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Jens Peter Norgaard - One of the best experts on this subject based on the ideXlab platform.

  • Pediatric Pharmacology of Desmopressin in Children with Enuresis: A Comprehensive Review
    Pediatric Drugs, 2020
    Co-Authors: Elke Gasthuys, Jens Peter Norgaard, Lien Dossche, Robin Michelet, Mathias Devreese, Siska Croubels, An Vermeulen, Jan Bocxlaer, Johan Vande Walle
    Abstract:

    Desmopressin is a synthetic analogue of the natural antidiuretic hormone arginine vasopressin. Over the years, it has been clinically used to manage nocturnal polyuria in children with enuresis. Various pharmaceutical formulations of Desmopressin have been commercialized for this indication—nasal spray, nasal drops, oral tablet and oral lyophilizate. Despite the fact that Desmopressin is a frequently prescribed drug in children, its use and posology is based on limited pediatric data. This review provides an overview of the current pediatric pharmacological data related to the different Desmopressin formulations, including their pharmacokinetics, pharmacodynamics and adverse events. Regarding the pharmacokinetics, a profound food effect on the oral bioavailability was demonstrated as well as different plasma concentration–time profiles (double absorption peak) of the Desmopressin lyophilizate between adults and children. Literature about maturational differences in distribution, metabolism and excretion of Desmopressin is rather limited. Regarding the pharmacodynamics, formulation/dose/food effect and predictors of response were evaluated. The lyophilizate is the preferred formulation, but the claimed bioequivalence in adults (200 µg tablet and 120 µg lyophilizate), could not be readily extrapolated to children. Prescribing the standard flat-dose regimen to the entire pediatric population might be insufficient to attain response to Desmopressin treatment, whereby dosing schemes based on age and weight were proposed. Moreover, response to Desmopressin is variable, whereby complete-, partial- and non-responders are reported. Different reasons were enumerated that might explain the difference in response rate to Desmopressin observed: different pathophysiological mechanisms, bladder capacity and other predictive factors (i.e. breast feeding, familial history, compliance, sex, etc.). Also, the relapse rate of Desmopressin treatment was high, rendering it necessary to use a pragmatic approach for the treatment of enuresis, whereby careful consideration of the position of Desmopressin within this treatment is required. Regarding the safety of the different Desmopressin formulations, the use of Desmopressin was generally considered safe, but additional measures should be taken to prevent severe hyponatremia. To conclude the review, to date, major knowledge gaps in pediatric pharmacological aspects of the different Desmopressin formulations still remain. Additional information should be collected about the clinical relevance of the double absorption peak, the food effect, the bioequivalence/therapeutic equivalence, the pediatric adapted dosing regimens, the study endpoints and the difference between performing studies at daytime or at nighttime. To fill in these gaps, additional well designed pharmacokinetic and pharmacodynamic studies in children should be performed.

  • gender difference in efficacy and dose response in japanese patients with nocturia treated with four different doses of Desmopressin orally disintegrating tablet in a randomized placebo controlled trial
    BJUI, 2013
    Co-Authors: Osamu Yamaguchi, Kristian Vinter Juul, Osamu Nishizawa, Jens Peter Norgaard
    Abstract:

