Clinical experiences with drospirenone: From reproductive to postmenopausal years

Maturitas

Volumn 60, Issue 2, 2008, Pages 78-91

  Pérez López, Faustino R ^a  

^a UNIVERSITY OF ZARAGOZA   (Spain)

Author keywords

Antimineralocorticoid; Drospirenone; Estradiol valerate; Ethinyl estradiol; Hirsutism; Hormone replacement therapy; Postmenopausal women; Premenopausal women; Premenstrual dysphoric disorder; Premenstrual syndrome; Progestin

Indexed keywords

ALDOSTERONE ANTAGONIST; ANGIOTENSIN RECEPTOR ANTAGONIST; CONJUGATED ESTROGEN PLUS MEDROXYPROGESTERONE ACETATE; DESOGESTREL PLUS ETHINYLESTRADIOL; DIANE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DROSPIRENONE; DROSPIRENONE PLUS ESTRADIOL; DROSPIRENONE PLUS ETHINYLESTRADIOL; ESTRADIOL; ESTRADIOL VALERATE; ETHINYLESTRADIOL; ETHINYLESTRADIOL PLUS GESTODENE; ETHINYLESTRADIOL PLUS LEVONORGESTREL; HEPARIN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; POTASSIUM DERIVATIVE; SPIRONOLACTONE;

ACNE; BLEEDING; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DIARRHEA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG WITHDRAWAL; FOOD; FOOD DRUG INTERACTION; HEADACHE; HIRSUTISM; HORMONAL THERAPY; HUMAN; HYPERTENSION; ISCHEMIC HEART DISEASE; LEUKORRHEA; LOW DRUG DOSE; MASTALGIA; MENOPAUSAL SYNDROME; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NONHUMAN; OSTEOPOROSIS; POSTMENOPAUSE; PREGNANCY RATE; REPRODUCTION; REVIEW; THROMBOEMBOLISM; THROMBOSIS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VAGINA CANDIDIASIS; VENOUS THROMBOEMBOLISM;

ALDOSTERONE ANTAGONISTS; ANDROSTENES; CONTRACEPTIVES, ORAL, COMBINED; ESTROGEN REPLACEMENT THERAPY; ETHINYL ESTRADIOL; FEMALE; HUMANS; MENOPAUSE;

EID: 45849118696     PISSN: 03785122     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.maturitas.2008.03.009     Document Type: Review

References (92)

