Department of Research & Evaluation News

The use of antidiabetic medications, such as insulin and metformin, before and during pregnancy increased from 2001 through 2007, according to a study published in the journal Obstetrics & Gynecology.

Dr. Jean M. Lawrence, ScD, MPH, MSSA, of Kaiser Permanente Southern California Department of Research & Evaluation led the study.  The research team investigated 437,950 pregnancies from 10 health maintenance organizations across the U.S. from 2001 through 2007. The study was published in January 2013.

The researchers found that

·         In more than 1 percent of deliveries, women had taken medications used to treat diabetes in the four months before becoming pregnant.   

·         The use of these medications before pregnancy increased from 0.66 percent of deliveries in 2001, to 1.66 percent of deliveries in 2007.

·         The 2.5-fold increase was due to a rise in the use of the drug metformin.

·         Of the women who used metformin, less than 15 percent had diabetes prior to pregnancy, while two-thirds had polycystic ovarian syndrome or infertility. 

·         In the cases where these medications were used to treat diabetes, just over 3 percent of deliveries were to women who used these medications during the second or third trimester of pregnancy. 

·         The use of these medications during pregnancy increased from 2.8 percent of deliveries in 2001, to 3.6 percent of deliveries in 2007, representing a 29 percent increase.

The size and the scope of this study allowed researchers to describe the exposure to antidiabetic medications before and during pregnancy, Lawrence said, and is the first step in the process toward understanding the potential public health effect of using antidiabetic medications during these important developmental periods.

The prevalence of gestational diabetes mellitus, diabetes, and insulin resistance likely led to the increase, Lawrence said.

Lawrence is part of the Medication Exposure in Pregnancy Risk Evaluation Program study, which is a collaborative effort between the U.S. Food and Drug Administration (FDA) and researchers from 11 health-plan affiliated research institutions: Kaiser Permanente Colorado, Georgia, Northern California, Southern California and Northwest (Oregon, Washington); Group Health Research Institute (Washington); Harvard Pilgrim Health Care Institute (Massachusetts); HealthPartners Research Foundation (Minnesota); LCF Research (New Mexico);  Meyers Primary Care Institute (Massachusetts);  and Tennessee State Medicaid (through the auspices of Vanderbilt University School of Medicine). The Tennessee group did not participate in this study.

Lawrence said the next step for the Medication Exposure in Pregnancy Risk Evaluation Program involves assessing fetal harm, including low birth weight, and prediction of women at highest risk for complications in relation to their use of antidiabetic medication.

In addition to Lawrence, authors on this study were

·         Susan E. Andrade, ScD, Meyers Primary Care Institute and University of Massachusetts Medical School, Worcester, Mass.

·         Lyndsay A. Avalos, PhD, MPH, Division of Research, Kaiser Permanente Northern California, Oakland, Calif.

·         Sarah J. Beaton, PhD, LCF Research, Albuquerque, N.M.

·         Vicki Y. Chiu, MS, Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, Calif.

·         Robert L. Davis, MD, MPH, Center for Health Research, Kaiser Permanente Georgia, Atlanta, Ga.

·         Sascha Dublin, MD, PhD, Group Health Research Institute, Seattle, Wash.

·         Pamala A. Pawloski, PharmD, HealthPartners Research Foundation, Bloomington, Minn.  

·         Marsha A. Raebel, PharmD, Institute for Health Research, Kaiser Permanente Colorado, Denver, Colo.

·         David H. Smith, RPh, PhD, Center for Health Research, Kaiser Permanente Northwest, Portland, Ore.

·         Sengwee Toh, ScD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.

·         Jean Q. Wang, MS, Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, Calif.

·         Sigal Kaplan, PhD, B Pharm, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Md.

·         Thushi Amini, PhD, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Md.

·         Christian Hampp, PhD, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Md.

·         Tarek A. Hammad, MD, PhD, MSc^, MS, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Md.;

^·          Pamela E. Scott, PhD^, MA, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Md.

·         T. Craig Cheetham, PharmD, MS,   Pharmacy Analytical Service, Kaiser Permanente Southern California, Downey, Calif. on behalf of the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) Study Group