    What's known on the subject? and What does the study add? Desmopressin orally disintegrating tablet (ODT) 60–240 μg has proved an effective and well-tolerated antidiuretic treatment in male and female patients with nocturia. The main adverse event is hyponatraemia. Recent studies suggest that female patients are more sensitive to Desmopressin ODT, achieving the same efficacy at lower doses than male patients. The study demonstrates the efficacy of Desmopressin ODT in male and female Japanese patients with nocturia. It provides further evidence that the optimum Desmopressin dose for the treatment of nocturia is lower in females than in males. Tailoring the dose according to gender provides an improved therapeutic window with the benefits of a decreased risk of hyponatraemia without compromising efficacy. Objectives To establish the dose–response efficacy of Desmopressin in a Japanese patient population for the treatment of nocturia. To explore gender differences in sensitivity to Desmopressin in Japanese patients with nocturia. Patients and Methods A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted. Subjects aged 55–75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of Desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg. The dose–response relationship of pharmacodynamic variables measured after a single dose of Desmopressin administered to water-loaded subjects (treatment period 1) was compared with the primary clinical endpoint of change from baseline in mean number of nocturnal voids, after 28 days of Desmopressin treatment (treatment period 2). Results A total of 116 patients were treated in treatment period 1 of whom 113 qualified for treatment period 2, and 111 completed the study. In treatment period 1 a dose–response relationship was observed, both overall and in each gender group. Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo. Female patients were found to be more sensitive to Desmopressin; DOA in female patients was longer than in male patients after Desmopressin 25 and 50 μg. Extrapolation suggests that male patients require ∼58 μg to achieve similar DOA to females receiving 25 μg. A dose–response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo. Similar dose–response relationships were also seen when the data were analysed by gender. Desmopressin ODT was well tolerated with no serious or severe adverse events. Conclusions A dose–response relationship for Desmopressin ODT was shown in a population of Japanese patients with nocturia. The study suggests that the optimum Desmopressin dose for the treatment of nocturia is lower in females than in males, indicating a gender-specific therapeutic window with a decreased risk of hyponatraemia without compromising efficacy on reduction of nocturnal voids. Further dose-finding studies are planned to confirm the recommended dose for the treatment of nocturia in a Japanese patient population.

  • efficacy and safety of Desmopressin orally disintegrating tablet in patients with central diabetes insipidus results of a multicenter open label dose titration study
    Endocrine Journal, 2013
    Co-Authors: Hiroshi Arima, Yutaka Oiso, Kristian Vinter Juul, Jens Peter Norgaard
    Abstract:

    : Central diabetes insipidus (CDI) is associated with arginine vasopressin (AVP) deficiency with resultant polyuria and polydipsia. Intranasal Desmopressin provides physiological replacement but oral formulations are preferred for their ease of administration. This study aimed to demonstrate the efficacy and safety of Desmopressin orally disintegrating tablet (ODT) in the treatment of Japanese patients with CDI, and confirm that antidiuresis is maintained on switching from intranasal Desmopressin to Desmopressin ODT. A total of 20 patients aged 6-75 years with CDI were included in this 4-week multicenter, open-label study. Following observation, patients switched from intranasal Desmopressin to Desmopressin ODT with titration to optimal dose over ≤5 days at the study site. Following three consecutive doses with stable patient fluid balance, patients were discharged with visits at Weeks 2 and 4. Following titration from intranasal Desmopressin to ODT, the mean 24-hour urine volume was unchanged, indicating similar antidiuresis with both formulations. The proportion of patients with endpoint measurements (urine osmolality, 24-hour urine volume, hourly diuresis rate and urine-specific gravity) within normal range at Days 1-2 (intranasal Desmopressin) and Week 4 (Desmopressin ODT) was similar. The mean daily dose ratio of intranasal Desmopressin to Desmopressin ODT (Week 4) was 1:24 but a wide range was observed across individuals to maintain adequate antidiuretic effect. Hyponatraemia was generally mild and managed by dose titration. Desmopressin ODT achieved sufficient antidiuretic control compared to intranasal therapy and was well tolerated over long-term treatment. The wide range of intranasal:ODT dose ratios underline the importance of individual titration.

