K. Tullus et al., Efficacy and safety during long-term treatment of primary monosymptomatic nocturnal enuresis with desmopressin, ACT PAEDIAT, 88(11), 1999, pp. 1274-1278
The Swedish Enuresis Trial (SWEET) was conducted to evaluate the long-term
safety and efficacy of intranasal desmopressin treatment in children with p
rimary, monosymptomatic nocturnal enuresis (PMNE). The study had an open, m
ulticentre design and comprised a 4-wk observation period, a 6-wk dose titr
ation period (with 20-40 mu g desmopressin) and a 1-y, long-term treatment
period. A treatment-free week was introduced every 3 mo to identify dry pat
ients. In total, 399 children aged 6-12 y with PMNE were recruited. Of thes
e, 245 patients (61%) experienced greater than or equal to 50% reduction in
the number of wet nights during the last 4-wk of dose titration compared w
ith the observation period. These responders entered the long-term phase of
the trial. The mean number of wet nights per week decreased from a median
of 5.3 (range 1.3-7.0) during: the observation period to a median of 0.8 (r
ange 0.0-5.0) during the last 3-mo period. Seventy-seven children became dr
y, 63 (83%) within 6 mo of treatment initiation. The percentage of children
who became dry was similar in all age groups. Significantly fewer children
in the lowest age group were defined as responders (52%; 95% CI 45, 59) am
ong the 6-7-y-olds compared to 65% (56, 74) and 81% (72, 90) in the two old
er age groups. Desmopressin was well tolerated. No serious drug-related adv
erse events were recorded and no clinical symptoms of hyponatraemia were re
ported. The SWEET trial has demonstrated that desmopressin is both safe and
effective for the long-term treatment of PMNE, with a significant therapeu
tic effect also in children of 6-7 y of age.