The effect of nasal steroid administration on intraocular pressure.
The effect of systemic steroid administration on intraocular pressure (IOP) is well established. However, less attention has been paid to the effect of steroids when administered in a nasal spray. We conducted a study to investigate a possible association between nasal steroids and elevated IOP in 54 patients who were being treated for allergic rhinitis, IOP was measured before the patients started therapy and thereafter every 5 days during that therapy. Follow-up ranged from 27 to 35 days (mean: 31). Statistical analysis revealed no significant elevation in IOP after nasal steroid administration. It seems that short-term administration of nasal steroids does not cause significant IOP elevation. Nevertheless, their long-term effects on this pressure should be investigated.
It is well known that steroids can cause an elevation of intraocular pressure (IOP), whether they are administered topically as skin creams (1) or ophthalmic drops, or when they are administered systemically for a long time. (2,3) For instance, topical ocular administration of a potent steroid for 4 to 6 weeks can produce an elevated IOP in approximately 40% of the general population. (4) The increase in IOP occurs more frequently in patients with chronic simple glaucoma or in those with a family history of this disease. (2) However, only a few studies have reported the effect of steroids on IOP when administered in nasal sprays. (5-9) The purpose of this study is to measure IOP after the nasal administration of steroids.
Patients and methods
Fifty-four patients--36 women and 18 men, aged 22 to 55 years (mean: 47)--who were examined in an outpatient setting at our institution were included in this study. All these patients had allergic rhinitis and were receiving nasal steroids for its treatment.
Patients were excluded from this study if they (1) had an ophthalmic disease or any systemic illness other than allergy, (2) were receiving any drugs topically or systemically other than nasal steroids, or (3) had reported any previous corticosteroid use. Patients who were not compliant with the treatment regimen or the IOP measuring program were dropped from the study.
Before therapy was initiated, a detailed personal, ophthalmic, and family history was obtained for each patient, and each underwent a full ophthalmic examination that included the measurement of IOP, checking of the angle of the anterior chamber, and direct ophthalmoscopy to define the concavity of the optic disc.
After therapy was initiated, IOP was measured every 5 days as long as no elevation of this pressure was noted and every 2 days when elevation was observed. IOP measurement was done with an applanation tonometer every morning to exclude accidental findings caused by the normal daily fluctuation of IOP. Follow-up ranged from 27 to 35 days (mean: 31).
The results of successive measurements were registered; subsequently, the observed IOP differences were statistically analyzed. The statistical analysis of the results was done using the paired Student's t-test.
All patients in the study were given an aerosol formulation containing a combination of tramazoline hydrochloride (120[micro]g) and dexamethasone (20[micro]g), administered as a nasal spray at a dosage of 1 spray in each nostril once daily.
Before patients started therapy, their IOPs ranged from 10 to 15 mm Hg. Thirty-six of the 54 patients (66.7%) showed no change, 6 (11.1%) had a 1-mm Hg increase, 5 (9.3%) had a 2-mm Hg increase, and 3 (5.6%) had a 3-mm Hg increase; only 4 patients (7.4%) had an elevation of 4 mm Hg. Despite these increases, all patients' IOPs remained within normal limits. Statistical analysis showed that the differences were not statistically significant (p > 0. 1).
Steroids administered in the form of nasal sprays are indicated mainly for the treatment of seasonal and perennial allergic rhinitis, but they are also given to many patients with bronchial asthma. Before this study, only a few reports correlated the administration of nasal steroid sprays with the formation of posterior capsular cataracts and glaucoma. However, it has been proven that the systemic absorption of steroids given as nasal sprays reaches or exceeds 50% (10); therefore, potential ophthalmic side effects should be expected and examined.
In 1990, Fraunfelder and Meyer were the first investigators to correlate the administration of beclomethasone nasal sprays with bilateral posterior capsular cataracts. (11) Most of the 21 patients with cataracts in their study had used that medication longer than 5 years, and 9 patients had received steroids systemically. In 1993, Simons et al did not observe cataracts in young patients who were successfully treated with inhaled steroids. (12)
Reports in the literature of IOP response to the administration of nasal steroids are conflicting. The first study to examine the relationship between inhaled or nasal steroid sprays and IOP was published in 1993 by Dreyer, reporting on 3 patients who presented with glaucoma after the administration of beclomethasone inhalation spray. (5) Two years later, Opatowsky et al described 3 patients with increased IOP that probably was related to beclomethasone nasal spray or inhalation. (6) Two of those patients had diabetes mellitus and the third had asthma, which necessitated the administration of steroids by mouth. In all 3 cases, the IOP returned to normal after the elimination of steroids.
