano T, Watanabe F, Oyama T, Miyashita Y, Shirai K: Pitavastatin enhanced lipoprotein lipase expression in 3T3-L1 preadipocytes. J. Atheroscler. Thromb. 12, 163–168 (2005).
   Google Scholar
• Maejima T, Yamazaki H, Aoki T et al.: Effect of pitavastatin on apolipoprotein A-I production in HepG2 cell. Biochem. Biophys. Res. Commun. 324, 835–839 (2004).
   Google Scholar
• Neuvonen PJ, Niemi M, Backman JT: Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance. Clin. Pharmacol. Ther. 80, 565–581 (2006).
   Google Scholar
• Fujino H, Yamada I, Kojima J, Hirano M, Matsumoto H, Yoneda M: Studies on the Metabolic Fate of NK-104, a new inhibitor of HMG-CoA reductase (5) in vitro metabolism and plasma protein binding in animals and human. Xenob. Metab. Dis. 14, 415–424 (1999).
   Google Scholar
• Lennernäs H, Fager G: Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Similarities and differences. Clin. Pharmacokinet. 32, 403–425 (1997).
   Google Scholar
• ▪ Review of statin pharmacokinetics and pharmacodynamics.
   Google Scholar
• White CM: A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J. Clin. Pharmacol. 42, 963–970 (2002).
   Google Scholar
• Yamada I, Fujino H, Shimada S, Kojima J: Metabolic fate of pitavastatin, a new inhibitor of HMG-CoA reductase: similarities and difference in the metabolism of pitavastatin in monkeys and humans. Xenobiotica 33, 789–803 (2003).
   Google Scholar
• Hirano M, Maeda K, Shitara Y, Sugiyama Y: Contribution of OATP2 (OATP1B1) and OATP8 (OATP1B3) to the hepatic uptake of pitavastatin in humans. J. Pharmacol. Exp. Ther. 311, 139–146 (2004).
   Google Scholar
• Romaine SP, Balmforth AJ, Bailey KM, Hall AS: Genetics and pharmacogenomics of cardiovascular disease. Circulation 118(2), S426 (2008).
   Google Scholar
• Ando H, Tsuruoka S, Yanagihara H et al.: Effects of grapefruit juice on the pharmacokinetics of pitavastatin and atorvastatin. Br. J. Clin. Pharmacol. 60, 494–497 (2005).
   Google Scholar
• ▪▪ Pharmacokinetic interaction profile between pitavastatin and CYP3A4 inhibitors.
   Google Scholar
• Nakagawa S, Hounslow N: Pitavastatin is not subject to clinically relevant pharmacokinetic interactions when administered with CYP3A4 inhibitors in healthy volunteers. Eur. Heart J. 30(Abstract Suppl.), 958 (2009).
   Google Scholar
• Mathew P, Cuddy T, Tracewell WG, Salazar D: An open-label study on the pharmacokinetics (PK) of pitavastatin (NK-104) when administered concomitantly with fenofibrate or gemfibrozil in healthy volunteers. Clin. Pharmacol. Ther. 75, P33 (2004).
   Google Scholar
• Kajinami K, Mabuchi H, Saito Y: NK-104: a novel synthetic HMG-CoA reductase inhibitor. Exp. Opin. Invest. Drugs 9, 2653–2661 (2000).
   Google Scholar
• Bizzaro N, Bagolin E, Milani L, Cereser C, Finco B: Massive rhabdomyolysis and simvastatin. Clin. Chem. 38, 1504 (1992).
   Google Scholar
• Boyd RA, Stern RH, Stewart BH et al.: Atorvastatin coadministration may increase digoxin concentrations by inhibition of intestinal P-glycoprotein-mediated secretion. J. Clin. Pharmacol. 40, 91–98 (2000).
   Google Scholar
• Niemi M: Role of OATP transporters in the disposition of drugs. Pharmacogenomics 8, 787–802 (2007).
   Google Scholar
• Shitara Y, Hirano M, Sato H, Sugiyama Y: Gemfibrozil and its glucuronide inhibit the organic anion transporting polypeptide 2 (OATP2/OATP1B1:SLC21A6)-mediated hepatic uptake and CYP2C8-mediated metabolism of cerivastatin: analysis of the mechanism of the clinically relevant drug–drug interaction between cerivastatin and gemfibrozil. J. Pharmacol. Exp. Ther. 311, 228–236 (2004).
   Google Scholar
• Hasunuma T, Masahiko N, Takashi Y et al.: The drug–drug interactions of pitavastatin (NK-104), a novel HMG-CoA reductase inhibitor and cyclosporine. J. Clin. Ther. Med. 19, 381–389 (2003).
   Google Scholar
• Kalliokoski A, Niemi M: Impact of OATP transporters on pharmacokinetics. Br. J. Pharmacol. 158, 693–705 (2009).
   Google Scholar
• Muzi M, Mankoff DA, Link JM et al.: Imaging of cyclosporine inhibition of P-glycoprotein activity using 11C-verapamil in the brain: studies of healthy humans. J. Nucl. Med. 50, 1267–1275 (2009).
   Google Scholar
• Arnaboldi L, Baetta R, Ferri N et al.: Inhibition of smooth muscle cell migration and proliferation by statins. Immunol. Endocr. Metab. Agents Med. Chem. 8, 122–140 (2008).
