Abstract |
An open-label multicentre trial was conducted to evaluate high-dose DDAVP ( desmopressin acetate) intranasal spray (Stimate; 1.5 mg mL(-1)), for the control of bleeding in 333 patients with mild haemophilia A, mild or moderate type 1 von Willebrand disease, or symptomatic carriers of haemophilia A. Overall, 278 patients received 2170 doses of high-dose DDAVP intranasal spray (1.5 mg mL(-1)). Using study-defined guidelines, patients evaluated the efficacy of high-dose DDAVP intranasal spray (1.5 mg mL(-1)) as 'excellent' or 'good' in 743 (95%) of 784 bleeding episodes. It demonstrated 'excellent' results in 384 (93%) of 413 administrations for prophylaxis and in eight of eight uses prior to acute surgical or dental procedures. When used for the treatment of menorrhagia, the efficacy of high-dose DDAVP intranasal spray (1.5 mg mL(-1)) was rated as 'excellent' after 655 (92%) of 721 daily uses. Of 2170 doses of high-dose DDAVP intranasal spray (1.5 mg mL(-1)), 172 (8%) were associated with adverse events. A total of 272 adverse events were reported among 80 patients. Of these, 239 (88%) were mild or moderate in intensity and only one patient was removed from the study due to an adverse event. These results demonstrate the safety and efficacy of high-dose DDAVP intranasal spray (1.5 mg mL(-1)) for control of bleeding episodes in patients with mildly decreased levels of factor VIII, von Willebrand factor, or both.
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Authors | C Leissinger, D Becton, C Cornell Jr, J Cox Gill |
Journal | Haemophilia : the official journal of the World Federation of Hemophilia
(Haemophilia)
Vol. 7
Issue 3
Pg. 258-66
(May 2001)
ISSN: 1351-8216 [Print] England |
PMID | 11380629
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Deamino Arginine Vasopressin
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Topics |
- Administration, Intranasal
- Adolescent
- Adult
- Blood Loss, Surgical
(prevention & control)
- Child
- Child, Preschool
- Cohort Studies
- Consumer Product Safety
- Deamino Arginine Vasopressin
(administration & dosage, toxicity)
- Female
- Follow-Up Studies
- Hemophilia A
(complications, drug therapy)
- Hemorrhage
(drug therapy, etiology, prevention & control)
- Heterozygote
- Humans
- Male
- Menorrhagia
(drug therapy, prevention & control)
- Middle Aged
- Therapeutic Equivalency
- von Willebrand Diseases
(complications, drug therapy)
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