Evaluation of a pharmacokinetic interaction between valsartan and simvastatin in healthy subjects

Current Medical Research and Opinion

Volumn 23, Issue 3, 2007, Pages 631-640

  Sunkara, Gangadhar ^a   Reynolds, Christine V ^a   Pommier, Francoise ^b   Humbert, Henri ^b   Yeh, ChingMing ^a   Prasad, Pratapa ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Drug Metabolism and Pharmacokinetics   (France)

Author keywords

Drug interactions; Pharmacokinetics; Simvastatin; Valsartan

Indexed keywords

SIMVASTATIN; VALSARTAN;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG METABOLISM; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; FEMALE; HUMAN; MALE; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL;

ADULT; ANTIHYPERTENSIVE AGENTS; ANTILIPEMIC AGENTS; CONFIDENCE INTERVALS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; EVALUATION STUDIES; FEMALE; HUMANS; MALE; PROBABILITY; REFERENCE VALUES; RISK FACTORS; SENSITIVITY AND SPECIFICITY; SIMVASTATIN; SINGLE-BLIND METHOD; TETRAZOLES; TIME FACTORS; VALINE;

EID: 33947357404     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079906X167471     Document Type: Article

References (20)

1. Diovan (Valsartan): Novartis Pharmaceuticals, NJ, USA, product information. In: Physician's desk reference, 2002, pp.2337-8
2. Criscione L, Bradley WA, Buhlmayer P, et al. Valsartan: preclinical and clinical profile of an antihypertensive angiotensin-II antagonist. Cardiovasc drug rev 1995;13:230-50
3. Kalbag J, Prasad P, Redaliew E. Plasma concentrations and antihypertensive effect of 10 to 160 mg doses of valsartan in hypertensive patients. Pharm Res 1994;11(Suppl):S367 [abstract]
4. Colussi DM, Parisot C, Rossolino ML, et al. Protein binding in plasma of valsartan, a new angiotensin II receptor antagonist. J Clin Pharmacol 1997;37:214-21
5. Brookman LJ, Rolan PE, Benjamin IS, et al. Pharmacokinetics of valsartan in patients with liver disease. Clin Pharmacol Ther 1997;62:272-8
6. Mauro VF. Simvastatin: a review of its pharmacology and clinical use. DICP 1991;25:257-64
7. Mauro VF. Clinical pharmacokinetics and practical applications of simvastatin. Clin Pharmacokinet 1993;24:195-202
8. Vickers S, Duncan CA, Vyas KP, et al. In vitro and in vivo biotransformation of simvastatin, an inhibitor of HMG CoA reductase. Drug Metab Dispos 1990;18:476-83
9. Zocor (simvastatin): Merck & Co., Inc., NJ, USA, product information. In: Physician's desk reference, 2002, pp.2219-23
10. Internal report - CGP 48933 - assessment of dose proportionality of valsartan following single oral doses of 80, 160 and 320 mg in healthy subjects, 1995 [data on file]
11. Bedigian MP, O'Connor R, Prasad PP, et al. Valsartan does not interfere with the pharmacokinetics of phenytoin. AAPS pharmsci 1999;1 [abstract 3068]
12. Kyrklund C, Backman JT, Kivistö KT, et al. Rifampin greatly reduces plasma simvastatin and simvastatin acid concentrations. Clin Pharmacol Ther 2000;68:592-97
13. Simard C, O'Hara GE, Prévost J, et al. Study of the drug-drug interaction between simvastatin and cisapride in man. Eur J Clin Pharmacol 2001;57:229-34
14. Prueksaritanont T, Gorham LM, Ma B, et al. In vitro metabolism of simvastatin in humans [SBT] identification of metabolizing enzymes and effect of the drug on hepatic P450s. Drug Metab Dispos 1997;25:1191-9
15. Prueksaritanont T, Subramanian R, Fang X, et al. Glucuronidation of Statins in Animals and Humans: A Novel Mechanism of Statin Lactonization. Drug Metab Dispos 2002;30:505-12
16. Transon C, Leemann T, Dayer P. In vitro comparative inhibition profiles of major human drug metabolising cytochrome P450 isozymes (CYP2C9, CYP2D6 and CYP3A4) by HMG-CoA reductase inhibitors. Eur J Clin Pharmacol 1996;50:209-15
17. Pelkonen O, Taavitsainen P, Kiukaanniemi K. In vitro inhibition of human hepatic P450 enzymes by four angiotensin II receptor antagonist. J Hum Hypertens 1999;13:S40 [abstract O55]
18. Lilja JJ, Kivisto KT, Neuvoven PJ. Grapefruit juice-simvastatin interaction: effect of serum concentrations of simvastatin, simvastatin acid and HMG-CoA reductase inhibitors. Clin Pharmacol Ther 1998;64:477-83
19. Kantola T, Kivistö KT, Neuvonen PJ. Erythromycin and verapamil considerably increase serum simvastatin and simvastatin acid concentrations. Clin Pharmacol Ther 1998;64:177-82
20. Schmidt EK, Antonin KH, Flesch G, et al. An interaction study with cimetidine and the new angiotensin II antagonist valsartan. Eur J Clin Pharmacol 1998;53:451-8