1. Jick H., Jick S.S., Gurewich V., Myers M.W., and Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 346 (1995) 1589-1593
2. Kemmeren J.M., Algra A., and Grobbee D.E. Third generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ 323 (2001) 131-134
3. 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 346 (1995) 1582-1588
4. Hulley S., Grady D., Bush T., et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA 280 (1998) 605-613
5. Rossouw J.E., Anderson G.L., Prentice R.L., et al., Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA 288 (2002) 321-333
6. Beral V., Bull D., Reeves G, and Million Women Study Collaborators. Endometrial cancer and hormone-replacement therapy in the Million Women Study. Lancet 365 (2005) 1543-1551
7. Collins P., Rosano G., Casey C., et al. Management of cardiovascular risk in the peri-menopausal woman: a consensus statement of European cardiologists and gynaecologists. Eur Heart J 28 (2007) 2028-2040
8. Rossouw J.E., Prentice R.L., Manson J.E., et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA 297 (2007) 1465-1477
9. Tannen R.L., Weiner M.G., Xie D., and Barnhart K. Estrogen affects post-menopausal women differently than estrogen plus progestin replacement therapy. Hum Reprod 22 (2007) 1769-1777
10. Oelkers W., Berger V., Bolik A., et al. Dihydrospirorenone, a new progestogen with antimineralocorticoid activity: effects on ovulation, electrolyte excretion, and the renin-aldosterone system in normal women. J Clin Endocrinol Metab 73 (1991) 837-842
11. Oelkers W., Foidart J.M., Dombrovicz N., Welter A., and Heithecker R. Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid metabolism. J Clin Endocrinol Metab 80 (1995) 1816-1821
12. Pollow K., Juchem M., Elger W., Jacobi N., Hoffmann G., and Möbus V. Dihydrospirorenone (ZK30595): a novel synthetic progestagen--characterization of binding to different receptor proteins. Contraception 46 (1992) 561-574
13. Report of a WHO Scientific Group. Cardiovascular disease and steroid hormone contraception. World Health Organ Tech Rep Ser 877 i-vii (1998) 1-89
14. Fuhrmann U., Krattenmacher R., Slater E.P., and Fritzemeier K.H. The novel progestin drospirenone and its natural counterpart progesterone: biochemical profile and antiandrogenic potential. Contraception 54 (1996) 243-251
15. Gallo M.F., Grimes D.A., Schulz K.F., and Helmerhorst F.M. Combination estrogen-progestin contraceptives and body weight: Systematic review of randomized controlled trials. Obstet Gynecol 103 (2004) 359-373
16. Gruppo di Studio Progetto Menopausa Italia. Risk factors for high blood pressure in women attending menopause clinics in Italy. Maturitas 53 (2006) 83-88
17. Yüksel H., Odabasi A.R., Demircan S., Köseoǧlu K., Kizilkaya K., and Onur E. Effects of postmenopausal hormone replacement therapy on body fat composition. Gynecol Endocrinol 23 (2007) 99-104
18. Muhn P., Krattenmacher R., Beier S., Elger W., and Schillinger E. Drospirenone: a novel progestogen with antimineralocorticoid and antiandrogenic activity. Pharmacological characterization in animal models. Contraception 51 (1995) 99-110
19. Blode H., Wuttke W, Loock W, Röll G., and Heithecker R. A 1-year pharmacokinetic investigation of a novel oral contraceptive containing drospirenone in healthy female volunteers. Eur J Contracept Reprod Health Care 5 (2000) 256-264
20. Oelkers W. Antimineralocorticoid activity of a novel oral contraceptive containing drospirenone, a unique progestogen resembling natural progesterone. Eur J Contracept Reprod Health Care 7 Suppl. 3 (2002) 19-26
21. Oelkers W.H. Drospirenone in combination with estrogens: for contraception and hormone replacement therapy. Climacteric 8 Suppl. 3 (2005) 19-27
22. Schürmann R., Blode H., Benda N., Cronin M., and Küfner A. Effect of drospirenone on serum potassium and drospirenone pharmacokinetics in women with normal or impaired renal function. Mol Cell Endocrinol 217 (2004) 255-261
23. Motivala A., and Pitt B. Drospirenone for oral contraception and hormone replacement therapy: are its cardiovascular risks and benefits the same as other progestogens?. Drugs 67 (2007) 647-655
24. Hunter M.H., and Carek P.J. Evaluation and treatment of women with hirsutism. Am Fam Physician 67 (2003) 2565-2572
25. Eng P.M., Seeger J.D., Loughlin J., Oh K., and Walker A.M. Serum potassium monitoring for users of ethinyl estradiol/drospirenone taking medications predisposing to hyperkalemia: physician compliance and survey of knowledge and attitudes. Contraception 75 (2007) 101-107
