Oral desmopressin lyophilisate (MELT) for monosymptomatic enuresis: Structured versus abrupt withdrawal

Ferrara, Pietro; Romano, Valerio; Cortina, Ivana; Ianniello, Francesca; Fabrizio, Giovanna Carmela; Chiaretti, Antonio

doi:10.1016/j.jpurol.2013.05.021

Cited by 32 publications

(24 citation statements)

References 19 publications

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“…Of the 260 initially enrolled patients, 23 (8.8%) were excluded for the following reasons because 15 patients had undergone therapy with desmopressin within the previous 3 months, 5 were lost to follow up, and 3 cases needed a further period of observation. Thus, 237 children were included in our study.…”

Section: Resultsmentioning

confidence: 99%

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

Ferrara¹,

Franceschini²,

Mercurio³

et al. 2018

Turkish Journal of Urology

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Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Introductionmentioning

confidence: 99%

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

Ferrara¹,

Franceschini²,

Mercurio³

et al. 2018

Turkish Journal of Urology

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“…Eighteen articles were excluded from metaanalysis but were included for systematic review and summarized in Supplemental Table 3. Four RCTs [10][11][12][13] that compare the efficacy of structured and abrupt withdrawal of desmopressin after response to therapy were included for this meta-analysis. The detailed study characteristics and risk of bias assessment of these included studies are summarized in Table 1 and Table 2, respectively.…”

Section: Assessment Of Heterogeneitymentioning

confidence: 99%

“…[7][8][9] Despite its popularity, available literature showed inconsistent results when compared with abrupt discontinuation of desmopressin. [10][11][12][13] Therefore, there is an imminent need to assess the clinical applicability of structured desmopressin withdrawal compared with abrupt discontinuation. Our aim is to assess the efficacy of different structured withdrawal strategies and an abrupt withdrawal strategy to prevent relapse and sustain dry nights for desmopressin-responsive patients with pediatric nocturnal enuresis.…”

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confidence: 99%

Desmopressin Withdrawal Strategy for Pediatric Enuresis: A Meta-analysis

et al. 2016

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CONTEXT: A high relapse rate after discontinuation of desmopressin treatment of pediatric enuresis is consistently reported. Structured withdrawal strategies have been used to prevent relapse. OBJECTIVE:To assess the efficacy of a structured withdrawal strategy of desmopressin on the relapse-free rate for desmopressin responder pediatric enuresis.DATA SOURCES: Systematic literature search up to November 2015 on Medline, Embase, Ovid, Science Direct, Google Scholar, Wiley Online Library databases, and related references without language restriction. STUDY SELECTION:Related clinical trials were summarized for systematic review. Randomized controlled trials on the efficacy of structured versus abrupt withdrawal of desmopressin in sustaining relapse-free status in pediatric enuresis were included for meta-analysis. DATA EXTRACTION:Eligible studies were evaluated according to Cochrane Collaboration recommendations. Relapse-free rate was extracted for relative risk (RR) and 95% confidence interval (CI). Effect estimates were pooled via the Mantel-Haenszel method with random effect model. RESULTS:Six hundred one abstracts were reviewed. Four randomized controlled trials (total 500 subjects) of adequate methodological quality were included for meta-analysis. Pooled effect estimates compared with the abrupt withdrawal, structured withdrawal results to a significantly better relapse-free rate (pooled RR: 1.38; 95% CI, 1.17-1.63; P = .0001). Subgroup analysis for a dose-dependent structured withdrawal regimen showed a significantly better relapse-free rate (pooled RR: 1.48; 95% CI, 1.21-1.80; P = .0001). LIMITATIONS:The small number of studies included in meta-analysis represents a major limitation.CONCLUSIONS: Structured withdrawal of desmopressin results in better relapse-free rates. Specifically, the dose-dependent structured withdrawal regimen showed significantly better outcomes.

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“…dDAVP is associated with a response rate of about 40-60%, however its effect may not be maintained on discontinuing treatment, and symptoms have been found to recur in about 50-80% after stopping treatment (3). The different formulations of dDAVP are an intranasal solution, an oral tablet formulation and the recent oral sublingual lyophilisate (MELT).…”

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confidence: 99%

Desmopressin 120 mcg, 180 mcg, 240 mcg: The right treatment for the right patient

Ferrara

Vescovo

Ianniello

et al. 2018

Arch Ital Urol Androl

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Background: The first-line drug therapy for patients with nocturnal enuresis (NE) associated with nocturnal polyuria and normal bladder function is desmopressin (dDAVP). Objective: To evaluate if increasing dose of oral desmopressin lyophilisate (MELT) can improve response rates to dDAVP and is useful in enuretic children. Materials and methods: We enrolled a total of 260 children all diagnosed with NE. Enuretic children were treated with increasing MELT at a dose of 120, 180 and 240 mcg a day. Results. We included in our study a total of 237 children, 164 males (69.2%) and 73 females (30.8%) aged between 5 and 18 years (mean age 10.32 ± 2.52 years). Of the 237 patients enrolled in the study and treated with MELT 120 mcg, a full response was achieved in 135 (56.9%). A partial response was achieved in 21 (8.9%) patients, therefore the dose was increased up to 180 mcg, with further improving symptoms (14.3%) or full response (9.5%), and up to 240 mcg, without usefulness. Conclusions: MELT at the dose of 120 mcg resulted efficacy and safety; the increased dose up to 180 mcg resulted poorly efficacy; finally, the further increase up to 240 mcg did not improve the symptoms with the increased risk of side effects.KEY WORDS: Desmopressin; Nocturnal enuresis. ated with nocturnal polyuria and normal bladder function is desmopressin (dDAVP) for a period of 3 months following by withdrawal. dDAVP is associated with a response rate of about 40-60%, however its effect may not be maintained on discontinuing treatment, and symptoms have been found to recur in about 50-80% after stopping treatment (3). The different formulations of dDAVP are an intranasal solution, an oral tablet formulation and the recent oral sublingual lyophilisate (MELT). The aim of this study is to evaluate if increasing dose of MELT (120, 180, 240 mcg/day) can improve response rates to dDAVP in enuretic children. MATERIALS AND METHODSWe enrolled a total of 260 children all diagnosed with NE, between April 2014 and April 2017, at the Paediatric Service of Campus Bio-Medico Hospital in Rome. Inclusion criteria were: age > 5 years and a diagnosis of primary MNE (PMNE) without NE treatment in the last 3 months. Exclusion criteria were the presence of secondary NE, any provided story of urinary infection, nephrogenic diabetes or congenital genitourinary anomalies. The children and their families were asked to participate in the study. This study was conducted in accordance with the regulatory standards of Good Clinical Practice and the Declaration of Helsinki. We carefully evaluated each patients with medical history and physical examination, including monitoring blood pressure, possible sign of spinal dysraphism or polythelia, neurological reflexes and genital examination. During the period of treatment, all patients and their parents were asked to keep a NE calendar depicting the wet and the dry nights and in addition, we educated both child and parents with dietary advices (4). During the follow-up, families were called to verify their adherence and respons...

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Oral desmopressin lyophilisate (MELT) for monosymptomatic enuresis: Structured versus abrupt withdrawal

Abstract: Our study suggests that a structured withdrawal program from MELT therapy doesn't offer advantages compared to an abrupt termination in children with monosymptomatic nocturnal enuresis.

Cited by 32 publications

References 19 publications

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

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

Desmopressin Withdrawal Strategy for Pediatric Enuresis: A Meta-analysis

Desmopressin 120 mcg, 180 mcg, 240 mcg: The right treatment for the right patient

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