A study of the pharmacokinetic interactions of the direct renin inhibitor aliskiren with allopurinol, celecoxib and cimetidine in healthy subjects

References

• Wood JM, Maibaum J, Rahuel J, et al. Structure-based design of aliskiren, a novel orally effective renin inhibitor. Biochem Biophys Res Commun 2003;308:698–705
   PubMed Web of Science ®Google Scholar
• Azizi M, Webb R, Nussberger J, Hollenberg NK. Renin inhibition with aliskiren: where are we now, and where are we going? J Hypertens 2006;24:243–56
   PubMed Web of Science ®Google Scholar
• Villamil A, Chrysant SG, Calhoun D, et al. Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. J Hypertens 2007;25:217–26
   PubMed Web of Science ®Google Scholar
• Kilo C, Taylor A, Tschope D, et al. Aliskiren, a novel renin inhibitor for treatment of hypertension, enhances renin system suppression by reducing plasma renin activity alone or in combination with ramipril in patients with diabetes. Eur Heart J 2006;27(Suppl):118–9 [P789]
   Google Scholar
• Munger MA, Drummond W, Essop MR, et al. Aliskiren as addon to amlodipine provides significant additional blood pressure lowering without increased oedema associated with doubling the amlodipine dose. Eur Heart J 2006;27(Suppl):117 [P784]
   Google Scholar
• Yarows SA, Oparil S, Patel S, et al. Suppression of the renin system with the oral direct renin inhibitor aliskiren alone and in combination with valsartan in patients with hypertension. J Hypertens 2007;25:S257–8 [abstract P28.364]
   Google Scholar
• Andersen K, Weinberger MH, Egan B, et al. Aliskiren-based therapy lowers blood pressure more effectively than ramipril-based therapy in patients with hypertension:a 6-month, randomized, double blind trial. J Am Coll Cardiol 2007;49:371A [P-1014-173]
   Google Scholar
• Schmieder RE, Philipp T, Guerediaga J, et al. Aliskiren-based therapy lowers blood pressure more effectively than hydrochlorothiazide-based therapy in patients with hypertension. J Clin Hypertens 2007;9(Suppl A):A182 [P–436]
   Google Scholar
• Vaidyanathan S, Jermany J, Yeh C-M, et al. Aliskiren, a novel orally effective renin inhibitor, exhibits similar pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects. Br J Clin Pharmacol 2006;62:690–8
   Google Scholar
• Waldmeier F, Glaenzel U, Wirz B, et al. Absorption, distribution, metabolism and elimination of the direct renin inhibitor aliskiren in healthy volunteers. Drug Metab Dispos 2007;35:1418–28
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Reynolds C, Yeh C-M, et al. The pharmacokinetics of the oral direct renin inhibitor aliskiren alone and in combination with the p-glycoprotein modulators ketoconazole, digoxin and atorvastatin in healthy subjects. Clin Pharmacol Ther 2007;81:S109 [PIII–75]
   Google Scholar
• Dieterich H-A, Kemp C, Vaidyanathan S, Yeh C-M. Aliskiren, the first in a new class of orally effective renin inhibitors, has no clinically significant drug interactions with digoxin in healthy volunteers. Clin Pharmacol Ther 2006;79:64 [PIII–24]
   Google Scholar
• Dieterle W, Corynen S, Mann J. Effect of the oral renin inhibitor aliskiren on the pharmacokinetics and pharmacodynamics of a single dose of warfarin in healthy subjects. Br J Clin Pharmacol 2004;58:433–6
   Google Scholar
• Vaidyanathan S, Valencia J, Kemp C, et al. Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers. Int J Clin Pract 2006;60:1343–56
   PubMed Web of Science ®Google Scholar
• Maas R, Boger RH. Antihypertensive therapy: special focus on drug interactions. Expert Opin Drug Saf 2003;2:549–79
   PubMedGoogle Scholar
• Murrell GA, Rapeport WG. Clinical pharmacokinetics of allopurinol. Clin Pharmacokinet 1986;11:343–53
   PubMed Web of Science ®Google Scholar
• Iwanaga T, Kobayashi D, Hirayama M, et al. Involvement of uric acid transporter in increased renal clearance of the xanthine oxidase inhibitor oxypurinol induced by a uricosuric agent, benzbromarone. Drug Metab Dispos 2005;33:1791–5
   PubMed Web of Science ®Google Scholar
• Breithaupt B, Tittel M. Kinetics of allopurinol after single intravenous and oral doses. Noninteraction with benzbromarone and hydrochlorothiazide. Eur J Clin Pharmacol 1982;22:77–84
   PubMed Web of Science ®Google Scholar
