A new fast-melting oral formulation of desmopressin

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May 3 2006

Vande Walle and colleagues performed this study to determine the pharmacodynamic properties as well as the safety and tolerability of a new oral lyophilisate formulation of desmopressin (in single doses of 30, 60, 120, 240, 360 or 480 µg) in children with known primary nocturnal enuresis (PNE).

They also identified dosages that provided duration of action corresponding to a typical length of night-time sleep in children with PNE. They randomized children with PNE (mean three or more wet nights/week), aged 6–12 years, into a double blind, placebo-controlled study. Over-hydration was used before dosing to suppress endogenous vasopressin. Dosing with desmopressin or placebo occurred when urinary production was >0.13 mL/min/kg. Urinary volume, osmolality and duration of urinary-concentrating action (above three threshold levels: 125, 200 and 400 mOsm/kg) were determined as endpoints.

All 72 participants receiving desmopressin had a pharmacodynamic response to the drug, while there was no change in urinary output in the 12 placebo-treated patients. There was a clear relationship between desmopressin dose and duration of action and osmolality during action, although the three highest-dose groups had similar results. According to dose, the mean duration of action of desmopressin at the lowest osmolality threshold level was 3.6 to 10.6 hours, while for the highest threshold; the values were 1.3 to 8.6 hours.

The group concluded that desmopressin, as the oral lyophilisate, causes a marked decrease in urinary output in hydrated children with PNE. Their statement that a small dose range (120–240 µg) is likely to control diuresis for a period corresponding to a night's sleep (7–11 h) in most children with PNE seems promising. They finish by adding that some patients might require a higher dose to obtain the same effect for the whole night.

By Pasquale Casale, MD

Reference:

BJU Int. 2006 Mar;97(3):603-9.