Analyses of data on nights with ≤1 nocturic void showed a dose-related benefit of AV-002, but with either dose of AV-002 across all age groups, patients experienced statistically significant increases from baseline in the percentage of nights with ≤1 nocturic void.
“Overall, patients treated with AV-002 experienced nearly 50% of nights with ≤1 nocturic void,” Dr. Brucker said.
“Increased nocturia correlates with increased degree of bother and difficulty sleeping, and that is why it is important to look at nocturic void episodes. Getting up no more than once during the night to void is usually not impactful on daytime function and quality of life.”
Severe hyponatremia, defined as serum sodium <125 mEq/L, occurred in five patients (1.1%) aged ≥65 years. All of the five patients were in the AV-002, 1.66 mcg treatment arm and four were on corticosteroid therapy that may have contributed to the hyponatremia, Dr. Brucker said.
Sixteen patients aged ≥65 years (3.2%) developed moderate hyponatremia (serum sodium, 126 mEq/L-129 mEq/L), including seven patients (2.8%) treated with AV-002, 0.83 mcg. All cases of moderate hyponatremia were discovered on routine laboratory testing and none were symptomatic.
Dr. Brucker noted that none of the patients enrolled in the pivotal trials had specific dietary or fluid modifications suggested to them and that patients with concomitant overactive bladder (OAB) or BPH were not excluded from participation.
“The pivotal trials do not give guidance on how to sequence AV-002 for the management of patients with BPH or OAB who are suffering from nocturia. However, I see no reason not to use AV-002 in these patients to address any problem they are having with overproduction of urine at night,” he told Urology Times.
Dr. Brucker is an adviser to and speaker for Avadel Pharmaceuticals, which provided funding for the study. One of Dr. Brucker’s co-authors is an investigator for Allergan.
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