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Metabolic syndrome and the effectiveness of low-dose aspirin on reproductive outcomes

Nobles, Carrie J.1; Mendola, Pauline1; Mumford, Sunni L.1; Kim, Keewan1; Sjaarda, Lindsey1; Hill, Micah2; Silver, Robert M.3; Naimi, Ashley I.4; Perkins, Neil J.1; Schisterman, Enrique F.1

doi: 10.1097/EDE.0000000000001019
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Background: Metabolic syndrome is associated with increases in both inflammation and aspirin resistance, but effectiveness of aspirin in improving reproductive health among women with metabolic syndrome is unknown. We evaluated the effectiveness of low-dose aspirin in improving reproductive outcomes across metabolic syndrome score.

Methods: The EAGeR trial randomly assigned 1228 women with a history of pregnancy loss to receive 81 mg aspirin or placebo for up to six menstrual cycles of attempting pregnancy and, if they became pregnant, throughout pregnancy. We assessed components of metabolic syndrome at enrollment, including: waist circumference ≥88 cm, triglycerides ≥150 mg/dL, high-density lipoprotein ≤50 mg/dL, blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic, and glucose ≥100 mg/dL. We summed components to calculate metabolic syndrome score.

Results: A total of 229 participants (20%) met full criteria for metabolic syndrome, 207 (18%) had two components, 366 (31%) one component, and 372 (32%) no components. Among those without any component of metabolic syndrome, aspirin was associated with 10.7 (95% CI 1.2, 20.2) more pregnancies and 13.7 (95% CI 3.3, 24.0) more live births per 100 couples. Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome.

Conclusions: Low-dose aspirin is most effective in increasing pregnancy and live birth among women with no or few components of metabolic syndrome. Reduced effectiveness among women with metabolic syndrome may be due to differences in effective dose or aspirin resistance.

1Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Bethesda MD 20817

2Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, 8901 Rockville Pike, Bethesda, MD 20852

3Obstetrics and Gynecology, School of Medicine, University of Utah, 50 North Medical Drive, Salt Lake City, UT 84132

4Department of Epidemiology, School of Public Health, University of Pittsburgh, 5131 Public Health Building, 130 DeSoto Street, Pittsburgh, PA 15261

Conflicts of Interest: None declared

Sources of Funding: This research was supported by the International Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (National Institutes of Health, Bethesda, MD, USA; contract numbers HHSN267200603423, HHSN267200603424, and HHSN267200603426); Ashley I Naimi was supported by R01 HD093602

Data Sharing: Please see http://grants.nih.gov/grants/policy/data_sharing/ for National Institutes of Health data sharing policy

Acknowledgments: We thank all of the EAGeR participants for their commitment to the study, the EAGeR investigators and staff and the members of the data safety monitoring board.

Clinical trials registration: ClinicalTrials.gov (no. NCT00467363)

Corresponding author: Enrique F. Schisterman, Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 20892, USA. Fax: 301-402-2084, Telephone: 301-435-6893, schistee@mail.nih.gov

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