H2020Индивидуална стипендия2020–2023

InPreSS · International Pregnancy Safety Study

„Хоризонт 2020“ — Действия „Мария Склодовска-Кюри“

Период: 2020-09-01 → 2023-03-04
Финансиране от ЕС: 219 876 €
Участници: 2
Схема: MSCA-IF

Линиите свързват координатора с партньорите.

Накратко на български

Безопасността на лекарствата срещу диабет тип 2, като метформин, се анализира чрез проследяване на риск от малформации при бебетата. Данните помагат на лекарите и бременните жени да вземат по-информирани решения за лечението, тъй като тези пациентки често липсват в клиничните изпитвания.

Този кратък обзор е генериран от изкуствен интелект

Кратко обяснение, генерирано от езиков модел по текста на CORDIS. Оригиналът е по-долу.

Резултати накратко

International Pregnancy Safety Study

The majority of pregnant women take prescribed medication. However, for many medications there is limited knowledge of the efficacy and safety for both the woman and fetus. Pregnant women are largely excluded from clinical trials and post-marketing surveillance has been scarce and inadequate thus far. Therefore, we must rely on studies based on observational data to provide evidence for health professionals and pregnant women to make informed decisions on their treatments. Among women of childbearing age, diabetes mellitus has become an increasingly important public health problem in the last decades. Consequently, type 2 diabetes is now one of the most common disorders complicating pregnancy. Poorly controlled type 2 diabetes has been associated with significant maternal, fetal, and neonatal morbidity and mortality. Therefore, there is an increasing demand for safe and effective antidiabetic medication (ADM) for use in pregnancy. Therefore, the overall objective of this fellowship was to assess the safety of the medications used to treat type 2 diabetes by investigating the risk of major malformations in infants prenatally exposed to metformin and to newer 2nd line non-insulin antidiabetic medications including sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogues, and sodium-glucose co-transporter 2 (SGLT2) inhibitors. This objective was achieved by using data from US insurance claims databases, health care data from Israel, and the Nordic population health registers within the International Pregnancy Safety Study consortium (InPreSS). Combined, these sources include data for an unprecedented number of pregnant women for use in these high-quality pharmacoepidemiological observational research studies.

Текст от CORDIS, на английски · Данни: CORDIS, © Европейски съюз

Цел на проекта

This is a proposal for a global fellowship position within the International Pregnancy Safety Study (InPreSS), a recently established international collaboration based at the Centre for Pharmacoepidemiology, Karolinska Institute (CPE/KI), Sweden, between researchers in all five Nordic countries and the Harvard School of Public Health (HSPH), USA. The majority of pregnant women take prescription drugs but there is limited evidence of their efficacy and safety. InPreSS aims to conduct exceedingly important research into the risk and benefits of prescribed drug use during pregnancy. The overarching objective of this fellowship is to provide advanced training in reproductive pharmacoepidemiology while creating a platform from which to launch an independent academic career in the EU. Three specific aims are to: 1) investigate the efficacy/safety of prescribed drugs used treatment of diabetes during pregnancy; 2) to trial the InPreSS international research model to evaluate short- and long-term infant and maternal health outcomes following use of prescribed drugs for chronic disease treatment during pregnancy using an unparalleled global resources of over 5 million pregnancies; 3) provide experience and mentorship at HSPH to design and deliver courses in pharmacoepidemiology in Sweden. Aims will be achieved via an 18-month out-going phase at HSPH where the Fellow will use the latest methodologies in pharmacoepidemiology to analyze a dataset comprised of US health insurance data, and a 12-month return-phase at CPE/KI where the results will be combined using meta-regression techniques. The Fellow will receive the highest quality support while facilitating long-term partnerships, training the next generation of researchers, and contributing to the field with studies that will directly impact clinical practice and guidelines for pregnant women.

Оригинален текст от CORDIS (на английски).

Участници

KAROLINSKA INSTITUTET · STOCKHOLMКоординаторШвеция
PRESIDENT AND FELLOWS OF HARVARD COLLEGE · CambridgeСъединени щати