STIMATE SUMMARY
Stimate®
(desmopressin acetate)
Nasal Spray, 1.5 mg/mL
Stimate® (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. Stimate® Nasal Spray contains 1.5 mg/mL desmopressin acetate in a pH-adjusted aqueous solution with chlorobutanol and sodium chloride as inactive ingredients. Stimate® Nasal Spray's compression pump delivers 0.1 mL (150 µg) of solution per spray.
Before the initial therapeutic administration of Stimate® Nasal Spray, the physician should establish that the patient shows an appropriate change in the coagulation profile following a test dose of intranasal administration of Stimate® Nasal Spray.2-4
Desmopressin acetate is also available as a solution for injection (DDAVP® 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.
Hemophilia A
Stimate® Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%.
Desmopressin acetate will also stop bleeding in patients with hemophilia A with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.2,3
In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 2 of the 5 patients. For those patients not responding in 100% of bleeding occasions, 45% (14 of 31) of bleeding episodes were effectively controlled with Stimate® Nasal Spray.
Desmopressin acetate is not indicated for the treatment of hemophilia A with Factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have Factor VIII antibodies.
von Willebrand's Disease (Type I)
Stimate® Nasal Spray is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with Factor VIII levels greater than 5%.
Desmopressin acetate will also stop bleeding in mild to moderate von Willebrand's disease patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding or menorrhagia.2,3
In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 75% of the patients (n=16). For those patients not responding in 100% of bleeding occasions, 78% (64 of 82) of bleeding episodes were effectively controlled with Stimate® Nasal Spray.
Patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and Factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked after initial administration of Stimate® Nasal Spray to ensure that adequate levels have been achieved.
Stimate® Nasal Spray is not indicated for the treatment of severe classic von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of Factor VIII antigen. See WARNINGS.
|
NEWS HIGHLIGHTSMedia Articles Related to Stimate (Desmopressin Nasal)
H1N1 6-Month Toll 22 Million, CDC Estimates
Source: MedPage Today Pulmonary [2009.11.12]
In the first six months of the H1N1 flu pandemic, 22 million Americans fell ill from the virus, the CDC now estimates.
Researchers Discuss Limitations Of Prevalence Estimates Of TBI And PTSD Among OIF/OEF Veterans
Source: Rehabilitation / Physical Therapy News From Medical News Today [2009.11.05]
In a special guest editorial, Bass and colleagues discuss the limitations of current estimates of the prevalence of traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) among Operation Iraqi Freedom and Operation Enduring Freedom (OIF/OEF) veterans. Since these estimates often determine the allocation of resources, the authors urge decision makers to understand the limitations of these prevalence estimates.
New Estimate on Swine Flu in U.S.
Source: MedicineNet Reye Syndrome Specialty [2009.09.11]
Title: New Estimate on Swine Flu in U.S.
Category: Health News
Created: 7/27/2009
Last Editorial Review: 9/11/2009
Transmission Of Huntington's Disease To Offspring Among Male Carriers: Risk Estimated By Researchers
Source: Huntingtons Disease News From Medical News Today [2009.06.11]
Researchers from Boston University School of Medicine (BUSM) have quantified the probability of a male who carries a "high normal" variant of the Huntington's Disease (HD) gene having a child who develops the disease. Although thought to be a very rare event, the probability has never been estimated using current information and disease guidelines. The findings, appear on-line in the American Journal of Medical Genetics, may be useful during prenatal genetic counseling.
Senators Blame HHS for Mishandling H1N1 Vaccination Effort
Source: MedPage Today Infectious Disease [2009.11.17]
WASHINGTON (MedPage Today) -- Senators on the Homeland Security Committee scolded Health and Human Services Secretary Kathleen Sebelius Tuesday for overly optimistic estimates of pandemic H1N1 flu vaccine supplies.