26. Schürmann R., Blode H., Benda N., Cronin M., and Küfner A. Effect of drospirenone on serum potassium and drospirenone pharmacokinetics in women with normal or impaired renal function. J Clin Pharmacol 46 (2006) 867-875
27. Oelkers W., Helmerhorst F.M., Wuttke W., and Heithecker R. Effect of an oral contraceptive containing drospirenone on the renin-angiotensin-aldosterone system in healthy female volunteers. Gynecol Endocrinol 14 (2000) 204-213
28. Palacios S., Foidart J.M., and Genazzani A.R. Advances in hormone replacement therapy with drospirenone, a unique progestogen with aldosterone receptor antagonism. Maturitas 55 (2006) 297-307
29. Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of a unique progestogen. Contraception 62 (2000) 29-38
30. Genazzani A.R., Pluchino N., Begliuomini S., et al. Drospirenone increases central and peripheral beta-endorphin in ovariectomized female rats. Menopause 14 (2007) 63-73
31. Pérez-López F.R., L'Hermite M., and Robyn C. Gonadotrophin hormone releasing tests in women receiving hormonal contraception. Clin Endocrinol (Oxf) 4 (1975) 477-485
32. Rivera R., Yacobson I., and Grimes D. The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices. Am J Obstet Gynecol 181 (1999) 1263-1269
33. Rosenbaum P., Schmidt W., Helmerhorst F.M., et al. Inhibition of ovulation by a novel progestogen (drospirenone) alone or in combination with ethinylestradiol. Eur J Contracept Reprod Health Care 5 (2000) 16-24
34. Huber J., Foidart J.M., Wuttke W., et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care 5 (2000) 25-34
35. Parsey K.S., and Pong A. An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception 61 (2000) 105-111
36. Lüdicke F., Johannisson E., Helmerhorst F.M., Campana A., Foidart J., and Heithecker R. Effect of a combined oral contraceptive containing 3 mg of drospirenone and 30 μg of ethinyl estradiol on the human endometrium. Fertil Steril 76 (2001) 102-107
37. Bachmann G., Sulak P.J., Sampson-Landers C., Benda N., and Marr J. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 μg ethinylestradiol and 3 mg drospirenone. Contraception 70 (2004) 191-198
38. Foidart J.M., Wuttke W., Bouw G.M., Gerlinger C., and Heithecker R. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care 5 (2000) 124-134
39. Gaspard U., Scheen A., Endrikat J., et al. A randomized study over 13 cycles to assess the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on carbohydrate metabolism. Contraception 67 (2003) 423-429
40. Gaspard U., Endrikat J., Desager J.P., Buicu C., Gerlinger C., and Heithecker R. A randomized study on the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on lipid and lipoprotein metabolism over a period of 13 cycles. Contraception 69 (2004) 271-278
41. Caruso S., Agnello C., Intelisano G., et al. Prospective study on sexual behavior of women using 30 μg ethinylestradiol and 3 mg drospirenone oral contraceptive. Contraception 72 (2005) 19-23
42. Schultz-Zehden B., and Boschitsch E. User experience with an oral contraceptive containing ethinylestradiol 30 μg and drospirenone 3mg (yasmin((r))) in clinical practice. Treat Endocrinol 5 (2006) 251-256
43. Paoletti A.M., Orrù M., Lello S., et al. Short-term variations in bone remodeling markers of an oral contraception formulation containing 3 mg of drospirenone plus 30 μg of ethinyl estradiol: observational study in young postadolescent women. Contraception 70 (2004) 293-298
44. Nappi C., Di Spiezio Sardo A., Greco E., et al. Effects of an oral contraceptive containing drospirenone on bone turnover and bone mineral density. Obstet Gynecol 105 (2005) 53-60
45. Blode H., Foidart J.M., and Heithecker R. Transfer of drospirenone to breast milk after a single oral administration of 3 mg drospirenone + 30 μg ethinylestradiol to healthy lactating women. Eur J Contracept Reprod Health Care 6 (2001) 167-171
46. Cibula D., Karck U., Weidenhammer H.G., Kunz J., Alincic S., and Marr J. Efficacy and safety of a low-dose 21-day combined oral contraceptive containing ethinylestradiol 20 μg and drospirenone 3 mg. Clin Drug Investig 26 (2006) 143-150
47. Spona J., Elstein M., Feichtinger W., et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception 54 (1996) 71-77
48. Sulak P.J., Scow R.D., Preece C., Riggs M.W., and Kuehl T.J. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol 95 (2000) 261-266