  • Desmopressin 30 years in clinical use a safety review
    Current Drug Safety, 2007
    Co-Authors: Johan Vande Walle, Ann Raes, Mette Stockner, Jens Peter Norgaard
    Abstract:

    Desmopressin acetate is the synthetic analogue of the antidiuretic hormone arginine vasopressin. It has been employed clinically for > 30 years in a range of formulations: intranasal solution (since 1972), injectable solution (since 1981), tablets (since 1987), and most recently, an oral lyophilisate (since 2005). The antidiuretic properties of Desmopressin have led to its use in polyuric conditions including primary nocturnal enuresis, nocturia, and diabetes insipidus. While a large body of clinical data is available for Desmopressin, and despite its widespread use, comprehensive reviews of the safety of Desmopressin are lacking (although some case series have attempted to correlate patient and/or dosing characteristics with the occurrence of adverse reactions). The purpose of this paper is to review the safety of Desmopressin, based on analyses of both published data (MedLine) and of adverse reactions reported to Ferring Pharmaceuticals, the major manufacturer of Desmopressin. Based on the findings, suggested strategies to reduce the risk of adverse reactions are proposed. Treatment with intranasal and oral formulations of Desmopressin is generally well tolerated, and side effects are usually minor. The risk of hyponatraemia, although small, can be reduced by adhering to the indications, dosing recommendations and precautions when prescribing Desmopressin.

  • Desmopressin in the treatment of nocturia a double blind placebo controlled study
    European Urology, 2007
    Co-Authors: Philip Van Kerrebroeck, Jens Peter Norgaard, Masoumeh Rezapour, A Cortesse, J W Thuroff, Anders Riis
    Abstract:

    Objectives: To investigate efficacy, safety, and impact on quality of sleep of Desmopressin in the treatment of nocturia. Methods: Adults aged >= 18 yr with nocturia (>= 2 voids/night) received Desmopressin tablets (0.1, 0.2, or 0.4 mg) during a 3-wk dose-titration period. Patients should show sufficient response during the dose-titration period (>= 20% reduction in nocturnal diuresis) and a return of nocturnal diuresis to >= 80% of baseline levels during washout. Eligible patients then entered a 3-wk double-blind treatment period and received either Desmopressin or placebo. Results: 127 patients were randomised to either Desmopressin (n = 61) or placebo (n = 66). Twenty (33%) Desmopressin-treated patients compared with seven (11%) placebo-treated patients showed a clinical response, defined as a >= 50% reduction in the number of nocturnal voids compared with baseline (p = 0.0014). Compared with placebo, Desmopressin resulted in a significant reduction in the mean number of nocturnal voids (39% reduction with Desmopressin vs. 15% with placebo; absolute difference -0.84, p < 0.0001) and duration of the first sleep period (prolonged by 108 min with Desmopressin vs. 41 min with placebo; p < 0.0001). Quality of sleep was also improved with clesmopressin versus placebo (statistically significant for one of the two parameters evaluated). Adverse events were mainly mild. Conclusions: Oral clesmopressin tablets provide an effective and well-tolerated treatment for nocturia. Compared with placebo, nocturnal voiding frequency is reduced, duration of the first sleep period is increased, and sleep quality may be improved.

Bryce A Kerlin - One of the best experts on this subject based on the ideXlab platform.

  • Desmopressin responsiveness in children with ehlers danlos syndrome associated bleeding symptoms
    British Journal of Haematology, 2009
    Co-Authors: Kelley J Mast, Mark E Nunes, Frederick B Ruymann, Bryce A Kerlin
    Abstract:

    Summary Ehlers-Danlos Syndrome (EDS) is caused by heritable collagen defects and may be associated with bleeding symptoms. Desmopressin has been described in case reports to decrease bleeding times in these patients. This study sought to assess bleeding time responsiveness to Desmopressin therapy in a cohort of children with EDS-associated bleeding manifestations. A retrospective chart review of children with EDS referred for bleeding symptoms was utilized. Twenty-six children were included; 19 (73%) had a Desmopressin challenge. The mean bleeding time was 11·26 (±4·39) min, decreasing to 5·95 (±2·41) min with treatment (P < 0·01). Desmopressin normalizes bleeding times in children with EDS.

Johan Vande Walle - One of the best experts on this subject based on the ideXlab platform.

