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Effects of Hormone Therapy on Intraocular Pressure: the Women's

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Effects of Hormone Therapy on Intraocular Pressure: the Women's Effects of Hormone Therapy on Intraocular Pressure: The Women’s Health Initiative-Sight Exam Study THASARAT S. VAJARANANT, PAULINE M. MAKI, LOUIS R. PASQUALE, ANNE LEE, HAJWA KIM, AND MARY N. HAAN PURPOSE: Previous studies suggest that hormone ther- determined. (Am J Ophthalmol 2016;165:115–124. apy favorably affects intraocular pressure (IOP). Here, Ó 2016 Elsevier Inc. All rights reserved.) we examined the association between hormone therapy use and IOP in the context of a large randomized trial. DESIGN: Secondary data analysis from a randomized LAUCOMA IS THE LEADING CAUSE OF IRREVERS- controlled trial. ible blindness worldwide, and the global burden 1–3 METHODS: We used data from the Women’s Health G is increasing as the population ages. Based on Initiative-Sight Exam (WHISE). Women with prior hys- a recent meta-analysis of 50 population-based studies, glau- terectomy received oral conjugated equine estrogen coma was estimated to affect 64.3 million people aged (0.625 mg/day) or placebo. Women with a uterus 40–80 years in 2013, and that number is predicted to in- received estrogen plus progestin (medroxyprogesterone crease to 76 million in 2020 and to 111.8 million in 3 acetate 2.5 mg/day) or placebo. IOP was measured 5 years 2040. Women comprise the majority of glaucoma cases 1 2,4–6 after randomization. Adjusted linear regression models worldwide and in the United States (U.S.). In were used to assess the association between hormone certain regions, women have less access to eye care than therapy and IOP. do men; even in developed nations such as the U.S., RESULTS: The WHISE included 1668 women in the women are 24% less likely than are men to receive 2,4 estrogen-alone trial (aged 63–86, mean 72 years) and treatment for glaucoma. Primary open-angle glaucoma 2679 women in the estrogen-plus-progestin trial (aged (POAG) is the most common type of glaucoma in the 63–87, mean 72 years). In multivariate analyses, U.S., and although a recent meta-analysis suggested that compared to placebo treatment, treatment with estrogen men have a 36% greater risk of POAG than do women, alone was associated with a 0.5 mm Hg reduction of the women comprise the majority of POAG cases in the 3 IOP in the right eye (95% CI: L0.8, L0.1, P [ .005) U.S., perhaps as a result of their longer lifespans. At pre- and a 0.6 mm Hg (95% CI: L0.9, L0.3, P < .001) sent, POAG affects 1.44 million women in the U.S., and reduction of the IOP in the left eye. In the estrogen- that number is projected to increase to 3.66 million by 5,6 plus-progestin trial, there was no significant difference 2050. Thus, from a public health perspective, glaucoma in IOP between the treatment and placebo groups screening and prevention in women is vital. (P [ .30 right eye and P [ .43 left eye). The risk of POAG in women is affected not only by CONCLUSIONS: This study represents an IOP analysis chronological age but also by advancing reproductive 2,7,8 in the largest hormone trial available. Estrogen-alone age. For example, in a Mayo Clinic study of 1044 therapy in postmenopausal women is associated with a women, early menopause as a result of bilateral small but significant IOP reduction of 0.5 mm Hg. The oophorectomy before the age of 43 years was associated 9 clinical significance of this small decrease remains to be with a 1.6-fold increase in the risk for POAG. Menopausal stage and sex steroid hormones influence the level of intra- ocular pressure (IOP), the major risk factor for glaucoma, Supplemental Material available at AJO.com. and is the only one that is modifiable. The Early Manifest Accepted for publication Feb 19, 2016. Glaucoma Treatment Trial (EMGT) suggested that each From the Departments of Ophthalmology and Visual Sciences (T.S.V.) 1 mm Hg reduction in IOP decreases the risk of glaucoma and Psychiatry (P.M.M.), and the Center for Clinical and Translational Science (H.K.), University of Illinois at Chicago, Chicago, Illinois; progression by 10% in patients with early POAG, normal- 10 Department of Ophthalmology, Mass Eye and Ear, Harvard Medical tension glaucoma, and exfoliation glaucoma. Compared School (L.R.P.), Boston, Massachusetts; Channing Division of Network to age-matched premenopausal women, postmenopausal Medicine, Brigham and Women’s Hospital, Harvard Medical School 11,12 (L.R.P.), Boston, Massachusetts; and Department of Epidemiology and women exhibited 1.5–2 mm Hg greater IOP. Small Biostatistics, University of California at San Francisco (A.L., M.N.H.), randomized trials and observational studies have shown San Francisco, California. that IOP decreased by 1–5 mm Hg following treatment Inquiries to Thasarat S. Vajaranant, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, 1855 W Taylor St, with hormone therapy in postmenopausal women with 12–22 Chicago, IL 60612; e-mail: [email protected] and without POAG. Based on these findings and 0002-9394/$36.00 Ó 2016 ELSEVIER INC.ALL RIGHTS RESERVED. 