Reports

This report is based on medical evidence presented at sanctioned medical congress, from peer reviewed literature or opinion provided by a qualified healthcare practitioner. The consumption of the information contained within this report is intended for qualified Canadian healthcare practitioners only.

PRIORITY PRESS - 20th Annual Congress of the European Respiratory Society

Barcelona, Spain / September 18-22, 2010

Early results from a survey of 2420 adults and parents of adolescents (age 12-17 years) carried out in 5 European countries and Canada indicate that asthma is not as well controlled as previously believed. “Too many of our asthma patients are experiencing severe ongoing symptoms that impact important aspects of their daily lives,” remarked Prof. David Price, University of Aberdeen, UK. He presented the first data from EUCAN AIM (Asthma Insight and Management in Europe and Canada), a survey conducted in 2010 of asthma-related patient perceptions, behaviours and presentation patterns and recent trends in asthma management.

The survey showed that patients with asthma have very low expectations for controlling their disease. About 80% said that they were completely or well controlled, but 50 to 60% said they had experienced symptoms in the past 4 weeks. About one quarter reported asthma symptoms every day or most days. “Clearly, in the realm of symptomatic control, we are doing badly,” Prof. Price stated. He suggested that much of the poor control is related to poor adherence. Around 25% of patients said they had not taken controller medicine in the past year and only half said they took medicine every day. The survey also showed that many patients took “treatment holidays,” e.g. 10% stopped taking their medication for up to 2 weeks and 20% stopped for 1 month or longer in the past year.

About 39% of patients reported having a sudden severe asthma episode in the past year. These episodes resulted in 50% of patients seeking primary or emergency care for worsening episodes in the past year, and 10% of patients were hospitalized overnight. During these episodes, up to 40% of patients felt that their life was in danger and about 10% overall thought that their life was in danger during an asthma episode in the past year. “The importance of severe episodes should not be underestimated,” Prof. Price stressed. “Our patients are at greater risk than maybe we previously thought, partly because we have not focused on exacerbations.”

Prof. Price suggested that one problem might be how physicians usually assess asthma. “Care tends to be technology-focused and not patient-centred,” he noted. The survey showed that a breathing test or spirometry was carried out in 25 to 50% of patients, but only 2 to 13% of physicians said they asked patients to complete a questionnaire and only 15 to 45% of physicians provided a written action plan for both acute and regular treatment. Physicians also appear to use language that patients do not understand (90% of patients recognized the term “asthma attack” but only 24% recognized “exacerbation”) and they are failing to convey the goals of asthma management to patients. “Ten years on from previous surveys, these data show us that we have not achieved what we have been setting out to do, and we need to stop and think urgently about how we need to change,” Prof. Price told delegates.

Findings from a GPRD Retrospective Analysis

The efficacy of inhaled corticosteroid (ICS) therapies has been demonstrated in randomized controlled trials, but differences in efficacy between therapies have not been demonstrated in real-world patients. Among the most prescribed agents worldwide are fluticasone propionate and beclomethasone dipropionate. While it is accepted that fluticasone is more potent on a per-mg basis than beclomethasone, the smaller particle size of the hydrofluoroalkane (HFA) beclomethasone formulation results in greater total and peripheral deposition in the lung.

A new rigorously conducted observational study has found that patients receiving extrafine HFA-beclomethasone dipropionate have a better chance of achieving asthma control than with fluticasone propionate (J Allergy Clin Immunol 2010;126:511-8). Prof. Price and colleagues conducted a retrospective analysis using data from the General Practice Research Database (GPRD), which contains the medical records of approximately 500 primary care practices in the UK. Asthma-related outcomes over 1 year were compared between 2 matched cohorts, each of 1569 patients aged 4 to 60 years, who received a first prescription (initiation population) or dose increase (step-up population) with fluticasone or HFA-beclomethasone delivered via metered dose inhaler (MDI). Patients were matched on baseline demographic and disease severity measures, resulting in 1319 patients in each of the treatment initiation and 250 patients in each of the step-up cohorts. The composite measures of asthma control were no unplanned visit or hospitalization for asthma; no oral corticosteroids or antibiotics for lower respiratory infections; and exacerbation rate.

Results showed that both treatments were very effective with asthma control achieved by 86% and 82.9% of patients administered HFA-beclomethasone and fluticasone, respectively. Overall, more than 88% of patients had no exacerbations during the outcome year. However, with HFA-beclomethasone, the adjusted odds ratio (OR) for achieving asthma control compared with fluticasone was 1.30 in the initiation group and 1.22 in the step-up group (Figure 1). Exacerbation rates were similar in both treatment populations. “I believe the main reason we are seeing this difference is due to the smaller particle size of the HFA-beclomethasone formulation, which unquestionably improves overall lung and small airways deposition,” Prof. Price told delegates.

Figure 1.

The improved outcomes with HFA-beclomethasone occurred with lower dosing. Fluticasone was prescribed at significantly higher doses in both the initiation and step-up populations (P=0.001). In the initiation population, 11% of patients had a mean fluticasone dose of =800 µg/day at index date compared with <1% of patients on HFA-beclomethasone; the respective rates in the step-up population were 30% and 5%. This is of concern since at doses of 375 µg/day, fluticasone is estimated to cause 30% adrenal suppression. Prof. Price and colleagues have repeated the study using a US database and they hope to present these findings in 2011.

Key Inhaler Attributes

Understanding which inhaler characteristics are important for physicians and patients may help build effective education programs, enhance adherence and help develop improved inhalation devices, noted Malcolm Small, Adelphi Real World, Macclesfield, UK. As part of a multinational, cross-sectional observational study conducted in 2008, Small and co-investigators asked 355 primary care physicians and specialists in France, Germany and the UK to rate the importance of inhaler characteristics. Six consecutive asthma patients identified by each physician were asked to identify the 3 features of their inhaler with which they were least satisfied. Most physicians (82%) identified the top priority for an inhaler device as having instructions that were simple and easy for patients to follow, but only 19% of patients rated this as a concern. Their top area of concern was lack of feedback when the dose had been inhaled correctly (44%). “That was a surprising finding, and one that is not really addressed, as far as we know,” Small admitted. Patients’ other top concerns were the ability to get a new inhaler with each prescription (25%), the need to breathe hard to inhale the dose (25%), the lack of a dose counter (24%), and inconsistent dose delivered in each inhalation (22%). Physicians also rated as priorities consistent delivery of the same correct dose (81%), minimal effort needed to inhale drug (73%), easy to hold and portable (71%), and consistent penetration to lower and peripheral airways (69%).

Summary

Guidelines for asthma management recommend starting monotherapy with an ICS and, as necessary, stepping up to a higher dose. Findings showing that HFA-beclomethasone-treated patients had a similar or better chance of achieving asthma control than those receiving fluticasone have important implications in clinical practice. The constant drug delivery of the extrafine HFA-beclomethasone formulation at the lower doses offers physicians and patients the possibility of achieving more stable asthma control and safety.