Efficacy of SEVISTA (Ormeloxifene) in treatment of mastalgia and fibrocystic breast disease
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20150426Keywords:
Mastalgia, Fibrocystic, SERM, OrmeloxifeneAbstract
Background: Mastalgia and fibrocystic breast disease is common in women. Ormeloxifene (SEVISTA) is a weak oestrogen receptor (ER) agonist, a strong ER antagonist (SERA) and therefore a selective ER modulator (SERM) used in the treatment of the disease. Aim of study was to see the efficacy of ormeloxifene in women with pain in breast associated with or without fibrocystic breast disease.
Methods: This was a randomized control trial of oral ormeloxifene 30 mg alternate day for 3 month in patients of 20 – 50 years old with breast pain and fibrocystic (without cancer). The pain was accessed by visual analogue scale and nodularity grade on a 5 – point.
Results: Total 203 patients were completed the study. The mean age was 32.8 ± 8.35 years. The mean pain level was continuously decrease over 5 visit (5.8 to 0.86) and there was significant improvement was observed in the nodularity grades i.e. at beginning of treatment 1 and 2 nodularity were seen in 62 (30.5%) patients where as grades 3, 4 and 5 were seen in 141(69.5%) and at the end of six month it was 188 (92.6%) patients had grades 1 and 2 and only 15 (7.4%) had grade 3, 4 and 5 nodularity.
Conclusion: SEVISTA (Ormeloxifene) showed significant efficacy for the treatment of mastalgia and fibrocystic breast disease.
References
Cooper A. Illustrations of the Diseases of the Breast, Part 1. London, England: Longman, Rees, Orme, Brown & Green; 1829.
Ader DN, South-Paul J, Adera T, Deuster PA. Cyclical mastalgia: Prevalence and associated health and behavioural factors. J Psychocsom Obstet Gynecol. 2001;22:71–6.
Didsbury W. Aetiological factors in benign breast disease. Br J Surg. 1994;81:788–9.
Smith RL, Pruthi S, Fitzpatrick LA. Evaluation and management of breast pain. Mayo Clin Proc. 2004;79(3):353-72.
Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of mastalgia: A meta-analysis of randomised trials. Breast. 2007;16:503–12.
Dhar A, Srivastava A. Role of centchroman in regression of mastalgia and fibroadenoma. World J Surg. 2007;31:1178–84.
Tejwani PL, Srivastava A, Nerkar H, Dhar A, Hari S, Thulkar S, et al. Centchroman regresses mastalgia: A randomized comparison with danazol. Indian J Surg. 2011;73:199–205.
Ader DN, Shriver CD. Cyclical mastalgia: Prevalence and impact in an outpatient breast clinic sample. J Am Coll Surg. 1997;185:466–7.
Santen RJ, Mansel R. Benign breast disorders. N Engl J Med. 2005;353:275–85.
Makker A, Tandon I, Goel MM, Singh M, Singh MM. Effect of ormeloxifene, a selective estrogen receptor modulator, on biomarkers of endometrial receptivity and pinopode development and its relation to fertility and infertility in Indian subjects. Fertility and Sterility. 2009;91(6):2298–307.
"HLL Product Overview" (http://www.hindlatex. com/TipsnGuidesdetails.aspx? valid=1&category=0&id=170&type=25.
Vaidya R, Joshi U, Meherji P, Rege N, Betrabet S, Joshi L, et al. Activity profile of Centchroman in healthy female volunteers. Indian J Exp Biol. 1977;15:1173–6.
Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for management of hormone-related clinical disorder. Med Res Rev. 2001;21:302–47.
Kumar S, Rai R, Agarwal GG, Dwivedi V, Kumar S, Das V. A randomized, double- blind, placebo-controlled trial of ormeloxofene in breast pain and nodularity. The National Medical Journal of India. 2013;26(2):69-74.
Gately CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990;43:330–2.
Hinton CP, Bishop HM, Holliday HW, Doyle PJ, Blamey RW. A double-blind controlled trial of danazol and bromocriptine in the management of severe cyclical breast pain. Br J Clin Pract. 1986;40:326–30.