Pharmacokinetics of Metformin in Girls Aged 9 Years
- PDF / 137,347 Bytes
- 4 Pages / 612.28 x 790.86 pts Page_size
- 35 Downloads / 178 Views
ORIGINAL RESEARCH ARTICLE
ª 2011 Adis Data Information BV. All rights reserved.
Pharmacokinetics of Metformin in Girls Aged 9 Years David Sa´nchez-Infantes,1 Marta Dı´az,1,2 Abel Lo´pez-Bermejo,3,4 Marı´a Victoria Marcos,5 Francis de Zegher6 and Lourdes Iba´n˜ez1,2 1 Endocrinology Unit, Hospital Sant Joan de De´u, University of Barcelona, Barcelona, Spain 2 Centro de Investigacio´n Biome´dica en Red de Diabetes y Enfermedades Metabo´licas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain 3 Department of Pediatrics, Dr Josep Trueta Hospital, Girona, Spain 4 Girona Institute for Biomedical Research, Girona, Spain 5 Endocrinology Unit, Hospital de Terrassa, Terrassa, Spain 6 Department of Woman & Child, University of Leuven, Leuven, Belgium
Abstract
Background and Objective: Metformin is a biguanide used in the treatment of type 2 diabetes mellitus. In girls with a low birth weight, and early-normal and rapidly progressive puberty, metformin therapy is capable of modifying this outcome, prolonging pubertal growth, increasing height gain, delaying the age at menarche towards normal and improving the endocrine-metabolic status of these girls. The pharmacokinetics of metformin have been studied in healthy adults and in patients with type 2 diabetes. The objective of this study was to study the pharmacokinetics of metformin in young, non-obese girls. Methods: The study population consisted of six girls with a combined history of low birth weight and earlynormal onset of puberty. At the time of the study, these girls were aged 9 years and had been receiving metformin (850 mg/day at dinner time) for a mean duration of 8 months. Blood samples were obtained from the girls before metformin intake and for 12 hours thereafter. Serum metformin concentrations were assessed by liquid chromatography with tandem mass spectrometry. The area under the serum concentrationtime curve (AUC), maximum serum concentration (Cmax), time to reach the Cmax (tmax), half-life (t½), volume of distribution (Vd) and total clearance (CL) were calculated. Results: Metformin concentration-time curves were similar in girls receiving similar metformin doses (range 21–29 mg/kg): in those girls, the mean AUC was 21 mg h/L, with a Cmax of 3 mg/L, tmax of 2.5 hours, t½ of 4 hours, Vd of 111 L and CL of 20 L/h. These values are comparable to those observed in adults. Conclusion: In girls aged 9 years, the pharmacokinetics of metformin were comparable to those in adults. Trial registration number (International Standard Randomized Controlled Trial Number Register): ISRCTN49334271
Background Metformin (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide developed from galegine, a guanidine derivative contained in Galega officinalis. Metformin is recommended as first-line therapy for patients with type 2 diabetes mellitus, regardless of age.[1] Metformin is also increasingly being used for other indications in the paediatric age range.[2] Girls with a low birth weight who experience rapid catch-up growth in infan
Data Loading...
