A review of drospirenone for safety and tolerability and effects on endometrial safety and lipid parameters contrasted with medroxyprogesterone acetate, levonorgestrel, and micronized progesterone

Journal of Women's Health

Volumn 15, Issue 5, 2006, Pages 584-590

  Shulman, Lee P ^a,b  

^a NORTHWESTERN UNIVERSITY   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DROSPIRENONE; DROSPIRENONE PLUS ESTRADIOL; ESTRADIOL; ESTRADIOL BENZOATE PLUS PROGESTERONE; ESTRADIOL PLUS LEVONORGESTREL; ESTRADIOL VALERATE PLUS MEDROXYPROGESTERONE ACETATE; GESTAGEN; HIGH DENSITY LIPOPROTEIN; LEVONORGESTREL; LOW DENSITY LIPOPROTEIN; MEDROXYPROGESTERONE ACETATE; PLACEBO; PROGESTERONE;

ACNE VULGARIS; BLOOD PRESSURE MEASUREMENT; BODY WEIGHT; CARDIOVASCULAR DISEASE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; DIZZINESS; DOSE RESPONSE; DROWSINESS; DRUG FORMULATION; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENDOMETRIUM HYPERPLASIA; FEMALE; HEADACHE; HIRSUTISM; HUMAN; HYPERTENSION; MASTALGIA; MENOPAUSAL SYNDROME; MONOTHERAPY; OSTEOPOROSIS; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RESPIRATORY TRACT INFECTION; REVIEW; STATISTICAL SIGNIFICANCE; TRIACYLGLYCEROL BLOOD LEVEL; UTERUS BLEEDING; VAGINA BLEEDING; WATER RETENTION;

ANDROSTENES; CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; ESTROGEN REPLACEMENT THERAPY; FEMALE; HUMANS; LEVONORGESTREL; MEDROXYPROGESTERONE 17-ACETATE; MEDROXYPROGESTERONE ACETATE; MENOPAUSE; PROGESTERONE; WOMEN'S HEALTH;

EID: 33746170146     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2006.15.584     Document Type: Review

References (52)

