Switching from branded to generic inhaled medications: potential impact on asthma and COPD.

Expert Opin Drug Deliv. 2013 Nov 14;

Authors: Lavorini F, Ninane V, Haughney J, Bjermer L, Molimard M, Dekhuijzen RP

Abstract
Pressure on healthcare budgets is increasing, while at the same time patent protection for many branded inhaled medications has expired, leading to the development and growing availability of generic inhaled medicines. Generic inhaled drugs are therapeutically equivalent to original branded options but may differ in their formulation and inhalation device. This new situation raises questions about the potential impact of switching from branded to generic drug/inhaler combination products in patients with asthma or COPD, with or without their consent, in countries where this is permitted. Inhalation devices, particularly dry powder inhalers, vary markedly in their design, method of operation and drug delivery to the lungs. Current guidelines stress the importance of training patients how to use their inhalers but offer little or no guidance on how this should be achieved. Non-adherence to therapy and incorrect inhaler usage are recognised as major factors in poorly or uncontrolled asthma and COPD and switching patients to a different inhaler device may exacerbate these problems, particularly in patients who disagree to switch. Where switching is permitted or mandatory, adequate patient instruction and follow-up monitoring should be provided routinely.

PMID: 24224777 [PubMed - as supplied by publisher]

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Disease models of chronic inflammatory airway disease: applications and requirements for clinical trials.

Curr Opin Pulm Med. 2013 Nov 13;

Authors: Diamant Z, Clarke GW, Pieterse H, Gispert J

Abstract
PURPOSE OF REVIEW: This review will discuss methodologies and applicability of key inflammatory models of respiratory disease in proof of concept or proof of efficacy clinical studies. In close relationship with these models, induced sputum and inflammatory cell counts will be addressed for phenotype-directed drug development. Additionally, important regulatory aspects regarding noninvestigational medicinal products used in bronchial challenges or clinical inflammatory models of respiratory disease will be highlighted.
RECENT FINDINGS: The recognition of an ever increasing number of phenotypes and endotypes within conditions such as asthma and chronic obstructive pulmonary disease urges phenotyping of study populations already in early clinical phases of drug development. Apart from the choice of a relevant disease model, recent studies show that especially targeted therapies need to be tested in well defined disease subsets for adequate efficacy assessment. Noninvasive biomarkers, especially sputum inflammatory cell counts, aid phenotyping and are useful outcome measures for novel, targeted therapies.
SUMMARY: Disease phenotyping becomes increasingly important for efficient and cost-effective drug development and subsequent disease management. Inflammatory models of respiratory disease combined with sputum biomarkers are important tools in this approach.

PMID: 24231465 [PubMed - as supplied by publisher]

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Effects of weight loss on asthma control in obese patients with severe asthma.

Eur Respir J. 2013 Nov 14;

Authors: Dias-Júnior SA, Reis M, de Carvalho-Pinto RM, Stelmach R, Halpern A, Cukier A

Abstract
Studies on the effects of weight loss in patients with asthma are scarce. No studies have been done in patients with severe asthma. To assess the impact of weight loss in patients with severe asthma associated with obesity.Open, prospective, randomized study of 2 parallel groups, in patients with severe uncontrolled asthma and moderate obesity. The primary outcome was the level of asthma control 6 months after initiation of the weight reduction program quantified by the Asthma Control Questionnaire (ACQ). We evaluated clinical parameters, and lung function, markers of airway inflammation and circulating cytokines.Twenty-two patients were randomized to undergo treatment for obesity, and 11 as the control group. The weight reduction program was associated with significant improvements in asthma control (ACQ mean±SE; 3.02±0.19 to 2.25±0.28 in the treatment group vs 2.91±0.25 to 2.90±0.16 in the controls, P=0.001). This improvement was not accompanied by changes in markers of airway inflammation or bronchial reactivity, but by an increase in forced vital capacity.Our results suggest that weight reduction in obese patients with severe asthma improves asthma outcomes by mechanisms not related to airway inflammation.

PMID: 24232701 [PubMed - as supplied by publisher]

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Fractional exhaled nitric oxide (FENO) measurements are recommended for the assessment of eosinophilic airway inflammation in asthma. Clinically relevant increases in FENO have been reported 24 h after positive specific inhalational challenge (SIC) tests in occupational asthma.
We aimed to determine whether positive SICs could be discriminated from control tests, on the basis of change in FENO.
METHODS: We reviewed all positive SICs to a variety of agents performed at our institution 2008-2012 and gathered data on age, sex, asthmatic response (immediate/dual/late), smoking status, inhaled corticosteroid usage, and FENO pre- and 24-h postcontrol and positive SIC from each worker. Changes in FENO after positive SICs were compared with control SICs from each worker, by using paired Student's t tests.
RESULTS: In 16 workers, negative control challenges were associated with mean changes in FENO of 9 % (95 % CI -1.14 to 19.01) or 1.1 ppb (95 % CI -3.59 to 5.84); 2 of 16 (13 %) workers tested showed increases in FENO that were clinically relevant based on recent guidelines. Subsequent positive SICs were associated with mean changes in FENO of 7 % (95 % CI -15.73 to 29.6) or 2.1 ppb (95 % CI -6.07 to 10.19), which were not significantly different to controls; only 2 of 16 (13 %) workers had FENO changes that were clinically relevant.
CONCLUSIONS: FENO changes above the upper confidence limits of ≥20 % or ≥6 ppb may be considered to be outside the range of normality. However, the majority of workers who had clearly positive SICs to common low molecular weight agents also had no statistically or clinically relevant increase in FENO. Therefore, change in FENO does not predict a positive SIC in this group.

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