Evaluation of bovhyaluronidase azoxymer efficacy in combined treatment of patients with endometriosis based on the results of multicenter prospective non-interventional study (ISLAND)

Abstract

Background. Endometriosis is a chronic progressive recurrent disease associated with pelvis pain, menses disorders and infertility. The prevalence of endometriosis (EGE) tends to increase steadily and reaches 15% among women of reproductive age. Endometriosis-associated pain can persist despite surgical and drug treatment of this disease, resulting in a significant decrease in the quality of life of patients. The main causes of EGE-associated pain are local inflammatory, adhesive, neuro- and angiogenic processes. Currently, the search for alternative methods of pathogenesis-based therapy of the disease is one of the priority tasks. Given its anti-inflammatory, enzymatic, antioxidant effects and anti-adhesion mechanism of action, bovhyaluronidase azoximer, an enzyme agent with hyaluronidase activity, is a promising drug in the complex therapy of EGE.
 Aim. To compare bovhyaluronidase azoxymer efficacy in complex therapy of patients with EGE using dienogest (2 mg) versus monotherapy with this progestogen in real clinical practice.
 Materials and methods. 149 female patients of reproductive age were enrolled in the study after surgical treatment for EGE. The patients were divided into two groups: the first group (n=94) was treated with complex therapy by dienogest (2 mg) daily within 6 months in combination with suppositories containing bovhyaluronidase azoxymer (3000 IU): 1 suppositorium once within 3 days,10 administrations; and then 1 suppositorium once in 7 days, 17 administrations, within 120 days; the second group (n=55) received monotherapy with dienogest (2 mg) daily up to 6 months. EGE-associated pelvic pain intensity, uterine bleeding severity and life quality were assessed during the study, after 30, 90, 150 and 180 days with regard to the basic values.
 Results. There was a statistically significant reduction of pain intensity observed in both groups compared to the basic level, using visual analogue scale of pain (VAS), the Biberoglu and Berman scale, but there was a distinct trend towards a more significant decrease in pelvic pain score basing on VAS in patients received complex therapy versus monotherapy with dienogest 2 mg after 30 days of treatment (p=0.051). Life quality assessment of patients in both groups revealed statistically significant increase in scores for all values of the SF-36 life quality scale just after the second follow-up visit. More significant life quality improvement in patients was observed with complex therapy with regard to such descriptors of the SF-36 Questionnaire as Physical functioning, Role-physical functioning, Pain intensity (p0.05).
 Conclusion. Bovhyaluronidase azoxymer in combination with dienogest (2 mg) improves the overall therapy effectiveness for EGE and is associated with more significant reduction in pelvic pain intensity, inflammatory and adhesive processes in the pelvis, and significant life quality improvement compared to monotherapy with 2 mg dienogest.