No clinically relevant drugdrug interactions when dalcetrapib is co-administered with atorvastatin

Expert Opinion on Investigational Drugs

Volumn 19, Issue 10, 2010, Pages 1135-1145

  Derks, Michael ^a   Abt, Markus ^a   Parr, Graeme ^b   Meneses Lorente, Georgina ^b   Young, Anne Marie ^b   Phelan, Mary ^b  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b ROCHE PRODUCTS LTD   (United Kingdom)

Author keywords

atorvastatin; CETP; dalcetrapib; drug drug interactions

Indexed keywords

ATORVASTATIN; CHOLESTEROL ESTER TRANSFER PROTEIN INHIBITOR; DALCETRAPIB; UNCLASSIFIED DRUG; HEPTANOIC ACID DERIVATIVE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT; LIPID; PYRROLE DERIVATIVE; THIOL DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG EFFECT; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; HEADACHE; HUMAN; MAXIMUM PLASMA CONCENTRATION; OPEN STUDY; ADULT; BLOOD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG COMBINATION; DRUG INTERACTION; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL;

ADULT; ANTICHOLESTEREMIC AGENTS; CROSS-OVER STUDIES; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; HEPTANOIC ACIDS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; LIPIDS; MALE; MIDDLE AGED; PYRROLES; SULFHYDRYL COMPOUNDS; YOUNG ADULT;

EID: 77956607209     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543784.2010.509342     Document Type: Article

References (24)

1. Fruchart JC, Sacks F, Hermans MP, et al. The residual risk reduction initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am J Cardiol 2008;102(10 Suppl):1K-34K
2. Robins SJ, Collins D, Wittes JT, et al.; VA-HIT Study Group. Veterans affairs high-density lipoprotein intervention trial. Relation of gemfibrozil treatment and lipid levels with major coronary events: VA-HIT: a randomized controlled trial. JAMA 2001;285:1585-1591
3. Canner PL, Furberg CD, McGovern ME. Benefits of niacin in patients with versus without the metabolic syndrome and healed myocardial infarction (from the Coronary Drug Project). Am J Cardiol 2006;97:477-479
4. Goldenberg I, Goldbourt U, Boyko V, et al.; BIP Study Group. Relation between on-treatment increments in serum high-density lipoprotein cholesterol levels and cardiac mortality in patients with coronary heart disease (from the Bezafibrate Infarction Prevention trial). Am J Cardiol 2006;97:466-471
5. Inazu A, Brown ML, Hesler CB, et al. Increased high-density lipoprotein levels caused by a common cholesteryl-ester transfer protein gene mutation. N Engl J Med 1990;323:1234-1238
6. Boekholdt SM, Kuivenhoven JA, Wareham NJ, et al. Plasma levels of cholesteryl ester transfer protein and the risk of future coronary artery disease in apparently healthy men and women: the prospective EPIC (European Prospective Investigation into Cancer and nutrition)-Norfolk population study. Circulation 2004;110:1418-1423
7. Stein EA, Stroes ES, Steiner G, et al. Safety and tolerability of dalcetrapib. Am J Cardiol 2009;104:82-91
8. Stein EA Roth EM, Rhyne JM, et al. Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial. Eur Heart J 2010;31:480-488
9. De Grooth GJ, Kuivenhoven JA, Stalenhoef AF, et al. Efficacy and safety of a novel cholesteryl ester transfer protein inhibitor, JTT-705, in humans: a randomized phase II dose-response study. Circulation 2002;105:2159-2165
10. Neuvonen PJ, Niemi M, Backman JT. Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance. Clin Pharmacol Ther 2006;80:565-581
11. Derks M, Abt M, Phelan M, et al. Coadministration of dalcetrapib with pravastatin, rosuvastatin, or simvastatin: no clinically relevant drug-drug interactions. J Clin Pharmacol In press, DOI: 10.1177/0091270009358709
12. Derks M, Fowler S, Kuhlmann O. In vitro and in vivo assessment of the effect of dalcetrapib on a panel of CYP substrates. Curr Med Res Opin 2009;25:891-902
13. Derks M, Fowler S, Kuhlmann O. A single-center, open-label, one-sequence study of dalcetrapib coadministered with ketoconazole, and an in vitro study of the S-methyl metabolite of dalcetrapib. Clin Ther 2009;31:586-599
14. Lau YY, Okochi H, Huang Y, Benet LZ. Multiple transporters affect the disposition of atorvastatin ans its two active hydroxy metabolites: application of in vitro and ex situ systems. J Pharmacol Exp Ther 2006;316:762-771
15. 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 2006;122:71-105
16. Bogman K, Peyer AK, Torok M, et al. HMG-CoA reductase inhibitors and P-glycoprotein modulation. Br J Pharmacol 2001;132:1183-1192
17. Chen C, Lin J, Smolarek T, Tremaine L. P-glycoprotein has differential effects on the disposition of statin acid and lactone forms in mdr1a/b knockout and wild-type mice. Drug Metab Dispos 2007;35:1725-1729
18. Kuivenhoven JA, de Grooth GJ, Kawamura H, et al. Effectiveness of inhibition of cholesteryl ester transfer protein by JTT-705 in combination with pravastatin in type II dyslipidemia. Am J Cardiol 2005;95:1085-1088
19. Moren X, Deakin S, Liu M-L, et al. HDL subfraction distribution of paraoxonase-1 and its relevance to enzyme activity and resistance to oxidative stress. J Lipid Res 2008;49:1246-1253
20. Mirdamadi HZ, Sztanek F, Derdak Z, et al. The human paraoxonase-1 phenotype modifies the effect of statins on paraoxonase activity and lipid parameters. Br J Clin Pharmacol 2008;66:366-374
21. Nagila A, Permpongpaiboon T, Tantrarongroj S, et al. Effect of atorvastatin on paraoxonase1 (PON1) and oxidative status. Pharmacol Rep 2009;61:892-898
22. Guerin M, Lassel TS, Le Goff W, et al. Action of atorvastatin in combined hyperlipidemia: preferential reduction of cholesteryl ester transfer from HDL to VLDL1 particles. Arterioscler Thromb Vasc Biol 2000;20:189-197
23. Kassai A, Illyes L, Mirdamadi HZ, et al. The effect of atorvastatin therapy on lecithin: cholesterol acyltransferase, cholesteryl ester transfer protein and the antioxidant paraoxonase. Clin Biochem 2007;40:1-5
24. Schwartz GG, Olsson AG, Ballantyne CM, et al. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J 2009;158:896-901