A reevaluation of the risk for venous thromboembolism with the use of oral contraceptives and hormone replacement therapy

Archives of Internal Medicine

Volumn 157, Issue 14, 1997, Pages 1522-1530

  Douketis, James D ^a,c   Ginsberg, Jeffrey S ^a   Holbrook, Anne ^a,b   Crowther, Mark ^a   Duku, Eric K ^a   Burrows, Robert F ^a  

^a MCMASTER UNIVERSITY   (Canada)

^b CENTRE FOR EVALUATION OF MEDICINES   (Canada)

^c ST JOSEPH S HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ORAL CONTRACEPTIVE AGENT;

EVALUATION AND FOLLOW UP; HORMONE SUBSTITUTION; HYPERCOAGULABILITY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; THROMBOEMBOLISM; VEIN THROMBOSIS;

EID: 0030802060     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.157.14.1522     Document Type: Review

References (95)

1. Rebar RW The ovaries. In: Wyngaarden JB, Smith LH Jr, Bennett JC, eds. Cecil Textbook of Medicine. Philadelphia, Pa: WB Saunders Co; 1992: 1372-1374.
2. Carr BR, Wilson JD; Isselbacher KJ, Braunwald E, Wilson JD, Martin JB, Fauci AS, Kasper DL, eds. Harrison's Principles of Internal Medicine. New York, NY: McGraw-Hill Book Co; 1994:2031-2033.
3. Sartwell PE, Stolley PD. Oral contraceptives and vascular disease. Epidemiol Rev. 1982;4:95-109.
4. Thorogood M, Vessey MP. An epidemiologic survey of cardiovascular disease in women taking oral contraceptives. Am J Obstet Gynecol. 1990;163: 274-281.
5. Stadel BV. Oral contraceptives and cardiovascular disease. N Engl J Med. 1981;305:612-618.
6. Scott JR, Di Saia PJ, Hammond CB, Spellacy WN, eds. Danforth's Obstetrics and Gynecology. Philadelphia, Pa: JB Lippincott Co; 1994:783-788.
7. Meade TW. Risks and mechanisms of cardiovascular events in users of oral contraceptives. Am J Obstet Gynecol. 1988;158:1646-1652.
8. Comp PC, Zacur HA. Contraceptive choices in women with coagulation disorders. Am J Obstet Gynecol. 1993;168:1990-1993.
9. Astedt B. Does estrogen replacement therapy predispose to thrombosis? Acta Obstet Gynecol Scand. 1985;130(suppl):71-74.
10. Salzman EW, Hirsh J. The epidemiology, pathogenesis and natural history of venous thrombosis. In: Colman RW, Hirsh J, Salzman EW, eds. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. Philadelphia, Pa: JB Lippincott; 1994:1275-1296.
11. Population reports: lower-dose pills. Popul Rep A. November 1988:1-31.
12. Belchetz PE. Hormonal treatment of postmenopausal women. N Engl J Med. 1994;330:1062-1071.
13. Goldzieher JW. Hormonal Contraception: Pills, Injections and Implants. London, Ontario: Emis-Canada; 1994:124-126.
14. American College of Physicians. Guidelines for counseling postmenopausal women about preventive hormone therapy. Ann Intern Med. 1992; 117-1038-1041.
15. Grady D, Rubin SM, Petitti DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med. 1992;117: 1016-1041.
16. Kiel DP, Felson DT, Anderson JJ, Wilson PWh, Moskowitz MA. Hip fracture and the use of estrogens in postmenopausal women. N Engl J Med. 1987;317:1169-1174.
17. Cauley JA, Seeley DG, Ensrud K, et al. Estrogen replacement therapy and fractures in older women. Ann Intern Med. 1995;122:9-16.
18. Barrett-Connor E, Bush TL. Estrogen use and coronary artery disease in women. JAMA. 1991;265: 1861-1867.
19. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology: A Basic Science for Clinical Medicine. Boston, Mass: Little Brown & Co Inc; 1991:283-304.
20. Horwitz RI, Feinstein AR, Hoak JC. Alternative data sources and discrepant results in case-control studies of estrogens and endometrial cancer. Am J Epidemiol. 1980;111:389-394.
21. Fleiss JL. Statistical Methods for Rates and Proportions. New York, NY: John Wiley & Sons Inc; 1973:1, 43-47.
22. Elwood JM. Causal Relationships in Medicine: A Practical Guide for Critical Appraisal. New York, NY: Oxford University Press Inc; 1988:125-162.
23. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies. J Natl Cancer Inst. 1959;22:719-748.
24. Vessey MP, Doll R. Investigation of relation between use of oral contraceptives and thromboembolic disease. BMJ. 1968;2:199-205.
25. Vessey MP, Doll R. Investigation of relation between use of oral contraceptives and thromboembolic disease: a further report. BMJ. 1969;2: 651-657.
26. Boston Collaborative Drug Surveillance Programme. Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumours. Lancet. 1973; 1:1399-1404.
27. Stolley PD, Tonascia JA, Tockman MS, Sartwell PE, Rutledge AH, Jacobs MP. Thrombosis with low-estrogen oral contraceptives. Am J Epidemiol. 1975;102:197-208.
28. Maguire MG,Tonascia J, Sartwell PE, Stolley PD, Tockman MS. Increased risk of thrombosis due to oral contraceptives: a further report. Am J Epidemiol. 1979;110:188-195.
29. Sartwell PE, Masi AT, Arthes FG, Greene GR, Smith HE. Thromboembolism and oral contraceptives: an epidemiologic case-control study. Am J Epidemiol. 1969;90:365-380.
30. Porter JB, Hunter JR, Jack H, Stergachis A. Oral contraceptives and non-fatal vascular disease. J Am Coll Obstet Gynecol. 1985;66:1-4.
31. Porter JB, Hunter JR, Danielson DA, Jick H, Stergachis A. Oral contraceptives and nonfatal vascular disease-recent experience. Obstet Gynecol. 1982;59:299-302.
32. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components Lancet. 1995;346:1589-593.
33. Helmrich SP, Piper JM, Kaufman DW, Strom B, Shapiro S. Venous thromboembolism in relation to oral contraceptive use. Obstet Gynecol. 1987; 69:91-95.
34. Valla D, Le MG, Poynard T, Zucman N, Rueff B, Benhamou J-P. Risk of hepatic vein thrombosis in relation to recent use of oral contraceptives: a case-control study. Gastroenterology. 1986;90: 807-811.
35. Quinn DA, Thompson T, Terrin M, et al. A prospective evaluation of pulmonary embolism in men and women. JAMA. 1992;268:1689-1696.
36. Vandenbroucke JP, Koster T, Briet E, 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;1:1453-1457.
37. Bloemenkamp KWM, Rosendaal FR, Helmerhorst FM, Buller HR, Vandenbroucke JP. Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet. 1995;346:1593-1596.
38. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Venous thromboembolic disease and oral contraceptives: results of international multicentre case-control study. Lancet. 1995;246:1575-1582.
39. World Health Organization Collaborative Study of Cardiovascular Disease and Steriod Hormone Contraception. Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet. 1995;346:1582-1588.
40. Spitzer WO, Lewis AL, Heinemann LAJ, Thorogood M, MacRae KD, on behalf of the 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;312:83-88.
41. Vessey M, Malt D, Smith A, Adeste D. Oral contraceptives and venous thromboembolism: findings in a large prospective study. BMJ. 1986;292: 526.
42. Royal College of General Practitioners' Oral Contraceptive Study. Oral contraceptives, venous thrombosis, and varicose veins. J R Coll Gen Pract 1978;28:393-399.
43. Grodstein F, Stampfer MJ, Goldhaber SZ, et al. Prospective study of exogenous hormone use and risk of pulmonary embolism. Lancet. 1996;348:983-987.
44. Records Unit and Research Advisory Service of the Royal College of General Practitioners. Oral contraception and thrombo-embolic disease. J R Coll Gen Pract. 1967;13:267-279.
45. Pettiti DB, Wingerd J, Pellegrin F, Ramcharan S. Oral contraceptives, smoking, and other factors in relation to risk of venous thrombotic disease. Am J Epidemiol. 1978;108:480-485.
46. Fuertes-de la Haba A, Curet JO, Pelegrina I, Bangdiwala I. Thrombophlebitis among oral and non-oral contraceptive users. J Reprod Med. 1971; 38:259-263.
47. The Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: the postmenopausal estrogen/progestin interventions (PEPI) trial. JAMA. 1995;273:199-208.