49. Willis S.A., Kuehl T.J., Spiekerman A.M., and Sulak P.J. Greater inhibition of the pituitary-ovarian axis in oral contraceptive regimens with a shortened hormone-free interval. Contraception 74 (2006) 100-103
50. Walker A., and Bancroft J. Relationship between premenstrual symptoms and oral contraceptive use: a controlled study. Psychosom Med 52 (1990) 86-96
51. Backstrom T., Andreen L., Birzniece V., et al. The role of hormones and hormonal treatments in premenstrual syndrome. CNS Drugs 17 (2003) 325-342
52. Fruzzetti F., Lello S., Lazzarini V., et al. The oral contraceptive containing 30 μg of ethinylestradiol plus 3 mg of drospirenone is able to antagonize the increase of extracellular water occurring in healthy young women during the luteal phase of the menstrual cycle: an observational study. Contraception 75 (2007) 199-203
53. Milsom I., Lete I., Bjertnaes A., et al. Effects on cycle control and bodyweight of the combined contraceptive ring, NuvaRing, versus an oral contraceptive containing 30 μg ethinyl estradiol and 3 mg drospirenone. Hum Reprod 21 (2006) 2304-2311
54. Apter D., Borsos A., Baumgärtner W., et al. Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms. Eur J Contracept Reprod Health Care 8 (2003) 37-51
55. Sangthawan M., and Taneepanichskul S. A comparative study of monophasic oral contraceptives containing either drospirenone 3 mg or levonorgestrel 150 μg on premenstrual symptoms. Contraception 71 (2005) 1-7
56. Freeman E.W., Kroll R., Rapkin A., et al. PMS/PMDD Research Group. Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder. J Womens Health Gend Based Med 10 (2001) 561-569
57. Paoletti A.M., Lello S., Fratta S., et al. Psychological effect of the oral contraceptive formulation containing 3 mg of drospirenone plus 30 μg of ethinyl estradiol. Fertil Steril 81 (2004) 645-651
58. Borges L.E., Andrade R.P., Aldrighi J.M., et al. Effect of a combination of ethinylestradiol 30 μg and drospirenone 3 mg on tolerance, cycle control, general well-being and fluid-related symptoms in women with premenstrual disorders requesting contraception. Contraception 74 (2006) 446-450
59. Taneepanichskul S., Jaisamrarn U., and Phupong V. Efficacy of Yasmin in premenstrual symptoms. Arch Gynecol Obstet 275 (2007) 433-438
60. Yonkers K.A., Brown C., Pearlstein T.B., Foegh M., Sampson-Landers C., and Rapkin A. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol 106 (2005) 492-501
61. Pearlstein T.B., Bachmann G.A., Zacur H.A., and Yonkers K.A. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception 72 (2005) 414-421
62. Coffee A.L., Kuehl T.J., Willis S., and Sulak P.J. Oral contraceptives and premenstrual symptoms: comparison of a 21/7 and extended regimen. Am J Obstet Gynecol 195 (2006) 1311-1319
63. Sulak P., Willis S., Kuehl T., Coffee A., and Clark J. Headaches and oral contraceptives: impact of eliminating the standard 7-day placebo interval. Headache 47 (2007) 27-37
64. Coffee A.L., Sulak P.J., and Kuehl T.J. Long-term assessment of symptomatology and satisfaction of an extended oral contraceptive regimen. Contraception 75 (2007) 444-449
65. Guido M., Romualdi D., Giuliani M., et al. Drospirenone for the treatment of hirsute women with polycystic ovary syndrome: a clinical, endocrinological, metabolic pilot study. J Clin Endocrinol Metab 89 (2004) 2817-2823
66. Batukan C., and Muderris I.I. Efficacy of a new oral contraceptive containing drospirenone and ethinyl estradiol in the long-term treatment of hirsutism. Fertil Steril 85 (2006) 436-440
67. Batukan C., Muderris I.I., Ozcelik B., and Ozturk A. Comparison of two oral contraceptives containing either drospirenone or cyproterone acetate in the treatment of hirsutism. Gynecol Endocrinol 23 (2007) 38-44
68. Pehlivanov B., and Mitkov M. Efficacy of an oral contraceptive containing drospirenone in the treatment of women with polycystic ovary syndrome. Eur J Contracept Reprod Health Care 12 (2007) 30-35
69. De Leo V., Morgante G., Piomboni P., Musacchio M.C., Petraglia F., and Cianci A. Evaluation of effects of an oral contraceptive containing ethinylestradiol combined with drospirenone on adrenal steroidogenesis in hyperandrogenic women with polycystic ovary syndrome. Fertil Steril 88 (2007) 113-117
70. van Vloten W.A., van Haselen C.W., van Zuuren E.J., Gerlinger C., and Heithecker R. The effect of 2 combined oral Contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea. Cutis 69 4 Suppl. (2002) 2-15