115 http://dx.doi.org/10.1016/j.ajo.2016.02.025 those of the EMGT, the observed IOP reduction, though each stratum, the women were randomly assigned to either small in magnitude, may be clinically significant in a hormone or a placebo arm. The WHI trial has been regis- postmenopausal women with glaucoma. tered at clinicaltrials.gov (identifier is NCT00000611). Notably, prior studies also suggest that medroxyproges- The present study was a secondary analysis of IOP data terone acetate can minimize the beneficial effects of estro- from the WHISE, an ancillary study to the WHI random- gen in the central nervous system.23 Similarly, a large ized hormone therapy trial.27 The WHISE study was con- claims database of 152 163 enrollees aged >50 years ducted between 2000 and 2002 to examine the showed that each additional month of hormone therapy association between prior randomization to hormone ther- containing estrogen, but not a combination of estrogen apy and AMD, where early or late AMD was assessed based and progesterone, was associated with a 0.4% reduced on fundus photography in women 65 years and older an risk for POAG.24 average of 5 years after randomization to hormone therapy To date, however, there has been no large, randomized, or placebo.28 WHISE recruited 4347 women who under- placebo-controlled trial with longitudinal follow-up went fundus photography of at least 1 eye at 21 WHI designed to assess the effect of postmenopausal hormone clinics. A flow diagram of the WHISE study is presented therapy on IOP. To examine the effect of estrogen and es- in the Figure. Overall, the WHISE study reached 96.6% trogen plus progestin on IOP in the context of a large ran- of its enrollment goal of 4500 eligible and consenting par- domized clinical trial, we performed a secondary data ticipants (15.9% of the WHI hormone trial, n ¼ 27 347) analysis of IOP outcomes on data collected during the before termination of the estrogen plus progestin study Women’s Health Initiative Sight Exam (WHISE) study, arm owing to an adverse risk-benefit profile after an average an ancillary study of the Women’s Health Initiative follow-up period of 5.2 years.29 The WHISE protocol was (WHI) randomized hormone trial that focused on age- approved by Institutional Review Boards at each clinic related macular degeneration (AMD). IOP was measured site, and all participants provided written informed consent 5 years after baseline in 2 groups: (1) women with prior hys- to participate. The Institutional Review Board at the Uni- terectomy who were randomized to receive either conju- versity of Illinois at Chicago waived the need for approval gated equine estrogens (estrogen-alone trial) or placebo; of this secondary data analysis. The study was conducted in and (2) women with a uterus who were randomized to accordance with Health Insurance Portability and receive conjugated equine estrogens combined with Accountability Act regulations and adhered to the tenets medroxyprogesterone acetate (estrogen-plus-progestin of the Declaration of Helsinki. trial) or placebo. Based on previous findings, we hypothe- sized that women who had been randomized to receive con- PARTICIPANT RANDOMIZATION TO HORMONE THER- jugated equine estrogens would have lower IOP compared APY AND ADHERENCE: Randomized treatment assignment to women randomized to receive placebo. In contrast, we was performed in the WHI hormone trial.28 In the WHI, hypothesized that this association would not be observed the women who had previously undergone hysterectomy in women randomized to receive conjugated equine estro- were randomized to receive either conjugated equine estro- gens and medroxyprogesterone acetate. gens (0.625 mg/day) or placebo; women with a uterus were randomized to receive oral conjugated equine estrogens and medroxyprogesterone acetate (0.625 mg/day þ 2.5 mg/day) or placebo. As reported previously, there METHODS were no differences within each randomized trial with respect to patient age, age at menarche or menopause, ed- STUDY DESIGN AND POPULATION: The WHI (the ucation, race, annual income, smoking, alcohol consump- parent study) was a 15-year research program initiated in tion, history of hormone use, or the incidence of diabetes 1991 by the National Institutes of Health consisting of a mellitus, stroke, myocardial infarction, peripheral artery set of clinical trials and an observational study, which disease, glaucoma, and cataracts in the WHI hormone together involved 161 808 generally healthy postmeno- trial.28 For the WHISE study, women aged 65 years and pausal women aged 50–79 years.25,26 The clinical trials older were recruited from the WHI hormone trial.
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