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Hormonal Contraception and Risk of Thromboembolism in Women With Diabetes Care Volume 40, February 2017 233 Hormonal Contraception and Risk Sarah H. O’Brien,1,2 Terah Koch,2 Sara K. Vesely,3 and of Thromboembolism in Women Eleanor Bimla Schwarz4 With Diabetes Diabetes Care 2017;40:233–238 | DOI: 10.2337/dc16-1534 EPIDEMIOLOGY/HEALTH SERVICES RESEARCH OBJECTIVE To investigate safety of hormonal contraception with regard to thromboembolic events in women with type 1 or 2 diabetes. RESEARCH DESIGN AND METHODS We used data from 2002–2011 in Clinformatics Data Mart to identify women in the U.S., 14–44 years of age, with an ICD-9-CM code for diabetes and a prescription for a diabetic medication or device. We examined contraceptive claims and com- pared time to thromboembolism (venous thrombosis, stroke, or myocardial in- farction) among women with diabetes dispensed hormonal contraception using a modification of Cox regression to control for age, smoking, obesity, hypertension, hyperlipidemia, diabetic complications, and history of cancer; we excluded data for 3 months after women gave birth. RESULTS We identified 146,080 women with diabetes who experienced 3,012 thromboem- bolic events. Only 28% of reproductive-aged women with diabetes had any claims for hormonal contraception, with the majority receiving estrogen-containing oral con- traceptives. Rates of thromboembolism were highest among women who used the 1Center for Innovation in Pediatric Practice, contraceptive patch (16 per 1,000 woman-years) and lowest among women who The Research Institute at Nationwide Children’s used intrauterine (3.4 per 1,000 woman-years) and subdermal (0 per 163 woman-years) Hospital, Columbus, OH contraceptives. Compared with use of intrauterine contraception, progestin-only in- 2Division of Pediatric Hematology/Oncology, jectable contraception was associated with increased risk of thromboembolism Nationwide Children’s Hospital/The Ohio State – University, Columbus, OH (12.5 per 1,000 woman-years; adjusted hazard ratio 4.69 [95% CI 2.51 8.77]). 3Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma CONCLUSIONS Health Sciences Center, Oklahoma City, OK The absolute risk of thromboembolism among women with type 1 or 2 diabetes 4Division of General Internal Medicine, Univer- using hormonal contraception is low. Highly effective, intrauterine and subdermal sity of California, Davis, Sacramento, CA contraceptives are excellent options for women with diabetes who hope to avoid Corresponding author: Sarah H. O’Brien, sarah. [email protected]. the teratogenic effects of hyperglycemia by carefully planning their pregnancies. Received 15 July 2016 and accepted 9 November 2016. It is estimated that 2% of women in the U.S. between the ages of 20 and 39 years This article is featured in a podcast available at have diabetes (1). Because birth defects affect 5–8% of pregnancies conceived by http://www.diabetesjournals.org/content/ women with diabetes, over twice the rate of the general population, preconception diabetes-core-update-podcasts. counseling is particularly important. Planning pregnancies allows for tight glycemic © 2017 by the American Diabetes Association. control before and during pregnancy, thus decreasing congenital malformations and Readers may use this article as long as the work is properly cited, the use is educational and not fetal macrosomia (2). However, nearly two-thirds of pregnancies in women with for profit, and the work is not altered. More infor- diabetes are unplanned (3,4), and women with diabetes are less likely to receive mation is available at http://www.diabetesjournals contraceptive counseling or use contraception than women without diabetes (5–9). .org/content/license. 234 Contraception and Thromboembolism in Diabetes Diabetes Care Volume 40, February 2017 Oneconcernwithprescribing hor- 47 million unique individuals contributed only, combination, or no hormonal con- monal contraception to women with di- information to the database. Clinformatics traception. As our goal was to examine abetes is the risk of thromboembolic is composed primarily of commercial the safety of available contraceptives complications, in particular cardiovascu- health plan data and contains medical for women with type 1 and type 2 di- lar disease and stroke. Prior epidemio- claims, outpatient pharmacy claims, labo- abetes, we restricted this analysis to logic studies suggest that combined ratory results, hospitalizations, standard women with new thromboembolic hormonal contraception influences the pricing, coverage dates for members, and events. New diagnoses of MI (ICD-9-CM risk of thromboembolism to the same demographic information. Inpatient and 410.xx and 412) or stroke (ICD-9-CM 433. extent in women with and without di- outpatient services are coded