The effect of nasal steroid administration on

ORIGINAL
ARTICLE
SPILIOTOPOULOS, MASTRONIKOLIS,
PETROPOULOS,
MELA, GOUMAS, GARTAGANIS
The effect of nasal steroid
administration on intraocular pressure
Christos Spiliotopoulos, MD; Nicholas S. Mastronikolis, MD, PhD;
Ioannis K. Petropoulos, MD; Ephigenia K. Mela, MD, PhD; Panos D. Goumas, MD, PhD;
Sotirios P. Gartaganis, MD, PhD
Abstract
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.
Introduction
It is well known that steroids can cause an elevation of
intraocular pressure (IOP), whether they are administered
topically as skin creams1 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.
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; email: [email protected]
394
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 μg) and dexamethasone (20 μg), administered as a nasal
spray at a dosage of 1 spray in each nostril once daily.
Results
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.
ENT-Ear, Nose & Throat Journal  July 2007
THE EFFECT OF NASAL STEROID ADMINISTRATION ON INTRAOCULAR PRESSURE
Despite these increases, all patients’ IOPs remained within normal limits. Statistical analysis showed that the differences were not statistically significant (p > 0.1).
Discussion
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.
Volume 86, Number 7
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.
Acknowledgments
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.
References
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.
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