Pharmacokinetics of conivaptan hydrochloride, a vasopressin V1A/V2-receptor antagonist, in patients with euvolemic or hypervolemic hyponatremia and with or without congestive heart failure from a prospective, 4-day open-label study

Clinical Therapeutics

Volumn 31, Issue 7, 2009, Pages 1542-1550

  Mao, Zhongping Lily ^a,b   Stalker, Dennis ^b,c   Keirns, James ^b  

^a Impax Pharmaceuticals   (United States)

^b ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^c Hospira Inc   (United States)

Author keywords

congestive heart failure; conivaptan; hypona tremia; pharmacokinetics

Indexed keywords

CONIVAPTAN;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ELIMINATION; DRUG TOLERABILITY; FEMALE; HALF LIFE TIME; HUMAN; HYPONATREMIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; PROSPECTIVE STUDY;

ADULT; AGED; AGED, 80 AND OVER; AREA UNDER CURVE; BENZAZEPINES; CONTROLLED CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HALF-LIFE; HEART FAILURE; HUMANS; HYPONATREMIA; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; RECEPTORS, VASOPRESSIN; YOUNG ADULT;

EID: 68649093279     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.07.011     Document Type: Article

References (26)

1. Ellison D.H., and Berl T. The syndrome of inappropriate antidi-uresis. N Engl J Med. 356 (2007) 2064-2072
2. Hoorn E.J., Lindemans J., and Zietse R. Development of severe hyponatraemia in hospitalized patients: Treatmentrelated risk factors and inadequate management. Nephrol Dial Transplant. 21 (2006) 70-76
3. Hawkins R.C. Age and gender as risk factors for hyponatremia and hypernatremia. Clin Chim Acta. 337 (2003) 169-172
4. Anderson R.J., Chung H.M., Kluge R., and Schrier R.W. Hyponatremia: A prospective analysis of its epidemiology and the pathogenetic role of vasopressin. Ann Intern Med. 102 (1985) 164-168
5. Gheorghiade M., Abraham W.T., Albert N.M., et al., the OPTIMIZE-HF Investigators and Coordinators. Relationship between admission serum sodium concentration and clinical outcomes in patients hospitalized for heart failure: An analysis from the OPTIMIZE-HF registry. Eur Heart J. 28 (2007) 980-988
6. Lee D.S., Austin P.C., Rouleau J.L., et al. Predicting mortality among patients hospitalized for heart failure: Derivation and validation of a clinical model. JAMA 290 (2003) 2581-2587
7. Borroni G., Maggi A., Sangiovanni A., et al. Clinical relevance of hyponatraemia for the hospital outcome of cirrhotic patients. Dig Liver Dis. 32 (2000) 605-610
8. Adrogué H.J. Consequences of inadequate management of hyponatremia. Am J Nephrol. 25 (2005) 240-249
9. Cawley M.J. Hyponatremia: Current treatment strategies and the role of vasopressin antagonists. Ann Pharmacother. 41 (2007) 840-850
10. Gross P. Correction of hyponatremia. Semin Nephrol. 21 (2001) 269-272
11. Smith D., Moore K., Tormey W., et al. Downward resetting of the osmotic threshold for thirst in patients with SIADH. Am J Physiol Endocrinol Metab. 287 (2004) E1019-E1023
12. Baylis P.H. The syndrome of inappropriate antidiuretic hormone secretion. Int J Biochem Cell Biol. 35 (2003) 1495-1499
13. Robertson G.L. Regulation of argin-ine vasopressin in the syndrome of inappropriate antidiuresis. Am J Med. 119 Suppl 1 (2006) S36-S42
14. Adrogué H.J., and Madias N.E. Hyponatremia. N Engl J Med. 342 (2000) 1581-1589
15. Liamis G., Kalogirou M., Saugos V., and Elisaf M. Therapeutic approach in patients with dysnatraemias. Nephrol Dial Transplant. 21 (2006) 1564-1569
16. Doggrell S.A. Conivaptan Yamanouchi. Curr Opin Investig Drugs. 6 (2005) 317-326
17. Sulemanjee N.Z., and Schwarz E.R. Conivaptan: A selective vasopressin antagonist. Drugs Today (Barc). 42 (2006) 379-386
18. Vaprisol® (conivaptan hydrochloride) injection [package insert] (2007), Astellas Pharma US, Inc, Deerfield, Ill
19. Tahara A., Tomura Y., Wada K., et al. Pharmacological profile of YM087, a novel potent nonpeptide vasopres-sin V1A and V2 receptor antagonist, in vitro and in vivo. J Pharmacol Exp Ther. 282 (1997) 301-308
20. Burnier M., Fricker A.F., Hayoz D., et al. Pharmacokinetic and pharmaco-dynamic effects of YM087, a combined V1/V2 vasopressin receptor antagonist in normal subjects. Eur J Clin Pharmacol. 55 (1999) 633-637
21. Ghali J.K., Koren M.J., Taylor J.R., et al. Efficacy and safety of oral conivaptan: A V1A/V2 vasopressin receptor antagonist, assessed in a randomized, placebo-controlled trial in patients with euvolemic or hypervolemic hyponatremia. J Clin Endocrinol Metab. 91 (2006) 2145-2152
22. Verbalis J.G., Rosansky S., Wagoner L.E., et al. Conivaptan for the treatment of hyponatremia in hospitalized patients: Results from an open-label study. Crit Care Med. 34 Suppl 2 (2006) A64 Abstract 242
23. Zeltser D., Rosansky S., van Rensburg H., et al., the Conivaptan Study Group. Assessment of the efficacy and safety of intravenous conivap-tan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 27 (2007) 447-457
24. Udelson J.E., Smith W.B., Hendrix G.H., et al. Acute hemodynamic effects of conivaptan, a dual V1(A) and V(2) vasopressin receptor antagonist, in patients with advanced heart failure. Circulation 104 (2001) 2417-2423
25. Verbalis J.G., Rosansky S., Wagoner L.E., et al. Conivaptan for the treatment of hyponatremia in hospitalized patients: Results from an openlabel study. Crit Care Med. 34 (2006) A64 Abstract 242
26. Goldsmith S.R., Verbalis J.G., Smith N., et al. Efficacy and safety of conivaptan, an arginine vasopressin antagonist, in patients with hypervolemic hyponatremia. J Am Coll Cardiol. 49 (2007) 98A Abstract 845-9