Open AccessEfficacy, safety and tolerability of the CCR 1 antagonist BAY 86‐5047 for the treatment of endometriosis‐associated pelvic pain: a randomized controlled trial
Author(s) -
Trummer Dietmar,
Walzer Anja,
GroettrupWolfers Esther,
Schmitz Heinz
Publication year - 2017
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/aogs.13105
Subject(s) - medicine , placebo , visual analogue scale , tolerability , endometriosis , pelvic pain , randomized controlled trial , analgesic , adverse effect , bay , anesthesia , surgery , civil engineering , alternative medicine , pathology , engineering
Antagonism of CC chemokine receptor type 1 ( CCR 1) may provide a novel treatment approach for women with symptomatic endometriosis. Studies of CCR 1 antagonists in these patients have not been reported. Material and methods Women ( n = 110; 18–45 years) with symptomatic endometriosis were randomized to BAY 86‐5047 or placebo for 12 weeks. Pelvic pain was assessed using the visual analogue scale ( VAS ) and women recorded the intake of pain medication in a diary. The primary efficacy outcome was a composite of the absolute change in VAS score and the cumulative change in consumption of analgesics between baseline and the end of treatment. Safety assessments included adverse events, blood and urine evaluation and electrocardiography. Results Mean VAS scores decreased from 64.8 mm at baseline to 49.2 mm at week 12 in the BAY 86‐5047 group and from 67.2 mm to 47.8 mm in the placebo group. The proportion of women using analgesics decreased from 33.9% to 11.5% or from 44.4% to 15.4% for patients who received BAY 86‐5047 or placebo, respectively. There was no significant difference between the two treatment groups in terms of change in VAS scores ( p = 0.45) or intake of analgesics ( p = 0.82). A three‐step sensitivity analysis failed to show superiority of BAY 86‐5047 over placebo ( p = 0.67). BAY 86‐5047 was well tolerated and no significant safety concerns arose during the study. Conclusions Based on these results, BAY 86‐5047 is unlikely to be useful in the treatment of women with endometriosis‐associated pelvic pain.