Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study

Baik Seol Cho, Ju Won Roh, Jonghoon Park, Kyungah Jeong, Tae Hee Kim, Yun Sook Kim, Yong Soon Kwon, Chi Heum Cho, Sung Ho Park, Sung Hoon Kim

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7 Scopus citations

Abstract

Dienogest (DNG) is a progestin with highly selective progesterone activity and known to be effective in the treatment of endometriosis. This prospective cohort study in patients who had been treated with DNG 2 mg (Visanne®) for endometriosis was conducted to assess the safety and effectiveness of DNG in a large Korean cohort. This study included 3356 patients with endometriosis from 73 centers in Korea. All patients were treated with DNG 2 mg daily and were followed up for at least 6 months after initial visit. Any adverse events were recorded including severity, onset/closing date, outcomes, treatments, and the causality with DNG. Effectiveness of DNG was measured by changes in visual analogue scale (VAS) from baseline at the end of follow-up. The mean age of the subjects was 34.96 years, and the mean duration of treatment was 285.44 days. Incidence of adverse drug reaction (ADR) was 13.27% (413/3113). The most frequently reported ADR were “abnormal uterine bleeding” 4.14% (129/3113), “increased weight” 2.57% (80/3113), and “headache” 1.22% (38/3113). The number of patients (%) with favorable bleeding patterns was observed to increase as the duration of treatment increases. Amenorrhea was observed in 29.63%, 41.25%, 46.26%, and 53.20% of patients at 3 months, 6 months, 12 months, and more than 12 months follow-up period, respectively. The mean (±SD) VAS change from baseline at the last follow-up visit was −28.19 ± 28.39 mm (P value < 0.0001). This large cohort study confirms, in routine clinical practice, that DNG is safe and effective for treatment of endometriosis.

Original languageEnglish
Pages (from-to)905-915
Number of pages11
JournalReproductive Sciences
Volume27
Issue number3
DOIs
StatePublished - 1 Mar 2020

Keywords

  • Cohort study
  • Dienogest
  • Effectiveness
  • Endometriosis
  • Safety

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