Skip to content

Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy: A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial)

Research output: Contribution to journalArticle

Standard

Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy : A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial). / Draman, Mohd Shazli; Morris, Daniel S.; Evans, Sam; Haridas, Anjana; Pell, Julie; Greenwood, Rosemary; Foy, Chris; Taylor, Peter; Pooprasert, Pakinee; Muller, Ilaria; Zhang, Lei; Lane, Carol; Okosieme, Onyebuchi; Ludgate, Marian; Dayan, Colin.

In: Thyroid, Vol. 29, No. 4, 09.04.2019, p. 563-572.

Research output: Contribution to journalArticle

Harvard

Draman, MS, Morris, DS, Evans, S, Haridas, A, Pell, J, Greenwood, R, Foy, C, Taylor, P, Pooprasert, P, Muller, I, Zhang, L, Lane, C, Okosieme, O, Ludgate, M & Dayan, C 2019, 'Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy: A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial)', Thyroid, vol. 29, no. 4, pp. 563-572. https://doi.org/10.1089/thy.2018.0506

APA

Vancouver

Author

Draman, Mohd Shazli ; Morris, Daniel S. ; Evans, Sam ; Haridas, Anjana ; Pell, Julie ; Greenwood, Rosemary ; Foy, Chris ; Taylor, Peter ; Pooprasert, Pakinee ; Muller, Ilaria ; Zhang, Lei ; Lane, Carol ; Okosieme, Onyebuchi ; Ludgate, Marian ; Dayan, Colin. / Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy : A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial). In: Thyroid. 2019 ; Vol. 29, No. 4. pp. 563-572.

Bibtex

@article{a66878d7934c444a97b810bc3b69601b,
title = "Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy: A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial)",
abstract = "Background: Previous in vitro experiments have demonstrated that prostaglandin F2-alpha (PF 2α ) reduced proliferation and adipogenesis in a murine cell line and human orbital fibroblasts derived from subjects with inactive Graves' orbitopathy (GO). The objective of this study was to determine if the PGF 2α analogue bimatoprost is effective at reducing proptosis in this population. Methods: A randomized controlled double-masked crossover trial was conducted in a single tertiary care academic medical center. Patients with long-standing, inactive GO but persistent proptosis (>20 mm in at least one eye) were recruited. Allowing for a 15{\%} dropout rate, 31 patients (26 females) were randomized in order to identify a treatment effect of 2.0 mm (p = 0.05; power 0.88). Following informed consent, participants were randomized to receive bimatoprost or placebo for three months, after which they underwent a two-month washout before switching to the opposite treatment. The primary outcome was the change in exophthalmometry readings over the two three-month treatment periods. Results: The mean exophthalmometer at baseline was 23.6 mm (range 20.0-30.5 mm), and the mean age of the patients was 55 years (range 28-74 years). The median duration of GO was 7.6 years (interquartile range 3.6-12.3 years). The majority were still suffering from diplopia (61.3{\%}) with bilateral involvement (61.3{\%}). Using multi-level modeling adjusted for baseline, period, and carry-over, bimatoprost resulted in a -0.17 mm (reduction) exophthalmometry change ([confidence interval -0.67 to +0.32]; p = 0.490). There was a mean change in intraocular pressure of -2.7 mmHg ([confidence interval -4.0 to -1.4]; p = 0.0070). One patient showed periorbital fat atrophy on treatment, which resolved on stopping treatment. Independent analysis of proptosis by photographic images (all subjects) and subgroup analysis on monocular disease (n = 12) did not show any apparent benefit. Conclusions: In inactive GO, bimatoprost treatment over a three-month period does not result in an improvement in proptosis.",
keywords = "Bimatoprost, fat atrophy, Graves' orbitopathy, prostaglandin F2a, thyroid eye disease",
author = "Draman, {Mohd Shazli} and Morris, {Daniel S.} and Sam Evans and Anjana Haridas and Julie Pell and Rosemary Greenwood and Chris Foy and Peter Taylor and Pakinee Pooprasert and Ilaria Muller and Lei Zhang and Carol Lane and Onyebuchi Okosieme and Marian Ludgate and Colin Dayan",
year = "2019",
month = "4",
day = "9",
doi = "10.1089/thy.2018.0506",
language = "English",
volume = "29",
pages = "563--572",
journal = "Thyroid",
issn = "1050-7256",
publisher = "Mary Ann Liebert Inc.",
number = "4",

}

RIS - suitable for import to EndNote

TY - JOUR

T1 - Prostaglandin F2-Alpha Eye Drops (Bimatoprost) in Graves' Orbitopathy

T2 - A Randomized Controlled Double-Masked Crossover Trial (BIMA Trial)

AU - Draman, Mohd Shazli

AU - Morris, Daniel S.

