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 ORCID: https://orcid.org/0000-0002-3436-422X, Pooprasert, Pakinee, Muller, Ilaria ORCID: https://orcid.org/0000-0003-2926-0722, Zhang, Lei ORCID: https://orcid.org/0000-0003-3536-8692, Lane, Carol, Okosieme, Onyebuchi, Ludgate, Marian and Dayan, Colin ORCID: https://orcid.org/0000-0002-6557-3462 2019. Prostaglandin F2-alpha eye drops (bimatoprost) in Graves' orbitopathy: a randomized controlled double-masked crossover trial (BIMA Trial). Thyroid Journal Program 29 (4) , pp. 563-572. 10.1089/thy.2018.0506

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Abstract

Abstract Background: Previous in vitro experiments have demonstrated that prostaglandin F2-alpha (PF2α) 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 PGF2α 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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Mary Ann Liebert
ISSN:	1050-7256
Date of First Compliant Deposit:	19 May 2021
Date of Acceptance:	13 February 2019
Last Modified:	05 Nov 2024 22:15
URI:	https://orca.cardiff.ac.uk/id/eprint/141454

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