  • Pediatric Pharmacology of Desmopressin in Children with Enuresis: A Comprehensive Review
    Pediatric Drugs, 2020
    Co-Authors: Elke Gasthuys, Jens Peter Norgaard, Lien Dossche, Robin Michelet, Mathias Devreese, Siska Croubels, An Vermeulen, Jan Bocxlaer, Johan Vande Walle
    Abstract:

    Desmopressin is a synthetic analogue of the natural antidiuretic hormone arginine vasopressin. Over the years, it has been clinically used to manage nocturnal polyuria in children with enuresis. Various pharmaceutical formulations of Desmopressin have been commercialized for this indication—nasal spray, nasal drops, oral tablet and oral lyophilizate. Despite the fact that Desmopressin is a frequently prescribed drug in children, its use and posology is based on limited pediatric data. This review provides an overview of the current pediatric pharmacological data related to the different Desmopressin formulations, including their pharmacokinetics, pharmacodynamics and adverse events. Regarding the pharmacokinetics, a profound food effect on the oral bioavailability was demonstrated as well as different plasma concentration–time profiles (double absorption peak) of the Desmopressin lyophilizate between adults and children. Literature about maturational differences in distribution, metabolism and excretion of Desmopressin is rather limited. Regarding the pharmacodynamics, formulation/dose/food effect and predictors of response were evaluated. The lyophilizate is the preferred formulation, but the claimed bioequivalence in adults (200 µg tablet and 120 µg lyophilizate), could not be readily extrapolated to children. Prescribing the standard flat-dose regimen to the entire pediatric population might be insufficient to attain response to Desmopressin treatment, whereby dosing schemes based on age and weight were proposed. Moreover, response to Desmopressin is variable, whereby complete-, partial- and non-responders are reported. Different reasons were enumerated that might explain the difference in response rate to Desmopressin observed: different pathophysiological mechanisms, bladder capacity and other predictive factors (i.e. breast feeding, familial history, compliance, sex, etc.). Also, the relapse rate of Desmopressin treatment was high, rendering it necessary to use a pragmatic approach for the treatment of enuresis, whereby careful consideration of the position of Desmopressin within this treatment is required. Regarding the safety of the different Desmopressin formulations, the use of Desmopressin was generally considered safe, but additional measures should be taken to prevent severe hyponatremia. To conclude the review, to date, major knowledge gaps in pediatric pharmacological aspects of the different Desmopressin formulations still remain. Additional information should be collected about the clinical relevance of the double absorption peak, the food effect, the bioequivalence/therapeutic equivalence, the pediatric adapted dosing regimens, the study endpoints and the difference between performing studies at daytime or at nighttime. To fill in these gaps, additional well designed pharmacokinetic and pharmacodynamic studies in children should be performed.

  • optimizing response to Desmopressin in patients with monosymptomatic nocturnal enuresis
    Pediatric Nephrology, 2017
    Co-Authors: Konstantinos Kamperis, Charlotte Van Herzeele, Søren Rittig, Johan Vande Walle
    Abstract:

    Most patients with monosymptomatic nocturnal enuresis can be effectively treated with an enuresis alarm or antidiuretic therapy (Desmopressin), depending on the pathophysiology of the condition in the individual patient. Desmopressin is first-line therapy for enuresis caused by nocturnal polyuria, an excessive urine output during the night. However, in a recent study, around one-third of patients thought to be resistant to Desmopressin were subsequently treated effectively with Desmopressin monotherapy in a specialist centre. The aim of this article is to review best practice in selecting patients for Desmopressin treatment, as well as outline eight recommendations for maximizing the chances of treatment success in patients receiving Desmopressin. The roles of formulation, dose, timing of administration, food and fluid intake, inter-individual variation in response, body weight, adherence, withdrawal strategies and combination therapies are discussed in light of the most recent research on Desmopressin and enuresis. Possible reasons for suboptimal treatment response are explored and strategies to improve outcomes in patients for whom Desmopressin is an appropriate therapy are presented. Through optimization of the treatment plan in primary and specialist care centres, the hope is that fewer patients with this distressing and often embarrassing condition will experience unnecessary delays in receiving appropriate care and achieving improvements.

