HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Correction (v111,p1449) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Cole, J. A. Articles by Walker, A. M. Search for Related Content PubMed PubMed Citation Articles by Cole, J. A. Articles by Walker, A. M. Related Collections Contraception Epidemiology/public health General gynecology Internal Medicine

Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users

From i3 Drug Safety, Auburndale, Massachusetts.

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

This article has been cited by other articles:

				E. H. QUINT Menstrual Issues in Adolescents with Physical and Developmental Disabilities Ann. N.Y. Acad. Sci., June 1, 2008; 1135(1): 230 - 236. [Abstract] [Full Text] [PDF]

				H. Roberts Type of hormone replacement therapy and risk of venous thromboembolism BMJ, May 31, 2008; 336(7655): 1203 - 1204. [Full Text] [PDF]

				J. V. Johnson, J. Lowell, G. J. Badger, J. Rosing, S. Tchaikovski, and M. Cushman Effects of Oral and Transdermal Hormonal Contraception on Vascular Risk Markers: A Randomized Controlled Trial Obstet. Gynecol., February 1, 2008; 111(2): 278 - 284. [Abstract] [Full Text] [PDF]

				Increased Venous Thromboembolism in Transdermal Contraceptive Users? Journal Watch (General), February 15, 2007; 2007(215): 2 - 2. [Full Text]