Effects of short-term and long-term danazol treatment on lipoproteins, coagulation, and progression of atherosclerosis: Two clinical trials in healthy volunteers and patients with hereditary angioedema

Clinical Therapeutics

Volumn 30, Issue 12, 2008, Pages 2314-2323

  Birjmohun, Rakesh S ^a   Kees Hovingh, G ^a   Stroes, Erik S G ^a   Hofstra, Jorit J ^a   Dallinga Thie, Geesje M ^a   Meijers, Joost C M ^a   Kastelein, John J P ^a   Levi, Marcel ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

androgens; C1 inhibitor; cardiovascular risk; danazol; HDL; lipids

Indexed keywords

APOLIPOPROTEIN A1; ARYLDIALKYLPHOSPHATASE 1; C REACTIVE PROTEIN; CHOLESTEROL ESTER TRANSFER PROTEIN; COMPLEMENT COMPONENT C1S INHIBITOR; DANAZOL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPOPROTEIN; PHOSPHATIDYLCHOLINE STEROL ACYLTRANSFERASE; PHOSPHOLIPID TRANSFER PROTEIN; PLACEBO;

ACNE; ADULT; ANGIONEUROTIC EDEMA; ARTERIAL WALL THICKNESS; ARTICLE; ATHEROGENESIS; ATHEROSCLEROSIS; BLOOD CLOTTING; BODY MASS; BODY WEIGHT; CARDIOVASCULAR RISK; CAROTID ARTERY; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE COURSE; DRUG EFFECT; DRUG TOLERABILITY; ENZYME ACTIVITY; FEMALE; FIBRINOLYSIS; GLUCOSE BLOOD LEVEL; HAIR LOSS; HEADACHE; HUMAN; INFLAMMATION; LONG TERM CARE; MALE; NORMAL HUMAN; SHORT COURSE THERAPY; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME;

ADULT; ANGIOEDEMA, HEREDITARY; APOLIPOPROTEIN A-I; ATHEROSCLEROSIS; BLOOD COAGULATION; CAROTID ARTERIES; CHOLESTEROL ESTER TRANSFER PROTEINS; CHOLESTEROL, HDL; CLINICAL TRIALS AS TOPIC; CROSS-OVER STUDIES; CROSS-SECTIONAL STUDIES; DANAZOL; DISEASE PROGRESSION; FEMALE; HUMANS; LIPOPROTEINS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TESTOSTERONE CONGENERS; TIME FACTORS; TRIGLYCERIDES; TUNICA INTIMA;

EID: 58249140089     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2008.12.021     Document Type: Article

References (42)