   Google Scholar
• Saito Y, Yamada N, Teramoto T et al.: Clinical efficacy of pitavastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, in patients with hyperlipidemia. Dose-finding study using the double-blind, three-group parallel comparison. Arzneimittelforschung 52, 251–255 (2002).
   Google Scholar
• Scandinavian Simvastatin Survival Study Group: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 344, 1383–1389 (1994).
   Google Scholar
• Budinski D, Arneson V, Hounslow N, Gratsiansky N: Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin. Lipidol. 4(3), 291–302 (2009).
   Google Scholar
• ▪▪ Non-inferiority of pitavastatin versus atorvastatin in LDL-C reduction.
   Google Scholar
• Ose L, Budinski D, Hounslow N, Arneson V: Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia. Atherosclerosis (2010), doi: 10.1016/j.atherosclerosis.2009.12.009 (Epub ahead of print).
   Google Scholar
• Ose L, Budinski D, Hounslow N, Arneson V: Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr. Med. Res. Opin. 25(11), 2755–2764 (2009).
   Google Scholar
• ▪▪ Long-term patients management with pitavastatin.
   Google Scholar
• Hiro T, Kimura T, Morimoto T et al.; JAPAN-ACS investigators: Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J. Am. Coll. Cardiol. 54, 293–302 (2009).
   Google Scholar
• Toi T, Taguchi I, Yoneda S et al.: Early effect of lipid-lowering therapy with pitavastatin on regression of coronary atherosclerotic plaque. Comparison with atorvastatin. Circ. J. 73, 1466–1472 (2009).
   Google Scholar
• 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). NIH Publication No. 02-5215, September 2002.
   Google Scholar
• Packard CJ, Ford I, Robertson M et al.; PROSPER Study Group: Plasma lipoproteins and apolipoproteins as predictors of cardiovascular risk and treatment benefit in the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). Circulation 112, 3058–3065 (2005).
   Google Scholar
• Stender S, Hounslow N: Robust efficacy of pitavastatin and comparable safety to pravastatin. Atheroscler. Suppl. 10(2), P770 (2009).
   Google Scholar
• Teramoto T, Shimano H, Yokote K, Urashima M: Effects of pitavastatin (LIVALO Tablet) on high density lipoprotein cholesterol (HDL-C) in hypercholesterolemia. J. Atheroscler. Thromb. 16, 654–661 (2009).
   Google Scholar
• ▪ Pitavastatin produces a clinically significant increase in HDL-C levels.
   Google Scholar
• Sviridov D, Nestel P, Watts G: Statins and metabolism of high density lipoprotein. Cardiovasc. Hematol. Agents Med. Chem. 5, 215–221 (2007).
   Google Scholar
• Yokote K, Bujo H, Hanaoka H et al.: Multicenter collaborative randomized parallel group comparative study of pitavastatin and atorvastatin in Japanese hypercholesterolemic patients: collaborative study on hypercholesterolemia drug intervention and their benefits for atherosclerosis prevention (CHIBA study). Atherosclerosis 201, 345–352 (2008).
   Google Scholar
• Sasaki J, Ikeda Y, Kuribayashi T et al.: A 52-week, randomized, open-label, parallelgroup comparison of the tolerability and effects of pitavastatin and atorvastatin on high-density lipoprotein cholesterol levels and glucose metabolism in Japanese patients with elevated levels of low-density lipoprotein cholesterol and glucose intolerance. Clin. Ther. 30(6), 1089–1101 (2008).
   Google Scholar
• Lund TM, Torsvik H, Falch D, Christophersen B, Skardal R, Gullestad L: Effect of morning versus evening intake of simvastatin on the serum cholesterol level in patients with coronary heart disease. Am. J. Cardiol. 90, 784–786 (2002).
   Google Scholar
• Wallace A, Chinn D, Rubin G: Taking simvastatin in the morning compared with in the evening: randomised controlled trial. BMJ 327, 788 (2003).
   Google Scholar
• Meyer Zu Schwabedissen HE, Kim RB: Hepatic OATP1B transporters and nuclear receptors PXR and CAR: interplay, regulation of drug disposition genes, and single nucleotide polymorphisms. Mol. Pharm. 6, 1644–1661 (2009).
   Google Scholar
• Nishizato Y, Ieiri I, Suzuki H et al.: Polymorphisms of OATP-C (SLC21A6) and OAT3 (SLC22A8) genes: consequences for pravastatin pharmacokinetics. Clin. Pharmacol. Ther. 73, 554–565 (2003).
   Google Scholar
• Link E, Parish S, Armitage A et al.; SEARCH Collaborative Group: SLCO1B1 variants and statin-induced myopathy – a genome wide study. N. Engl. J. Med. 359, 789–799 (2008).
   Google Scholar
• Corsini A, Bellosta S: Drug–drug interaction with statins. Expert Rev. Clin. Pharmacol. 1, 105–113 (2008).
   Google Scholar
• Bellosta S, Paoletti R, Corsini A: Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation 109(23 Suppl. 1), III50–III57 (2004).
   Google Scholar
• ▪ Comparison of statin safety and pharmacokinetics.
   Google Scholar
• Poirier A, Funk C, Lavé T, Noé J: New strategies to address drug–drug interactions involving OATPs. Curr. Opin. Drug Discov. Devel. 10, 74–83 (2007).
   Google Scholar