  • pharmacokinetics of Desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocturnal enuresis
    European Journal of Pediatrics, 2014
    Co-Authors: Pauline De Bruyne, Ann De Guchtenaere, Charlotte Van Herzeele, Ann Raes, Jo Dehoorne, Piet Hoebeke, Erik Van Laecke, Johan Vande Walle
    Abstract:

    Desmopressin 120 μg oral lyophilisate and 200 μg tablet are considered bioequivalent, based on extrapolation of studies in a limited number of adults and on one dose-finding study of Desmopressin oral lyophilisate in children. However, no comparative pharmacokinetic study in children was executed confirming this statement. No data are available on the influence of food intake on the bioavailability of Desmopressin tablet in a pediatric setting, although studies in adults have documented that food intake results in a significantly lower Desmopressin plasma concentration. In this study, we analyzed plasma concentrations of Desmopressin oral lyophilisate and tablet with concomitant food intake. Twenty-three children with monosymptomatic nocturnal enuresis (mean age, 12.7 years) were recruited. Two tests were performed on two separate days in identical conditions with a standardized food and fluid intake. Desmopressin was administered as Desmopressin tablet or Desmopressin oral lyophilisate immediately after a meal. Desmopressin plasma concentration was measured at 1 h, 2 h, and 6 h postdosing. No significant difference in plasma concentration of 120 μg Desmopressin oral lyophilisate and 200 μg tablet was demonstrated, even with concomitant food intake. A significant difference in variability was found, identifying a smaller variance for Desmopressin oral lyophilisate plasma concentrations at all time points. This study demonstrates comparable plasma levels for Desmopressin oral lyophilisate, despite the lower dose. The dosage for Desmopressin oral lyophilisate is more predictable due to the significantly smaller variance. Therefore, Desmopressin oral lyophilisate seems more suitable, especially in the younger age group for which time interval between dinner and drug administration is limited.

  • Desmopressin 30 years in clinical use a safety review
    Current Drug Safety, 2007
    Co-Authors: Johan Vande Walle, Ann Raes, Mette Stockner, Jens Peter Norgaard
    Abstract:

    Desmopressin acetate is the synthetic analogue of the antidiuretic hormone arginine vasopressin. It has been employed clinically for > 30 years in a range of formulations: intranasal solution (since 1972), injectable solution (since 1981), tablets (since 1987), and most recently, an oral lyophilisate (since 2005). The antidiuretic properties of Desmopressin have led to its use in polyuric conditions including primary nocturnal enuresis, nocturia, and diabetes insipidus. While a large body of clinical data is available for Desmopressin, and despite its widespread use, comprehensive reviews of the safety of Desmopressin are lacking (although some case series have attempted to correlate patient and/or dosing characteristics with the occurrence of adverse reactions). The purpose of this paper is to review the safety of Desmopressin, based on analyses of both published data (MedLine) and of adverse reactions reported to Ferring Pharmaceuticals, the major manufacturer of Desmopressin. Based on the findings, suggested strategies to reduce the risk of adverse reactions are proposed. Treatment with intranasal and oral formulations of Desmopressin is generally well tolerated, and side effects are usually minor. The risk of hyponatraemia, although small, can be reduced by adhering to the indications, dosing recommendations and precautions when prescribing Desmopressin.

  • Desmopressin toxicity due to prolonged half life in 18 patients with nocturnal enuresis
    The Journal of Urology, 2006
    Co-Authors: Jo Dehoorne, Ann Raes, Piet Hoebeke, Erik Van Laecke, Johan Vande Walle
    Abstract:

    Purpose: Desmopressin has been used extensively for primary nocturnal enuresis and it is associated with a low incidence of adverse effects. The only reported serious side effect is seizure or altered levels of consciousness resulting from water intoxication, which has been reported for the nasal spray. We describe 18 children with clinical symptoms of water intoxication due to the prolonged bioactivity of Desmopressin nasal spray.Materials and Methods: We evaluated 18 patients with clinical suspicion of prolonged Desmopressin bioactivity during treatment with intranasal Desmopressin for primary nocturnal enuresis. The control group consisted of 50 children with primary nocturnal enuresis and proven nocturnal polyuria who were treated with the same Desmopressin regimen.Results: All patients had prolonged maximal urinary concentration capacity and delayed restoration of daytime diluting capacity (p <0.01). Of the patients 15 had the characteristic clinical symptoms of water intoxication with vomiting, head...

