Edge Given to Hydrofluoroalkane-Beclomethasone Over Fluticasone Propionate for Asthma Control

Becky McCall

October 01, 2010

October 1, 2010 (Barcelona, Spain) — In a retrospective comparison of 2 inhaled corticosteroids (ICSs), both delivered by metered dose inhaler, hydrofluoroalkane-beclomethasone (HFA-BDP; QVAR, Teva Pharmaceutical Industries, Petach Tikva, Israel) showed a similar or better chance of achieving asthma control at lower prescribed doses than fluticasone propionate (Flovent, GlaxoSmithKline, United Kingdom), according to the results of a real-life observational study using the British General Practice Research Database (GPRD).

"The choice of an [ICS] is typically guided by practical considerations, such as convenience and cost, rather than by differences in therapeutic effect, because randomized controlled trials have not identified consistent or significant differences in outcomes among available ICSs," the investigators write in their study, published in the September issue of the Journal of Allergy and Clinical Immunology. The publication coincided with the presentation of the poster here at the European Respiratory Society 2010 Annual Congress. "However, long-term trials comparing ICSs, particularly in real-world populations, are lacking."

David Price, MD, professor of primary care respiratory medicine at the University of Aberdeen Center of Academic Care, United Kingdom, was the principal investigator of the study and presented the results.

"Retrospective studies like the GPRD study provide real-life evidence that indicates there may be clinically meaningful differences in asthma outcomes, depending on which inhaled corticosteroid agent is used," he said.

Patients were matched by demographics and by disease-severity measures. Data were drawn from the GPRD database, which is administered by the UK Medicines and Healthcare products Regulatory Agency, and comprises data from around 500 practices in the United Kingdom. Information was retrieved from records dating from 1997 to 2007, and represented asthma-related outcomes over 1 year.

Two groups were studied. In the initiation group, 1319 patients received HFA-BDP and 1319 received fluticasone as a first prescription. In the step-up group, 250 patients received an increase in their dose of HFA-BDP and 250 received an increase in their dose of fluticasone. Patients were between 5 and 60 years of age.

Primary outcome measures included asthma control and asthma exacerbation rates.

More than 80% of patients in each group achieved asthma control, with 10% in the initiation group and 16% in the step-up group receiving add-on therapy or combination therapy in the year.

The adjusted odds ratios for achieving asthma control favored HFA-BDP, at 1.30 (95% confidence interval [CI], 1.02 - 1.65) relative to fluticasone in the initiation group, and at 1.22 (95% CI, 0.66 - 2.26) in the step-up group. Fluticasone was given in higher doses than HFA-BDP in both groups.

"From my perspective, both treatments are effective, but fluticasone tends to be used at higher doses in the same patients. HFA-BDP, even at lower doses, had at least as good, and for some end points, better outcomes," Dr. Price told Medscape Medical News.

He added that the probable reason for this is the better overall lung deposition with HFA-BDP and the possibly greater deposition in the small airways.

Commenting on the paper, Christine Jenkins, MD, clinical professor of medicine at the University of Sydney, and thoracic physician at Concord Hospital, in Australia, stressed that it is important to have real-world studies and randomized controlled trials. "They complement each other and it is important to have both. This is actually a retrospective real-world study, so as such it is a database review and it needs to be understood in that context."

"Often a database review has shown a drug to be more efficacious than a [randomized controlled trial], so I think we have to be guarded in declaring that a real-world observational study is the gold standard," she pointed out.

Dr. Jenkins explained that the results could mean that physicians misinterpret the dose range for the 2 medications, reflecting errors in prescribing, with patients receiving more fluticasone than necessary. "It doesn't necessarily mean that HFA-BDP is inherently safer or a more effective drug. However, it does suggest that, in the way these medications are prescribed, HFA-BDP achieves as good results, if not better, than fluticasone, and that HFA-BDP is a very effective inhaled corticosteroid. I have always believed it was," concluded Dr. Jenkins.

Access to data from the General Practice Research Database was funded by Merck & Co, and the analysis was funded by Teva Pharmaceuticals. Dr. Price reports being a consultant for Aerocrine, Boehringer Ingelheim, Dey Pharmaceuticals, GlaxoSmithKline, Merck, Merck Generics, Sharpe and Dohme, Novartis, Schering-Plough, Teva, and Bayer; speaking at meetings sponsored by Boehringer Ingelheim, GlaxoSmithKline, Merck, Sharp & Dohme, Pfizer, Schering-Plough, Altana Pharma, and Chiesi; and receiving research support from the UK National Health Centre, Aerocrine, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Sharp & Dohme, Novartis, Pfizer, Schering-Plough, and Teva. Dr. Jenkins reports receiving speaking and consultancy fees from GlaxoSmithKline, AstraZeneca, Novartis, and Nycomed.

J Allergy Clin Immunol. 2010;126:511-518.e1-10. Abstract

European Respiratory Society (ERS) 2010 Annual Congress: Poster P4558. Presented September 21, 2010.

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