[Comparison of two sublingual types of desmopressin in 6-year-old and more children with primary nocturnal enuresis. About an international randomized cross-over study].
OBJECTIVE
Desmopressin (a structural analogue of hormone arginine-vasopressine) is an effective treatment of primary nocturnal enuresis (PNE). A new oral formulation (oral lyophilisate; Minirinmelt has recently been developed. The principal objective of this study was to compare the preference of patients for the oral lyophilisate versus tablet.


METHODS
This open-label, randomized, cross-over study was undertaken at 26 centres across Europe and included patients with PNE. All were already receiving a stable dose of desmopressin tablets 0,2 or 0,4 mg. Two hundred and fourteen patients aged 6 to 15 years were randomised (1:1) to receive the treatment in the order lyophilisate/tablet (n=108) or tablet/lyophilisate (n=106). Each formulation was taken during 3 weeks.


RESULTS
Of the patients (intention to treat), 55,2% preferred the oral lyophilisate (p=0,16). Patients less than 12 years (n=153) had a preference for the lyophilisate compared to tablets (60,1%; p=0,015). Efficacy was the same for both formulations in terms of mean incidence of bedwetting episodes per week (treatment difference: -0,08; p=0,33). No serious adverse event was reported. The use was considered to be easy for the two forms (p=0,85). Of patients on the lyophilisate, 94,3% had compliance levels of greater or equal to 80%.


CONCLUSIONS
The majority of patients preferred the sublingual lyophilisate. This preference was marked in patients less than 12 years on exploratory analysis. The new formulation of desmopressin requires no water intake and retains similar levels of efficacy and safety than the tablet.
Lottmann
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Service de chirurgie viscérale pédiatrique, hôpital Necker-Enfants-Malades, 149, rue de Sèvres, Paris, France. henri.lottmann@wanadoo.fr
D000286:Administration, Sublingual; D000293:Adolescent; D050034:Antidiuretic Agents / Q000008:administration & dosage*; D002648:Child; D018592:Cross-Over Studies; D003894:Deamino Arginine Vasopressin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D053206:Nocturnal Enuresis / Q000188:drug therapy*; D017060:Patient Satisfaction; D011446:Prospective Studies
D050034:Antidiuretic Agents; D003894:Deamino Arginine Vasopressin