Vaprisol (Conivaptan Hydrochloride Conjunctival) - Summary

VAPRISOL SUMMARY

Vaprisol^®
(conivaptan hydrochloride injection)

VAPRISOL^® (conivaptan hydrochloride injection) is a nonpeptide, dual antagonist of arginine vasopressin (AVP) V_1A and V₂ receptors.

VAPRISOL is indicated for the treatment of euvolemic hyponatremia (e.g., the syndrome of inappropriate secretion of antidiuretic hormone, or in the setting of hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients.

VAPRISOL is not indicated for the treatment of patients with congestive heart failure. (See PRECAUTIONS)

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NEWS HIGHLIGHTS

Media Articles Related to Vaprisol (Conivaptan Conjunctival)

Hypothyroidism
Source: MedicineNet Frostbite Specialty [2008.07.22]
Title: Hypothyroidism
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 7/22/2008

Preeclampsia Tied to Future Thyroid Issues (CME/CE)
Source: MedPage Today Endocrinology [2009.11.19]
Women who develop preeclampsia during pregnancy are at increased risk of hypothyroidism later in life, researchers said.

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Published Studies Related to Vaprisol (Conivaptan Conjunctival)

Efficacy and Safety of Oral Conivaptan, a Vasopressin-Receptor Antagonist, Evaluated in a Randomized, Controlled Trial in Patients With Euvolemic or Hypervolemic Hyponatremia. [2009.01]
BACKGROUND:: In most cases of hyponatremia, arginine vasopressin secretion is inappropriately high. This placebo-controlled, randomized, double-blind multicenter study evaluated the efficacy and safety of oral conivaptan, a V1A/V2-receptor antagonist, in patients with euvolemic or hypervolemic hyponatremia... CONCLUSION:: Oral conivaptan was effective in increasing serum [Na] in patients with euvolemic or hypervolemic hyponatremia and had a favorable safety profile.

Intravenous conivaptan. [2008]
*Conivaptan is an arginine vasopressin V1A and V2 receptor antagonist...

Intravenous conivaptan: effects on the QTc interval and other electrocardiographic parameters in healthy volunteers. [2007.03]
Prolongation of the QT interval is clinically important because it may be associated with torsade de pointes, a potentially fatal arrhythmia. The objective of this study was to define the effects on electrocardiogram (ECG) of intravenous conivaptan, the first arginine vasopressin V1A/V2-receptor antagonist indicated for the treatment of euvolemic hyponatremia, on hospitalized patients without congestive heart failure...

Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. [2007]
BACKGROUND: Most cases of hyponatremia--serum sodium concentration ([Na+]) < 135 mEq/l (< 135 mM)--are associated with an elevated plasma arginine vasopressin level. This study investigated the efficacy and tolerability of intravenous conivaptan (YM087), a vasopressin V1A/V2-receptor antagonist, in treating euvolemic and hypervolemic hyponatremia... CONCLUSION: Among patients with euvolemic or hypervolemic hyponatremia, 4-day intravenous infusion of conivaptan 40 mg/day significantly increased serum [Na+] and was well tolerated. 2007 S. Karger AG, Basel

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. [2006.06]
CONTEXT: Hyponatremia [serum sodium concentration ([Na(+)]), <135 mEq/liter] is the most common fluid and electrolyte abnormality among hospitalized patients. It is frequently caused by the inappropriate release of arginine vasopressin. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of oral conivaptan, a vasopressin V(1A)/V(2) receptor antagonist, in patients with euvolemic or hypervolemic hyponatremia... CONCLUSION: Oral conivaptan (40 and 80 mg/d) was well tolerated and efficacious in correcting serum [Na(+)] in hyponatremia.

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Clinical Trials Related to Vaprisol (Conivaptan Conjunctival)

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia [Completed]
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.

Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure [Completed]
This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.

Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury [Recruiting]
The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.

Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients [Recruiting]
Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).

This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).

Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function [Recruiting]
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.

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