Population pharmacokinetic and pharmacodynamic analysis of a class IC antiarrhythmic, pilsicainide, in patients with cardiac arrhythmias

Journal of Clinical Pharmacology

Volumn 46, Issue 1, 2006, Pages 59-68

  Ogawa, Ryuichi ^a   Kishi, Ryoji ^b   Mihara, Kiyoshi ^a   Takahashi, Harumi ^a   Takagi, Akihiko ^b   Matsumoto, Naoki ^b   Masuhara, Keisou ^b   Nakazawa, Kiyoshi ^b   Miyake, Fumihiko ^b   Kobayashi, Shinichi ^b   Echizen, Hirotoshi ^a  

^a MEIJI PHARMACEUTICAL UNIVERSITY   (Japan)

^b ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Brugada syndrome; Pharmacokinetics pharmacodynamics; Pilsicainide

Indexed keywords

ANTIARRHYTHMIC AGENT; CREATININE; PILSICAINIDE; SODIUM CHANNEL BLOCKING AGENT;

ADULT; AGED; ARTICLE; BRUGADA SYNDROME; CREATININE CLEARANCE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG RESPONSE; EFFECT COMPARTMENT MODEL; ELECTROCARDIOGRAM; FEMALE; GENDER; HEART ATRIUM FIBRILLATION; HIS BUNDLE; HUMAN; KIDNEY DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MODEL; NONLINEAR MIXED EFFECTS MODEL; PHARMACODYNAMICS; PHARMACOKINETICS; POPULATION PHARMACODYNAMICS; POPULATION PHARMACOKINETICS; PURKINJE CELL; ST SEGMENT ELEVATION;

ADULT; AGED; ANTI-ARRHYTHMIA AGENTS; ARRHYTHMIA; ATRIAL FIBRILLATION; BUNDLE-BRANCH BLOCK; CREATININE; ELECTROCARDIOGRAPHY; FEMALE; HEART CONDUCTION SYSTEM; HUMANS; KIDNEY; LIDOCAINE; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; SEX FACTORS; SODIUM CHANNEL BLOCKERS;

EID: 29644445830     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270005283281     Document Type: Article

References (30)

