Term
Step 3 is +/- LABA
Step 4 have to be on a LABA
add LABA to ICS to improve asthma control and potentially decrease amount of ICS needed
risks of ICS include increased risk of infection, rate of growth reduction, BMD versus risks of LABA |
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Definition
| where do LABAs fit in the NAEPP Asthma Guidelines? |
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Term
[image]
no compliance measure |
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Definition
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Term
primary: occurrence of combined respiratory deaths (PNA, asthma, fibrosis) or respiratory related life-threatening experiences (intubation and mechanical ventilation)
secondary: any death, any hospitalization |
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Definition
| primary and secondary outcomes of the SMART trail |
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Term
relative risk: risk of an event in people with treatment compared to risk in people without treatment
RR > 1 = increased risk
RR = 1 = equal chances or no association between treatment and outcome
RR < 1 = decreased risk |
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Definition
| definition of relative risk |
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Term
findings in AA:
relative risk of asthma-related death or life-threatening experience was 4.9 compared to 1.7 in Caucasian population
relative risk of asthma-related death was 7.2 compared to 4.3 in Caucasian population
Primary outcomes = low occurrence, not statistically different
Secondary outcomes = significant, largely due to AA subgroup
difficulties with enrollment |
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Definition
| why was the SMART trail terminated? |
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Term
in this trail, < 50% of patients were on ICS
today it would be 100%; if starting on a LABA, you need to be on an ICS |
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Definition
| how many patients in the SMART trail were on ICS? |
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Term
PEF, % predicted
C: 85.3% (> 80% = mild persistent asthma)
AA: 78.1% (< 80%, more severe asthma)
baseline ICS use
C: 49
AA: 38
AA had more ED visits, more hospitalizations in the last 12 months and in their lifetime, and more intubations for asthma |
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Definition
| differences in baseline characteristics between Caucasians and African Americans |
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Term
| eight more asthma-related deaths per 10,000 patients among patients treated with salmeterol than among those given placebo |
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Definition
| results of the SMART trail |
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Term
STRENGTHS
trail design
LABA naive
LIMITATIONS
concurrent medications not standardized
AA more severe disease versus Caucasians
no adherence monitoring
LABA not indicated for mild, persistent asthma
half not on maintenance therapy with ICS
cannot extrapolate to < 12 years or for Advair use (or other combination products)
study did not have sufficient power |
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Definition
| strengths and limitations of the SMART trail |
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Term
overall found an increased risk of an asthma event with the use of LABAs
RISK APPEARS TO INCREASE AS AGE DECREASES!
[image] |
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Definition
| results of the FDA meta analysis of LABAS |
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Term
single agent LABAs:
unanimously agreed benefits do NOT outweigh the risks in children 4-11 years of age
most agreed benefits do NOT outweigh the risks in adolescents and adults
combination products:
agreed benefits DO outweigh risks for ADVAIR in children 4-11 years of age
most agreed benefits DO outweigh the risks in adolescents
unanimously agreed benefits do outweigh the risks in adults
product for patient < 12 yo: ONLY COMBINATION PRODUCT THAT CAN BE USED IS ADVAIR |
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Definition
| FDA recommendations for single agent LABAs and combination products |
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Term
LABA use is contraindicated without the use of a controller
SINGLE-INGREDIENT LABAS SHOULD ONLY BE USED IN COMBINATION WITH AN ICS AND SHOULD NOT BE USED ALONE
LABAs should only be used lon-term in patients whose asthma cannot be adequately controlled on a controller
LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved; patients should then be maintained on an asthma controller medication
PEDIATRIC AND ADOLESCENT patients who require the addition of a LABA to an inhaled corticosteroid should use a COMBINATION PRODUCT CONTAINING BOTH AN ICS AND A LABA TO ENSURE COMPLIANCE WITH BOTH MEDICATIONS |
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Definition
| FDA safety recommendations |
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