Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis

Abstract

Primary nocturnal enuresis is a prevalent childhood condition that can persist into adulthood. Desmopressin is an antidiuretic available as orally disintegrating lyophilisate (melt) or solid tablet. Recent findings suggesting different food interactions and clinical characteristics, including compliance, between desmopressin melt and tablet motivated a post hoc analysis of a previously reported randomised, crossover study. The efficacy of desmopressin melt compared with tablet was evaluated using the International Children’s Continence Society (ICCS) responder definitions. Compliance was further analysed using detailed criteria, and the association between efficacy and compliance was examined. In total, 221 patients aged 5–15 years, already receiving desmopressin tablets were randomised to the treatment sequence melt (120/240 μg)/tablet (0.2/0.4 mg) or tablet/melt in two consecutive 3-week periods. The probability of being a responder (partial or full) during either period was significantly more likely with desmopressin melt compared with tablet (odds ratio, 2.0; confidence intervals, 1.07–3.73; p = 0.03). There was no period effect on compliance in the tablet/melt sequence and no difference in the number of completely compliant patients in each formulation group; however, more patients were >75 % compliant in period 1 compared with period 2 in the melt/tablet sequence. Increased compliance was associated with greater reductions in the number of wet nights for both formulations. Conclusions: Desmopressin melt, compared with tablet, improves the probability of being a responder. Switching from tablet to melt formulation increased patient compliance. Increased compliance was associated with increased efficacy. Switching to desmopressin melt may benefit patients with suboptimal responses to desmopressin tablet.

Is Response to Enuresis Treatment with Desmopressin Influenced by Family History, Associated Comorbidities or Obesity?

“…compared with tablet, in children with primary monosymptomatic nocturnal enuresis, mainly due to increased compliance [5,6] .…”

Optimizing response to desmopressin in patients with monosymptomatic nocturnal enuresis

“…There is some evidence that the oral lyophilisate may, despite bioequivalent dosing, achieve a greater reduction in the number of wet nights than the tablet [34]. This may be a result of the different pharmacokinetic and pharmacodynamic characteristics of the oral lyophilisate, administration method and/or effects of the formulation on adherence (discussed later in this review).…”

“…Despite the closely monitored setting of a clinical trial, therefore, up to around 20 % of patients were not fully adherent to treatment, even during the run-in phase, and over 30 % were not fully adherent at later stages. Poor adherence to treatment could therefore explain a poor response in some patients since the reduction in wet nights/week, as would be expected, is significantly greater for a higher adherence rate compared with lower adherence [34, 44]. It is crucial that clinicians advise patients of the importance of full adherence with desmopressin therapy, as well as adherence with the instructions regarding the timings of desmopressin administration, fluid intake, among other factors (discussed earlier in this review) to achieve the best possible efficacy.…”

“…There are some data to suggest that adherence to treatment increases when patients are switched from the tablet to the oral lyophilisate formulation of desmopressin [34]. This, coupled with younger children’s preference for the lyophilisate [32], suggests it may contribute to improved outcomes via higher adherence levels.…”

The adverse effects of oral desmopressin lyophilisate (MELT): personal experience on enuretic children

“…MELT with its higher bioavailability guarantees the same therapeutic response of other formulations with lower doses and represents the firstline and safe treatment for the NE. [5][6][7] The aim of this study was to evaluate adverse effects of MELT in enuretic children.…”