Pharmacokinetics and Pharmacodynamics of the Oral Disintegrating Tablet of Desmopressin in Adults with Nocturnal Polyuria: A Pilot Study (original) (raw)
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The Journal of Urology, 2013
Previous studies suggest a lower dose of desmopressin orally disintegrating tablet may be effective in females compared to males with nocturia. We confirm the efficacy and safety of 25 g desmopressin orally disintegrating tablet compared to placebo in female patients. Materials and Methods: In this 3-month, randomized, double-blind, parallel group study 25 g desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids). The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders). Results: The full analysis set comprised 261 patients (age range 19 to 87 years). Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (Ϫ0.22, p ϭ 0.028 and OR 1.85, p ϭ 0.006, respectively). Desmopressin increased the mean time to first nocturnal void by 49 minutes compared to placebo at 3 months (p ϭ 0.003). The response to desmopressin was seen by week 1 of treatment and was sustained throughout the trial. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated. Serum sodium levels remained greater than 125 mmol/L throughout the trial and 3 transient decreases to less than 130 mmol/L were recorded. Conclusions: At a dose of 25 g, desmopressin orally disintegrating tablet is an effective and well tolerated treatment for women with nocturia. Treatment provides rapid and sustained improvement in nocturia and quality of life.
Nocturnal polyuria in monosymptomatic nocturnal enuresis refractory to desmopressin treatment
American Journal of Physiology-Renal Physiology, 2006
The transition from day to night is associated with a pronounced decline in diuresis with reductions in the amount of excreted water, electrolytes, and other end products of our metabolism. Failure to do so leads to a large urine output at night, a condition known as nocturnal polyuria, encountered in a large proportion of children with nocturnal enuresis. The aim of this study was to clarify the mechanisms responsible for the nocturnal polyuria seen in enuretics with inadequate response to desmopressin (dDAVP). Forty-six enuretics (7–14 yr of age) and fifteen age-matched controls were admitted for a 24-h protocol with standardized fluid and sodium intake, comprising urine collections, blood sampling, and blood pressure monitoring. We included patients with severe enuresis (5 ± 1 wet nights/wk) showing <50% reduction in wet nights on dDAVP. We characterized the patients on the basis of their nocturnal urine production. The children with nocturnal polyuria excreted larger amounts ...
Hyponatremia associated with desmopressin for the treatment of nocturnal polyuria
Urology, 2002
Desmopressin diacetate arginine vasopressin (DDAVP) is a synthetic analogue of the mammalian arginine vasopressin used in the treatment of central diabetes insipidus, bleeding disorders, and incontinence. The primary adverse reaction associated with DDAVP is hypotonic hyponatremia. Hyponatremia has been reported in adults treated with DDAVP for Von Willebrand&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease and hemophilia and in children treated for enuresis, but as yet few cases of hyponatremia developing in enuretic adults treated with DDAVP have been reported. We report the cases of two elderly women taking DDAVP for nocturnal polyuria who developed severe hyponatremia. One patient died in the hospital.
Optimizing response to desmopressin in patients with monosymptomatic nocturnal enuresis
Pediatric Nephrology, 2016
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.
Journal of Korean medical science, 2010
To investigate the efficacy and safety of desmopressin in patients with mixed nocturia, Patients aged ≥ 18 yr with mixed nocturia (≥ 2 voids/night and a nocturnal polyuria index [NPi] >33% and a nocturnal bladder capacity index [NBCi] >1) were recruited. The optimum dose of oral desmopressin was determined during a 3-week dose-titration period and the determined dose was maintained for 4 weeks. The efficacy was assessed by the frequency-volume charts and the sleep questionnaire. The primary endpoint was the proportion of patients with a 50% or greater reduction in the number of nocturnal voids (NV) compared with baseline. Among 103 patients enrolled, 94 (79 men and 15 women) were included in the analysis. The proportion of patients with a 50% or greater reduction in NV was 68 (72%). The mean number of NV decreased significantly (3.20 to 1.34) and the mean nocturnal urine volume, nocturia index, NPi, and NBCi decreased significantly. The mean duration of sleep until the first N...
Desmopressin in the Treatment of Nocturia: A Double-Blind, Placebo-Controlled Study
European Urology, 2007
Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men. Patients and methods Men aged o18 years with verified nocturia (otwo voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A 3-week dosetitration 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.
The Scientific World Journal, 2013
Objective. To compare efficacy of desmopressin for treatment of nocturia between patients with normal and high nocturnal bladder capacity index (NBCi).Methods. Retrospective analysis of adult patients treated with desmopressin for nocturia. Patients were analyzed according to high or normal NBCi value before treatment.Results. 55 patients were identified, aged 49–84, 47 males, 8 females, who started desmopressin 0.2 mg nocte between 2009 and 2011. Two groups (N: normal and H: high NBCi) were similar regarding number, gender, age, 24 h urine volume, and nocturnal urine volume. On treatment, nocturnal volume decreased by mean of 364 mL. Number of nightly voids decreased in N group from 3.11 to 1.50, in H from 3.96 to 1.44. Nocturnal polyuria and nocturia indices also decreased significantly. NBCi remained the same in N group (0.56 on therapy) and in H group decreased to mean 0.63. All on-treatment values were statistically similar in N and H groups. Pretreatment differences were aboli...
BJU International, 2002
Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men. Patients and methods Men aged o18 years with verified nocturia (otwo voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A 3-week dosetitration 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.
Oral Desmopressin in the Management of Adults with Nocturia
Open Journal of Urology, 2011
We investigated the efficacy of oral desmopressin in the treatment of adult nocturia. In an analytical study between 2007-2009 in Zahedan-Iran, Thirty patients ≥55 years with verified nocturia (≥two voids/night) were enrolled. Patients with a history of an obstructive cause of nocturia, those with diseases getting worse by the anti-diuretic affect of desmopressin and those with well-defined curable causes (e.g. cystitis) were excluded. Patients received 0.2 mg of oral desmopressin at bed time for a period of 3 weeks. p < 0.05 was taken as the significant level. All 30 patients enrolled completed the trial. Fourteen (47 %) patients receiving desmopressin had fewer than half the number of nocturnal voids relative to base line (p < 0.001). The mean number of nocturnal voids decreased from 4.6 to 2.4 (p < 0.001). Fatigue (10%), headache (3%) and dizziness (3%) were reported. All adverse events were of mild intensity and there were no instances of hyponatremia. Oral desmopressin is an effective treatment in patients with nocturia and is well-tolerated.