1. Schiff I, Tulchinsky D, Cramer D, Ryan KJ. Oral medroxyprogesterone in the treatment of postmenopausal symptoms. JAMA 1980;244:1443.
2. Leonetti HB, Longo S, Anasti JN. Transdermal progesterone cream for vasomotor symptoms and postmenopausal bone loss. Obstet Gynecol 1999;94:225.
3. Battino S, Ben-Ami M, Geslevich Y, Weiner E, Shalev E. Factors associated with withdrawal bleeding after administration of oral dydrogesterone or medroxyprogesterone acetate in women with secondary amenorrhea. Gynecol Obstet Invest 1996;42:113.
4. Shangold MM, Tomai TP, Cook JD, et al. Factors associated with withdrawal bleeding after administration of oral micronized progesterone in women with secondary amenorrhea. Fertil Steril 1991;56:1040.
5. Sitruk-Ware R. New progestogens: A review of their effects in perimenopausal and postmenopausal women. Drugs Aging 2004;21:865.
6. Skouby SO. The rationale for a wider range of progestogens. Climacteric 2000;3(Suppl 2):14.
7. Schneider HP. Androgens and antiandrogens. Ann NY Acad Sci 2003;997:292.
8. Sitruk-Ware R. Pharmacological profile of progestins. Maturitas 2004;47:277.
9. 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 2002;288:321.
10. 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 1998;280:605.
11. Grady D, Herrington D, Bittner V, et al. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002;288:49.
12. Lemay A. The relevance of the Women's Health Initiative results on combined hormone replacement therapy in clinical practice. J Obstet Gynaecol Can 2002;24:711,
13. Buist DS, Newton KM, Miglioretti DL, et al. Hormone therapy prescribing patterns in the United States. Obstet Gynecol 2004;104:1042.
14. Muhn P, Fuhrmann U, Fritzemeier KH, Krattenmacher R, Schillinger E. Drospirenone: A novel progestogen with antimineralocorticoid and antiandrogenic activity. Ann NY Acad Sci 1995;761:311.
15. Krattenmacher R. Drospirenone: Pharmacology and pharmacokinetics of a unique progestogen. Contraception 2000;62:29.
16. Potts RO, Lobo RA. Transdermal drug delivery: Clinical considerations for the obstetrician-gynecologist. Obstet Gynecol 2005;105:953.
17. Berman RS, Epstein RS, Lydick E. Risk factors associated with women's compliance with estrogen replacement therapy. J Womens Health 1997;6:219.
18. Cano A. Compliance to hormone replacement therapy in menopausal women controlled in a third level academic centre. Maturitas 1994;20:91.
19. Erenus M, Karakoc B, Gurler A. Comparison of effects of continuous combined transdermal with oral estrogen and oral progestogen replacement therapies on serum lipoproteins and compliance. Climacteric 2001;4:228.
20. Ettinger B, Pressman A, Bradley C. Comparison of continuation of postmenopausal hormone replacement therapy: Transdermal versus oral estrogen. Menopause 1998;5:152.
21. Sitruk-Ware R, Bricaire C, De Lignieres B, Yaneva H, Mauvais-Jarvis P. Oral micronized progesterone. Bioavailability pharmacokinetics, pharmacological and therapeutic implications-A review. Contraception 1987;36:373.
22. Oelkers W, Foidart JM, Dombrovicz N, Welter A, 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 1995;80:1816.
23. Heikkinen J, Vaheri R, Timonen U. Long-term safety and tolerability of continuous-combined hormone therapy in post-menopausal women: Results from a seven-year randomised comparison of low and standard doses. J Br Menopause Soc 2004;10:95.
24. Mattsson LA, Skouby SO, Heikkinen J, Vaheri R, Maenpaa J, Timonen U. A low-dose start in hormone replacement therapy provides a beneficial bleeding profile and few side-effects: Randomized comparison with a conventional-dose regimen. Climacteric 2004; 7:59.
25. Bruhat M, Rudolf K, Vaheri R, Kainulainen P, Timonen U, Viitanen A. Effective bleeding control and symptom relief by lower dose regimens of continuous combined hormone replacement therapy: A randomized comparative dose-ranging study. Maturitas 2001;40:259.
26. Rees MC, Kuhl H, Engelstein M, Mattila L, Maenpaa J, Mustonen M; Study Groups. Endometrial safety and tolerability of triphasic sequential hormone replacement estradiol valerate/medroxyprogesterone acetate therapy regimen. Climacteric 2004;7:23.
27. Sturdee DW, van de Weijer P, von Holst T. Endometrial safety of a transdermal sequential estradiol-levonorgestrel combination. Climacteric 2002;5:170.
28. van de Weijer PH, Sturdee DW, von Holst T. Estradiol and levonorgestrel: Effects on bleeding pattern when administered in a sequential combined regimen with a new transdermal patch. Climacteric 2002;5:36.
29. Shulman LP, Yankov V, Uhl K. Safety and efficacy of a continuous once-a-week 17 beta-estradiol/levonorgestrel transdermal system and its effects on vasomotor symptoms and endometrial safety in postmenopausal women: The results of two multicenter double-blind, randomized, controlled trials. Menopause 2002;9:195.