48. Natchigall LE, Natchigall RH, Natchigall RD, Beckman EM. Estrogen replacement therapy, II: a prospective study in the relationship to carcinoma and cardiovascular and metabolic problems. Obstet Gynecol. 1979;54:74-79.
49. Boston Collaborative Drug Surveillance Program, Boston University Medical Center. Surgically confirmed gallbladder disease, venous thromboembolism, and breast tumors in relation to postmenopausal estrogen therapy. N Engl J Med. 1974;290:15-19.
50. Pettiti DB, Wingerd J, Pellegrin F, Ramcharan S. Risk of vascular disease in women: smoking, oral contraceptives, concontraceptive estrogens, and other factors. JAMA. 1979;242:1150-1154.
51. Devor M, Barrett-Connor E, Renvall M, Feigal D Jr, Ramsdell J. Estrogen replacement and the risk of venous thrombosis. Am J Med. 1992;92:275-282.
52. Jick H, Derby LE, Myers MW, Vasilakis C, Newton KM. Risk of hospital admission tor idiopathic venous thromboembolism among users of postmenopausal oestrogens. Lancet. 1996;348:981-983.
53. Daly E, Vessey MP, Hawkins MM, Carson JL, Gough P, Marsh S. Risk of venous thromboembolism in users of hormone replacement therapy. Lancet. 1996;348:977-980.
54. Daly E, Vessey MP, Painter R, Hawkins MM. Case-control study of venous thromboembolism risk in users of hormone replacement therapy. Lancet. 1996;348:1027.
55. Vessey MP, McPherson K, Johnson B. Mortality among women participating in the Oxford/ Family Planning Association Contraception Study. Lancet. 1977;2:731-733.
56. Thorogood M, Mann J, Murphy M, Vessey M. Risk factors for fatal venous thromboembolism in young women: a case-control study. Int J Epidemiol. 1992;21:48-52.
57. Fuertes-de la Haba A, Cuevas JOC, Pelegrina I, Bangdiwala I. Deaths among users of oral and non-oral contraceptives. Obstet Gynecol. 1970;36: 597-602.
58. Royal College of General Practitioners' Oral Contraception Study. Further analysis of mortality in oral contraceptive users. Lancet. 1981;1:541-546.
59. Inman WHW, Vessey MP. Investigation of deaths from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. BMJ. 1968;2:193-199.
60. Landis RJ, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159-174.
61. Vessey MP. Some rare methodologic problems in the investigation of rare adverse effects to oral contraceptives. Am J Epidemiol. 1971;94:202-209.
62. The pros and cons of the pill. Time. 1968;58:60.
63. A new warning about birth control pills. Good Housekeeping. 1968;167:156.
64. Perils of the pill. Newsweek. 1968;71:66.
65. Keirkegaard A. Deep vein thrombosis and the oestrogen content in oral contraceptives: an epidemiologic analysis. Contraception. 1985;31:29-41.
66. Coon WW, Willis PW III, Keller JB. Venous thromboembolism and other venous disease in the Tecumseh Community Health Study. Circulation. 1973;43:839-846.
67. McLachlin J, Richards T, Paterson JC. An evaluation of clinical signs in the diagnosis of venous thrombosis. Arch Surg. 1962;85:58-64.
68. 125I-labelled fibrinogen. Br J Surg. 1968;55:742-747.
69. Nicholaides AN, Kakkar VV, Field ES, Renney JTG. The origin of deep vein thrombosis: a venographic study. Br J Radiol. 1971;44:653-663.
70. Haeger K. Problems of acute deep vein thrombosis, I: the interpretation of clinical signs and symptoms. Angiology. 1969;20:219-223.
71. Barnes RW, Wu KK, Hoak JC. Fallibility of the clinical diagnosis of deep vein thrombosis. JAMA. 1975;234:605-607.
72. Hildner FJ, Ormond RS. Accuracy of the clinical diagnosis of pulmonary embolism. JAMA 1967; 202:115-118.
73. Dalen JE, Brooks HL, Johnson LW, Meister SG, Szucs M Jr, Dexter L. Pulmonary angiography in acute pulmonary embolism: indications, techniques, and results in 367 patients. Am Heart J. 1971;81:175-185.
