How can you assess and communicate your perceived Inhaled Corticosteroids ICS related side effects A

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How can you assess and communicate your
perceived Inhaled Corticosteroids (ICS) related
side effects? - A self-rating scale for
patient-perceived side effects of ICS"
Thys van der Molen, MD, PhD Professor of Primary
Care Respiratory Medicine University Medical
Center Groningen, The Netherlands
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Question for you!

• Question 1
• Have you ever perceived side effects of any drug?

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Question for you!

• Question 2
• What did you do?
• A Stopped using the drug
• B Reduced the dosage or reduced the number of
  days you used the drug
• C Went to your physician to talk about it!

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Adherence to medication why do patients take
medication?
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Adherence to ICS in asthma patients
100

• Major reasons for noncompliance
• Belief that ICS was not necessary when
  asymptomatic
• General concern about side effects

80
60
Percentage of patients who were100 compliant
38
40
20
38
0

• Cross-sectional survey carried out over 12 family
  practices
• A total of 394 asthma patients aged 18-49 years,
  who had been prescribed ICS

Chambers CV, et al. Respir Med. 1999 93(2)
88-94.
Chambers CV, et al. Respir Med. 19999388-94.
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Almost all cells in the body have corticosteroids
receptors!

• Systemic
• bruising and thinning of skin
• growth
• eye
• behavioral changes
• insomnia
• listlessness

• Local
• hoarseness
• cough
• thirst
• dysphonia
• oral thrush

Toogood JH. J Allergy Clin Immunol.
1998102705-713. Williamson IJ, et al. Eur
Respir J. 19958590592. Shim C, Williams MH.
Chest. 198791207-209. Capewell S, et al. Br Med
J. 19903001548-551. Mak VHF, et al. Eur Respir
J. 199251068-1074. Cumming RG, et al. N Engl J
Med. 19973378-14. Jick SS, et al. Epidemiology.
200112229-234. Mitchell P, et al.
Ophthalmology. 19991062301-2305. Connett G,
Lenney W. Lancet. 1991338634635.
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Why do inhaled corticosteroids cause side
effects? Effect and side effect!
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What makes the difference in side effects?
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Patient self-report of ICS-related side effects
the Inhaled CorticosteroidQuestionnaire (ICQ)
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Development of the ICQ

• Focus groups and interviews with patients using
  ICS (N22, 15 male, mean age 53 years) whose mean
  daily dose was 827 µg (range 400-2000 ?g)
• 68 side effects from which the 57 item Likert
  scale ICQ was developed

Foster JM, et al. Respir Med. 20061001318-1336.
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Effect of ICS dose on ICQ scores
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Patient-perceived Side Effects with ICS

• Methods
• 395 inhaler users from community pharmacy
• divided into 4 daily dosage groups
• ?2-agonist without ICS (N66)
• low-dose (?400 ?g, N109)
• mid-dose (401-800 ?g, N151)
• high-dose (gt800 ?g, N69)
• Patients reported how much they were affected by
  side effects on a 7-point scale

Foster JM, et al. Respir Med. 20061001318-1336.
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Mean side effect scores by dosage group
Mean Score
All Plt0.001
Foster JM, et al. Respir Med. 20061001318-1336.
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Common and bothersome side effects
Foster JM, et al. Respir Med. 20061001318-1336.
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ICS side effects measured by ICQ

• 45 of ICS users reported being affected by ?10
  side effects of a moderate intensity or greater
  (ICQ ?3) versus 29 for ?2-agonist without ICS
  subjects
• There were statistically significant differences
  among the four dosage groups for scoring of 31
  of 57 side effect items for which the majority
  showed a rising prevalence as dose increased
• The total ICQ score also showed a statistically
  significant rising intensity of perceived side
  effect with each increasing dose

Foster JM, et al. Respir Med. 20061001318-1336.
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ICQ Simplicity of items as reported by patients
Foster JM, et al. Presented at ATS, 2006
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ICQ Patient-reported completion time
Foster JM, et al. Presented at ATS, 2006.
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Patient self-reports of ICS-related side effects
are sensitive to dosing changes
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Changes in ICQ Scores with Increased ICS Dose
Foster JM, et al. Presented at ATS, 2006.
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Changes in ICQ Scores with Decreased ICS Dose
0
0
0
-1
-2
-3
-3
-4
-5
-6
-8
Score Change from Baseline to 6 Months
-10
-12
-12
-14
-16
-16
-18
Total Score
VoiceProblems
OropharynxProblems
UnpleasantTaste
Skin, Hair Nails
MoodProblems
TasteDisruption
Perspiration
Foster JM, et al. Presented at ATS, 2006.
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Study Design

• Patients (N472, intention-to-treat ITT
  population age 12-74 years) with FEV1 60-80
  predicted (rescue medication) or ?80 predicted
  (low dose ICS) and defined criteria for rescue
  medication use and asthma symptoms
• Centrally randomized system to receive either 400
  µg ciclesonide once daily (HFA-MDI), or 200 µg FP
  twice daily (Diskus) Patients completed the ICQ
  (57 questions, 7-point scale, 15 domains)

Follow-up
BaselinePeriod
TreatmentPeriod
(12 weeks)
(1 - 4 weeks)
Either rescue medication only or FP up to 250 µg
/day or equivalent
Ciclesonide 400 µg PM
Fluticasone 200 µg BID
Visit
B0
B1
B2
B3
B4
T0
T4
T8
T12
FU
B baseline, T treatment, FP fluticasone
propionate, FU follow-up
van der Molen T, et al. Presented at ERS, 2006
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ICQ Within-Treatment Differences (ITT)

Ciclesonide
5.00


Fluticasone Propionate


4.00




3.00

LS Mean (Tlast T0)


2.00



1.00
0.00
-1.00
Thirst (2)
Itching (2)
Overall (57)
Tiredness (2)
Eye Dryness (1)
Perspiration (2)
Skin, Hair, Nails (7)
Facial Edema (1)
Oral Candidiasis (1)
Mood Problems (3)
Taste Disruption (3)
Unpleasant Taste (7)
Voice problems (15)
Vision Deterioration (1)
Dental Deterioration (1)
Oropharynx Problems (9)
Plt0.05
van der Molen T, et al.
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What to do when you perceive side effects

• Talk about it with your physician. Ask for a
  solution. Complete control scale(ACQ). Complete
  side effects scale (ICQ)
• Any ICQ item of 3 or higher needs attention!
• Action could be
• Change of dose
• Chance of device (spacer/rinsing)
• Change of product

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Conclusions

• Relatively mild perceived side effects of ICS can
  be measured
• The ICQ is a reproducible tool for measuring the
  side effects of ICS
• The ICQ can be completed independently in around
  10 minutes
• We may accept ICS side effects becauseof the
  benefits of the treatment. However, we should
  discuss this with our physician.