30. Lagrelius A, Fredricsson B, Hirt M, Weintraub L. Clinical experience with a low-dose combination of estradiol valerate and levonorgestrel. Double-blind comparative study between SH D 386 F and Cyclabil. Effects on symptoms, lipids and endometrial condition. Acta Obstet Gynecol Scand 1986;134 (Suppl):97.
31. Warming L, Ravn P, Nielsen T, Christiansen C. Safety and efficacy of drospirenone used in a continuous combination with 17beta-estradiol for prevention of postmenopausal osteoporosis. Climacteric 2004;7:103.
32. Schürmann R, Holler T, Benda N. Estradiol and drospirenone for climacteric symptoms in postmenopausal women: A double-blind, randomized, placebo-controlled study of the safety and efficacy of three dose regimens. Climacteric 2004;7:189.
33. Saarikoski S, Yliskoski M, Penttila I. Sequential use of norethisterone and natural progesterone in pre-menopausal bleeding disorders. Maturitas 1990;12:89.
34. Hargrove JT, Maxson WS, Wentz AC, Burnett LS. Menopausal hormone replacement therapy with continuous daily oral micronized estradiol and progesterone. Obstet Gynecol 1989;73:606.
35. Marengo M, Rodriguez Vidal D, Gil Deza E. Hormonal replacement therapy. Evaluation of a novel 25 days regimen with percutaneous estradiol and micronized oral progesterone. Presented at the 8th International Congress on the Menopause, November 3-7, 1996, Sydney, Australia. Abstract P299.
36. Gillet JY, Andre G, Faguer B, et al. Induction of amenorrhea during hormone replacement therapy: Optimal micronized progesterone dose. A multicenter study. Maturitas 1994;19:103.
37. Moyer DL, de Lignieres B, Driguez P, Pez JP. Prevention of endometrial hyperplasia by progesterone during long-term estradiol replacement: Influence of bleeding pattern and secretory changes. Fertil Steril 1993;59:992.
38. Marslew U, Riis BJ, Christiansen C. Desogestrel in hormone replacement therapy: Long-term effects on bone, calcium and lipid metabolism, climacteric symptoms, and bleeding. Eur J Clin Invest 1991;21:601.
39. Egarter C, Geurts P, Boschitsch E, Speiser P, Huber J. The effects of estradiol valerate plus medroxyprogesterone acetate and conjugated estrogens plus medrogestone on climacteric symptoms and metabolic variables in perimenopausal women. Acta Obstet Gynecol Scand 1996;75:386.
40. Tufekci M, Colak Z, Ozan H, Kimya Y, Aydinlar A. Effect of progestogens on estrogen-induced lipoprotein changes. Eur J Obstet Gynecol Reprod Biol 1993;49:169.
41. Ottosson UB, Johansson BG, von Schoultz B. Subfractions of high-density lipoprotein cholesterol during estrogen replacement therapy: A comparison between progestogens and natural progesterone. Am J Obstet Gynecol 1985;151:746.
42. Marslew U, Overgaard K, Riis BJ, Christiansen C. Two new combinations of estrogen and progestogen for prevention of postmenopausal bone loss: Long-term effects on bone, calcium and lipid metabolism, climacteric symptoms, and bleeding. Obstet Gynecol 1992;79:202.
43. Moorjani S, Dupont A, Labrie F, et al. Changes in plasma lipoprotein and apolipoprotein composition in relation to oral versus percutaneous administration of estrogen alone or in cyclic association with utrogestan in menopausal women. J Clin Endocrinol Metab 1991;73:373.
44. Mosnier-Pudar H, Faguer B, Guyenne TT, Tchobroutsky G. [Effects of deprivation and replacement by percutaneous 17 beta estradiol and oral progesterone on blood pressure and metabolic parameters in menopause patients with non-insulin-dependent diabetes]. Arch Mal Coeur Vaiss 1991;84:1111.
45. von Holst T, Salbach B. Efficacy of a new 7-day transdermal sequential estradiol/levonorgestrel patch in women. Maturitas 2002;1:231.
46. Hassager C, Riis BJ, Strom V, Guyene TT, Christiansen C. The long-term effect of oral and percutaneous estradiol on plasma renin substrate and blood pressure. Circulation 1987;76:753.
47. Dupont A, Dupont P, Cusan L, et al. Comparative endocrinological and clinical effects of percutaneous estradiol and oral conjugated estrogens as replacement therapy in menopausal women. Maturitas 1991;13:297.
48. Preston RA, White WB, Pitt B, Bakris G, Norris PM, Hanes V. Effects of drospirenone/17-beta estradiol on blood pressure and potassium balance in hypertensive postmenopausal women. Am J Hypertens 2005;18:797.
49. Bjorn I, Backstrom T. Drug-related negative side-effects is a common reason for poor compliance in hormone replacement therapy. Maturitas 1999;32:77.
50. Norman RJ, Flight IH, Rees MC. Oestrogen and progestogen hormone replacement therapy for peri-menopausal and post-menopausal women: Weight and body fat distribution. Cochrane Database Syst Rev 2000;2:CD001018.
51. de Lignieres B. Oral micronized progesterone. Clin Ther 1999;21:41.
52. Liu JH, Muse KN. The effects of progestins on bone density and bone metabolism in postmenopausal women: A randomized controlled trial. Am J Obstet Gynecol 2005;192:1316.