Coadministration of dalcetrapib with pravastatin, rosuvastatin, or simvastatin: No clinically relevant drug-drug interactions

Journal of Clinical Pharmacology

Volumn 50, Issue 10, 2010, Pages 1188-1201

  Derks, Michael ^a   Abt, Markus ^a   Phelan, Mary ^a   Turnbull, Lynn ^a   Meneses Lorente, Georgina ^a   Bech, Nuria ^a   White, Anne Marie ^a   Parr, Graeme ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

CETP; dalcetrapib; drug interactions; statin

Indexed keywords

APOLIPOPROTEIN A1; APOLIPOPROTEIN A2; APOLIPOPROTEIN B; CHOLESTEROL ESTER TRANSFER PROTEIN; CHOLESTEROL ESTER TRANSFER PROTEIN INHIBITOR; DALCETRAPIB; DRUG METABOLITE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; VERY LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD PRESSURE MEASUREMENT; BLOOD SAMPLING; CHOLESTEROL BLOOD LEVEL; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG WITHDRAWAL; HEADACHE; HEPATOMEGALY; HUMAN; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MONOTHERAPY; MYALGIA; NORMAL HUMAN; RADIUS FRACTURE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TANDEM MASS SPECTROMETRY; TRIACYLGLYCEROL BLOOD LEVEL;

ADULT; ANTICHOLESTEREMIC AGENTS; AREA UNDER CURVE; CHOLESTEROL ESTER TRANSFER PROTEINS; CHOLESTEROL, HDL; CHOLESTEROL, LDL; CROSS-OVER STUDIES; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; PRAVASTATIN; PYRIMIDINES; SIMVASTATIN; SULFHYDRYL COMPOUNDS; SULFONAMIDES;

EID: 77956565180     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009358709     Document Type: Article

References (17)

1. Baigent C., Keech A., Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 ; 366: 1267-1278.
2. 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.
3. Goldbourt U., Yaari S., Medalie JH Isolated low HDL cholesterol as a risk factor for coronary heart disease mortality. A 21-year follow-up of 8000 men. Arterioscler Thromb Vasc Biol. 1997 ; 17: 107-113.
4. Schaefer EJ, Lamon-Fava S., Ordovas JM, et al. Factors associated with low and elevated plasma high density lipoprotein cholesterol and apolipoprotein A-I levels in the Framingham Offspring Study. J Lipid Res. 1994 ; 35: 871-882. (Pubitemid 24157238)
5. Assmann G., Schulte H., von Eckardstein A., Huang Y. High-density lipoprotein cholesterol as a predictor of coronary heart disease risk. The PROCAM experience and pathophysiological implications for reverse cholesterol transport. Atherosclerosis. 1996 ; 124 (Suppl): S11 - S20.
6. 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.
7. 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.
8. Goldenberg I., Goldbourt U., Boyko V., Behar S., Reicher-Reiss H. ; 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.
9. 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.
10. 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.
11. Stein EA, Stroes ESG, Steiner G., et al. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 ; 104: 82-91.
12. 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.
13. Neuvonen PJ, Niemi M., Backman JT Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance. Clin Pharmacol Ther. 2006 ; 80: 565-581.
14. 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.
15. 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.
16. Stein EA, Roth EM, Rhyne JM, et al. Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial. Am J Cardiol. 2009 ; 104: 82-91.
17. 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.