Efficacy and safety of an oral contraceptive containing ethinylestradiol 20 µg/drospirenone 3 mg (24/4 regimen) in three indications in the People's Republic of China: a comparison with international studies

Abstract

While combined oral contraceptives are a popular choice in developed Western countries, they are used by only 1% of women who are married or in a relationship in the People's Republic of China. The purpose of this review is to describe the efficacy and safety of the combined oral contraceptive containing ethinylestradiol (EE) 20 µg/drospirenone 3 mg taken in a 24/4 regimen (YAZ^®; Bayer HealthCare Pharmaceuticals, Berlin, Germany) by Chinese women and to compare these results with those in women assessed in the international studies. Studies of EE 20 µg/drospirenone 3 mg in three different indications (contraception, acne, and premenstrual dysphoric disorder [PMDD]) have been conducted in Chinese women. The results of these three studies indicate that the EE 20 µg/drospirenone 3 mg combined oral contraceptive is a good long-term contraceptive option in Chinese women, providing 99% contraceptive protection over the observed 1-year treatment period, and additionally had a favorable effect on moderate acne vulgaris and relieved the symptoms of PMDD. The contraceptive efficacy, improvement in acne, and relief from PMDD symptoms observed in these studies did not differ from the effects observed in other international studies of EE 20 µg/drospirenone 3 mg, indicating that EE 20 µg/drospirenone 3 mg is as effective in Chinese women as in other ethnicities. Further, EE 20 µg/drospirenone 3 mg demonstrated a similar safety and tolerability profile in women enrolled in the Chinese and international trials, with no unexpected adverse events reported in any of the three Chinese trials. Overall, the efficacy, tolerability, and degree of non-contraceptive benefits with EE 20 µg/drospirenone 3 mg appear similar in Chinese women when compared with those reported in larger studies done at other international centers.

Keywords: People’s Republic of China; YAZ®; acne; contraception; ethinylestradiol/drospirenone; premenstrual dysphoric disorder.

Figure 1

Comparison of unadjusted Pearl Index scores in women after treatment over 1 year with the ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraceptive (YAZ^®) in three international studies conducted in the People’s Republic of China (Caiyan et al18), Europe, Latin America, and the USA (Bachmann et al10), and Europe (Hernádi et al20).

Figure 2

Percentage change from baseline to endpoint (defined as cycle 6 with last observation carried forward for dropouts) in mean total acne lesion count in women with moderate acne treated with ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraceptive (YAZ^®) or placebo in the studies conducted in the People’s Republic of China (Zhang et al17) and the USA (Koltun et al and Maloney et al12). Values for the Koltun et al study are approximate as they were estimated from the graph presented in their publication. *P<0.001 versus placebo.

Figure 3

Change from baseline in DRSP scale scores after three cycles of treatment in women with premenstrual dysphoric disorder in ethinylestradiol 20 µg/drospirenone 3 mg combined oral contraceptive (YAZ^®) placebo-controlled studies conducted in the People’s Republic of China (Fu et al19) and the USA (Yonkers et al and Pearlstein et al13). *P<0.001 versus placebo. Abbreviation: DRSP, Daily Record of Severity of Problems.