AU - Evans, Sam

AU - Haridas, Anjana

AU - Pell, Julie

AU - Greenwood, Rosemary

AU - Foy, Chris

AU - Taylor, Peter

AU - Pooprasert, Pakinee

AU - Muller, Ilaria

AU - Zhang, Lei

AU - Lane, Carol

AU - Okosieme, Onyebuchi

AU - Ludgate, Marian

AU - Dayan, Colin

PY - 2019/4/9

Y1 - 2019/4/9

N2 - Background: Previous in vitro experiments have demonstrated that prostaglandin F2-alpha (PF 2α ) reduced proliferation and adipogenesis in a murine cell line and human orbital fibroblasts derived from subjects with inactive Graves' orbitopathy (GO). The objective of this study was to determine if the PGF 2α analogue bimatoprost is effective at reducing proptosis in this population. Methods: A randomized controlled double-masked crossover trial was conducted in a single tertiary care academic medical center. Patients with long-standing, inactive GO but persistent proptosis (>20 mm in at least one eye) were recruited. Allowing for a 15% dropout rate, 31 patients (26 females) were randomized in order to identify a treatment effect of 2.0 mm (p = 0.05; power 0.88). Following informed consent, participants were randomized to receive bimatoprost or placebo for three months, after which they underwent a two-month washout before switching to the opposite treatment. The primary outcome was the change in exophthalmometry readings over the two three-month treatment periods. Results: The mean exophthalmometer at baseline was 23.6 mm (range 20.0-30.5 mm), and the mean age of the patients was 55 years (range 28-74 years). The median duration of GO was 7.6 years (interquartile range 3.6-12.3 years). The majority were still suffering from diplopia (61.3%) with bilateral involvement (61.3%). Using multi-level modeling adjusted for baseline, period, and carry-over, bimatoprost resulted in a -0.17 mm (reduction) exophthalmometry change ([confidence interval -0.67 to +0.32]; p = 0.490). There was a mean change in intraocular pressure of -2.7 mmHg ([confidence interval -4.0 to -1.4]; p = 0.0070). One patient showed periorbital fat atrophy on treatment, which resolved on stopping treatment. Independent analysis of proptosis by photographic images (all subjects) and subgroup analysis on monocular disease (n = 12) did not show any apparent benefit. Conclusions: In inactive GO, bimatoprost treatment over a three-month period does not result in an improvement in proptosis.

AB - Background: Previous in vitro experiments have demonstrated that prostaglandin F2-alpha (PF 2α ) reduced proliferation and adipogenesis in a murine cell line and human orbital fibroblasts derived from subjects with inactive Graves' orbitopathy (GO). The objective of this study was to determine if the PGF 2α analogue bimatoprost is effective at reducing proptosis in this population. Methods: A randomized controlled double-masked crossover trial was conducted in a single tertiary care academic medical center. Patients with long-standing, inactive GO but persistent proptosis (>20 mm in at least one eye) were recruited. Allowing for a 15% dropout rate, 31 patients (26 females) were randomized in order to identify a treatment effect of 2.0 mm (p = 0.05; power 0.88). Following informed consent, participants were randomized to receive bimatoprost or placebo for three months, after which they underwent a two-month washout before switching to the opposite treatment. The primary outcome was the change in exophthalmometry readings over the two three-month treatment periods. Results: The mean exophthalmometer at baseline was 23.6 mm (range 20.0-30.5 mm), and the mean age of the patients was 55 years (range 28-74 years). The median duration of GO was 7.6 years (interquartile range 3.6-12.3 years). The majority were still suffering from diplopia (61.3%) with bilateral involvement (61.3%). Using multi-level modeling adjusted for baseline, period, and carry-over, bimatoprost resulted in a -0.17 mm (reduction) exophthalmometry change ([confidence interval -0.67 to +0.32]; p = 0.490). There was a mean change in intraocular pressure of -2.7 mmHg ([confidence interval -4.0 to -1.4]; p = 0.0070). One patient showed periorbital fat atrophy on treatment, which resolved on stopping treatment. Independent analysis of proptosis by photographic images (all subjects) and subgroup analysis on monocular disease (n = 12) did not show any apparent benefit. Conclusions: In inactive GO, bimatoprost treatment over a three-month period does not result in an improvement in proptosis.

KW - Bimatoprost

KW - fat atrophy

KW - Graves' orbitopathy

KW - prostaglandin F2a

KW - thyroid eye disease

UR - http://www.scopus.com/inward/record.url?scp=85064205911&partnerID=8YFLogxK

U2 - 10.1089/thy.2018.0506

DO - 10.1089/thy.2018.0506

M3 - Article

VL - 29

SP - 563

EP - 572

JO - Thyroid

JF - Thyroid

SN - 1050-7256

IS - 4

ER -