The increased risk of venous thromboembolism and the use of third generation progestagens: Role of bias in observational research

Contraception

Volumn 54, Issue 1, 1996, Pages 5-13

  Lewis, Michael A ^a,b   Heinemann, Lothar A J ^b,c   MacRae, Kenneth D ^d   Bruppacher, Rudolph ^a,b,e   Spitzer, Walter O ^b  

^a Potsdam Inst P   (Germany)

^b MCGILL UNIVERSITY   (Canada)

^c Berlin Center for Epidemiology and Health Research   (Germany)

^d CHARING CROSS HOSPITAL   (United Kingdom)

^e UNIVERSITY OF BASEL   (Switzerland)

Author keywords

bias; case control study; norgestimate; oral contraceptives; susceptibility; venous thromboembolism

Indexed keywords

CHLORMADINONE ACETATE PLUS MESTRANOL; CONCEPLAN; DESOGESTREL; DESOGESTREL PLUS ETHINYLESTRADIOL; DIANE; DIENOGEST PLUS ETHINYLESTRADIOL; ETHINYLESTRADIOL; ETHINYLESTRADIOL PLUS ETYNODIOL DIACETATE; ETHINYLESTRADIOL PLUS GESTODENE; ETHINYLESTRADIOL PLUS LEVONORGESTREL; ETHINYLESTRADIOL PLUS LYNESTRENOL; ETHINYLESTRADIOL PLUS NORETHISTERONE ACETATE; ETHINYLESTRADIOL PLUS NORGESTIMATE; GESTAGEN; GESTODENE; LEVONORGESTREL; LYNESTRENOL PLUS MESTRANOL; NEO EUNOMIN; NON OVLON; NORGESTIMATE; ORAL CONTRACEPTIVE AGENT; OXYSMEN; UNCLASSIFIED DRUG;

ADOLESCENT; ADULT; ARTICLE; CASE CONTROL STUDY; CLINICAL TRIAL; CONTRACEPTION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG FORMULATION; FEMALE; GERMANY; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; RISK ASSESSMENT; THROMBOEMBOLISM; UNITED KINGDOM;

EID: 0030200017     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/0010-7824(96)00112-6     Document Type: Article

References (20)

1. 1. Thorogood M. Oral contraceptives and cardiovascular disease: An epidemiologic overview. Pharmacoepidemiol Drug Saf 1993;2:3-16.
2. 2. Farley TMM, Meirik O, Chang CL, Marmot MG, Poulter NR, World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet 1995;346:1582-8.
3. 3. Spitzer WO, Lewis MA, Heinemann LAJ, Thorogood M, MacRae KD, Transnational Research Group on Oral Contraceptives and the Health of Young Women. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. BMJ 1996;312:83-8.
4. 4. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG, World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case-control study. Lancet 1995;346:1575-82.
5. 5. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 1995;346:1589-93.
6. 6. Bloemenkamp KWM, Rosendaal FR, Helmerhorst FM, Büller HR, Vandenbroucke JP. Enhancement of factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet 1995;346:1589-93.
7. 7. Simpson JL, Elstein M. Safety of modern oral contraceptives (Letter). Lancet 1996;347:257.
8. 8. Lewis MA, Spitzer WO, Heinemann LAJ, MacRae KD, Bruppacher R, Thorogood M. Transnational Research Group on Oral Contraceptives and the Health of Young Women. Third generation oral contraceptives and risk of myocardial infarction: an international case-control study. BMJ 1996;312:88-90.
9. 9. Jick H, Jick SS, Myers MW. Risk of acute myocardial infarction and low-dose combined oral contraceptives (Letter). BMJ 1996;347:627-8.
10. 10. Spitzer WO, Thorogood M, Heinemann L. Trinational case-control study of oral contraceptives and health. Pharmacoepidemiol Drug Saf 1993;2:21-31.
11. 11. Lewis MA, Assman A, Heinemann L, Spitzer WO. Transnational case-control study of oral contraceptives and health. Approved protocol revisions through September, 1995. Pharmacoepidemiol Drug Saf 1996;5:43-51.
12. 12. Poulter NR, Chang CL, Farley TMM, Marmot MG, World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. A multinational case-control study of cardiovascular disease and steroid hormone contraceptives. Description and validation of methods. J Clin Epidemiol 1995;48:1513-47.
13. 13. StataCorp. Stata Statistical Software: Release 4.0. College Station, TX: Stata Corporation, 1995.
14. 14. Heinemann LAJ, Lewis MA, Assmann A, Gravens L, Guggenmoos-Holzmann I. Could preferential prescribing and referral behaviour of physicians explain the elevated thrombosis risk found to be associated with third generation oral contraceptives? Pharmacoepidemiol Drug Saf (in press).
15. 15. Kuhnz W, Beier S. Comparative progestational and androgenic activity of norgestimate and levonorgestrel in the rat. Contraception 1994;49:275-89.
16. 16. Kuhnz W, Blode H, Mahler M. Systematic availability of levonorgestrel after single dose oral administration of a norgestimate-containing combination oral contraceptive to 12 young women. Contraception 1994;49:255-63.
17. 17. Royal College of General Practitioners. Oral Contraceptives and Health. London: Pitman Medical, 1974.
18. 18. Royal College of General Practitioners. Oral Contraceptives, venous thrombosis, and varicose veins: Royal College of General Practitioners' Oral Contraception Study. Coll Gen Pract 1978;28:393-9.
19. 19. Vandenbroucke JP, Koster T, Briet EP, Reitsma PH, Bertina RM, Rosendaal FR. Increased risk of venous thrombosis in oral contraceptive users who are carriers of factor V Leiden mutation. Lancet 1994;344:1453-7.
20. 20. Rees DC, Cox M, Clegg JB. World distribution of factor V Leiden. Lancet 1995;346:1133-4.