Tags

Type your tag names separated by a space and hit enter

Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users.
Obstet Gynecol. 2007 Feb; 109(2 Pt 1):339-46.OG

Abstract

OBJECTIVE

To estimate the incidence of venous thromboembolism, acute myocardial infarction, and ischemic stroke among transdermal contraceptive system users compared with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol.

METHODS

We began with insurance claims data from UnitedHealthcare. We identified women exposed to the transdermal contraceptive system or norgestimate-containing oral contraceptives from April 2002 through December 2004. Outcomes were confirmed from medical records. We calculated incidence rates and age-adjusted incidence rate ratios. In a nested case-control analysis, we investigated and controlled for confounding.

RESULTS

There were 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman-years of norgestimate-containing oral contraceptives exposure. There was a more than two-fold increase in the venous thromboembolism rate (incidence rate ratio 2.2, 95% confidence interval [CI] 1.3-3.8) among transdermal contraceptive system users (20 cases, 40.8 per 100,000 woman-years) compared with norgestimate-containing oral contraceptives users (37 cases, 18.3 per 100,000 woman-years). Acute myocardial infarction occurred in three transdermal contraceptive system users compared with seven among norgestimate-containing oral contraceptives users (incidence rate ratio 1.8, 95% CI 0.5-6.8). No strokes occurred among transdermal contraceptive system users, whereas 10 occurred among norgestimate-containing oral contraceptives users. In the nested case-control analysis, after exclusions for high-risk factors, the odds ratio for venous thromboembolism was 2.4 (95% CI 1.1-5.5).

CONCLUSION

There was a more than two-fold increase in the risk of venous thromboembolism associated with use of the transdermal contraceptive system. Acute myocardial infarction and stroke occurred too rarely to ascertain precise risk estimates.

LEVEL OF EVIDENCE

II.

Authors+Show Affiliations

i3 Drug Safety, Auburndale, Massachusetts, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17267834

Citation

Cole, J Alexander, et al. "Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users." Obstetrics and Gynecology, vol. 109, no. 2 Pt 1, 2007, pp. 339-46.
Cole JA, Norman H, Doherty M, et al. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007;109(2 Pt 1):339-46.
Cole, J. A., Norman, H., Doherty, M., & Walker, A. M. (2007). Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstetrics and Gynecology, 109(2 Pt 1), 339-46.
Cole JA, et al. Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users. Obstet Gynecol. 2007;109(2 Pt 1):339-46. PubMed PMID: 17267834.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. AU - Cole,J Alexander, AU - Norman,Heather, AU - Doherty,Michael, AU - Walker,Alexander M, PY - 2007/2/3/pubmed PY - 2007/2/28/medline PY - 2007/2/3/entrez SP - 339 EP - 46 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 109 IS - 2 Pt 1 N2 - OBJECTIVE: To estimate the incidence of venous thromboembolism, acute myocardial infarction, and ischemic stroke among transdermal contraceptive system users compared with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol. METHODS: We began with insurance claims data from UnitedHealthcare. We identified women exposed to the transdermal contraceptive system or norgestimate-containing oral contraceptives from April 2002 through December 2004. Outcomes were confirmed from medical records. We calculated incidence rates and age-adjusted incidence rate ratios. In a nested case-control analysis, we investigated and controlled for confounding. RESULTS: There were 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman-years of norgestimate-containing oral contraceptives exposure. There was a more than two-fold increase in the venous thromboembolism rate (incidence rate ratio 2.2, 95% confidence interval [CI] 1.3-3.8) among transdermal contraceptive system users (20 cases, 40.8 per 100,000 woman-years) compared with norgestimate-containing oral contraceptives users (37 cases, 18.3 per 100,000 woman-years). Acute myocardial infarction occurred in three transdermal contraceptive system users compared with seven among norgestimate-containing oral contraceptives users (incidence rate ratio 1.8, 95% CI 0.5-6.8). No strokes occurred among transdermal contraceptive system users, whereas 10 occurred among norgestimate-containing oral contraceptives users. In the nested case-control analysis, after exclusions for high-risk factors, the odds ratio for venous thromboembolism was 2.4 (95% CI 1.1-5.5). CONCLUSION: There was a more than two-fold increase in the risk of venous thromboembolism associated with use of the transdermal contraceptive system. Acute myocardial infarction and stroke occurred too rarely to ascertain precise risk estimates. LEVEL OF EVIDENCE: II. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/17267834/Venous_thromboembolism_myocardial_infarction_and_stroke_among_transdermal_contraceptive_system_users_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=17267834.ui DB - PRIME DP - Unbound Medicine ER -