#152 Tempered Enthusiasm for Tiotropium in Asthma
CLINICAL QUESTION
Is tiotropium useful as add-on therapy in asthmatic patients who are poorly controlled on an Inhaled Corticosteroid (ICS) or ICS + Long-Acting Beta Agonist (LABA)?
BOTTOM LINE
In moderate-severe asthma, uncontrolled on ICS or ICS+LABA, the addition of Tiotropium prevents exacerbations for one in 18-36 patients over 4-52 weeks. Much of the research is at high risk of bias and changes in other surrogate outcomes (like FEV1) are of uncertain clinical importance.
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EVIDENCE
- Systematic review, 13 RCTs (4,966 patients >12 years), asthma, 4-52 weeks duration, 11/13 trials used Respimat® inhaler:1
- Tiotropium + ICS versus ICS (moderate asthma):
- Improved PEF (22-24 L/min) and FEV1 (140-150 mL).
- Reduced number of patients with ≥1 exacerbation [10.5% versus 13.3%, Number Needed to Treat (NNT)=36].
- Tiotropium + ICS + LABA versus ICS + LABA (severe asthma):
- Improved PEF (16-20 L/min) and FEV1 (80-120 mL).
- Reduced number of patients with ≥1 exacerbation (18.2% versus 24.0%, NNT=18).
- No difference in adverse events.
- Minimum clinically important difference (MCID) for FEV1 is 230 mL.2
- Limitations: 6/13 trials were unpublished manufacturer trials.
- Tiotropium + ICS versus ICS (moderate asthma):
- Two of the above unpublished trials were subsequently published together.3
- 2,103 asthma patients on ICS, randomized to once-daily tiotropium (Respimat® inhaler), twice-daily salmeterol or placebo, 24 weeks:
- Both tiotropium and salmeterol had similar statistically significant improvement in FEV1 although neither reached MCID.2
- Asthma exacerbations (requiring oral steroids) not well reported, conflicting results.
- Limitations: Industry-sponsored, multiple outcomes with selective reporting, no mention of rescue medications or hospitalizations.
- 2,103 asthma patients on ICS, randomized to once-daily tiotropium (Respimat® inhaler), twice-daily salmeterol or placebo, 24 weeks:
- Smaller systematic reviews (5-6 RCTs) report that tiotropium added to ICS ± LABA increases PEF and FEV1.4,5
- 2015 Global Initiative for Asthma guidelines state tiotropium is an option in patients on medium- to high-dose ICS + LABA in patients ≥18 years.6
- Tiotropium is available in two types of inhalers: HandiHaler® (dry powder capsule inhaler) and Respimat® (aqueous solution soft mist inhaler).7
- There is controversy regarding the possibility of increased mortality with tiotropium delivered via the Respimat® inhaler in COPD, particularly in those with cardiovascular disease and arrhythmias, but the data is inconsistent.8-10
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