74. Lensing AWA, Hirsh J, Buller H. Diagnosis of deep vein thrombosis. In: Colman RW, Hirsh J, Marder VJ, Salzman JB, eds. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. Philadelphia, Pa: JB Lippincott; 1994:1297-321.
75. Hirsh J, Betman M, Coates G, Hull RD. Diagnosis of pulmonary embolism. In: Colman RW, Hirsh J, Marder VJ, Salzman JB, eds. Hemostasis and Thrombosis: Basic Principles and Clinical Practice. Philadelphia, Pa: JB Lippincott; 1994:1322-1330.
76. McLachlan MSF, Thomson JG, Taylor DW, Kelly ME, Sacken DL. Observer variation in the interpretation of lower limb venograms. Am J Radiol. 1979;132:227-229.
77. Rossman J. True incidence of pulmonary embolization and vital statistics. JAMA. 1974;230:1677-1683.
78. Petersen KR, Sidelmann J, Skouby SO, Jespersen J. Effects of low-dose oral contraceptives on fibrin formation and resolution in young women. Am J Obstet Gynecol. 1993;168:32-38.
79. Quehenberger P, Loner U, Kapiotis S, et al. Increased levels of activated factor VII and decreased plasma protein S activity and circulating thrombomodulin during use of oral contraceptives. Thromb Haemost. 1996;76:729-734.
80. Boerger LM, Morris PC, Thurnau GR, Esmon CT, Comp PC. Oral contraceptives and gender affect protein S status. Blood. 1987;69:692-694.
81. Daly L, Bonnar J. Comparative studies of 30 μg ethinyl estradiol combined with gestodene and desogestrel on blood coagulation, fibrinolysis, and platelets. Am J Obstet Gynecol. 1990;163:430-437.
82. Jesperson J, Pertersen KR, Skouby SO. Effects of newer oral contraceptives on the inhibition of coagulation in relation to the dosage and the type of steroid. Am J Obstet Gynecol. 1990;163:396-403.
83. Skouby SO. Oral contraceptives: effects on glucose and lipid metabolism on insulin-dependent women and women with previous gestational diabetes. Dan Med Bull. 1988;35:157-166.
84. Mammen EF. Oral contraceptives and blood coagulation: a critical review. Am J Obstet Gynecol. 1982;142:781-790.
85. Lewis MA, Heinemann LAJ, MacRae KD, Bruppacher R, Spitzer WO. The increased risk of venous thromboembolism and the use of third generation progestogens: role of bias in observational research. Contraception. 1996;54:5-13.
86. The Coronary Drug Project Research Group. The coronary drug project: initial findings leading to modifications of its research protocol. JAMA. 1970; 214:1303-1313.
87. The Coronary Drug Project Research Group. The coronary drug project: findings leading to discontinuation of the 2.5-mg/day estrogen group. JAMA. 1973;226:652-657.
88. Williams SR, Frenchek B, Speroff T, Speroff L. A study of combined continuous ethinyl estradiol and norethindrone acetate for postmenopausal hormone replacement. Am J Obstet Gynecol. 1990; 162:438-446.
89. Levesque H, Cailleux N, Courtois H. Hormone replacement therapy in menopause, hemostasis and thromboembolic risk. J Mal Vasc. 1994;19:93-97.
90. Bush TL, Barrett-Connor E. Noncontraceptive estrogen use and cardiovascular disease. Epidemiol Rev. 1985;7:80-104.
91. Schulman S, Rhedin A-S, Lindmarker P, et al. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. N Engl J Med. 1995; 322:1661-1665.
92. Prandoni P, Lensing AWA, Buller HR, et al. Deep-vein thrombosis and the incidence of subsequent symptomatic cancer. NEngl J Med. 1992; 327:1128-1133.
93. Levine M, Hirsh J, Gent M, et al. Optimal duration of oral anticoagulant therapy: a randomized trial comparing four weeks with three months of warfarin in patients with proximal deep vein thrombosis. Thromb Haemost. 1995;74:1-6.
94. Research Committee of the British Thoracic Society. Optimum duration of anticoagulation for deep-vein thrombosis and pulmonary embolism. Lancet. 1992;340:873-876.
95. Prandoni P, Lensing AWA, Cogo A, et al. The long-term clinical course of acute deep vein thrombosis. Ann Intern Med. 1996;125:1-7.