Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial

Olivia Horga, Mercer University College of Pharmacy

The National Heart, Lung, and Blood Institute (NHLBI) defines asthma as a disease that inflames and narrows the airways. Although there is no cure for asthma, the NHLBI suggests that the goal of asthma is to control the disease through the use of medications. [1]

According to a set of asthma treatment guidelines, short-acting beta agonists (SABA) such as albuterol and levalbuterol are used to control intermittent asthma in patients 12 years or older. For patients suffering from persistent asthma, the guidelines suggest daily treatment with inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). These include fluticasone/salmeterol, mometasone/formoterol, and budesonide and formoterol. [2]

According to the Centers for Disease Control and Prevention (CDC), approximately 2.8 million non-Hispanic blacks reported having asthma in 2012. The CDC reports that African Americans were 20 percent more likely to have asthma than non-Hispanic whites in 2012. [3]

The CDC also reports that in 2013, African Americans were three times more likely to die from asthma related causes than the white population. [4]

Title: Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial [5]
Design Multisite, open-label, parallel-group, randomized; N = 20
Objective To compare the effectiveness and safety of tiotropium versus long-acting beta agonists (LABA), when used with inhaled corticosteroids (ICS) in black adults with asthma
Study Groups Black adults with moderate to severe asthma in the United States
Methods Patients received ICS plus either once-daily tiotropium (n = 532) or twice-daily LABAs (n = 538); follow-up for up to 18 months
Duration March 2011 to July 2013
Primary Outcome Measure Time to asthma exacerbation, reported as the mean number of exacerbations per person per year
Baseline Characteristics Patient Characteristics LABA + ICS

(n = 538)

Tiotropium + ICS

(n = 532)

Age, mean, years 45.1 45.2
Men, n 130 127
Hispanic/Latino, n 36 31
Height, mean, cm 166.7 166.8
Weight, mean, kg 94.9 95.5
BMI, mean 34.2 34.4
Smoking environment, n 86 83
Former smoker, n 180 195
Asthma episodes in past 12 months requiring unscheduled visit to physician, emergency department, or hospital, n 322 314
Medication use
ICS use alone, n 148 149
Combination therapy with one device, n 370 375
Results Mean number of exacerbations per person per year LABA + ICS = 0.42 Tiotropium + ICS = 0.37 rate ratio [RR], 0.90 [95% CI, 0.73 to 1.11], p = 0.31
Adverse Events Common and Serious Adverse Events: non-asthma related (2% of LABA + ICS versus 3% of tiotropium + ICS)
Percentage that Discontinued due to Adverse Events: three deaths in tiotropium + ICS (0.6 %, p = 0.12), two of the deaths were asthma-related (0.4 %, p = 0.25)
Study Author Conclusions Among black adults with asthma treated with ICS, adding a LABA did not improve time to asthma exacerbation compared with adding tiotropium. These findings do not support the superiority of LABA + ICS compared with tiotropium + ICS for black patients with asthma.

This study did not find LABA + ICS to be more effective than tiotropium + ICS in delaying asthma exacerbations. Although a difference in the number of exacerbations was not determined by the study, the population experienced a high rate of exacerbations. Further studies are needed in order to reduce the rate of asthma exacerbations in this population. [5]

Based on a set of asthma treatment guidelines, patients suffering from persistent asthma may benefit from the treatment with inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). [2]

Due to the fact that there was no improvement in the number of exacerbations per year as a result of adding a LABA to black patients treated with inhaled corticosteroids when compared with anticholinergic tiotropium, both medications are options for treating asthma in black adults. A set of current guidelines mention LABA plus ICS as preferred therapy, and based on this study, the treatment seems appropriate. In fact, anticholinergic tiotropium plus ICS may also be an option when treating asthma exacerbations in black patients.

References

  1. National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/health-topics/topics/asthma. Accessed November 3, 2015.
  2. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007;120(5 Suppl):S94-138.
  3. Centers for Disease Control and Prevention. http://www.cdc.gov/nchs/data/series/sr_10/sr10_260.pdf. Accessed November 3, 2015.
  4. Centers for Disease Control and Prevention.   http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf. Accessed November 3, 2015.
  5. Wechsler ME, Yawn BP, Fuhlbrigge AL, et al. Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial. JAMA. 2015;314(16):1720-1730.
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