1. Miller G.J., and Miller N.E. Plasma-high-density-lipoprotein concentration and development of ischaemic heart-disease. Lancet 1 (1975) 16-19
2. Miller N.E., Thelle D.S., Forde O.H., and Mjos O.D. The Tromsθ Heart-Study. High-density lipoprotein and coronary heart-disease: A prospective case-control study. Lancet 1 (1977) 965-968
3. Miller N.E., La Ville A., and Crook D. Direct evidence that reverse cholesterol transport is mediated by high-density lipoprotein in rabbit. Nature 314 (1985) 109-111
4. Sampietro T., Bigazzi F., Dal Pino B., et al. Increased plasma C-reactive protein in familial hypoalphalipoproteinemia: A proinflammatory condition?. Circulation 105 (2002) 11-14
5. Eichinger S., Pecheniuk N.M., Hron G., et al. High-density lipoprotein and the risk of recurrent venous thromboembolism. Circulation 115 (2007) 1609-1614
6. Bisoendial R.J., Hovingh G.K., Levels J.H., et al. Restoration of endothelial function by increasing high-density lipoprotein in subjects with isolated low high-density lipoprotein. Circulation 107 (2003) 2944-2948
7. Hovingh G.K., Brownlie A., Bisoendial R.J., et al. A novel apoA-I mutation (L178P) leads to endothelial dysfunction, increased arterial wall thickness, and premature coronary artery disease. J Am Coll Cardiol 44 (2004) 1429-1435
8. Birjmohun R.S., Hutten B.A., Kastelein J.J., and Stroes E.S. Efficacy and safety of high-density lipoprotein cholesterol-increasing compounds: A meta-analysis of randomized controlled trials. J Am Coll Cardiol 45 (2005) 185-197
9. Gooren L.J., and Giltay E.J. Review of studies of androgen treatment of female-to-male transsexuals: Effects and risks of administration of androgens to females. J Sex Med 5 (2008) 765-776
10. Weidmann P., de Courten M., Ferrari P., and Böhlen L. Serum lipoproteins during treatment with antihypertensive drugs. J Cardiovasc Pharmacol 22 Suppl 6 (1993) S98-S105
11. Hoogerbrugge N., Jansen H., and Birkenhäger J.C. Danazol in the treatment of endometriosis and hereditary angiooedema. J Intern Med 237 (1995) 603-604
12. Gelfand J.A., Sherins R.J., Alling D.W., and Frank M.M. Treatment of hereditary angioedema with danazol. Reversal of clinical and biochemical abnormalities. N Engl J Med 295 (1976) 1444-1448
13. Pappalardo E., Zingale L.C., and Cicardi M. Increased expression of C1-inhibitor mRNA in patients with hereditary angioedema treated with danazol. Immunol Lett 86 (2003) 271-276
14. Drouet C., Désormeaux A., Robillard J., et al. Metallopeptidase activities in hereditary angioedema: Effect of androgen prophylaxis on plasma aminopeptidase P. J Allergy Clin Immunol 121 (2008) 429-433
15. Széplaki G., Varga L., Valentin S., et al. Adverse effects of danazol prophylaxis on the lipid profiles of patients with hereditary angioedema. J Allergy Clin Immunol 115 (2005) 864-869
16. Packard C.J., and Shepherd J. Action of danazol on plasma lipids and lipoprotein metabolism. Acta Obstet Gynecol Scand Suppl 159 (1994) 35-40
17. Shepherd J. Danazol and plasma lipoprotein metabolism. Int J Gynaecol Obstet 50 Suppl 1 (1995) S23-S26
18. Szegedi R., Széplaki G., Varga L., et al. Long-term danazol prophylaxis does not lead to increased carotid intimamedia thickness in hereditary angioedema patients. Atherosclerosis 198 (2008) 184-191
19. Friedewald W.T., Levy R.I., and Fredrickson D.S. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 18 (1972) 499-502
20. Mackness B., Durrington P., McElduff P., et al. Low paraoxonase activity predicts coronary events in the Caerphilly Prospective Study. Circulation 107 (2003) 2775-2779
21. Mezdour H., Kora I., Parra H.J., et al. Two-site enzyme immunoassay of cholesteryl ester transfer protein with monoclonal and oligoclonal antibodies. Clin Chem 40 (1994) 593-597
22. Hovingh G.K., Hutten B.A., Holleboom A.G., et al. Compromised LCAT function is associated with increased atherosclerosis. Circulation 112 (2005) 879-884
