Study finds two-thirds of asthma patients take combined ICS/LABA treatment

Despite national guidelines recommending that inhaled corticosteroid (ICS) be used alone as the preferred treatment for patients with mild persistent asthma, a new study finds that nearly two-thirds of these patients are taking more costly drugs that combine an ICS and a long-acting beta agonist (LABA) – with no apparent additional clinical benefit noted based on pharmacy and medical claims. The analysis was conducted by the Medco Research Institute™ -- the research subsidiary of Medco Health Solutions, Inc. (NYSE: MHS) – was presented over the weekend during the Annual Scientific Meeting of The American College of Allergy, Asthma & Immunology.

"This study confirms that, based on pharmacy and medical claims, patients with mild asthma using only an inhaled corticosteroid seem to control their asthma just as well as those who take a combined ICS/LABA treatment such as Advair® or Symbicort®," said Luis Salmun, MD, the lead study researcher and National Practice Leader of the Medco Pulmonary/Immunology Therapeutic Resource Center® (TRC).  "While these combination therapies are important treatments for patients with more severe asthma, it's concerning that they are being used by a majority of patients with milder asthmatic symptoms given that these medications are more costly and that clinical guidelines prefer ICS therapy alone for these patients."  

The study evaluated 8,424 patients treated for mild asthma and found that 5,523 were on combined ICS/LABA therapy and 2,901 were using an ICS alone.  Among the two groups of patients there was no significant difference in their use of acute asthma medications, emergency room visits or hospitalizations, indicating that there was no apparent additional clinical benefit gained from using the combined therapy compared to ICS monotherapy.  However, the study did find a difference in costs:  the average asthma-related health care costs for those using the combination ICS/LABA therapy were $264 higher per patient per year than those using the ICS treatment alone.  The study included all combination ICS/LABA drugs, confirming that this is a class effect rather than attributed to a single product.

Findings also revealed that the rate of ICS/LABA combination therapy was highest among patients ages 18 to 49.

In 2010, the Food & Drug Administration (FDA) updated the label on long-acting beta agonists to specify that they should not be used in patients with well-controlled asthma. In patients where a LABA is necessary, once asthma control is achieved and maintained, patients should begin step-down therapy that eliminates the use of long-acting beta agonist while continuing on their ICS treatment.  Lastly, it states that long-acting beta agonists should only be used as additional therapy for patients with uncontrolled asthma currently taking an ICS.

Mild Persistent Asthma

Asthma severity can be classified into one of the following four categories:  intermittent, mild persistent, moderate persistent or severe persistent. Characteristics of a patient classified with mild persistent asthma in this study are:

• Claims-confirmed diagnosis of asthma and lack of COPD (chronic obstructive pulmonary disease) diagnosis
• In the previous 12 months:
• Sporadic use of reliever medications (less than 4 canisters)
• No exacerbation requiring hospital or ER visits