Obstet Gynecol Sci.  2017 Mar;60(2):213-217. 10.5468/ogs.2017.60.2.213.

Efficacy and safety of drospirenone 2 mg/17β-estradiol 1 mg hormone therapy in Korean postmenopausal women

• Park BR
• Park HN
• Jung JB
• Lee ES
• Kim JS
• Choi GY
• Lee JJ
• Lee IS

• KMID: 2372807
• DOI: http://doi.org/10.5468/ogs.2017.60.2.213

Abstract

This regulatory post-marketing surveillance study aimed to evaluate the therapeutic efficacy and safety of drospirenone (DRSP) 2 mg/estradiol (Eâ‚‚) 1 mg tablet in Korean postmenopausal women. A total of 4,149 patients were enrolled and the study was conducted at 207 clinical research centers. The patients' source data was collected between November 2006 and November 2012. More than 85% of patients experienced improvement of menopausal symptoms. The most frequently reported adverse events were vaginal bleeding and breast pain; most of the women suffering from these symptoms fully recovered. The incidence of adverse event was higher in patients of younger age (20 to 39 years), in patients with concomitant diseases, previous hormone replacement therapy in medical history, those treated with DRSP 2 mg/Eâ‚‚ 1 mg for shorter duration (3 years or less) and in patients using concomitant medication. In conclusion, the results from this large post-marketing surveillance study confirm the efficacy and safety of DRSP 2 mg/Eâ‚‚ 1 mg tablet in Korean postmenopausal women.

Keyword

Drospirenone; Effectiveness; Menopause; Safety

MeSH Terms

Female
Hormone Replacement Therapy
Humans
Incidence
Mastodynia
Menopause
Uterine Hemorrhage

Reference

1. Shifren JL, Gass ML. NAMS Recommendations for Clinical Care of Midlife Women Working Group. The North American Menopause Society recommendations for clinical care of midlife women. Menopause. 2014; 21:1038–1062. PMID: 25225714.

2. de Villiers TJ, Pines A, Panay N, Gambacciani M, Archer DF, Baber RJ, et al. Updated 2013 International Menopause Society recommendations on menopausal hormone therapy and preventive strategies for midlife health. Climacteric. 2013; 16:316–337. PMID: 23672656.

3. Muhn P, Fuhrmann U, Fritzemeier KH, Krattenmacher R, Schillinger E. Drospirenone: a novel progestogen with antimineralocorticoid and antiandrogenic activity. Ann N Y Acad Sci. 1995; 761:311–335. PMID: 7625729.

4. Fuhrmann U, Krattenmacher R, Slater EP, Fritzemeier KH. The novel progestin drospirenone and its natural counterpart progesterone: biochemical profile and antiandrogenic potential. Contraception. 1996; 54:243–251. PMID: 8922878.

5. Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of a unique progestogen. Contraception. 2000; 62:29–38. PMID: 11024226.

6. Losert W, Casals-Stenzel J, Buse M. Progestogens with antimineralocorticoid activity. Arzneimittelforschung. 1985; 35:459–471. PMID: 4039568.

7. Pollow K, Juchem M, Elger W, Jacobi N, Hoffmann G, Mobus V. Dihydrospirorenone (ZK30595): a novel synthetic progestagen: characterization of binding to different receptor proteins. Contraception. 1992; 46:561–574. PMID: 1493716.

8. Rubig A. Drospirenone: a new cardiovascular-active progestin with antialdosterone and antiandrogenic properties. Climacteric. 2003; 6(Suppl 3):49–54. PMID: 15018248.

9. Archer DF, Thorneycroft IH, Foegh M, Hanes V, Glant MD, Bitterman P, et al. Long-term safety of drospirenone-estradiol for hormone therapy: a randomized, double-blind, multicenter trial. Menopause. 2005; 12:716–727. PMID: 16278615.

10. US Food and Drug Administration. What is a serious adverse event? [Internet]. Silver Spring (MD): US Food and Drug Administration;2016. cited 2017 Feb 10. Available from: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.

11. Lee BS, Kang BM, Yoon BK, Choi H, Park HM, Kim JG. Efficacy and tolerability of estradiol 1 mg and drospirenone 2 mg in postmenopausal Korean women: a double-blind, randomized, placebo-controlled, multicenter study. Maturitas. 2007; 57:361–369. PMID: 17467203.

12. Schurmann 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; 7:189–196. PMID: 15497908.

13. Archer DF. Drospirenone and estradiol: a new option for the postmenopausal woman. Climacteric. 2007; 10(Suppl 1):3–10. PMID: 17364592.