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Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen.
Lancet. 1995 Dec 16; 346(8990):1593-6.Lct

Abstract

Recent concern about the safety of combined oral contraceptives (OCs) with third-generation progestagens prompted an examination of data from a population-based case-control study (Leiden Thrombophilia Study). We compared the risk of deep-vein thrombosis (DVT) during use of the newest OCs, containing a third-generation progestagen, with the risk of "older" products. We also investigated the influence of family history of thrombosis, previous pregnancy, age, and the thrombogenic factor V Leiden mutation. We selected 126 women with DVT and 159 controls aged 15-49 (mean age 34.9) and premenopausal and found, as compared with non-users, the highest age-adjusted relative risks to be that for an OC containing desogestrel and 30 micrograms ethinyloestradiol (relative risk [RR] 8.7, 95% CI 3.9-19.3). We found lower relative risks for all other types of OC, ranging from 2.2 to 3.8. In a direct comparison, users of the desogestrel-containing oral contraceptive had a 2.5-fold higher risk (95% CI 1.2-5.2) than users of all other OC types combined. The relative risk for the desogestrel-containing OC was similar among women with and without a family history--ie, preferential prescription because of family history cannot explain our findings. Nor could the excess risk be explained by previous pregnancy, and it was highest in the youngest age categories, where we would expect most new users. The age-adjusted RR for the desogestrel-containing contraceptive was 9.2 (3.9-21.4) among non-carriers of the factor V Leiden mutation and 6.0 (1.9-19.0) among carriers of the mutation. This latter risk is superimposed on the 8-fold increased risk of venous thrombosis for carriers of the factor V Leiden mutation. The risk of carriers using the desogestrel-containing OC as compared with noncarrier non-users will therefore be increased almost 50-fold. Use of low-dose OCs with a third-generation progestagen carries a higher risk of DVT than the previous generation of OCs. The absolute risk of DVT associated with these OCs seems to be especially high among carriers of the factor V Leiden mutation and among women with a family history of thrombosis. However, the higher risk associated with OC with a third-generation progestagen compared with previous generations was also present in women without factor V Leiden and with no family history.

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Authors+Show Affiliations

Bloemenkamp KW
Department of Obstetrics, Gynaecology, and Reproductive Medicine, University Hospital Leiden, Netherlands.
Rosendaal FR
No affiliation info available
Helmerhorst FM
No affiliation info available
Büller HR
No affiliation info available
Vandenbroucke JP
No affiliation info available

MeSH

AdolescentAdultContraceptives, Oral, CombinedDesogestrelEthinyl EstradiolFactor VFemaleHumansMiddle AgedMutationProgestinsRisk FactorsThrombophlebitis

Pub Type(s)

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

Language

eng

PubMed ID

7500751

Citation

Bloemenkamp, K W., et al. "Enhancement By Factor V Leiden Mutation of Risk of Deep-vein Thrombosis Associated With Oral Contraceptives Containing a Third-generation Progestagen." Lancet (London, England), vol. 346, no. 8990, 1995, pp. 1593-6.
Bloemenkamp KW, Rosendaal FR, Helmerhorst FM, et al. Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet. 1995;346(8990):1593-6.
Bloemenkamp, K. W., Rosendaal, F. R., Helmerhorst, F. M., Büller, H. R., & Vandenbroucke, J. P. (1995). Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet (London, England), 346(8990), 1593-6.
Bloemenkamp KW, et al. Enhancement By Factor V Leiden Mutation of Risk of Deep-vein Thrombosis Associated With Oral Contraceptives Containing a Third-generation Progestagen. Lancet. 1995 Dec 16;346(8990):1593-6. PubMed PMID: 7500751.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. AU - Bloemenkamp,K W, AU - Rosendaal,F R, AU - Helmerhorst,F M, AU - Büller,H R, AU - Vandenbroucke,J P, PY - 1995/12/16/pubmed PY - 1995/12/16/medline PY - 1995/12/16/entrez KW - Biology KW - Case Control Studies KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Methods KW - Desogestrel KW - Developed Countries KW - Diseases KW - Embolism KW - Europe KW - Family Planning KW - Genetics KW - Levonorgestrel KW - Netherlands KW - Oral Contraceptives KW - Oral Contraceptives, Combined KW - Research Methodology KW - Research Report KW - Studies KW - Thromboembolism KW - Thrombosis--determinants KW - Vascular Diseases KW - Western Europe SP - 1593 EP - 6 JF - Lancet (London, England) JO - Lancet VL - 346 IS - 8990 N2 - Recent concern about the safety of combined oral contraceptives (OCs) with third-generation progestagens prompted an examination of data from a population-based case-control study (Leiden Thrombophilia Study). We compared the risk of deep-vein thrombosis (DVT) during use of the newest OCs, containing a third-generation progestagen, with the risk of "older" products. We also investigated the influence of family history of thrombosis, previous pregnancy, age, and the thrombogenic factor V Leiden mutation. We selected 126 women with DVT and 159 controls aged 15-49 (mean age 34.9) and premenopausal and found, as compared with non-users, the highest age-adjusted relative risks to be that for an OC containing desogestrel and 30 micrograms ethinyloestradiol (relative risk [RR] 8.7, 95% CI 3.9-19.3). We found lower relative risks for all other types of OC, ranging from 2.2 to 3.8. In a direct comparison, users of the desogestrel-containing oral contraceptive had a 2.5-fold higher risk (95% CI 1.2-5.2) than users of all other OC types combined. The relative risk for the desogestrel-containing OC was similar among women with and without a family history--ie, preferential prescription because of family history cannot explain our findings. Nor could the excess risk be explained by previous pregnancy, and it was highest in the youngest age categories, where we would expect most new users. The age-adjusted RR for the desogestrel-containing contraceptive was 9.2 (3.9-21.4) among non-carriers of the factor V Leiden mutation and 6.0 (1.9-19.0) among carriers of the mutation. This latter risk is superimposed on the 8-fold increased risk of venous thrombosis for carriers of the factor V Leiden mutation. The risk of carriers using the desogestrel-containing OC as compared with noncarrier non-users will therefore be increased almost 50-fold. Use of low-dose OCs with a third-generation progestagen carries a higher risk of DVT than the previous generation of OCs. The absolute risk of DVT associated with these OCs seems to be especially high among carriers of the factor V Leiden mutation and among women with a family history of thrombosis. However, the higher risk associated with OC with a third-generation progestagen compared with previous generations was also present in women without factor V Leiden and with no family history. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/7500751/Enhancement_by_factor_V_Leiden_mutation_of_risk_of_deep_vein_thrombosis_associated_with_oral_contraceptives_containing_a_third_generation_progestagen_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(95)91929-5 DB - PRIME DP - Unbound Medicine ER -