Abstract

EFFICACY AND SAFETY OF ULIPRISTAL ACETATE AND LETROZOLE IN SYMPTOMATIC UTERINE LEIOMYOMAS

Sanjana Dawra, Sarita Goyal*, Nirmala Duhan and Mahesh Chander Gupta

ABSTRACT

Objective: To compare the efficacy and safety of ulipristal acetate and letrozole, in women with symptomatic uterine leiomyomas. Materials and methods: Prospective interventional study conducted on 64 premenopausal women aged between 20 and 50 years with menstrual or pressure symptoms and having one or more uterine myoma of >2 cm to 10 cm. They received either tablet ulipristal acetate 5mg or tablet letrozole 2.5 mg daily for 12 weeks. Efficacy of drugs was assessed by resolution of menorrhagia by using Pictorial Bleeding Assessment Chart (PBAC) score, reduction in pain by Visual Analog scale (VAS) and ultrasonography for change in size of myoma. Safety was assessed by doing an active adverse drug reaction monitoring. Results: In ulipristal acetate, group PBAC score for menorrhagia at baseline was 265.37 ± 13.56 which reduced to 74.15 ± 17.33 whereas in letrozole, group it reduced from 262.65 ± 13.78 to 99.21 ± 10.07 at week 12. Baseline VAS score for dysmenorrhea was 63.12 ± 2.54 with ulipristal acetate which reduced to 30.09 ± 2.84 and with letrozole, reduction in VAS score was from 64.84 ± 2.19 to 38.75 ± 2.29 at 12 weeks as compared to baseline score. The mean myoma size reduced from 4.60 ± .23cm to 3.68 ± .22 cm with ulipristal acetate and from 4.62 ± .22 cm to 3.04 ± .22 cm with letrozole group, at end of 12 weeks. Both drugs showed improvement in hemoglobin concentration. Headache, abdominal pain with ulipristal acetate and hot flushes with letrozole were the most common adverse effects observed. Conclusion: Both, ulipristal acetate and letrozole were safe and equally effective in leiomyomas. Any of above mentioned drugs can be used by clinicians for the conservative treatment of leiomyomas. Both drugs significantly reduced myoma size and its symptoms.

Keywords: Letrozole, Ulipristal acetate, Uterine leiomyomas, PBAC score.