Open AccessThe study of clinical bioequivalence drug Nativa (generic desmopressin acetate tablets) in patients with central diabetes insipidus
Author(s) -
Ekaterina Pigarova,
Larisa Dzeranova
Publication year - 2016
Publication title -
ožirenie i metabolizm
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.154
H-Index - 5
eISSN - 2306-5524
pISSN - 2071-8713
DOI - 10.14341/omet2016146-48
Subject(s) - medicine , diabetes insipidus , desmopressin , diuresis , pediatrics , urology , diabetes mellitus , endocrinology , renal function
Materials and methods. The study included 15 patients (9 women and 6 men) with central diabetes insipidus (CDI), compensated by therapy with a tablet formulation Minirin (diuresis up to 3000 ml). The average age of the patients was 44 ± 8 years. For 3 days during treatment Minirin we evaluated the clinical manifestations of the CDI. On the fourth day, Minirin was replaced by Nativa in the equivalent dose, with further correction whennecessary. From the 4th to the 6th day of treatment with Nativawe assessed the same parameters as on the initial therapy.Results. The vast majority of patients did not require dose adjustment and, if necessary, dose adjustment was small and accounted for about 20% of the original dose. Average dose did not differ in patients receiving Minirin or Nativa, 0.43 ± 0.26 vs. 0.45 ± 0.32 (p 0.05).Conclusions. Nativa is characterized by therapeutic equivalence to Minirin in patients with a central form of diabetes insipidus.