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Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data.
BMJ. 2011 Apr 21; 342:d2151.BMJ

Abstract

OBJECTIVE

To compare the risk of non-fatal venous thromboembolism in women receiving oral contraceptives containing drospirenone with that in women receiving oral contraceptives containing levonorgestrel.

DESIGN

Nested case-control and cohort study.

SETTING

The study was based on information from PharMetrics, a United States based company that collects information on claims paid by managed care plans.

PARTICIPANTS

The study encompassed all women aged 15 to 44 years who received an oral contraceptive containing either drospirenone or levonorgestrel after 1 January 2002. Cases were women with current use of a study oral contraceptive and a diagnosis of venous thromboembolism in the absence of identifiable clinical risk factors (idiopathic venous thromboembolism). Up to four controls were matched to each case by age and calendar time.

MAIN OUTCOME MEASURES

Odds ratios comparing the risk of non-fatal venous thromboembolism in users of the two contraceptives; incidence rates and rate ratios of non-fatal venous thromboembolism for users of each of the study contraceptives.

RESULTS

186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100,000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100,000 woman years among users of oral contraceptives containing levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing levonorgestrel was 2.8 (2.1 to 3.8).

CONCLUSIONS

The risk of non-fatal venous thromboembolism among users of oral contraceptives containing drospirenone seems to be around twice that of users of oral contraceptives containing levonorgestrel, after the effects of potential confounders and prescribing biases have been taken into account.

Authors+Show Affiliations

Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, MA 02421, USA. sjick@bu.eduNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

21511805

Citation

Jick, Susan S., and Rohini K. Hernandez. "Risk of Non-fatal Venous Thromboembolism in Women Using Oral Contraceptives Containing Drospirenone Compared With Women Using Oral Contraceptives Containing Levonorgestrel: Case-control Study Using United States Claims Data." BMJ (Clinical Research Ed.), vol. 342, 2011, pp. d2151.
Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ. 2011;342:d2151.
Jick, S. S., & Hernandez, R. K. (2011). Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ (Clinical Research Ed.), 342, d2151. https://doi.org/10.1136/bmj.d2151
Jick SS, Hernandez RK. Risk of Non-fatal Venous Thromboembolism in Women Using Oral Contraceptives Containing Drospirenone Compared With Women Using Oral Contraceptives Containing Levonorgestrel: Case-control Study Using United States Claims Data. BMJ. 2011 Apr 21;342:d2151. PubMed PMID: 21511805.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. AU - Jick,Susan S, AU - Hernandez,Rohini K, Y1 - 2011/04/21/ PY - 2011/4/23/entrez PY - 2011/4/23/pubmed PY - 2011/7/12/medline SP - d2151 EP - d2151 JF - BMJ (Clinical research ed.) JO - BMJ VL - 342 N2 - OBJECTIVE: To compare the risk of non-fatal venous thromboembolism in women receiving oral contraceptives containing drospirenone with that in women receiving oral contraceptives containing levonorgestrel. DESIGN: Nested case-control and cohort study. SETTING: The study was based on information from PharMetrics, a United States based company that collects information on claims paid by managed care plans. PARTICIPANTS: The study encompassed all women aged 15 to 44 years who received an oral contraceptive containing either drospirenone or levonorgestrel after 1 January 2002. Cases were women with current use of a study oral contraceptive and a diagnosis of venous thromboembolism in the absence of identifiable clinical risk factors (idiopathic venous thromboembolism). Up to four controls were matched to each case by age and calendar time. MAIN OUTCOME MEASURES: Odds ratios comparing the risk of non-fatal venous thromboembolism in users of the two contraceptives; incidence rates and rate ratios of non-fatal venous thromboembolism for users of each of the study contraceptives. RESULTS: 186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100,000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100,000 woman years among users of oral contraceptives containing levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing levonorgestrel was 2.8 (2.1 to 3.8). CONCLUSIONS: The risk of non-fatal venous thromboembolism among users of oral contraceptives containing drospirenone seems to be around twice that of users of oral contraceptives containing levonorgestrel, after the effects of potential confounders and prescribing biases have been taken into account. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/21511805/Risk_of_non_fatal_venous_thromboembolism_in_women_using_oral_contraceptives_containing_drospirenone_compared_with_women_using_oral_contraceptives_containing_levonorgestrel:_case_control_study_using_United_States_claims_data_ L2 - http://www.bmj.com/cgi/pmidlookup?view=long&pmid=21511805 DB - PRIME DP - Unbound Medicine ER -