Skin Manifestations of Inhaled Corticosteroids in COPD Patients: LHS

A few randomized, placebo-controlled clinical trials in persons with COPD have systematically evaluated the frequency of bruising as a complication of moderate-to-high doses of ICSs.-’ However, these relied mainly on nondirected complaints regarding adverse events or direct observation of large ecchy-motic areas (ie, > 5 cm) on the forearm only and may therefore have underestimated the true frequency of bruising in the study population. Moreover, potentially important cofactors that might be associated with bruising, such as age, gender, and compliance with ICS therapy, have not been analyzed in these studies. Furthermore, few studies have examined the impact of ICS therapy on other skin manifestations, such as skin healing, acne, and rash, which are known to be affected by systemic steroids.

Lung Health Study (LHS) II was a 4.5-year (November 1994 to April 1999) placebo-controlled clinical trial of the possible benefit of ICSs in slowing the rate of decline in FEV1 in 1,116 continuing smokers and recent ex-smokers who had participated in or been screened for LHS I, an early intervention study in 5,887 smokers aged 35 to 60 years with mild-to-moderate COPD. Findings from LHS II failed to show an impact of ICSs (triamcinolone, acetonide [TAA] 600 ^g bid) on FEV1 decline but did demonstrate modest benefits in terms of symptom improvement and a reduction in the frequency of acute exacerbations. On the other hand, while no statistically significant effects were noted on basal or stimulated serum cortisol levels, at 3 years following drug assignment, bone mineral density (BMD) declined more in participants receiving the ICS than in those assigned to receive placebo.
This report describes the relationship between bruising (as reported in response to a structured questionnaire) and assignment to ICS therapy vs placebo therapy in both well-compliant and poorly compliant participants, and analyzes this relationship in participants who have been stratified by gender and age. Significant effects were noted on the frequency of bruising at most time points during this 4.5-year study, especially in participants who are compliant with the use of their assigned medication, as determined by canister weighing. The association between ICS therapy and other skin manifestations that have been historically reported with systemic steroid therapy is also examined. In addition, the relationship between the presence or absence of easy bruising and other systemic effects, namely, measures of HPA axis suppression and change in BMD, was explored in the subset of LHS II participants in whom these measures were obtained.

This entry was posted in COPD and tagged copd, inhaled corticosteroids, rash, skin bruising, slow healing.