EE-drospirenone-levomefolate calcium versus EE-drospirenone + folic acid: Folate status during 24 weeks of treatment and over 20 weeks following treatment cessation

International Journal of Women's Health

Volumn 5, Issue 1, 2013, Pages 149-163

  Diefenbach, Konstanze ^a   Trummer, Dietmar ^a   Ebert, Frank ^a   Lissy, Michael ^b   Koch, Manuela ^b   Rohde, Beate ^a   Blode, Hartmut ^c  

^a BAYER PHARMA AG   (Germany)

^b Nuvisan GmbH   (Germany)

^c Bayer HealthCare Pharmaceuticals Global R and D Center   (China)

Author keywords

Drospirenone; Ethinylestradiol; Folic acid; Levomefolate calcium; Neural tube defect; Oral contraception

Indexed keywords

5 METHYLTETRAHYDROFOLIC ACID; DROSPIRENONE PLUS ETHINYLESTRADIOL PLUS FOLIC ACID; DROSPIRENONE PLUS ETHINYLESTRADIOL PLUS MEFOLATE CALCIUM; DRUG METABOLITE; FOLIC ACID DERIVATIVE; HOMOCYSTEINE; PLACEBO; UNCLASSIFIED DRUG;

ACOUSTIC NEURINOMA; ADULT; ARTICLE; BREAST DISEASE; BREAST TENDERNESS; CELL LEVEL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSMENORRHEA; ERYTHROCYTE; FEMALE; FOLATE METABOLISM; FOLIC ACID BLOOD LEVEL; GASTROINTESTINAL DISEASE; GENITAL SYSTEM DISEASE; HUMAN; HUMAN EXPERIMENT; MASTALGIA; MENTAL DISEASE; METRORRHAGIA; MULTIPLE CYCLE TREATMENT; NORMAL HUMAN; ORAL CONTRACEPTION; PATIENT COMPLIANCE; PLASMA CONCENTRATION-TIME CURVE; PREGNANCY; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; TREATMENT DURATION; TREATMENT RESPONSE; ULCERATIVE COLITIS; WOUND HEALING IMPAIRMENT;

EID: 84876189412     PISSN: None     EISSN: 11791411     Source Type: Journal    
DOI: 10.2147/IJWH.S37254     Document Type: Article

References (44)

