Bayer’s endometriosis treatment Visanne (ingredient: dienogest) demonstrated long-term pain reduction and improvement in quality of life in real-world settings in six Asian countries, the company said.
Bayer published the final results of the real-world ENVISIOeN trial of Visanne in Reproductive Science on Feb. 2.
ENVISIOeN is a 24-month follow-up study of 887 endometriosis patients from 36 institutions in six Asian countries, including Korea, Indonesia, Thailand, Malaysia, the Philippines, and Singapore.
The research team evaluated score changes of endometriosis-associated pelvic pain (EAPP) and the Endometriosis Health Profile-30 (EHP-30) questionnaire to assess health-related quality of life (HRQoL), confirming the effect of Visanne.
The results showed that 91.6 percent of Visanne-treated patients improved EAPP 24 months after the treatment. In addition, from baseline to month 24, rates of normal bleeding decreased from 85.8 percent to 17.5 percent, while rates of amenorrhea increased from 3.5 percent to 70.8 percent.
Visanne improved patients’ quality of life, too. Scores for all EHP-30 scales improved with the largest mean changes at six months and 24 months in scale pain (−28.9 ± 27.5 and − 34 ± 28.4) and control and powerlessness (−23.7 ± 28.2 and − 28.5 ± 26.2).
In the long-term, Visanne improved all EHP-30 core scores in patients with endometriosis treated for 36 months.
Most doctors and patients who participated in the study were satisfied with Visanne treatment, and over 80 percent of the patients said their symptoms improved. In addition, safety profiles were consistent with the previous results.
Professor Lee Byung-seok of obstetrics and gynecology at Yonsei University College of Medicine, who participated in the study, said endometriosis is a chronic disease that threatens women's physical and mental health due to pelvic pain and deterioration in the quality of life. Thus, the disease requires long-term management through medications, he said.
“This study aimed to determine the clinical effect of dienogest for 24 months in real settings in patients diagnosed with endometriosis clinically or surgically in six Asian countries, including Korea,” he said. “It is meaningful that the drug improved EAPP and HRQoL significantly.”
Lee added that the study confirmed that dienogest could be used as a safe, effective first-line treatment for endometriosis patients.