Philip Van Kerrebroeck - One of the best experts on this subject based on the ideXlab platform.

  • Desmopressin in the treatment of nocturia a double blind placebo controlled study
    European Urology, 2007
    Co-Authors: Philip Van Kerrebroeck, Jens Peter Norgaard, Masoumeh Rezapour, A Cortesse, J W Thuroff, Anders Riis
    Abstract:

    Objectives: To investigate efficacy, safety, and impact on quality of sleep of Desmopressin in the treatment of nocturia. Methods: Adults aged >= 18 yr with nocturia (>= 2 voids/night) received Desmopressin tablets (0.1, 0.2, or 0.4 mg) during a 3-wk dose-titration period. Patients should show sufficient response during the dose-titration period (>= 20% reduction in nocturnal diuresis) and a return of nocturnal diuresis to >= 80% of baseline levels during washout. Eligible patients then entered a 3-wk double-blind treatment period and received either Desmopressin or placebo. Results: 127 patients were randomised to either Desmopressin (n = 61) or placebo (n = 66). Twenty (33%) Desmopressin-treated patients compared with seven (11%) placebo-treated patients showed a clinical response, defined as a >= 50% reduction in the number of nocturnal voids compared with baseline (p = 0.0014). Compared with placebo, Desmopressin resulted in a significant reduction in the mean number of nocturnal voids (39% reduction with Desmopressin vs. 15% with placebo; absolute difference -0.84, p < 0.0001) and duration of the first sleep period (prolonged by 108 min with Desmopressin vs. 41 min with placebo; p < 0.0001). Quality of sleep was also improved with clesmopressin versus placebo (statistically significant for one of the two parameters evaluated). Adverse events were mainly mild. Conclusions: Oral clesmopressin tablets provide an effective and well-tolerated treatment for nocturia. Compared with placebo, nocturnal voiding frequency is reduced, duration of the first sleep period is increased, and sleep quality may be improved.

  • efficacy of Desmopressin minirin in the treatment of nocturia a double blind placebo controlled study in women
    American Journal of Obstetrics and Gynecology, 2003
    Co-Authors: Gunnar Lose, Othon Lalos, Robert Freeman, Philip Van Kerrebroeck
    Abstract:

    OBJECTIVE: The purpose of this study was to investigate the efficacy and safety of oral Desmopressin in the treatment of nocturia in women. STUDY DESIGN: Women aged 18 years or older with nocturia (>or=2 voids per night with a nocturia index score >1) received Desmopressin (0.1 mg, 0.2 mg, or 0.4 mg) during a 3-week dose-titration period. After a 1-week washout period, patients who responded in this period received Desmopressin or placebo in a double-blind fashion for 3 weeks. RESULTS: In double-blind phase, 144 patients were randomly assigned to groups (Desmopressin, n=72; placebo, n=72). For Desmopressin, 33 (46%) patients had a 50% or greater reduction in nocturnal voids against baseline levels compared with 5 (7%) patients receiving placebo (P<.0001). The mean number of nocturnal voids, duration of sleep until the first nocturnal void, nocturnal diuresis, and ratios of nocturnal per 24 hours and nocturnal per daytime urine volumes changed significantly in favor of Desmopressin versus placebo (P<.0001). In the dose-titration phase headache (22%), nausea (8%), and hyponatremia (6%) were reported. Two deaths occurred, although neither could be directly associated with the study drug. CONCLUSION: Oral Desmopressin is an effective and well-tolerated treatment for nocturia in women.

