Higher patient perceived side effects related to higher daily doses of inhaled corticosteroids in the community: a cross-sectional analysis.
The range and extent of inhaled corticosteroid (ICS) side effects experienced by patients in the general community are likely to be underestimated.


OBJECTIVE
To identify the side effects of ICS perceived by patients in the community and, through the use of a self-report questionnaire, measure their intensity, prevalence and relationship with daily medication dose.


METHODS
Focus groups and in-depth interviews were conducted to identify side effects that patients associated with their use of ICS. In an international multicentre cross-sectional survey, 395 inhaler users from community pharmacy (mean age 50, 53% female), divided into 4 daily dosage groups (beta2-agonist without ICS n=66, beclometasone dipropionate (BDP) equivalent ICS low dose 400 microg, n=109; mid dose 401-800 microg, n=151; and high dose>800 microg, n=69) reported how much they were affected by these side effects on a 7-point Likert scale.


RESULTS
Focus groups and interviews revealed 57 side effects that were associated with ICS use. Cross-sectional survey results showed significant differences in side effect perception between the four dosage groups for 31 items (all P0.01) and a rising intensity with increasing ICS dose for total side effect score (P<0.001). For ICS users reporting the most bothersome side effects (scoring 3 on 0-6 scale) there was a rising prevalence as ICS dose increased for 34 items. A multivariate model confirmed that mid and high ICS dosages were statistically significantly associated with side effect perception after controlling for the other factors and covariates.


CONCLUSIONS
Higher daily ICS doses were associated with a higher intensity and a higher prevalence of many patient perceived side effects, lending support to the call for dose titration in clinical practice. Results indicate the usefulness of patient self-report scales for understanding the burden of side effects of ICS in the community.
Foster
Juliet M
JM
Department of General Practice and Primary Care, University of Aberdeen, Foresterhill AB25 2AY, Scotland. j.foster@abdn.ac.uk
Aucott
Lorna
L
van der Werf
Rik H W
RH
van der Meijden
Mariken J
MJ
Schraa
Gysbert
G
Postma
Dirkje S
DS
van der Molen
Thys
T
D000280:Administration, Inhalation; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000009:adverse effects*; D003430:Cross-Sectional Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D036301:Qualitative Research; D012606:Scotland
D000318:Adrenergic beta-Agonists; D005938:Glucocorticoids; D001507:Beclomethasone