Comparison of Inhaled Corticosteroids: An Update

H William Kelly, PharmD


The Annals of Pharmacotherapy. 2009;43(3):519-527. 

In This Article

Limitations of Studies

The clinical comparative chart is based on comparative efficacy trials and not studies that assess the therapeutic index of the inhaled corticosteroids. Too few studies assess relative therapeutic indexes.[17] Those that do tend to be short term and use surrogate biomarkers as opposed to clinical outcomes.[3,4,30,31] The dose response to inhaled corticosteroids is relatively flat, making it very difficult to detect dose-response differences between doubling doses.[18,19,30] The pivotal clinical trials submitted to the FDA to gain approval of the drugs are not designed to determine whether a patient does not respond adequately to a low dose, with dose escalation required to improve control. Instead, each pivotal trial for each dose of the inhaled corticosteroids is run separately, with different entry criteria, so it is unknown whether patients on high doses may have been adequately controlled with low doses or whether patients uncontrolled on low doses would be controlled on high doses. The best studies for assessing dose response of the inhaled corticosteroids have been in those comparing escalating doses of inhaled corticosteroids with the addition of a long-acting inhaled β2 agonist.[20,68,69,70] The studies assessing prevention of exacerbation clearly demonstrate significant reduction in exacerbation when the inhaled corticosteroid dose is quadrupled over the baseline dose.[68,69,70]


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