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Medco Study: Despite FDA Warnings, Nearly One-Third of Asthma Patients Still Treated with Long-Acting Beta Agonists Without Controller Medications, Increasing Their Risk for Complications and Hospitalizations
Date:5/11/2010

FRANKLIN LAKES, N.J., May 11 /PRNewswire-FirstCall/ -- Nearly one-third of asthma patients are taking long-acting beta agonists (LABAs) alone, and not in combination with other asthma control medications, despite years of warnings from the Food and Drug Administration (FDA) on the risk of worsening asthma symptoms and death associated with this practice.  This according to a new study from the Medco Research Institute™ and the Medco Pulmonary Therapeutic Resource Center® (TRC), presented at the 2010 Eastern Allergy Conference and coinciding with National Asthma and Allergy Awareness Month.  

The National Heart, Lung and Blood Institute (NHLBI) asthma treatment guidelines recommend that LABAs should be used in combination with inhaled corticosteroids (ICS) or leukotriene modifiers for the treatment of asthma, and not used as monotherapy, due to the potential risks of asthma-related hospitalizations, intubations and death.  

Medco researchers found that 31 percent of patients who were prescribed either the LABA Severent™ or Foradil™ during 2009 were taking them as monotherapy and not in combination with other controller medications.  Those patients who received treatment from an allergist or pulmonologist were 43 percent less likely to be on LABA monotherapy than those who received treatment from a general practitioner, and the highest rate of LABA monotherapy use was seen in patients between the ages of 12 to 17.

"We've identified a gap in care that needs to be shared with the medical community in order to improve patient health and reduce the rate of preventable hospitalizations and emergency room visits," said Dr. Peter Juhn, president of the Medco Therapeutic Resource Centers.  "This study demonstrates that specialized care can significantly improve clinical outcomes when treating patients with asthma."

The FDA requires product label warnings against the use of LABAs as monotherapy, and the national prescribing guidelines call for use of LABAs alone only in rare cases when the patient's asthma cannot be managed effectively with other medications.  Each year asthmatic attacks cause 500,000 hospitalizations, 217,000 ER visits and more than 4,000 deaths.  

"Whether physicians are not following the prescribing guidelines for LABAs or patients are not filling the prescriptions for their other controller medications, taking LABAs alone presents a significant safety risk for asthma patients, especially for children," said Dr. Luis Salmun, National Practice Leader for the Medco Pulmonary TRC.  "Patients may feel like they are getting symptom relief from using LABAs alone, but they are actually masking the underlying inflammation, which could put them at serious risk for complications from the disease."

The Medco study evaluated medication claims data for asthma patients who had continuous prescription drug coverage during calendar year 2009.  The number of asthma patients using LABA therapy during a six month period between April and September was collected and the percentage of those patients using LABA monotherapy was calculated by excluding patients with overlapping days' supplies for inhaled corticosteroids (ICS) or leukotriene modifiers during the study period or three months before or after that time-frame.  Patients being treated for COPD were also excluded from the study.  

Researchers identified 9,841 patients who were taking a LABAs and found that 3,043 of those patients were using it as monotherapy.  While 21 percent of patients treated by an asthma-related specialist, such as an allergist or pulmonologist, were found to be using LABA monotherapy, as many as 37 percent of patients treated by a general practitioner were taking the medication alone.  Among different age groups, 19 percent of patients under the age of 12, 38 percent of patients between the ages of 12-17, 35 percent of patients between the ages of 18-45 and 28 percent of patients older than 45 were being treated with LABA monotherapy.

"We know from previous studies that the vast majority of physicians are aware of FDA warnings for LABA monotherapy, yet our study shows they have either not  fully acted upon the warning by incorporating it into clinical practice or are not aware that their patients may not be filling their prescriptions for their controller medications," said Salmun.  "The fact that patients who were treated by a specialist were less likely to be on LABA monotherapy  demonstrates the need for greater educational efforts for general practitioners and their patients, as well as better coordinated efforts to identify patients using LABA monotherapy and alert physicians so they are aware of those patients at risk."

For additional information about Medco studies, please go to www.medcoresearch.com.

About Medco Research Institute

Medco Research Institute™ is an evidence-based research organization focused solely on novel research, analytics and new discoveries that close the gap between scientific discovery and medical practice for improved patient outcomes and lower overall healthcare costs. More information about the Medco Research Institute's peer-reviewed research can be found at www.medcoresearch.com.

About Medco

Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter™ for approximately 65 million members.

With more than 20,000 employees dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2009 revenues of nearly $60 billion, Medco ranks 35th on the Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies.

For more information, go to http://www.medcohealth.com.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.


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