1. Botto LD, Moore CA, Khoury MJ, Erickson JD. Neural tube defects. N Engl J Med. 1999;341:1509-1519.
2. [No authors listed]. Prevention of neural tube defects: Results of the Medical Research Council Vitamin Study. MRC Vitamin Study Research Group. Lancet. 1991;338:131-137.
3. Daly LE, Kirke PN, Molloy A, Weir DG, Scott JM. Folate levels and neural tube defects. Implications for prevention. JAMA. 1995;274:1698-1702.
4. Busby A, Abramsky L, Dolk H, et al. Preventing neural tube defects in Europe: a missed opportunity. Reprod Toxicol. 2005;20:393-402.
5. US Preventive Services Task Force. Folic acid for the prevention of neural tube defects: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;150:626-631.
6. European Surveillance of Congenital Anomalies (EUROCAT). Folic acid special reports: survey of folic acid policy and practice in European countries, Dec 2007. Available from: http://www.eurocat-network.eu/preventionandriskfactors/folicacid/folicacidspecialreports. Accessed January 24, 2013.
7. Smithells RW, Sheppard S, Schorah CJ, et al. Possible prevention of neural tube defects by periconceptional vitamin supplementation. Lancet. 1980;1:339-340.
8. Laurence KM, James N, Miller MH, Tennant GB, Campbell H. Double-blind randomised controlled trial of folate treatment before conception to prevent recurrence of neural-tube defects. Br Med J (Clin Res Ed). 1981;282:1509-1511.
9. Mulinare J, Cordero JF, Erickson JD, Berry RJ. Periconceptional use of multivitamins and the occurrence of neural tube defects. JAMA. 1988;260:3141-3145.
10. Bower C, Stanley FJ. Dietary folate as a risk factor for neural-tube defects: evidence from a case-control study in western australia. Med J Aust. 1989;150:613-619.
11. Mitchell A. Case control study of neural tube defects and periconceptional vitamin use. Paediatr Perinat Epidemiol. 1989;3:216.
12. Vergel RG, Sanchez LR, Heredero BL, Rodriguez PL, Martinez AJ. Primary prevention of neural tube defects with folic acid supplementation: Cuban experience. Prenat Diagn. 1990;10:149-152.
13. Czeizel AE, Dudas I. Prevention of the first occurrence of neural-tube defects by periconceptional vitamin supplementation. N Engl J Med. 1992;327:1832-1835.
14. Werler MM, Shapiro S, Mitchell AA. Periconceptional folic acid exposure and risk of occurrent neural tube defects. JAMA. 1993;269:1257-1261.
15. Shaw GM, Schaffer D, Velie EM, Morland K, Harris JA. Periconceptional vitamin use, dietary folate, and the occurrence of neural tube defects. Epidemiology. 1995;6:219-226.
16. Berry RJ, Li Z, Erickson JD, et al. Prevention of neural-tube defects with folic acid in china. China-US. Collaborative project for neural tube defect prevention. N Engl J Med. 1999;341:1485-1490.
17. De-Regil LM, Fernandez-Gaxiola AC, Dowswell T, Pena-Rosas JP. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010; 10: CD007950.
18. Mathews TJ, Honein MA, Erickson JD. Spina bifida and anencephaly prevalence-United States, 1991-2001. MMWR Recomm Rep. 2002;51:9-11.
19. Ray JG, Singh G, Burrows RF. Evidence for suboptimal use of periconceptional folic acid supplements globally. BJOG. 2004;111:399-408.
20. Tinker SC, Cogswell ME, Devine O, Berry RJ. Folic acid intake among US women aged 15-44 years, National Health and Nutrition Examination Survey, 2003-2006. Am J Prev Med. 2010;38:534-542.
21. Spina bifida and anencephaly before and after folic acid mandate-United States, 1995-1996 and 1999-2000. MMWR Morb Mortal Wkly Rep. 2004;53:362-365.
22. US Food and Drug Administration. Summary minutes advisory committee for reproductive health drugs meeting, December 15, 2003. Available from: http://www.fda.gov/ohrms/dockets/ac/03/minutes/4002M1_Final.pdf. Accessed January 24, 2013.
23. Lassi ZS, Bhutta ZA. Clinical utility of folate-containing oral contraceptives. Int J Womens Health. 2012;4:185-190.
24. Lamers Y, Prinz-Langenohl R, Bramswig S, Pietrzik K. Red blood cell folate concentrations increase more after supplementation with [6s]-5-methyltetrahydrofolate than with folic acid in women of childbearing age. Am J Clin Nutr. 2006;84:156-161.
25. Lamers Y, Prinz-Langenohl R, Moser R, Pietrzik K. Supplementation with [6s]-5-methyltetrahydrofolate or folic acid equally reduces plasma total homocysteine concentrations in healthy women. Am J Clin Nutr. 2004;79:473-478.
26. Venn BJ, Green TJ, Moser R, Mann JI. Comparison of the effect of low-dose supplementation with l-5-methyltetrahydrofolate or folic acid on plasma homocysteine: a randomized placebo-controlled study. Am J Clin Nutr. 2003;77:658-662.
27. Venn BJ, Green TJ, Moser R, McKenzie JE, Skeaff CM, Mann J. Increases in blood folate indices are similar in women of childbearing age supplemented with [6s]-5-methyltetrahydrofolate and folic acid. J Nutr. 2002;132:3353-3355.
28. Pietrzik K, Bailey L, Shane B. Folic acid and l-5-methyltetrahydrofolate: comparison of clinical pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2010;49:535-548.
29. Yaz [prescribing information]. Berlin, Germany: Bayer HealthCare Pharmaceuticals Inc; 2012.
30. Pernet P, Lasnier E, Vaubourdolle M. Evaluation of the AxSym homocysteine assay and comparison with the IMX homocysteine assay. Clin Chem. 2000;46:1440-1441.
31. Smith DE, Kok RM, Teerlink T, Jakobs C, Smulders YM. Quantitative determination of erythrocyte folate vitamer distribution by liquid chromatography-tandem mass spectrometry. Clin Chem Lab Med. 2006;44:450-459.
32. Bakker DJ, de Jong-van den Berg LT, Fokkema MR. Controlled study on folate status following folic acid supplementation and discontinuation in women of child-bearing age. Ann Clin Biochem. 2009;46:231-234.
33. Hao L, Yang QH, Li Z, et al. Folate status and homocysteine response to folic acid doses and withdrawal among young chinese women in a large-scale randomized double-blind trial. Am J Clin Nutr. 2008;88:448-457.
34. Heseker H, Schmitt G. Effect of long-term supplementation of folate on folate status in plasma and erythrocytes. J Nutr Sci Vitaminol (Tokyo). 1987;33:163-168.
35. Blode H, Klipping C, Richard F, Trummer D, Rohde B, Diefenbach K. Bioequivalence study of an oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium relative to Yaz® and to levomefolate calcium alone. Contraception. 2012;85:177-184.
36. Pentieva K, McNulty H, Reichert R, et al. The short-term bioavailabilities of [6s]-5-methyltetrahydrofolate and folic acid are equivalent in men. J Nutr. 2004;134:580-585.
37. Vollset SE, Refsum H, Irgens LM, et al. Plasma total homocysteine, pregnancy complications, and adverse pregnancy outcomes: The Hordaland Homocysteine Study. Am J Clin Nutr. 2000;71:962-968.
38. Bart SS, Marr J, Diefenbach K, Trummer D, Sampson-Landers C. Folate status and homocysteine levels during a 24-week oral administration of a folate-containing oral contraceptive: a randomized, double-blind, active-controlled, parallel-group, us-based, multicenter study. Contraception. 2012;85:42-50.
39. Pietrzik K, Lamers Y, Bramswig S, Prinz-Langenohl R. Calculation of red blood cell folate steady state conditions and elimination kinetics after daily supplementation with various folate forms and doses in women of childbearing age. Am J Clin Nutr. 2007;86:1414-1419.
40. Hursthouse NA, Gray AR, Miller JC, Rose MC, Houghton LA. Folate status of reproductive age women and neural tube defect risk: the effect of long-term folic acid supplementation at doses of 140 μg and 400 μg per day. Nutrients. 2011;3:49-62.
41. Cronin M, Schellschmidt I, Dinger J. Rate of pregnancy after using drospirenone and other progestin-containing oral contraceptives. Obstet Gynecol. 2009;114:616-622.
42. Bachmann G, Sulak PJ, Sampson-Landers C, Benda N, Marr J. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20micrograms ethinylestradiol and 3mg drospirenone. Contraception. 2004;70:191-198.
43. Cronin M, Korner P. The safety profile of Yasmin is similar to other combined oral contraceptives. Clin Appl Thromb Hemost. 2008;14: 245-246.
44. Endrikat J, Muller U, Dusterberg B. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20micrograms ethinylestradiol/75micrograms gestodene and 30micrograms ethinylestradiol/75micrograms gestodene, with respect to efficacy, cycle control, and tolerance. Contraception. 1997;55:131-137.