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The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect.
BJU Int. 2005 Apr; 95(6):804-9.BI

Abstract

OBJECTIVE

To investigate the pharmacokinetic profile of oral desmopressin in elderly patients with nocturia, and to analyse any possible correlation between the absorption and clinical effect.

PATIENTS AND METHODS

In all, 32 patients were screened to determine the baseline number of nocturnal voids and the nocturia index; of these, 24 fulfilled the inclusion criteria and were enrolled for a pharmacokinetic evaluation of oral desmopressin 400 microg. A double-blind, randomized, placebo-controlled, crossover-effect evaluation period was then used to test the association between the absorption of desmopressin and pharmacodynamic effect. Serial plasma samples were collected for 8 h for a pharmacokinetic analysis of desmopressin. The pharmacodynamics after an equivalent oral dose before bedtime were assessed by measuring changes in the number of nocturnal voids, time to first nocturnal void and nocturnal diuresis, from placebo to active treatment.

RESULTS

There was a linear relationship between plasma desmopressin at 2 h after dosing and the area under the plasma concentration curve from 0 to infinity (Pearson's rho 0.923, P < 0.001). Women had a significantly higher plasma desmopressin concentration than men (P = 0.0012) and more adverse events. There was no correlation between plasma desmopressin at 2 h after dosing and the within-patient response in any of the effect variables. Generally, the number of nocturnal voids and nocturnal diuresis were half that with placebo. The time to the first nocturnal void was almost doubled compared with placebo.

CONCLUSIONS

There seems to be a relationship between gender, plasma level of desmopressin and the incidence of adverse events. Plasma desmopressin at 2 h after dosing cannot be used to predict the pharmacodynamic response, although desmopressin lowers the nocturnal diuresis and the number of nocturnal voids.

Authors+Show Affiliations

Department of Clinical Experimental Research, Aarhus University Hospital, DK-8200 Aarhus N, Denmark. g.hvistendahl@dadlnet.dkNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15794787

Citation

Hvistendahl, Gitte M., et al. "The Pharmacokinetics of 400 Microg of Oral Desmopressin in Elderly Patients With Nocturia, and the Correlation Between the Absorption of Desmopressin and Clinical Effect." BJU International, vol. 95, no. 6, 2005, pp. 804-9.
Hvistendahl GM, Riis A, Nørgaard JP, et al. The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect. BJU Int. 2005;95(6):804-9.
Hvistendahl, G. M., Riis, A., Nørgaard, J. P., & Djurhuus, J. C. (2005). The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect. BJU International, 95(6), 804-9.
Hvistendahl GM, et al. The Pharmacokinetics of 400 Microg of Oral Desmopressin in Elderly Patients With Nocturia, and the Correlation Between the Absorption of Desmopressin and Clinical Effect. BJU Int. 2005;95(6):804-9. PubMed PMID: 15794787.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect. AU - Hvistendahl,Gitte M, AU - Riis,Anders, AU - Nørgaard,Jens P, AU - Djurhuus,Jens C, PY - 2005/3/30/pubmed PY - 2005/5/17/medline PY - 2005/3/30/entrez SP - 804 EP - 9 JF - BJU international JO - BJU Int VL - 95 IS - 6 N2 - OBJECTIVE: To investigate the pharmacokinetic profile of oral desmopressin in elderly patients with nocturia, and to analyse any possible correlation between the absorption and clinical effect. PATIENTS AND METHODS: In all, 32 patients were screened to determine the baseline number of nocturnal voids and the nocturia index; of these, 24 fulfilled the inclusion criteria and were enrolled for a pharmacokinetic evaluation of oral desmopressin 400 microg. A double-blind, randomized, placebo-controlled, crossover-effect evaluation period was then used to test the association between the absorption of desmopressin and pharmacodynamic effect. Serial plasma samples were collected for 8 h for a pharmacokinetic analysis of desmopressin. The pharmacodynamics after an equivalent oral dose before bedtime were assessed by measuring changes in the number of nocturnal voids, time to first nocturnal void and nocturnal diuresis, from placebo to active treatment. RESULTS: There was a linear relationship between plasma desmopressin at 2 h after dosing and the area under the plasma concentration curve from 0 to infinity (Pearson's rho 0.923, P < 0.001). Women had a significantly higher plasma desmopressin concentration than men (P = 0.0012) and more adverse events. There was no correlation between plasma desmopressin at 2 h after dosing and the within-patient response in any of the effect variables. Generally, the number of nocturnal voids and nocturnal diuresis were half that with placebo. The time to the first nocturnal void was almost doubled compared with placebo. CONCLUSIONS: There seems to be a relationship between gender, plasma level of desmopressin and the incidence of adverse events. Plasma desmopressin at 2 h after dosing cannot be used to predict the pharmacodynamic response, although desmopressin lowers the nocturnal diuresis and the number of nocturnal voids. SN - 1464-4096 UR - https://www.unboundmedicine.com/medline/citation/15794787/The_pharmacokinetics_of_400_microg_of_oral_desmopressin_in_elderly_patients_with_nocturia_and_the_correlation_between_the_absorption_of_desmopressin_and_clinical_effect_ L2 - https://doi.org/10.1111/j.1464-410X.2005.05405.x DB - PRIME DP - Unbound Medicine ER -