25584
document
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 . 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 . DESIGN The study design was a 5-d placebo-controlled , randomized , double-blind study . SETTING The study was performed at a hospital . INTERVENTION Oral conivaptan ( 40 or 80 mg/d ) or placebo was given in two divided doses . PATIENTS Seventy-four patients ( average baseline serum [ Na ( + ) ] , 115 to < 130 mEq/liter ) were studied . MAIN OUTCOME MEASURE The main outcome measure was the change from baseline in serum [ Na ( + ) ] area under the curve . RESULTS The least-squares mean change from baseline in the serum [ Na ( + ) ] area under the curve with conivaptan ( 40 and 80 mg/d ) was 2.0-fold ( P = 0.03 ) and 2.5-fold ( P < 0.001 ) greater , respectively , than that with placebo . The median time to achieve a confirmed increase in serum [ Na ( + ) ] of 4 mEq/liter or more from baseline was 71.7 h for placebo , 27.5 h for 40 mg/d conivaptan ( P = 0.044 ) , and 12.1 h for 80 mg/d conivaptan ( P = 0.002 ) . The mean total times during which patients had a serum [ Na ( + ) ] level of 4 mEq/liter or more above baseline were 46.5 , 69.8 , and 88.8 h ( P = 0.001 ) , respectively . The least-squares mean change in serum [ Na ( + ) ] from baseline to end of treatment was 3.4 mEq/liter for placebo , 6.4 mEq/liter for 40 mg/d conivaptan , and 8.2 mEq/liter for 80 mg/d conivaptan ( P = 0.002 ) . A confirmed normal serum [ Na ( + ) ] ( > /=135 mEq/liter ) or increase of 6 mEq/liter or more was observed in 48 % of patients given placebo , 71 % given 40 mg/d conivaptan , and 82 % given 80 mg/d conivaptan ( P = 0.014 ) . Headache , hypotension , nausea , constipation , and postural hypotension were the most common adverse events . CONCLUSION Oral conivaptan ( 40 and 80 mg/d ) was well tolerated and efficacious in correcting serum [ Na ( + ) ] in hyponatremia .
25585
Intervention_Pharmacological
oral conivaptan
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Intervention_Pharmacological
V1A/V2 vasopressin receptor antagonist
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
conivaptan
25589
Intervention_Pharmacological
vasopressin V ( 1A ) /V ( 2 ) receptor antagonist
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Intervention_Control
placebo-controlled
25591
Intervention_Pharmacological
Oral conivaptan
25592
Intervention_Control
placebo
25593
Intervention_Pharmacological
conivaptan
25594
Intervention_Control
placebo
25595
Intervention_Control
placebo
25596
Intervention_Pharmacological
conivaptan
25597
Intervention_Pharmacological
conivaptan
25598
Intervention_Control
placebo
25599
Intervention_Pharmacological
conivaptan
25600
Intervention_Pharmacological
conivaptan
25601
Intervention_Control
placebo
25602
Intervention_Pharmacological
conivaptan
25603
Intervention_Pharmacological
conivaptan
25604
Intervention_Pharmacological
conivaptan
25605
Outcome_Other
Efficacy and safety
25606
Outcome_Other
efficacy and safety
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Outcome_Physical
was the change from baseline in serum [ Na ( + ) ] area under the curve .
25608
Outcome_Physical
serum
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Outcome_Physical
serum [ Na ( + ) ]
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Outcome_Physical
mean change in serum [ Na ( + ) ]
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Outcome_Physical
normal serum [ Na ( + ) ]
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Outcome_Adverse-effects
Headache , hypotension , nausea , constipation , and postural hypotension
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Participant_Condition
euvolemic or hypervolemic hyponatremia
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Participant_Condition
hospitalized patients
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Participant_Condition
euvolemic
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Participant_Condition
hypervolemic hyponatremia
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Participant_Sample-size
Seventy-four