Formoterol and Budesonide Combination Safe in Asthma Patients

Highlights

• Long-acting beta agonists (LABA) like salmeterol and formoterol have been associated with asthma-related deaths
• The FDA requested post-marketing studies on these drugs when combined with corticosteroids
• Results of a published study indicate that the safety of the combination of formoterol with budesonide is comparable to that of budesonide alone.

A study published in the New England Journal of Medicine indicates that the safety of the combination of two anti-asthma drugs formoterol and budesonide is similar to that of budesonide alone when used in individuals over the age of 12 years. Treatment of the respiratory disease asthma has seen several advances in the recent years with newer groups of drugs being introduced. The use of inhalers provides local relief from asthma symptoms and prevents side effects to other parts of the body. Prevention of asthma attacks rather than treating them as and when they come has a positive impact on the life of the patients.

Long-acting beta-agonists (LABAs) like salmeterol and formoterol have been used in the treatment of asthma patients. They are often combined with the anti-inflammatory corticosteroids like budesonide and fluticasone. However, they have been associated with asthma-related deaths and the FDA required post-marking studies to compare the safety of these drugs when used with corticosteroids, in comparison to using corticosteroids alone.

Researchers evaluated the safety of the combination of salmeterol and formoterol in a study conducted over a period of 26 weeks. Among the 11,693 participants of the study, 5846 were assigned to receive the budesonide–formoterol combination while 5847 patients were assigned to receive only budesonide. The participants of the study were individuals of 12 years or older with moderate-to-severe asthma. They required daily asthma medication and had between one to four attacks of asthma in the previous year.

The researchers found that the combination of budesonide and formoterol did not result in a significant increase in serious adverse effects. An asthma-related event occurred in 43 patients who took the combination treatment and 40 individuals who took only budesonide. Two asthma-related deaths did occur in the group that took the combination treatment.

The researchers also found that the combination treatment is effective in controlling asthma. Participants who took the combination had a 16.5 percent decreased risk of asthma attacks as compared to those who took budesonide alone.

Another study in the same issue of the journal evaluated the use of the combination of another LABA salmeterol with the corticosteroid fluticasone in children. Among the 6208 participants in the study, 27 patients in the salmeterol-fluticasone combination group and 21 patients in the group taking fluticasone had a serious asthma-related event, that is, they had to be hospitalized. The combination appeared to be effective - 8.5% patients in the combination group compared to 10% patients taking fluticasone had a severe asthma attack.

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Based on these studies, it appears that the safety aspect of a LABA with a corticosteroid does not appear to be a major concern in the treatment of asthma.

References:

1. Peters SP et al. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. N Engl J Med 2016; 375:850-860September 1, 2016 DOI: 10.1056/NEJMoa1511190
2. Stempel DA et al. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. N Engl J Med 2016; 375:840-849September 1, 2016 DOI: 10.1056/NEJMoa1606356
3. FDA Drug Safety Communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs) - (http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm)

Source-Medindia