SUMMARY
Desmopressin Acetate Rhinal Tube is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation.
Desmopressin Acetate Rhinal Tube is indicated for the following:
Primary Nocturnal Enuresis: Desmopressin Acetate Rhinal Tube is indicated for the management of primary nocturnal enuresis. It may be used alone or adjunctive to behavioral conditioning or other non-pharmacological intervention. It has been shown to be effective in some cases that are refractory to conventional therapies.
Central Cranial Diabetes Insipidus: Desmopressin Acetate Rhinal Tube is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus.
The use of Desmopressin Acetate Rhinal Tube in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.
There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.
Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal Desmopressin acetate can be monitored by urine volume and osmolality.
Desmopressin acetate is also available as a solution for injection when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
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NEWS HIGHLIGHTS
Published Studies Related to Desmopressin Rhinal Tube
The relationship between the action of arginine vasopressin and responsiveness to oral desmopressin in older men: a pilot study. [2007.04]
OBJECTIVES: To identify whether oral desmopressin (ddAVP) reduced nocturnal urine volume (NUV) in older men with nocturia without obvious bladder outlet obstruction and to determine whether deficiencies in arginine vasopressin (AVP) release and action demonstrated using water deprivation testing predicted responsiveness to ddAVP... CONCLUSION: In this small randomized, controlled trial in older men with nocturia, ddAVP reduced NUV. Counter to expectations, participants deemed normal according to water deprivation tests had approximately equivalent responsiveness to ddAVP. Although this study cannot offer definitive conclusions on the lack of prediction of water deprivation testing for ddAVP benefit, these data offer additional information that may help clarify the pathophysiology and optimal treatment of nocturia in older men.
Clinical Trials Related to Desmopressin Rhinal Tube
Desmopressin Response in the Young [Completed]
The purpose of this study is to determine whether desmopressin administered as a melt tablet
is effective in reducing the number of wet nights in children and adolescents who suffer from
bedwetting.
Effect of Aspirin, Hemodilution and Desmopressin on Platelet Dysfunction [Not yet recruiting]
Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of
aspirin, hemodilution and mild hypothermia
Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to
increased surgical bleeding and increased transfusion requirement during surgery. Although
this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is
not always possible or desirable.
Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in
uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a
recent study, we have found that subcutaneous injection of 1. 5 mcg (1/10th the usual dose)
is already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have
demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted
sample predicts increased postoperative bleeding after total knee replacement.
We have therefore designed this study as a follow up to our last two studies on DDAVP and
hypothermia, to investigate whether hemodilution affects hypothermia induced platelet
dysfunction and the response to DDAVP. In addition, another common cause of perioperative
platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients.
Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response
to DDAVP, will also be investigated.
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation [Not yet recruiting]
Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are
considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal
enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal
spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%,
tablet 0. 2%, MELT 0. 5%). There 's insufficient evidence to confirm the actually used
bioequivalent doses ( 10µg spray = 120µg MELT= 0. 2mg tablet).
Although so frequently used, very few pharmacokinetic and - dynamic data on desmopressin are
available for children.
Due to prolonged half life, associated with waterintoxication,the nasal spray has a black
box warning from the FDA and is no longer recommended . For some authors oral formulations
appear to be a safer alternative. However, based on clinical experience of less response
rate with oral formulations, lower biodisponibility is suspected. Adult research confirms
low bioavailability of tablets but also show major influences by food-intake and changes in
gastro-intestinal motility.
To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before
bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never
is 3 hours between evening meal and bedtime.
In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties
for desmopressin Lyophilisate MELT formula.
Since these results implicate superior action of MELT, often a change to MELT is recommended
if there is a suboptimal response with tablet: sublingual absorption would eliminate the
influence of food-intake.
However, for this statement there's no evidence, since these tests were all conducted in
children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT
and tablet.
Hypothesis is that desmopressin MELT formulation has a better bioavailability when
administered together with meal due to its sublingual absorption.
Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic [Recruiting]
In this study we will compare pain intensity and side effects at different time points after
the intranasal administration of desmopressin or placebo in patients with acute renal colic
pain.
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients [Recruiting]
The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia
in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the
quality of life will be measured.
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