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Comparative Effectiveness Research Study in Mayo Clinic Proceedings Demonstrated Asthma Patients Had Better Overall Results with Oral Controllers than Inhaled Products

WILMINGTON, Del., Aug. 26 /PRNewswire/ -- Mayo Clinic Proceedings published a peer-reviewed comparative effectiveness study performed by HealthCore, Inc. in its August edition. The study demonstrated that asthma patients in general had better clinical outcomes with oral controllers than inhaled corticosteroids.

"WellPoint's National Pharmacy and Therapeutics Committee requested the comparative effectiveness study to help ensure that its drug formulary for asthma therapies was aligned with their real-world use and outcomes," said Dr. Joseph Singer, vice president of clinical affairs for HealthCore, the outcomes research subsidiary for WellPoint, Inc. "We believe the study to be the first comprehensive comparative effectiveness research study on all asthma controller medications."

"Clinical superiority of the inhaled products has been well documented in clinical trials and the HealthCore study confirmed this for those who take their medication properly," Singer said. "However, we were surprised to discover that in looking at all patients in real-world settings, oral controllers appeared to be a better choice of treatment because of better compliance. Patients with the best outcomes were those who were compliant with inhaled corticosteroids."

The study, "Impact of Asthma Controller Medications on Clinical, Economic and Patient-Reported Outcomes," revealed that users of oral controllers were significantly better at adhering to their medication than users of inhaled corticosteroids and probably obtained greater treatment benefit. After the study was complete in 2008, WellPoint's National Pharmacy and Therapeutics Committee chose to keep the oral controller used by the vast majority of its members on the same preferred formulary tier and lift its prior authorization requirement.

Asthma is a common and chronic inflammatory disorder of the airways that affects more than 22 million Americans. In 2004, it resulted in 14.7 million outpatient visits, 1.8 million emergency department visits and nearly 500,000 hospitalizations.

"It's important for physicians and health plans alike to know that 'one size fits all' does not apply when treating asthma patients," said Singer. "These results speak to the power of comparative effectiveness research and its ability to give physicians the information they need to customize treatment for patients in the real world."

Lead authors of the HealthCore study in the August edition of Mayo Clinical Proceedings were HealthCore researchers Hiangkiat Tan, Chaitanya Sarawate and Dr. Joseph Singer. Other authors included Dr. Kurt Elward, Dr. Rubin Cohen, Dr. Brian Smart, Dr. Michael Busk, Dr. James Lustig, Dr. Jeana O'Brien and Dr. Michael Schatz.

Both Elward and Schatz sit on the National Asthma Education and Prevention Program Expert Panel for the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health, which develops guidelines for diagnosis and management of asthma.

The comparative effectiveness research study assessed the following outcomes: use of short-acting beta-agonists, use of oral corticosteroids, inpatient/emergency room visits, and total cost of care attributable to asthma during the 12-month period after the index date.

HealthCore retrospectively pulled the medical and pharmacy claims data of more than 55,000 patients from eight health plans who had used at least one of six types of asthma controller medications between 2003 and 2005. The study was conducted in collaboration with a scientific steering committee consisting of physicians recommended by the American Academy of Family Physicians, the American Academy of Pediatrics and the American Association of Allergy and Immunology.

These data were integrated with quality-of-life surveys of more than 800 asthma patients from the same plans to evaluate potential differences in quality of life between the types of controller medications.

Both oral and inhaled treatments offered comparable impacts on patient-reported quality of life and productivity. Among patients taking more than one drug to control their asthma, HealthCore found that a combination of inhaled corticosteroids and long-acting beta-agonists were the best course of treatment in terms of better clinical outcomes and better quality of life.

In the group of patients who adhered to their medication, those taking leukotriene modifiers--oral asthma controllers--were more likely to have an emergency room or inpatient physician visit, less likely to use six or more short-acting beta agonist canisters and incurred higher annual costs. Those who were compliant with their inhaled corticosteroids had better outcomes than those who adhered to their oral controllers, but so few of those taking inhaled corticosteroids adhered properly to their medication that it had little impact on the overall population studied.

About the study

The observational study used administrative claims data obtained from eight geographically dispersed commercial health plans that represent approximately 17.5 million members. The study also included the following criteria:

  • The administrative data set consisted of integrated medical claims, pharmacy claims and eligibility files.
  • The study database was developed in compliance with the regulations of the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
  • Eligible patients were 18-64 years old with at least one medical claim with an ICD-9-CM code for asthma from Sept. 1, 2002 through Aug. 31, 2006 and at least one prescription claim for an asthma controller medication from Sept. 1, 2003 through Aug. 31, 2005.
  • Patients who had medication in their possession for 80 percent of the year or longer were considered to be adherent to therapy.

About HealthCore

HealthCore, based in Wilmington, Del., is the clinical outcomes research subsidiary of WellPoint. HealthCore has a team of highly experienced researchers including physicians, biostatisticians, pharmacists, epidemiologists, health economists and other scientists who study the "real world" safety and effectiveness of drugs, medical devices and care management interventions. HealthCore offers insight on how to best use this data and communicates these findings to health care decision-makers to support evidence-based medicine, product development decisions, safety monitoring, coverage decisions, process improvement and overall cost-effective health care. For more information, go to

SOURCE HealthCore and WellPoint, Inc.
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