71. Thorneycroft H., Gollnick H., and Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis 74 (2004) 123-130
72. Moser M. Update on the management of hypertension: recent clinical trials and the JNC 7. J Clin Hypertens (Greenwich) 6 10 Suppl. 2 (2004) 4-13
73. White W.B., Pitt B., Preston R.A., and Hanes V. Antihypertensive effects of drospirenone with 17β-estradiol, a novel hormone treatment in postmenopausal women with stage 1 hypertension. Circulation 112 (2005) 1979-1984
74. White W.B., Hanes V., and Chauhan V.B. Effects of a new hormone therapy, drospirenone and 17-β-estradiol, in postmenopausal women with hypertension. Hypertension 48 (2006) 246-253
75. White W.B. Drospirenone with 17beta-estradiol in the postmenopausal woman with hypertension. Climacteric 10 Suppl. 1 (2007) 25-31
76. Preston R.A., White W.B., Pitt B., Bakris G., Norris P.M., and Hanes V. Effects of drospirenone/17-beta estradiol on blood pressure and potassium balance in hypertensive postmenopausal women. Am J Hypertens 18 (2005) 797-804
77. Tankó L.B., and Christiansen C. Effects of 17beta-oestradiol plus different doses of drospirenone on adipose tissue, adiponectin and atherogenic metabolites in postmenopausal women. J Intern Med 258 (2005) 544-553
78. Christiansen C. Effects of drospirenone/estrogen combinations on bone metabolism. Gynecol Endocrinol 18 Suppl. 1 (2004) 33
79. Margolis K.L., Adami H.O., Luo J., Ye W., and Weiderpass E. A prospective study of oral contraceptive use and risk of myocardial infarction among Swedish women. Fertil Steril 88 (2007) 310-316
80. Moreau C., Trussell J., Gilbert T., Bajos N., and Bouyer J. Oral contraceptive tolerance - does the type of pill matter?. Obstet Gynecol 109 (2007) 1277-1285
81. Heinemann L.A., and Dinger J. Safety of a new oral contraceptive containing drospirenone. Drug Saf 27 (2004) 1001-1018
82. Dinger J.C., Heinemann L.A., and Kühl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 75 (2007) 344-354
83. Seeger J.D., Loughlin J., Eng P.M., Clifford C.R., Cutone J., and Walker A.M. Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol 110 (2007) 587-593
84. Kluft C., Endrikat J., Mulder S.M., Gerlinger C., and Heithecker R. A prospective study on the effects on hemostasis of two oral contraceptives containing drospirenone in combination with either 30 or 20 μg ethinyl estradiol and a reference containing desogestrel and 30 μg ethinyl estradiol. Contraception 73 (2006) 336-343
85. Merz C.N., Johnson B.D., Berga S., Braunstein G., Reis S.E., and Bittner V. WISE Study Group Past oral contraceptive use and angiographic coronary artery disease in postmenopausal women: data from the National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation. Fertil Steril 85 (2006) 1425-1431
86. Dallongeville J., Marecaux N., Isorez D., Zylbergberg G., Fruchart J.C., and Amouyel P. Multiple coronary heart disease risk factors are associated with menopause and influenced by substitutive hormonal therapy in a cohort of French women. Atherosclerosis 118 (1995) 123-133
87. Arias-Loza P.A., Hu K., Schäfer A., et al. Medroxyprogesterone acetate but not drospirenone ablates the protective function of 17 beta-estradiol in aldosterone salt-treated rats. Hypertension 48 (2006) 994-1001
88. Simoncini T., Fu X.D., Caruso A., et al. Drospirenone increases endothelial nitric oxide synthesis via a combined action on progesterone and mineralocorticoid receptors. Hum Reprod 22 (2007) 2325-2334
89. White W.B., Hanes V., and Korner P. Drospirenone and 17-β estradiol reduces 24-h blood pressure in postmenopausal women with hypertension. Obstet Gynecol 107 (2006) 23S-24S
90. Knuuti J., Kalliokoski R., Janatuinen T., et al. Effect of estradiol-drospirenone hormone treatment on myocardial perfusion reserve in postmenopausal women with angina pectoris. Am J Cardiol 99 (2007) 1648-1652
91. Gelfand M.M., Moreau M., Ayotte N.J., Hilditch J.R., Wong B.A., and Lau C.Y. Clinical assessment and quality of life of postmenopausal women treated with a new intermittent progestogen combination hormone replacement therapy: a placebo-controlled study. Menopause 10 (2003) 29-36
92. Schwarz S., Völzke H., Alte D., et al. Menopause and determinants of quality of life in women at midlife and beyond: the study of health in Pomerania (SHIP). Menopause 14 (2007) 123-134