open access

Vol 1, No 6 (2012)
Review articles (submitted)
Published online: 2013-03-11
Get Citation

Safety of rapid-acting insulin analogues in pregnant women with diabetes in view of approved prescribing information

Jacek Sieradzki, Adam Stefański
Diabetologia Kliniczna 2012;1(6):233-238.

open access

Vol 1, No 6 (2012)
Review articles (submitted)
Published online: 2013-03-11

Abstract

Diabetes accompanying pregnancy exposes both the mother and the foetus to a number of risks. Good glycaemic control during pregnancy is a key factor to reduce those risks and, therefore, glycaemic goals in this condition are very restrictive. In Poland, only insulin is recommended for the pharmacological treatment of diabetes during pregnancy. Due to the specific situation of pregnant women, when the safety of medicines affects both the mother and the foetus, clinical trials are subject to significant limitations and their results are evaluated with extreme caution. For many years, there have been discussions about the safety of rapid-acting insulin analogues and the possibility of their use during pregnancy. The current records of registration in Poland (summaries of product characteristics) indicate that insulin aspart, lispro and glulisine are registered in all types of diabetes, and they do not explicitly prohibit use of any of them in pregnant women. At the same time they inform about the various states of knowledge on the safety of each of the analogues in pregnancy. The safety of insulin aspart and lispro appears to be well substantiated, but lack of data from studies with insulin glulisine makes it not possible to assess its safety in pregnancy.

Abstract

Diabetes accompanying pregnancy exposes both the mother and the foetus to a number of risks. Good glycaemic control during pregnancy is a key factor to reduce those risks and, therefore, glycaemic goals in this condition are very restrictive. In Poland, only insulin is recommended for the pharmacological treatment of diabetes during pregnancy. Due to the specific situation of pregnant women, when the safety of medicines affects both the mother and the foetus, clinical trials are subject to significant limitations and their results are evaluated with extreme caution. For many years, there have been discussions about the safety of rapid-acting insulin analogues and the possibility of their use during pregnancy. The current records of registration in Poland (summaries of product characteristics) indicate that insulin aspart, lispro and glulisine are registered in all types of diabetes, and they do not explicitly prohibit use of any of them in pregnant women. At the same time they inform about the various states of knowledge on the safety of each of the analogues in pregnancy. The safety of insulin aspart and lispro appears to be well substantiated, but lack of data from studies with insulin glulisine makes it not possible to assess its safety in pregnancy.

Get Citation

Keywords

gestational diabetes; pregestational diabetes; rapid-acting insulin analogues safety; summary of product characteristics

About this article
Title

Safety of rapid-acting insulin analogues in pregnant women with diabetes in view of approved prescribing information

Journal

Clinical Diabetology

Issue

Vol 1, No 6 (2012)

Pages

233-238

Published online

2013-03-11

Bibliographic record

Diabetologia Kliniczna 2012;1(6):233-238.

Keywords

gestational diabetes
pregestational diabetes
rapid-acting insulin analogues safety
summary of product characteristics

Authors

Jacek Sieradzki
Adam Stefański

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

 

Wydawcą serwisu jest  "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk

tel.:+48 58 320 94 94, faks:+48 58 320 94 60, e-mail:  viamedica@viamedica.pl