with Current xx–436.xx, 437.6, 438.xx, and 671.5) had abetes, but the absolute risk of throm- Procedural Terminology codes or Health- to be associated with a hospital admis- boembolism is higher in those with care Common Procedure Coding System sion. In addition, participants identified diabetes because of the increased spon- codes. Diagnoses are coded with ICD- as having suffered a venous thromboem- taneous incidence of thromboembolism 9-CM diagnoses codes. All claims include bolism, whether that was a deep vein in these patients (10,11). In a 15-year the dates of service. Outpatient pharmacy thrombosis or pulmonary embolism, Danish historical cohort study, the rela- data include National Drug Codes, drug were required to have been dispensed tive risk of stroke and myocardial in- brand names, generic classifications, quan- an anticoagulant within 30 days of farction (MI) among women who filled tity, days supplied, and date dispensed. In- the service date indicated by the prescriptions for medications to treat di- patient drugs are not included. relevant ICD-9 code for the throm- abetes, as compared with women with- boembolism. Other health conditions Study Population out such prescriptions, was 2.73 for considered to be potential confounders We examined claims from 2002 to 2011 stroke (95% CI 2.32–3.22) and 4.66 for included hyperlipidemia (272.0–272.4), for females of reproductive age (14–44 MI (95% CI 3.88–5.61) (12). hypertension (401.x–405.x), cancer years) who had at least one ICD-9 code For women with medical conditions (140.x–172.x, 174.x–195.8x, and 200. for diabetes (250.xx) and a prescription that increase their baseline risk of throm- x–208.x), smoking (305.1 and 649.0– for a diabetic medication or device. A list boembolism, such as women with ad- 649.04), and obesity (278.00–278.01). of diabetic medications and devices was vanced diabetes, or women with diabetes Women with ICD-9 codes indicating developed by a board-certified internist and other cardiovascular risk factors, pregnancy or a postpartum state were based on medications/devices/supplies progestin-only contraceptives are rec- removed from analysis from the time of contained in the Clinformatics data set. ommended by the World Health Orga- fi Advanced diabetes, a covariate of interest, rst pregnancy code until 3 months af- nization (13). However, the majority of was defined as at least one ICD-9 code ter any diagnostic or procedure code published studies regarding progestin- indicating nephropathy (250.4x), retino- consistent with infant delivery. only contraception and thromboembo- pathy (250.5x), neuropathy (250.6x), or lism have included only healthy women Hormonal Contraception macrovascular disease (250.7x). We calcu- (14). This gap in evidence may be con- Hormonal contraception was stratified lated a Charlson Comorbidity Index for tributing to lower rates of contraceptive by type (combined oral contraceptives, each participant using modified code counseling, prescriptions, or services for transdermal patch, vaginal ring, progestin- from the Manitoba Center for Health women with diabetes as compared with only pills, injection, subcutaneous implant, Policy (16). The majority of the diagnoses women without a chronic medical con- or intrauterine device [IUD]), type of listed in the Clinformatics database ex- dition (15). progestin (categorized as desogestrel/ tended to the fourth or fifth digit, allow- In a recent systematic review, most gestodene, drospirenone, or levonorges- ing the comorbidity index to produce progestin-only contraceptives were not trel/other), and estrogen dose ($30 reliable results. associated with increased odds of venous or ,30 mg). Duration of contraception Age at entry was based on a woman’s or arterial thrombotic events (14). How- use was calculated in woman-years. This first ICD-9 code for diabetes or prescrip- ever, even in the few studies in which allowed fluidity among the groups so tion for a diabetic medication. However, women with diabetes were included, that a woman using more than one type if an individual was ,14 years of age at the sample sizes were small, and women of hormonal birth control over the time of time of first ICD-9 code for diabetes, she with diabetes were not analyzed sepa- her participation in the cohort could be was not included in the cohort until she rately. Our study, therefore, used a large included in multiple contraceptive groups. turned 14 years of age. Likewise, women administrative health care claims data- Length of time on each hormonal con- were excluded from the cohort once they set to investigate dispensing of prescrip- traceptive was determined by using the turned 45 years of age. Observation time tion contraception to women with type 1 Medication History Estimator (MHE) pro- was calculated
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