23. Dullaart R.P., Sluiter W.J., Dikkeschei L.D., et al. Effect of adiposity on plasma lipid transfer protein activities: A possible link between insulin resistance and high density lipoprotein metabolism. Eur J Clin Invest 24 (1994) 188-194
24. Speijer H., Groener J.E., van Ramshorst E., and van Tol A. Different locations of cholesteryl ester transfer protein and phospholipid transfer protein activities in plasma. Atherosclerosis 90 (1991) 159-168
25. van Doorn M.B., Burggraaf J., van Dam T., et al. A phase I study of recombinant human C1 inhibitor in asymptomatic patients with hereditary angioedema. J Allergy Clin Immunol 116 (2005) 876-883
26. Allen J.K., and Fraser I.S. Cholesterol, high density lipoprotein and danazol. J Clin Endocrinol Metab 53 (1981) 149-152
27. Burry K.A., Patton P.E., and Illingworth D.R. Metabolic changes during medical treatment of endometriosis: Nafarelin acetate versus danazol. [published correction appears in Am J Obstet Gynecol. 1989;161:1755]. Am J Obstet Gynecol 160 (1989) 1454-1459 discussion 1459-1461
28. Crook D., Gardner R., Worthington M., et al. Zoladex versus danazol in the treatment of pelvic endometriosis: Effects on plasma lipid risk factors. Horm Res 32 Suppl 1 (1989) 157-160
29. Fåhraeus L., Larsson-Cohn U., Ljungberg S., and Wallentin L. Plasma lipoproteins during and after danazol treatment. Acta Obstet Gynecol Scand Suppl 123 (1984) 133-135
30. Fåhraeus L., Larsson-Cohn U., Ljungberg S., and Wallentin L. Profound alterations of the lipoprotein metabolism during danazol treatment in premenopausal women. Fertil Steril 42 (1984) 52-57
31. Fraser I.S., Shearman R.P., Jansen R.P., and Sutherland P.D. A comparative treatment trial of endometriosis using the gonadotrophin-releasing hormone agonist, nafarelin, and the synthetic steroid, danazol. Aust N Z J Obstet Gynaecol 31 (1991) 158-163
32. Henzl M.R., Corson S.L., Moghissi K., et al. Administration of nasal nafarelin as compared with oral danazol for endometriosis. A multicenter doubleblind comparative clinical trial. N Engl J Med 318 (1988) 485-489
33. The Nafarelin European Endometriosis Trial Group (NEET). Nafarelin for endometriosis: A large-scale, danazol-controlled trial of efficacy and safety, with 1-year follow-up. Fertil Steril 57 (1992) 514-522
34. Schweppe K.W., and Assmann G. Changes of plasma lipids and lipoprotein levels during danazol treatment for endometriosis. Horm Metab Res 16 (1984) 593-597
35. Telimaa S., Penttilä I., Puolakka J., et al. Circulating lipid and lipoprotein concentrations during danazol and high-dose medroxyprogesterone acetate therapy of endometriosis. Fertil Steril 52 (1989) 31-35
36. Välimäki M., Nilsson C.G., Roine R., and Ylikorkala O. Comparison between the effects of nafarelin and danazol on serum lipids and lipoproteins in patients with endometriosis. J Clin Endocrinol Metab 69 (1989) 1097-1103
37. Crook D., and Seed M. Endocrine control of plasma lipoprotein metabolism: Effects of gonadal steroids. Baillieres Clin Endocrinol Metab 4 (1990) 851-875
38. Birjmohun R.S., van Leuven S.I., Levels J.H., et al. High-density lipoprotein attenuates inflammation and coagulation response on endotoxin challenge in humans. Arterioscler Thromb Vasc Biol 27 (2007) 1153-1158
39. Nicholls S.J., Dusting G.J., Cutri B., et al. Reconstituted high-density lipoproteins inhibit the acute prooxidant and proinflammatory vascular changes induced by a periarterial collar in normocholesterolemic rabbits. Circulation 111 (2005) 1543-1550
40. Saidi P., Lega B.Z., Kim H.C., and Raska Jr. K. Effect of danazol on clotting factor levels, bleeding incidence, factor infusion requirements, and immune parameters in hemophilia. Blood 68 (1986) 673-679
41. Cugno M., Cicardi M., Bottasso B., et al. Activation of the coagulation cascade in C1-inhibitor deficiencies. Blood 89 (1997) 3213-3218
42. Cugno M., Cicardi M., and Agostoni A. Activation of the contact system and fibrinolysis in autoimmune acquired angioedema: A rationale for prophylactic use of tranexamic acid. J Allergy Clin Immunol 93 (1994) 870-876