Add treatment option for heavy menstrual bleeding
Add treatment option for heavy menstrual bleeding
About three million U.S. women experience heavy menstrual bleeding each year.1 With the recent Food and Drug Administration (FDA) approval of Natazia (Bayer HealthCare Pharmaceuticals, Wayne, NJ) for treatment in women who choose an oral contraceptive (OC), clinicians now have another therapeutic option.
The combination pill received FDA approval as a birth control option in 2010. It is a four-phase, estrogen step-down, progestin step-up regimen that contains the estrogen estradiol valerate and the progestin dienogest.
"As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an OC for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition," said Pamela Cyrus, MD, Bayer HealthCare vice president and head of U.S. medical affairs in a statement accompanying the approval.
Heavy menstrual bleeding is more than a nuisance; for some women, the bleeding is severe enough to adversely affect their social, physical, and emotional well-being. Use of oral contraceptives for treatment of heavy menstrual bleeding is not new; a 2009 review of available data looked at their effectiveness compared with other medical therapies, placebo, or no therapy.2 Having an FDA-approved indication for Natazia as a treatment for heavy menstrual bleeding separates it from other oral contraceptives without this indication. Approval should improve the willingness of insurance companies to cover its use the same as other medications for therapeutic indications aside from contraception, says Jeffrey Jensen, MD, MPH, director of the Women's Health Research Unit at Oregon Health & Science University in Portland.
Check study findings
Jensen served as lead investigator in a 2011 double-blind, placebo-controlled randomized study that looked at women age 18 or older with prolonged, frequent, or heavy menstrual bleeding. Study participants were assigned Natazia or a placebo. To perform the analysis, data from the last 90 days of treatment were compared to information collected from a 90-day pretreatment run-in interval. The primary variable was the complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume. Secondary variables included objective changes in menstrual blood loss volume, using alkaline hematin methodology, and iron metabolism parameters.3
About three-quarter (75.8%) of the treatment group and 85.7% of the placebo group had heavy bleeding at baseline; resolution was seen in 56% and 26.7%, respectively. Scientists report the mean reduction in blood loss from pretreatment to post-treatment was significantly greater in the treatment group (64.2%) compared to the placebo group (7.8%). Levels of hemoglobin, hematocrit, and ferritin also showed improvement in the treatment group, data suggest.3
In a pooled analysis of data from the 2011 study and an identically designed randomized, placebo-controlled, multiple center investigation conducted in Europe and Australia, 63.6% and 11.9% of patients were successfully treated with Natazia and placebo, respectively.4
Look at options
When it comes to treatment of heavy menstrual bleeding, the levonorgestrel intrauterine system (Mirena LNG IUS, Bayer HealthCare Pharmaceuticals) has been the gold standard, says Jensen. The device received FDA approval for this indication in 2009. A 2009 review of all available data indicated the Mirena is as effective as endometrial ablation in reducing heavy menstrual bleeding.5
A 2011 single-center, open, randomized clinical trial looked at 112 women with excessive menstruation who desired contraception.6 The study participants were randomized to receive the LNG IUS or combined oral contraceptives. Results suggested that the LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to the study pills.
Jensen notes that in earlier studies, which were limited by small sample size, data indicated about a 40% reduction in blood loss with an oral contraceptive. However, if the results of the Natazia studies are added in, reduction in blood loss climbs over 80%, says Jensen. This increase makes pills comparable, although inferior, to the approximate 96% reduction seen with the IUS, he observes.
Another medication option for heavy menstrual bleeding is tranexamic acid. Approved by the FDA in 2009 for treatment of cyclic heavy menstrual bleeding, it is marketed as Lysteda by Ferring Pharmaceuticals of Saint-Prex, Switzerland. (See "Options for treatment of heavy bleeding in focus," CTU, December 2009, p. 137.) Its antifibrinolytic activity works downstream of the coagulation cascade and slows the dissolution of fibrin, therefore reducing excessive bleeding. Available evidence indicates that tranexamic acid therapy in women with idiopathic menorrhagia resulted in 34-54% reduction in menstrual blood loss.7 (To check Contraceptive Technology's approach to therapeutic treatment of heavy menstrual bleeding, see the story, below.)
References
- Lumsden MA, Wedisinghe L. Tranexamic acid therapy for heavy menstrual bleeding. Expert Opin Pharmacother 2011; 12:2,089-2,095.
- Farquhar C, Brown J. Oral contraceptive pill for heavy menstrual bleeding. Cochrane Database Syst Rev 2009; 4:CD000154.
- Jensen JT, Parke S, Mellinger U, et al. Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest: a randomized controlled trial. Obstet Gynecol 2011; 117(4):777-787.
- Fraser IS, Jensen J, Schaefers M, et al. Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. Contraception 2012; Doi: 10.1016/j.contraception.2011.11.011.
- Kaunitz AM, Meredith S, Inki P, et al. Levonorgestrel-releasing intrauterine system and endometrial ablation in heavy menstrual bleeding: a systematic review and meta-analysis. Obstet Gynecol 2009; 113(5):1,104-1,116.
- Shaaban MM, Zakherah MS, El-Nashar SA, et al. Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial. Contraception 2011; 83(1):48-54.
- Naoulou B, Tsai MC. Efficacy of tranexamic acid in the treatment of idiopathic and non-functional heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand 2012. Doi: 10.1111/j.1600-0412.2012.01361.x.
'Contraceptive Technology' offers treatment reference What does the latest edition of "Contraceptive Technology" say when it comes to therapeutic approaches to heavy menstrual bleeding? First, clinicians must understand the terminology of heavy menstrual bleeding. Chapter co-authors advance the idea that "a woman's blood loss is excessive when she says it is excessive."1 The co-authors are Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles, and Suzy Baldwin, MD, MPH, Health Assessment Unit chief in the Office of Health Assessment and Epidemiology at the Los Angeles (CA) County Department of Public Health. Consider the following therapeutic options when controlling chronic heavy menstrual bleeding:
References
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