Pharmacokinetic Interaction Between Pitavastatin and Valsartan: A Randomized, Open-Labeled Crossover Study in Healthy Male Korean Volunteers

Clinical Therapeutics

Volumn 34, Issue 4, 2012, Pages 958-965

  Jung, Jin Ah ^a,c   Noh, Yook Hwan ^b   Jin, Seokjoon ^c   Kim, Mi Jo ^c   Kim, Yo Han ^c   Lim, Hyeong Seok ^c,d   Bae, Kyun Seop ^c,d  

^a Samsung Medical Center   (South Korea)

^b Asan Medical Center   (South Korea)

^c University of Ulsan   (South Korea)

^d University of Ulsan College of Medicine   (South Korea)

Author keywords

Interaction; Pharmacodynamics; Pharmacokinetics; Pitavastatin; Valsartan

Indexed keywords

BILIRUBIN; CHOLESTEROL; CREATINE KINASE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PITAVASTATIN; TRIACYLGLYCEROL; VALSARTAN;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; BODY MASS; BODY WEIGHT; CHOLESTEROL BLOOD LEVEL; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CROSSOVER PROCEDURE; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFECT; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; HEADACHE; HUMAN; HUMAN EXPERIMENT; KOREA; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NORMAL HUMAN; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; SIDE EFFECT; SORE THROAT; SPUTUM; SYSTOLIC BLOOD PRESSURE; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

EID: 84859575440     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.01.026     Document Type: Article

References (21)

1. Ferdinand K.C., Kleinpeter M.A. Management of hypertension and dyslipidemia. Curr Hypertens Rep 2006, 8:489-496.
2. Morgado M., Rolo S., Macedo A.F., Castelo-Branco M. Association of statin therapy with blood pressure control in hypertensive hypercholesterolemic outpatients in clinical practice. J Cardiovasc Dis Res 2011, 2:44-49.
3. Wong N.D., Lopez V., Tang S., Williams G.R. Prevalence, treatment, and control of combined hypertension and hypercholesterolemia in the United States. Am J Cardiol 2006, 98:204-208.
4. Lloyd-Jones D., Adams R., Carnethon M., et al. Heart disease and stroke statistics-2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2009, 119:480-486.
5. Preston R.A., Harvey P., Herfert O., et al. A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the Respond Trial. J Clin Pharmacol 2007, 47:1555-1569.
6. Sica D.A. Fixed-dose combination therapy-is it time for this approach to hypertension and dyslipidemia management?. J Clin Hypertens (Greenwich) 2004, 6:164-167.
7. Nazzaro P., Manzari M., Merlo M., et al. Distinct and combined vascular effects of ACE blockade and HMG-CoA reductase inhibition in hypertensive subjects. Hypertension 1999, 33:719-725.
8. Hirata Y., Sata M. Synergistic protection against vascular inflammation with a calcium channel blocker and a statin. Hypertens Res 2011, 34:441-442.
9. Hussein O., Shneider J., Rosenblat M., Aviram M. Valsartan therapy has additive anti-oxidative effect to that of fluvastatin therapy against low-density lipoprotein oxidation: studies in hypercholesterolemic and hypertensive patients. J Cardiovasc Pharmacol 2002, 40:28-34.
10. Liu L., Zhao S.P., Zhou H.N., et al. Effect of fluvastatin and valsartan, alone and in combination, on postprandial vascular inflammation and fibrinolytic activity in patients with essential hypertension. J Cardiovasc Pharmacol 2007, 50:50-55.
11. Ceriello A., Assaloni R., Da Ros R., et al. Effect of atorvastatin and irbesartan, alone and in combination, on postprandial endothelial dysfunction, oxidative stress, and inflammation in type 2 diabetic patients. Circulation 2005, 111:2518-2524.
12. Grimm R., Malik M., Yunis C., et al. Simultaneous treatment to attain blood pressure and lipid goals and reduced CV risk burden using amlodipine/atorvastatin single-pill therapy in treated hypertensive participants in a randomized controlled trial. Vasc Health Risk Manag 2010, 6:261-271.
13. Yamashiro W., Maeda K., Hirouchi M., et al. Involvement of transporters in the hepatic uptake and biliary excretion of valsartan, a selective antagonist of the angiotensin II AT1-receptor, in humans. Drug Metab Dispos 2006, 34:1247-1254.
14. Chung J.Y., Cho J.Y., Yu K.S., et al. Effect of OATP1B1 (SLCO1B1) variant alleles on the pharmacokinetics of pitavastatin in healthy volunteers. Clin Pharmacol Ther 2005, 78:342-350.
15. Hua W.J., Hua W.X., Fang H.J. The role of OATP1B1 and BCRP in pharmacokinetics and DDI of novel statins. Cardiovasc Ther 2011 May 25, [Epub ahead of print].
16. Catapano A.L. Pitavastatin-pharmacological profile from early phase studies. Atheroscler Suppl 2010, 11:3-7.
17. Israili Z.H. Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension. J Hum Hypertens 2000, 14(Suppl 1):S73-S86.
18. Muller P., Flesch G., de Gasparo M., et al. Pharmacokinetics and pharmacodynamic effects of the angiotensin II antagonist valsartan at steady state in healthy, normotensive subjects. Eur J Clin Pharmacol 1997, 52:441-449.
19. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000, 284:3043-3045. World Medical Association.
20. Gabrielsson J., Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications 2007, Swedish Pharmaceutical Press, Stockholm. 4th ed.
21. Hirano M., Maeda K., Shitara Y., Sugiyama Y. Drug-drug interaction between pitavastatin and various drugs via OATP1B1. Drug Metab Dispos 2006, 34:1229-1236.