  • efficacy of Desmopressin in the treatment of nocturia a double blind placebo controlled study in men
    BJUI, 2002
    Co-Authors: Anders Mattiasson, Philip Van Kerrebroeck, Paul Abrams, Steen Walter, Jeffrey P Weiss
    Abstract:

    OBJECTIVE: To investigate the efficacy and safety of oral Desmopressin in the treatment of nocturia in men. PATIENTS AND METHODS: Men aged >/=18 years with verified nocturia (>or=two voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A 3-week dose-titration phase established the optimum Desmopressin dose (0.1, 0.2 or 0.4 mg). After a 1-week 'washout' period, patients who responded in the dose-titration period were randomized to receive the optimal dose of Desmopressin or placebo in a double-blind design for 3 weeks. RESULTS: In all, 151 patients entered the double-blind period (86 treated with Desmopressin, 65 with placebo). In the Desmopressin group 28 (34%) patients and in the placebo group two (3%) patients (P<0.001) had fewer than half the number of nocturnal voids relative to baseline; the mean number of nocturnal voids decreased from 3.0 to 1.7 and from 3.2 to 2.7, respectively, reflecting a mean decrease of 43% and 12% (P<0.001). The mean duration of the first sleep period increased by 59% (from 2.7 to 4.5 h) in the Desmopressin group, compared with an increase of 21% (from 2.5 to 2.9 h) in the placebo group (P<0.001). The mean nocturnal diuresis decreased by 36% (from 1.5 to 0.9 mL/min) in the Desmopressin group and by 6% (from 1.7 to 1.5 mL/min) in the placebo group (P<0.001). The mean ratio of night/24-h urine volume decreased by 23% and 1% (P<0.001), and the mean ratio of night/day urine volume decreased by 27% and increased by 3% (P<0.001) for the Desmopressin and placebo groups, respectively. In the double-blind treatment period, similar numbers of patients had adverse events; 15 (17%) patients in the Desmopressin and 16 (25%) patients in the placebo group. Most adverse events were mild. Serum sodium levels were <130 mmol/L in 10 (4%) patients and this occurred during dose-titration. CONCLUSIONS: Orally administered Desmopressin is an effective and well-tolerated treatment for nocturia in men.

Rodrigo B Cavalcanti - One of the best experts on this subject based on the ideXlab platform.

  • Desmopressin to prevent rapid sodium correction in severe hyponatremia a systematic review
    The American Journal of Medicine, 2015
    Co-Authors: Thomas E Macmillan, Terence Tang, Rodrigo B Cavalcanti
    Abstract:

    Abstract Background Hyponatremia is common among inpatients and is associated with severe adverse outcomes such as osmotic demyelination syndrome. Current guidelines recommend serum sodium concentration correction targets of no more than 8 mEq/L per day in patients at high risk of osmotic demyelination syndrome. Desmopressin is recommended to control high rates of serum sodium concentration correction in severe hyponatremia. However, recommendations are based on limited data. The objective of this study is to review current strategies for DDAVP use in severe hyponatremia. Methods Systematic literature search of 4 databases of peer-reviewed studies was performed and study quality was appraised. Results The literature search identified 17 observational studies with 80 patients. We found 3 strategies for Desmopressin administration in hyponatremia: 1) proactive, where Desmopressin is administered early based on initial serum sodium concentration; 2) reactive, where Desmopressin is administered based on changes in serum sodium concentration or urine output; 3) rescue, where Desmopressin is administered after serum sodium correction targets are exceeded or when osmotic demyelination appears imminent. A proactive strategy of Desmopressin administration with hypertonic saline was associated with lower incidence of exceeding serum sodium concentration correction targets, although this evidence is derived from a small case series. Conclusions Three distinct strategies for Desmopressin administration are described in the literature. Limitations in study design and sample size prevent definitive conclusions about the optimal strategy for Desmopressin administration to correct hyponatremia. There is a pressing need for better quality research to guide clinicians in managing severe hyponatremia.