Oral lixivaptan effectively increases serum sodium concentrations in outpatients with euvolemic hyponatremia

Kidney International

Volumn 82, Issue 11, 2012, Pages 1215-1222

  Abraham, William T ^a   Decaux, Guy ^b   Josiassen, Richard C ^c   Yagil, Yoram ^d   Kopyt, Nelson ^e   Thacker, Hemant P ^f   Mannelli, Massimo ^g   Bichet, Daniel G ^h   Orlandi, Cesare ⁱ  

^a OHIO STATE UNIVERSITY   (United States)

^b ERASME HOSPITAL   (Belgium)

^c DREXEL UNIVERSITY COLLEGE OF MEDICINE   (United States)

^d BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

^e LEHIGH VALLEY HOSPITAL   (United States)

^f Bhatia Hospital   (India)

^g UNIVERSITY OF FLORENCE   (Italy)

^h HÔPITAL DU SACRÉ COEUR DE MONTRÉAL   (Canada)

ⁱ Cardiokine Biopharma Inc   (United States)

Author keywords

clinical trial; hyponatremia; vasopressin

Indexed keywords

LIXIVAPTAN; PLACEBO; SODIUM;

ACUTE HEART FAILURE; ADULT; AGED; ANEMIA; ARTICLE; BRONCHITIS; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; COUGHING; DEHYDRATION; DEMYELINATION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; EUVOLEMIC HYPONATREMIA; FALLING; FEMALE; FLATULENCE; GRAND MAL EPILEPSY; HEART MUSCLE ISCHEMIA; HEMATOLOGICAL PARAMETERS; HUMAN; HYPERTENSION; HYPONATREMIA; LUNG SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NURSING HOME PATIENT; OSMOTIC DEMYELINATION SYNDROME; OUTPATIENT; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; POLYURIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RENAL SYSTEM PARAMETERS; SEPTIC SHOCK; SIDE EFFECT; SODIUM BLOOD LEVEL; SUICIDE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VITAL SIGN; VOMITING; WEIGHT CHANGE;

EID: 84869238944     PISSN: 00852538     EISSN: 15231755     Source Type: Journal    
DOI: 10.1038/ki.2012.274     Document Type: Article

References (24)

1. Hawkins RC. Age and gender as risk factors for hyponatremia and hypernatremia. Clin Chim Acta 2003; 337: 169-172. (Pubitemid 37329815)
2. Kleinfeld M, Casimir M, Borra S. Hyponatremia as observed in a chronic disease facility. J Am Geriatr Soc 1979; 27: 156-161. (Pubitemid 9176802)
3. Miller M, Morley JE, Rubenstein LZ. Hyponatremia in a nursing home population. J Am Geriatr Soc 1995; 43: 1410-1413.
4. Upadhyay A, Jaber BL, Madias NE. Incidence and prevalence of hyponatremia. Am J Med 2006; 119: S30-S35.
5. Schrier RW. Does 'asymptomatic hyponatremia' exist? Nat Rev Nephrol 2010; 6: 185.
6. Renneboog B, Musch W, Vandemergel X et al. Mild chronic hyponatremia is associated with falls, unsteadiness, and attention deficits. Am J Med 2006; 119: 71e1-71e8.
7. Gankam Kengne FG, Andres C, Sattar L et al. Mild hyponatremia and risk of fracture in the ambulatory elderly. Q J Med 2008; 101: 583-588. (Pubitemid 351912001)
8. Stelfox HT, Ahmed SB, Khandwala F et al. The epidemiology of intensive care unit-acquired hyponatraemia and hypernatraemia in medicalsurgical intensive care units. Crit Care 2008; 12: R162-R169.
9. Waikar SS, Mount DB, Curhan GC. Mortality after hospitalization with mild, moderate, and severe hyponatremia. Am J Med 2009; 122: 857-865.
10. Hannon MJ, Thompson CJ. The syndrome of inappropriate antidiuretic hormone: prevalence, causes and consequences. Eur J Endocrinol 2010; 162: S5-S12.
11. Anderson RJ. Hospital-associated hyponatremia. Kidney Int 1986; 29: 1237-1247. (Pubitemid 16094240)
12. Hoorn EJ, Lindemans J, Zietse R. Development of severe hyponatraemia in hospitalized patients: treatment-related risk factors and inadequate management. Nephrol Dial Transplant 2006; 21: 70-76. (Pubitemid 43057112)
13. Verbalis JG, Goldsmith SR, Greenberg A et al. Hyponatremia treatment guidelines 2007: expert panel recommendations. Am J Med 2007; 120: S1-S21. (Pubitemid 350027722)
14. Finley IV JJ, Konstam MA, Udelson JE. Arginine vasopressin antagonists for the treatment of heart failure and hyponatremia. Circulation 2008; 118: 410-421.
15. Gross P, Bisaha JG, Smith N. Conivaptan, a novel V1A and V2 antagonist, increases serum sodium and effective water clearance in patients with hyponatremia. Circulation 2004; 110(Suppl 3): 723 (abstract 3345).
16. Ghali JK, Koren MJ, Tylor JR et al. Conivaptan Study Group: 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 2006; 91: 2145-2152. (Pubitemid 43854997)
17. Zeltser D, Rosansky S, van Rensburg H et al. Conivaptan Study Group: assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol 2007; 27: 447-457. (Pubitemid 47482001)
18. Schrier RW, Gross P, Gheorghiade M et al. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med 2006; 355: 2099-2112. (Pubitemid 44749318)
19. Chan PS, Couplet J, Park HC et al. VPA-985, A nonpeptide orally active and selective vasopressin V2 receptor antagonist. Adv Exp Med Biol 1998; 449: 439-443. (Pubitemid 28566418)
20. Guyader D, Patat A, Ellis-Grosse EJ et al. Pharmacodynamic effects of a nonpeptide antidiuretic hormone V2 antagonist in cirrhotic patients with ascites. Hepatology 2002; 36: 1197-1205. (Pubitemid 35253436)
21. Wong F, Blei AT, Blendis LM et al. A vasopressin receptor antagonist (VPA-985) improves serum sodium concentration in patients with hyponatremia: a multicenter, randomized, placebo-controlled trial. Hepatology 2003; 37: 182-191. (Pubitemid 36042159)
22. Abraham WT, Shamshirsaz AA, McFann K et al. Aquaretic effect of lixivaptan, an oral, nonpeptide, selective V2 receptor vasopressin antagonist, in New York Heart Association functional class II and III chronic heart failure patients. J Am Coll Cardiol 2006; 47: 1615-1621.
23. Vaidya C, Ho W, Freda BJ. Management of hyponatremia: providing treatment and avoiding harm. Cleve Clin J Med 2010; 77: 715-726.
24. Abraham WT, Hensen J, Gross PA et al. for the LIBRA study group. Lixivaptan safely and effectively corrects serum sodium concentrations in hospitalized patients with euvolemic hyponatremia. Kidney International 2012; (e-pub ahead of print).