(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Ocular-Hypertension

To evaluate the effect of 6 weeks administration of beclomethasone nasal spray on intraocular pressure (IOP) in patients with ocular hypertension or controlled primary open-angle glaucoma.. Randomized double-masked controlled trial. Patients were randomized to twice daily beclomethasone versus placebo saline nasal spray. There were a total of 4 study visits: baseline and weeks 2, 4, 6 after starting the spray. Each study visit was at the same time within a 1-hour time window. Primary outcome measure was IOP. Secondary measures included visual acuity, anterior segment changes, patient reported side effects, and compliance. Study endpoint was 6 weeks from the start of treatment or an IOP increase of >20% from baseline. A sample size calculation suggested that 8 patients in each arm would be sufficient to detect a difference of 3.2 mm Hg with a power of 80%.. Nineteen consecutive consenting patients completed the study-9 in the steroid arm and 10 in the placebo arm. There were no statistically significant differences between groups in baseline characteristics, IOP at each study visit, or change in IOP from baseline at any time point. At 6 weeks, the change in mean IOP from baseline was +0.50±1.52 versus +0.70±1.44 mm Hg in the steroid and saline nasal spray groups, respectively (P=0.77).. Patients with ocular hypertension and primary open-angle glaucoma showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray.

Topics: Beclomethasone; Double-Blind Method; Female; Glaucoma, Open-Angle; Glucocorticoids; Humans; Intraocular Pressure; Male; Middle Aged; Nasal Sprays; Ocular Hypertension; Prospective Studies; Tonometry, Ocular; Visual Acuity

Increased levels of glucocorticoids are associated with raised intraocular pressure (IOP). The activity of glucocorticoids is regulated at a prereceptor level by 11beta-hydroxysteroid dehydrogenases (11beta-HSD). This study was an investigation of the central and peripheral sensitivity to glucocorticoids in patients with POAG or ocular hypertension (OHT) and the differential metabolism of glucocorticoids by 11beta-HSDs.. Patients with POAG or OHT and normal control subjects were studied. Peripheral sensitivity to glucocorticoids was assessed as dermal blanching and central sensitivity by dexamethasone suppression testing. Daily production rates of glucocorticoids were determined by quantifying metabolites in 24-hour urine. Plasma cortisol levels were determined at baseline (9 AM) and after an overnight low-dose dexamethasone suppression test. In a separate study, plasma and aqueous humor cortisol levels were determined in patients with POAG and normal subjects.. Patients with POAG exhibited a greater cutaneous vasoconstrictor response to glucocorticoids than patients with OHT and normal subjects (20.7 +/- 3.1 vs. 8.5 +/- 4.4 and 8.6 +/- 4.5 arbitrary units, respectively; P < 0.05 in each case). Total glucocorticoid production rates were not different between groups, nor were total circulating cortisol levels before or after suppression of the hypothalamic-pituitary-adrenal axis by dexamethasone or concentrations in aqueous humor. The ratio of urinary cortisol to cortisone metabolites was elevated in POAG versus normal control and OHT (1.74 +/- 0.13 vs. 1.34 +/- 0.11 and 1.32 +/- 0.14; P < 0.05 in each case), indicating a change in the balance of 11beta-HSDs, without a change in other metabolic pathways.. Patients with POAG exhibit increased peripheral vascular sensitivity to glucocorticoids. Increased sensitivity of glucocorticoid receptors, may enhance local glucocorticoid action in the eye and exacerbate the adverse effects of glucocorticoids in this condition.

Topics: Administration, Oral; Administration, Topical; Aged; Aqueous Humor; Beclomethasone; Dexamethasone; Glaucoma, Open-Angle; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Ocular Hypertension; Pituitary-Adrenal System; Regional Blood Flow; Skin; Vasoconstriction

It is possible that corticosteroids administered via nasal spray might reach ocular structures in levels sufficient to provoke an ocular hypertensive response and cause posterior subcapsular cataracts (PSCs) in susceptible individuals. In the present study, 26 patients who had undergone endoscopic sinus surgery were evaluated prospectively with respect to intraocular pressure and PSC formation following the use of nasal steroids for at least three months. Eighteen patients (69%) self-administered 200 micrograms/day of budesonide nasal spray twice daily, and eight patients (31%) self-administered 200 micrograms/day of beclomethasone dipropionate nasal spray twice daily, for a period of three to 19 months (mean 8.8 +/- 3.6 months). Ophthalmologic examination, tonometry, visual field testing and biomicroscopic studies revealed no evidence of ocular hypertension or PSCs during postoperative follow-up. We conclude that intranasal corticosteroids can be used safely for prolonged periods without increasing the risk of ocular hypertension or PSCs.

Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Cataract; Cataract Extraction; Female; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Retrospective Studies; Time Factors

The ocular hypertensive response to corticosteroids is well established. Elevated intraocular pressure (IOP) secondary to corticosteroids by nasal spray or inhalation has rarely been reported.. Three patients showed a possible ocular hypertensive response to beclomethasone dipropionate by nasal spray or inhalation. In two patients, the IOP returned to pretreatment levels after discontinuing nasal corticosteroid spray. One patient required medication to control IOP with continued inhaled corticosteroid. One patient later demonstrated an ocular hypertensive response to oral steroids.. Corticosteroids by nasal spray or inhalation may cause ocular hypertension in susceptible patients. The authors recommend surveillance of IOP in patients using these medications.

Topics: Administration, Inhalation; Administration, Intranasal; Aged; Asthma; Beclomethasone; Female; Humans; Intraocular Pressure; Male; Middle Aged; Nebulizers and Vaporizers; Ocular Hypertension; Rhinitis