Spironolactone / Idiopathic Hirsutim

[~MaryO~]

From Medscape:  http://www.medscape.com/viewarticle/453151

Spironolactone Cost-Effective in Idiopathic Hirsutism  CME

News Author: Laurie Barclay, MD

CME Author: Bernard M. Sklar, MD, MS

 

April 28, 2003 ? Cyproterone acetate, finasteride, and spironolactone are equally effective in the short-term control of idiopathic hirsutism, according to the results of a prospective, randomized clinical trial published in the April issue of Fertility & Sterility. But spironolactone was effective longer, and the investigators suggest that this treatment was also cost-effective.

 

"Spironolactone is a competitive inhibitor of aldosterone that competes with dihydrotestosterone in target tissues and has antiandrogenic properties," write Francho Lumachi, MD, and Riccardo Rondinone, MD, from the University of Padua in Italy.

 

Forty-one women with idiopathic hirsutism who had requested use of an oral contraceptive were randomized to 12 months of treatment with cyproterone acetate, 12.5 mg/day for the first 10 days of the cycle; finasteride, 5 mg/day; or spironolactone, 100 mg/day.

 

At completion of treatment, the Ferriman-Gallwey score decreased by about 39% in all three groups. One year after treatment, the Ferriman-Gallwey score in the spironolactone group was 6.74 ? 1.41, significantly lower than in the cyproterone acetate group (7.92 ? 1.08) or the finasteride group (9.08 ? 0.99). The androgenic profile did not change significantly during treatment.

 

"Spironolactone is especially useful for women in whom an oral contraceptive alone is ineffective," the authors write. "The combination of spironolactone (100 mg/day) and a monophasic oral contraceptive was effective for a longer time than was treatment with the other two drugs and was cost-effective."

 

Fertil Steril. 2003;79:942-946

 

 

Clinical Context

Many women seek treatment for unwanted hair growth. These women initially should be evaluated for endocrine abnormalities and these abnormalities should be treated when found. About 80% will be found to have treatable abnormalities. The other 20% will be found to have idiopathic hirsutism.

 

Hirsute women with both normal ovarian function (history of regular and ovulatory menstrual cycles), and normal circulating androgen levels are considered to have idiopathic hirsutism. Hirsutism affects 5% to 10% of women, depending on their ethnic group. Many of these women will request treatment for idiopathic hirsutism.

 

A commonly used method to grade hair growth is the modified scale of Ferriman and Gallwey, in which each of nine androgen-sensitive sites is graded from 0 to 4. These areas are the upper lip, chin, chest, abdomen, pubic area, legs, back and buttocks.

 

According to Danforth's Obstetrics and Gynecology, there is no drug currently approved by the U.S. Food and Drug Administration for the treatment of hirsutism. In milder forms of hirsutism in women not satisfied cosmetically with mechanical removal, an oral contraceptive pill may be the best first-line drug. Spironolactone and cyproterone have previously been shown to be equivalent in effectiveness. Cyproterone is not available in the U.S. In more severe forms of hirsutism, a GnRH agonist (Buserellin) plus an oral contraceptive may be chosen over flutamide or ketoconazole, particularly when hepatic problems are a concern. Finasteride appears to have the fewest adverse effects of all and may be very effective in treating women with a low or no risk of pregnancy.

 

Study Highlights

 

• 41 young women (median age, 21 years [range, 18-34 years]) with idiopathic hirsutism who had requested prescription for an oral contraceptive.
   
  
• Inclusion criteria were a modified Ferriman-Gallwey score of 6 or greater, regular menstrual cycles of 21 to 35 days; progesterone levels greater than 13 nmol/L in the luteal phase; normal circulating serum levels of free T, DHEAS, androstenedione and 17-hydroxyprogesterone. The mean Ferriman-Gallwey score at the beginning of treatment was about 11 to 12.  
  
• No patient had any other disease or had received oral contraceptives or antiandrogenic drugs in the previous two years. Patients with abnormal results on routine laboratory tests were excluded.  
  
• Patients were randomized to 12 months of treatment with cyproterone acetate, 12.5 mg/day for the first 10 days of the cycle; finasteride, 5 mg/day; or spironolactone, 100 mg/day. All patients also received an oral contraceptive during the two-year study.  
  
• After one year, the Ferriman-Gallwey score decreased by about 39% in all three groups. One year after treatment ended (two years from the start of the study), the Ferriman- Gallwey score in the spironolactone group was 6.74 ? 1.41, significantly lower than in the cyproterone acetate group (7.92 ? 1.08) or the finasteride group (9.08 ? 0.99). The androgenic profile did not change significantly during treatment.  
  
• The authors conclude, "Spironolactone is especially useful for women [with idiopathic hirsutism] in whom an oral contraceptive alone is ineffective. The combination of spironolactone (100 mg/day) and a monophasic oral contraceptive was effective for a longer time than was treatment with the other two drugs and was cost-effective."
  

 

Pearls for Practice

 

• Cyproterone acetate, finasteride, and spironolactone, given along with an oral contraceptive, were equally effective in reducing unwanted body hair during the period of administration of the study drug (one year).  
  
• The effect of spironolactone was more persistent (one year after treatment ended) than was cyproterone acetate or finasteride.
  

About News CME

News CME is designed to keep physicians abreast of current research and related clinical developments that are likely to affect practice, as reported by the Medscape Medical News group. Medscape Medical News Coordinator is Deborah Flapan. Clinical review is provided by Gary Vogin, MD. News CME is managed by Elliott Silverman. Send comments or questions about this program to cmenews@webmd.net.

 

Medscape Medical News 2003. ? 2003 Medscape

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