• Turnheim K, Krivanek P, Oberbauer R. Pharmacokinetics and pharmacodynamics of allopurinol in elderly and young subjects. Br J Clin Pharmacol 1999;48:501–9
   Google Scholar
• Drayer DE. Pharmacologically active drug metabolites: therapeutic and toxic activities, plasma and urine data in man, accumulation in renal failure. Clin Pharmacokinet 1976;1:426–43
   PubMed Web of Science ®Google Scholar
• Conaghan PG, Day RO. Risks and benefits of drugs used in the management and prevention of gout. Drug Saf 1994;11:252–8
   PubMed Web of Science ®Google Scholar
• Pea F. Pharmacology of drugs for hyperuricemia. Mechanisms, kinetics and interactions. Contrib Nephrol 2005;147:35–46
   PubMed Web of Science ®Google Scholar
• Davies NM, McLachlan AJ, Day RO, Williams KM. Clinical pharmacokinetics and pharmacodynamics of celecoxib: a selective cyclo-oxygenase-2 inhibitor.Clin Pharmacokinet 2000;38:225–42
   PubMed Web of Science ®Google Scholar
• Garnett WR. Clinical implications of drug interactions with coxibs. Pharmacotherapy 2001;21:1223–32
   PubMed Web of Science ®Google Scholar
• Werner U, Werner D, Rau T, et al. Celecoxib inhibits metabolism of cytochrome P450 2D6 substrate metoprolol in humans. Clin Pharmacol Ther 2003;74:130–7
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Jin Y, Schiller H, Jensen C. Aliskiren, a novel oral renin inhibitor, has no interaction with cytochrome P450 isoenzymes in vitro. Basic Res Pharmacol Toxicol 2005;97(Suppl 1):239
   Google Scholar
• Dieterle W, Corynen S, Vaidyanathan S, Mann J. Pharmacokinetic interactions of the oral renin inhibitor aliskiren with lovastatin, atenolol, celecoxib and cimetidine. Int J Clin Pharmacol Ther 2005;43:527–35
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Bigler H, Yeh C, et al. Pharmacokinetics of the oral direct renin inhibitor aliskiren alone and in combination with irbesartan in renal impairment.Clin Pharmacokinet 2007;46:661–75
   PubMed Web of Science ®Google Scholar
• Somogyi A, Gugler R. Clinical pharmacokinetics of cimetidine. Clin Pharmacokinet 1983;8:463–95
   PubMed Web of Science ®Google Scholar
• Collett A, Higgs NB, Sims E, et al. Modulation of the permeability of H2 receptor antagonists cimetidine and ranitidine by P-glycoprotein in rat intestine and the human colonic cell line Caco-2. J Pharmacol Exp Ther 1999;288:171–8
   PubMed Web of Science ®Google Scholar
• Urakami Y, Akazawa M, Saito H, et al. cDNA cloning, functional characterization, and tissue distribution of an alternatively spliced variant of organic cation transporter hOCT2 predominantly expressed in the human kidney. J Am Soc Nephrol 2002;13:1703–10
   PubMed Web of Science ®Google Scholar
• Burckhardt BC, Brai S, Wallis S, et al. Transport of cimetidine by flounder and human renal organic anion transporter 1. Am J Physiol Renal Physiol 2003;284:F503–F509
   Google Scholar
• Cha SH, Sekine T, Fukushima JI, et al. Identification and characterization of human organic anion transporter 3 expressing predominantly in the kidney. Mol Pharmacol 2001;59:1277–86
   PubMed Web of Science ®Google Scholar
• Martinez C, Albet C, Agundez JA, et al. Comparative in vitro and in vivo inhibition of cytochrome P450 CYP1A2, CYP2D6, and CYP3A by H2-receptor antagonists. Clin Pharmacol Ther 1999;65:369–76
   PubMed Web of Science ®Google Scholar
• Somogyi A, Muirhead M. Pharmacokinetic interactions of cimetidine 1987. Clin Pharmacokinet 1987;12:321–66
   PubMed Web of Science ®Google Scholar
• Baciewicz AM, Baciewicz Jr FA. Effect of cimetidine and ranitidine on cardiovascular drugs. Am Heart J 1989;118:144–54
   PubMed Web of Science ®Google Scholar
• van Crugten J, Bochner F, Keal J, Somogyi A. Selectivity of the cimetidine-induced alterations in the renal handling of organic substrates in humans. Studies with anionic, cationic and zwitterionic drugs. J Pharmacol Exp Ther 1986;236:481–7
   PubMed Web of Science ®Google Scholar
• Oh BH, Mitchell J, Herron J, et al. Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. J Am Coll Cardiol 2007;49:1157–63
   PubMed Web of Science ®Google Scholar
• Gradman AH, Schmieder RE, Lins RL, et al. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005;111:1012–8
   PubMed Web of Science ®Google Scholar