Side Effects With Inhaled Corticosteroids: Conclusion
How often do you monitor for (1) systemic or (2) local adverse events?
When asked to rate the overall safety of ICS on a scale of 1 (very safe) to 6 (dangerous), 25% of participants in this meeting rated ICS as very safe, most (40%) chose 2 on the scale, and 35% chose 3 or 4. Participants believed that local side effects were most likely to lead to discontinuation of therapy. Approximately two thirds of the participants monitored for local side effects at each visit; the remainder relied on the patient to alert them to any problems. Most of the group (50%) investigated systemic side effects only in the event of a patient indicating that there was a problem. The remainder monitored at regular periods: every 6 months (21%), every quarter (4%), or every visit (25%). Considerable reservations remain for parents and many pediatricians regarding the effect of ICS on linear growth in children: cataracts may be more common with ICS in older patients; bone density is a risk in postmenopausal women and elderly men; patients with a family history of glaucoma may be more at risk of this side effect with ICS; and skin bruising occurs even at moderate ICS doses. review
When reading the NAEPP 1997 guidelines, understanding the potential side effects of ICS therapy and their control and monitoring seems relatively clear and straightforward. In this context, the concerns of many physicians (and patients) may seem misplaced. However, on closer examination of the clinical trial data used to develop the guidelines, as well as subsequent studies, we see that there are many unknowns and gaps in our knowledge, leaving space for doubt and confusion.
We know that local side effects such as oral candidiasis, pharyngitis, and dysphonia/cough can be unpleasant and lead to poor therapy adherence, even though they are not serious. The fear of systemic side effects, such as reduced bone mineral density, skin bruising, glaucoma, cataracts, and growth retardation in children, may appear to be out of proportion to the risks. However, given the seriousness of these potential side effects and the lack of clear data, these fears are understandable.
We know that ICS are a highly effective therapy for control of asthma symptoms, and we must now concentrate on furthering our understanding of the risks of therapy. Different perceptions of the risks of ICS therapy will result in different balance points for the risk/benefit decision that physicians and patients must make on initiating ICS therapy. There is a need for an ICS formulation that will allow high-dose therapy for extended periods, with a confirmed dose response and with a decreased potential for side effects (ie, a broader therapeutic window). The introduction of new agents with improved safety profiles will also reassure physicians and patients as to the benefits of ICS therapy.