1. Hattori Y, Inomata N, Aisaka K, Ishihara T. Electrophysiological actions of N-(2, 6-dimethylphenyl)-8-pyrrolizidine-acetamide hydrochloride hemihydrate (SUN1165), a new antiarrhythmic agent. J Cardiovasc Pharmacol. 1986;8:998-1002.
2. Hattori Y, Inomata N. Modes of the Na channel blocking action of pilsicainide, a new antiarrhythmic agent, in cardiac cells. Jpn J Pharmacol. 1992;58:365-373.
3. Nakashima M, Kanamaru M. Phase I study of pilsicainide hydrochloride (SUN1165) injection. J Clin Ther Med. 1998;14:47-61.
4. Antzelevitch C, Brugada P, Borggrefe M, et al. Brugada syndrome: report of the second consensus conference. Circulation. 2005;111:659-670.
5. Miyazaki T, Mitamura H, Miyoshi S, Soejima K, Ogawa S, Aizawa Y. Autonomic and antiarrhythmic drug modulation of ST segment elevation in patients with Brugada syndrome. J Am Coll Cardiol. 1996;27:1061-1070.
6. Scheiner LB, Rosenberg B, Marathe W. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm. 1977;5:445-479.
7. Brugada R, Brugada J, Antzelevitch C, et al. Sodium channel blockers identify risk for sudden death patients with ST-segment elevation and right bundle branch block but structurally normal hearts. Circulation. 2000;101:510-515.
8. Shiga T, Hashiguchi M, Urae A, Kasanuki H, Rikihisa T. Effect of cimetidine and probenecid on pilsicainide renal clearance in humans. Clin Pharmacol Ther. 2000;67:222-228.
9. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
10. Parke J, Holford NH, Charles BG. A procedure for generating bootstrap samples for the validation of nonlinear mixed-effects population models. Comput Methods Programs Biomed. 1999;59:19-29.
11. Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther. 1979;25:358-371.
12. Ailings M, Wilde A. Brugada syndrome: clinical data and suggested pathophysiological mechanism. Circulation. 1999;99:666-673.
13. Konishi T, Bito K, Matsumura T, Kanamaru M. The clinical pharmacokinetics and antiarrhythmic effect of intravenous pilsicainide hydrochloride [SUN1165 (inj)]. J Clin Ther Med. 1998;14:107-121.
14. Somogyi A, McLean A, Heinzow B. Cimetidine-procainamide pharmacokinetic interaction in man: evidence of competition for tubular secretion of basic drugs. Eur J Clin Pharmacol. 1983;25:339-345.
15. Somogyi A, Stockley C, Keal J, Rolan P, Bochner F. Reduction of metformin renal tubular secretion by cimetidine in man. Br J Clin Pharmacol. 1987;23:545-551.
16. Kleinman LI, Lowenstein MS, Goldstein L. Sex difference in the transport of p-aminohippurate by the rat kidney. Endocrinology. 1966;78:403-406.
17. Bowman HM, Hook JB. Sex differences in organic ion transport by rat kidney. Proc Soc Exp Biol Med. 1972;141:258-262.
18. Urakami Y, Nakamura N, Takahashi K, et al. Gender differences in expression of organic cation transporter OCT2 in rat kidney. FEBS Lett. 1999;461:339-342.
19. Urakami Y, Okuda M, Saito H, Inui K. Hormonal regulation of organic cation transporter OCT2 expression in rat kidney. FEBS Lett. 2000;473:173-176.
20. Reyes JL, Melêndez E, Alegrîa A, Jaramillo-Juarez F. Influence of sex differences on the renal secretion of organic anions. Endocrinology. 1998;139:1581-1587.
21. Kato Y, Kuge K, Kusuhara H, Meier PJ, Sugiyama Y. Gender difference in the urinary excretion of organic anions in rats. J Pharmacol Exp Ther. 2003;302:483-489.
22. Micardis (telmisartan) [product information]. Ridgefield, Conn: Boehringer Ingelheim Pharmaceuticals; 1998.
23. Nishino A, Kato Y, Igarashi T, Sugiyama Y. Both cMOAT/MRP2 and another unknown transporter(s) are responsible for the biliary excretion of glucuronide conjugate of the nonpeptide angiotensin II antagonist, telmisartan. Drug Metab Dispos. 2000;28:1146-1148.
24. Shimizu W, Antzelevitch C, Suyama K, et al. Effect of sodium channel blockers on ST segment, QRS duration, and corrected QT interval in patients with Brugada syndrome. J Cardiovasc Electrophysiol. 2000;11:1320-1329.
25. Takenaka S, Kusano KF, Hisamatsu K, et al. Relatively benign clinical course in asymptomatic patients with Brugada-type electrocardiogram without family history of sudden death. J Cardiovasc Electrophysiol. 2001;21:2-6.
26. Chen Q, Kirsch GE, Zhang D, et al. Genetic basis and molecular mechanism for idiopathic ventricular fibrillation. Nature. 1998;392:293-296.
27. Vatta M, Dumaine R, Varghese G, et al. Genetic and biophysical basis of sudden unexplained nocturnal death syndrome (SUNOS), a disease allelic to Brugada syndrome. Hum Mol Genet. 2002;11:337-345.
28. Vatta M, Dumaine R, Antzelevitch C, et al. Novel mutations in domain I of SCN5A cause Brugada syndrome. Mol Genet Metab. 2002;75:317-324.
29. Towbin JA. Molecular genetic basis of sudden cardiac death. Cardiovasc Pathol. 2001;10:283-295.
30. Brugada R, Roberts R. Genetic aspects of arrhythmias. Am J Med Genet. 2000;97:310-318.