Skin Manifestations of Inhaled Corticosteroids in COPD Patients: ICS therapy

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: ICS therapyWeaknesses of the above-cited older studies are that they were cross-sectional, nonrandomized surveys and that they relied on retrospective reporting of previous, as well as current, ICS use. Moreover, some subjects had received oral corticosteroids in variable amounts at least in short courses, potentially contributing to the occurrence of cutaneous as well as other systemic side effects. More recently, the incidence of skin bruising has been examined in three large-scale, prospective, 2.5-year to 3-year, randomized controlled clinical trials of high-dose ICSs in the management of stable patients with COPD (Table 7). Bruising was assessed either by subjective self-reports of side effects or by the direct observation of ecchymotic areas > 5 cm2 in size on the volar side of the forearm. In two of these clinical trials, the proportion of subjects in whom bruising was found was numerically but not significantly higher in the ICS group than the placebo group (7.3% vs 4%, respectively, in one study; and 7% vs 6%, respectively, in the other study). In the third trial, the highest prevalence of bruises at any visit was significantly higher in the ICS arm than in the placebo arm (4.9% vs 1.4%, respectively). canadian health and care mall

The reason for the marked disparity between the relatively low incidence of bruising in these randomized prospective trials among COPD patients receiving ICSs and the much higher prevalence of easy bruising noted in the earlier cross-sectional, retrospective studies in mostly asthmatic patients on ICS therapy is not clear. This disparity might be related to differences in the study design and reliance, in the COPD trials, on relatively insensitive indicators of bruising, such as nondirected reports of any side effects (as opposed to questionnaires focused more specifically on purpura) and physical assessment of the presence or absence of large ecchymotic areas in only a limited anatomic location. Although the development of bruising secondary to ICS therapy appears to be related to both dose and age, these factors were roughly comparable across the different studies. Although the underlying diagnosis was generally different in the earlier studies compared to the more recent studies (asthma vs COPD, respectively), it does not appear likely that differences in diagnosis would account for the disparity in the incidence of bruising. Moreover, the ages of the subjects in the different studies were generally comparable (mean age in all studies, sixth decade), although fewer women were included in the COPD trials (25 to 36%) than in the earlier studies in mainly asthmatic subjects (42 to 66%).
Table 7—Incidence of Skin Bruising Reported in Randomized Controlled Clinical Trials of ICS in COPD

Study/Year/N Drug Arm/Drug/N Placebo Arm Proportion of Participants With Bruising, % Method of Assessment of Bruising pValue t
ICS Placebo
Pauwels et al/1999/n = 634/budesonide, 800 ^,g/d/n = 643 4.9 1.4 Observed ecchymoses a 5 cm2 < 0.001
on volar side of forearm
Burge et al/2000/n = 372/FP, 1,000 ^g/d/n = 379 7.3 4.1 Questionnaire 0.059
Calverley et al/2003/n = 374/FP, 1,000 ^g/d/n = 361 7 6 Observed ecchymoses a 5 cm2 on volar side of forearm NS
Present study (all participants)/n = 544/TAA, 1,200 ^,g/d/n = 542 7.6 3.6 Questionnaire 0.002
Present study (good inhaler compliers|)/n = 297/TAA/n = 323 11.2 3.5 Questionnaire < 0.001
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