In agreement with those reports, Bui et al showed some years later that discontinuing nasal steroids might lower IOP in eyes with glaucoma, (7) suggesting that nasal steroids might contribute to IOP increase. Yet Garbe et al reported that only patients receiving high doses of inhaled or nasal steroids for 3 or more months were at increased risk for ocular hypertension or open-angle glaucoma. (8) However, in a large, prospective, controlled study of 360 patients using placebo or one of three different nasal topical steroids for 1 year, Bross-Soriano et al showed that the observed variations in IOP were within normal limits. (9) Evidently, more data are needed to confirm or contradict the above conflicting reports.
A review of the literature reveals that our 54 patients compose one of the largest groups in whom the correlation of the administration of nasal steroid sprays with increased IOP has been studied to date. It is also the first time that the combination of tramazoline and dexamethasone was correlated with IOP.
Our results demonstrate no statistically significant increase in IOP after the short-term administration of tramazoline/dexamethasone nasal spray. We believe, therefore, that the combination of tramazoline and dexamethasone, administered for a short time for the treatment of nasal allergy, is safe in terms of its effect on IOP.
It is likely that the side effects of the absorbed steroids depend not only on the type of steroid given, but also on the duration of administration. Therefore, further research is needed to determine the possible relationship between steroids and IOP when administered over a long period. Until that relationship has been established, we recommend that IOP and the condition of the optic nerve be observed during long-term administration of nasal steroids.
The authors address special thanks to Prof. John X. Koliopoulos, MD, PhD, former chairman of the Department of Ophthalmology of the University Hospital of Patras, Greece, for his support in conducting the above study. They also thank Vassilios Margaritis, MD, for collection of data.
[1.] Aggarwal RK, Potamitis T, Chong NH, et al. Extensive visual loss with topical facial steroids. Eye 1993;7(Pt 5):664-6.
[2.] Urban RC Jr., Dreyer EB. Corticosteroid-induced glaucoma. Int Ophthalmol Clin 1993;33(2):135-9.
[3.] Rennie IG. Clinically important ocular reactions to systemic drug therapy. Drug Saf 1993;9(3): 196-211.
[4.] Wordinger RJ, Clark AF. Effects of glucocorticoids on the trabecular meshwork: Towards a better understanding of glaucoma. Prog Retin Eye Res 1999;18(5):629-67.
[5.] Dreyer EB. Inhaled steroid use and glaucoma. N Engl J Med 1993;329(24): 1822.
[6.] Opatowsky I, Feldman RM, Gross R, Feldman ST. Intraocular pressure elevation associated with inhalation and nasal corticosteroids. Ophthalmology 1995;102(2):177-9.
[7.] Bui CM, Chen H, Shyr Y, Joos KM. Discontinuing nasal steroids might lower intraocular pressure in glaucoma. J Allergy Clin Immunol 2005; 116(5): 1042-7.
[8.] Garbe E, LeLorier J, Boivin JF, Suissa S. Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma. JAMA 1997;277(9):722-7.
[9.] Bross-Soriano D, Hanenberg-Milver C, Schimelmitz-Idi J, et al. Effects of three nasal topical steroids in the intraocular pressure compartment. Otolaryngol Head Neck Surg 2004; 130(2):187-91.
[10.] USP DI Drug Information for the Health Care Professional. 12th ed. Rockville, Md.: United States Pharmacopeial Convention 1992:56-62.
[11.] Fraunfelder FT, Meyer SM. Posterior subcapsular cataracts associated with nasal or inhalation corticosteroids. Am J Ophthalmol 1990; 109(4):489-90.
[12.] Simons FE, Persaud MP, Gillespie CA, et al. Absence of posterior subcapsular cataracts in young patients treated with inhaled glucocorticoids. Lancet 1993;342(8874):776-8.
From the Department of Ophthalmology (Dr. Spiliotopoulos, Dr. Petropoulos, Dr. Mela, and Dr. Gartaganis) and the Department of Otorhinolaryngology-Head and Neck Surgery (Dr. Mastronikolis and Dr. Goumas), University Hospital of Patras Medical School, Patras, Greece.
Reprint requests: Christos Spiliotopoulos, MD, 3 Egeou & Lerou St., GR-25006 Akrata Achaias, Greece. Phone: 30-2696-033-007; e-mail: c.spiliotopoulos @ yahoo.com
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|Author:||Spiliotopoulos, Christos; Mastronikolis, Nicholas S.; Petropoulos, Ioannis K.; Mela, Ephigenia K.; G|
|Publication:||Ear, Nose and Throat Journal|
|Article Type:||Clinical report|
|Date:||Jul 1, 2007|
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