Published Studies Related to Stimate (Desmopressin Nasal)
Clinical study shows improved absorption of desmopressin with novel formulation. [2009.07]
PURPOSE: To create improved pharmaceutical formulations for nasal and sublingual administration of desmopressin and investigate their pharmacokinetic profiles in comparison with a commercial nasal liquid spray and finally to evaluate the volunteers' opinions on the different dosage forms... CONCLUSIONS: The nasal powder formulation is a promising new dosage form for the delivery of desmopressin and other compounds. The sublingual tablet has a beneficial means of production and may be further developed by decreasing its disintegration time.
Multisite management study of menorrhagia with abnormal laboratory haemostasis: a prospective crossover study of intranasal desmopressin and oral tranexamic acid. [2009.04]
The optimal management of menorrhagia among women with abnormal laboratory haemostasis is uncertain. In a crossover study, 116 women with menorrhagia [pictorial blood assessment chart (PBAC) score >100], negative gynaecological evaluation and abnormal laboratory haemostasis were randomly assigned to either intranasal desmopressin (IN-DDAVP) or tranexamic acid (TA) therapy for two menstrual cycles...
[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.] [2009.02]
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((R))) has recently been developed. The principal objective of this study was to compare the preference of patients for the oral lyophilisate versus tablet... 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.
Desmopressin, as a "designer-drug," in the treatment of overactive bladder syndrome. [2009]
AIMS: This study looked at whether oral desmopressin, by decreasing kidney urine production, would prolong bladder filling-time thereby increasing the time to reach maximum capacity, thus reducing overactive bladder (OAB) symptoms, and providing an alternative method of treatment to OAB sufferers... CONCLUSIONS: Antidiuresis, using oral desmopressin tablets, is a novel, feasible and safe (short-term basis) method of treatment for adults with OAB, and could be considered in the armamentarium of drugs available for the treatment of OAB. (c) 2008 Wiley-Liss, Inc.
Combination therapy with desmopressin and an anticholinergic medication for nonresponders to desmopressin for monosymptomatic nocturnal enuresis: a randomized, double-blind, placebo-controlled trial. [2008.11]
OBJECTIVE: Desmopressin is an approved medical therapy for the treatment of monosymptomatic primary nocturnal enuresis. In cases of limited response to desmopressin, we have added anticholinergic therapy to desmopressin (combination therapy). To evaluate this treatment strategy, we examined the efficacy of combination therapy for primary nocturnal enuresis in desmopressin-nonresponders... CONCLUSIONS: This study represents the first prospective, placebo-controlled trial examining the effect of desmopressin in combination with long-acting, anticholinergic, bladder-relaxing therapy for monosymptomatic primary nocturnal enuresis.
Clinical Trials Related to Stimate (Desmopressin Nasal)
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.
A 6-Week Open Label Cross-Over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE) [Active, not recruiting]
To evaluate the preference of subjects for MinirinĀ® oral lyophilisate treatment compared with
MinirinĀ® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using
diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a
PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2
formulations
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis [Terminated]
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase
and is emerging as the main cause of death due to leptospirosis in many countries, including
Thailand.
Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone
as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with
leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia [Recruiting]
The purpose of this study is to investigate the efficacy and safety of several doses of the
melt formulation of desmopressin in a broad population of adult patients with nocturia.
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery [Recruiting]
Some patients undergoing cardiac surgery develop excessive postoperative bleeding.
Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the
ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired
platelet disorders. In this study the investigators will investigate wether desmopressin
reduces postoperative microvascular bleeding. The investigators will investigate wether
desmopressin reduces platelet activation as measured by plasma concentration of neutrophil
activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however,
be total postoperative bleeding and need for transfusions of blood components after surgery.
The need for transfusions will be registered during the whole hospital stay. Patient with
excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two
hours during the first four hours) will be randomized into two groups and given either
desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for
plasma concentration measurements will be drawn before infusion of desmopressin/placebo,
immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be
registered for 16 hours. The need for any transfusions of blood products will be registered
for the whole hospital stay.
|
