VAIL, COLO. — Drospirenone-ethinyl estradiol is an attractive option for treatment of polycystic ovary syndrome in patients who don’t desire pregnancy, Dr. Alan H. DeCherney said at a conference on obstetrics and gynecology sponsored by the University of Colorado. "There’s no evidence that Yasmin [drospirenone-ethinyl estradiol] is better than other OCs in polycystic ovary syndrome (PCOS), but theoretically–and I’m sure there are studies going on–the fact that you replace the progestin with a spironolactone analogue makes me think that this would work much better in PCOS … and it’s certainly no worse than any other birth control pill," said Dr. DeCherney, professor and chair of ob.gyn. at the University of California, Los Angeles. Each tablet contains 0.03 mg of ethinyl estradiol and 3.0 mg of drospirenone, a novel progestin and spironolactone analogue with antiandrogenic and antimineralocorticoid properties. Spironolactone at 25 mg b.i.d. to 100 mg b.i.d. was once a popular second-line drug for the treatment of PCOS. Spironolactone effectively reduced patients’ hirsutism and reversed endometrial hyperplasia while decreasing testosterone production. But at higher doses it tended to cause heavy vaginal bleeding and orthostatic hypotension. There has been a recent flurry of interest in routinely putting all PCOS patients, or at least the half who are insulin resistant, on an insulin-sensitizing agent such as metformin. Dr. DeCherney favors using metformin indefinitely in these patients except during pregnancy because the drug corrects a key metabolic defect in PCOS.

Starting Yasmin(Ethinylestradiol/Drospirenone) vs Other Oral Contraceptives May Have Similar Thromboembolic September 11, 2007 - The risk for thromboembolism is similar in young, relatively healthy women starting ethinylestradiol/drospirenone vs other oral contraceptives, according to a study published in the September issue of Obstetrics & Gynecology. "The oral contraceptive Yasmin (ethinylestradiol 0.03 mg/drospirenone 3 mg) contains a progestin component that differs from other oral contraceptives," write John D. Seeger, PharmD, DrPH, from i3 Drug Safety, Ingenix, in Waltham, Massachusetts, and colleagues. "Case reports and prescription event monitoring suggested that ethinylestradiol/drospirenone might be associated with an elevated risk of thromboembolism. We sought to estimate the association between ethinylestradiol/drospirenone and risk of thromboembolism relative to the association among other oral contraceptives." Using a US health insurer database, the investigators identified women who started treatment with ethinylestradiol/drospirenone (n = 22,429), and a 2-fold larger group of women (n = 44,858) who started treatment with other oral contraceptives between June 2001 and June 2004. Both groups had similar demographic and healthcare characteristics before oral contraceptive initiation. During follow-up (average duration, 7.6 months), thromboembolism was identified through claims for medical services, and only those cases confirmed by medical record review were included in the analyses. During follow-up, there were 18 cases of thromboembolism in the ethinylestradiol/drospirenone group and 39 in the comparison group (rate ratio, 0.9; 95% confidence interval, 0.5 - 1.6). To observe a difference of 1 case of thromboembolism, more than 9000 women would have to be prescribed oral contraceptives. As-treated analysis yielded similar findings to those of the as-matched analysis. "Yasmin(Ethinylestradiol/drospirenone) initiators and initiators of other oral contraceptives are similarly likely to experience thromboembolism," the authors write. "Prior thromboembolism, other chronic medical conditions, and age were all associated with elevated risks for thromboembolism, indicating that the study, which did not indicate any difference between ethinylestradiol/drospirenone and other oral contraceptives, was sufficiently sensitive to pick up known medical risk factors for thromboembolism." A research contract between i3 Drug Safety and Berlex, the maker of ethinylestradiol/drospirenone, funded this study. Four of the authors have disclosed performing contracted research with Berlex (Bayer HealthCare Pharmaceuticals, Montville, New Jersey).

Acute myocardial infarction associated with Yasmin oral contraceptive The new third-generation contraceptive Yasmin (30 µg ethinylestradiol and 3 mg of drospirenone; Bayer Schering Pharma, Kenilworth, NJ) has been available on the market in all of the European Union countries since the year 2000. This contraceptive has certain characteristics that differentiate it from others because it has a lower estrogen component in its composition compared with previous oral contraceptives. It has also been suggested that it has a lower risk of thrombosis than other oral contraceptives. This is because interim results from Schering’s postmarketing surveillance study of 1 million cycles showed that after 1 year, 1 episode of venous thrombosis occurred among Yasmin users compared with 5 episodes among users of other oral contraceptives This opinion is not shared by other authors, however, who state that despite this difference at the chemical level, there is no difference in thrombosis risk , with the risk being very similar: 60 per 100 000 cases of deep vein thrombosis a year inwomen who take Yasmin compared with 60 to 73 per 100 000 cases a year in women who take other older contraceptive pills. Although different cases of thromboembolism have been reported in patients taking Yasmin, no report has been published about Yasmin and myocardial infarction