BMC Pulmonary Medicine | |
Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study | |
Isabelle Boucot5  Stéphane Schück3  Nathalie Texier3  Déborah Poirier3  Bruno Housset4  Philippe Serrier1  Eric Van Ganse2  Céline Pribil6  Nicolas Roche7  | |
[1] Private Medical Practice, Paris, France;Department of Pharmacoepidemiology, CHU-Lyon, Lyon, France;Kappa Santé, Paris, France;Department of Pulmonology, CHI Creteil Hospital, Créteil, France;Respiratory and Immuno-Inflammation Department, GlaxoSmithKline, Marly Le Roi, France;Department of Pharmacoepidemiology and Medico-Economic Modelling, GlaxoSmithKline, Marly Le Roi, France;Respiratory and Intensive Care Medicine, Cochin Hospital Group, AP-HP, University Paris Descartes, HIA du Val de Grâce 4e C, Paris, France | |
关键词: Pulmonologist; Primary care; Population-based; Questionnaire; Prescription; GOLD; France; COPD; | |
Others : 863105 DOI : 10.1186/1471-2466-14-56 |
|
received in 2013-10-31, accepted in 2014-03-24, 发布年份 2014 | |
【 摘 要 】
Background
In Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting β2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Minimal data are available on the use of the fluticasone propionate/salmeterol xinafoate combination (FSC) in the real-life COPD setting and prescription compliance with the licensed specifications.
Methods
A French observational study was performed to describe the COPD population prescribed with FSC, prescription modalities, and the coherence of prescription practices with the market authorized population. Data were collected for patients initiating FSC treatment (500 μg fluticasone propionate, 50 μg salmeterol, dry powder inhaler) prescribed by a general practitioner (GP) or a pulmonologist, using physician and patient questionnaires.
Results
A total of 710 patients were included, 352 by GPs and 358 by pulmonologists. Mean age was over 60 years, and 70% of patients were male. More than half were retired, and overweight or obese. Approximately half were current smokers and one-third had cardiovascular comorbidities. According to both physician evaluation and GOLD 2006 classification, the majority of patients (>75%) had moderate to very severe COPD. Strict compliance by prescribing physicians with the market-approved population for dry powder inhaler SFC in COPD was low, notably in ICS-naïve patients; all three conditions were fulfilled in less than a quarter of patients with prior ICS and less than 7% of ICS-naïve patients.
Conclusions
Prescription of dry powder inhaler SFC by GPs and pulmonologists has very low conformity with the three conditions defining the licensed COPD population. Prescription practices need to be improved and systematic FEV1 evaluation for COPD diagnosis and treatment management should be emphasized.
【 授权许可】
2014 Roche et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20140725025059533.pdf | 313KB | download | |
49KB | Image | download |
【 图 表 】
【 参考文献 】
- [1]Murray CJ, Lopez AD: Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study. Lancet 1997, 349:1498-1504.
- [2]GOLD: Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2014. Available from http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html webcite. (Accessed April 2014)
- [3]Jenkins CR, Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, Yates JC, Willits LR, Vestbo J: Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res 2009, 10:59. doi:10.1186/1465-9921-10-59 BioMed Central Full Text
- [4]Fitch K, Iwasaki K, Pyenson B, Plauschinat C, Zhang J: Variation in adherence with Global Initiative for Chronic Obstructive Lung Disease (GOLD) drug therapy guidelines: a retrospective actuarial claims data analysis. Curr Med Res Opin 2011, 27:1425-1429.
- [5]Incalzi RA, Corsonello A, Pedone C, Masotti G, Bellia V, Grassi V, Rengo F: From Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines to current clinical practice: an overview of the pharmacological therapy of stable chronic obstructive pulmonary disorder. Drugs Aging 2006, 23:411-420.
- [6]Roche N, Lepage T, Bourcereau J, Terrioux P: Guidelines versus clinical practice in the treatment of chronic obstructive pulmonary disease. Eur Respir J 2001, 18:903-908.
- [7]Han MK, Kim MG, Mardon R, Renner P, Sullivan S, Diette GB, Martinez FJ: Spirometry utilization for COPD: how do we measure up? Chest 2007, 132:403-409.
- [8]Olsen S, Jarbøl DE, Kofoed M, Abildskov K, Pedersen ML: Prevalence and management of patients using medication targeting obstructive lung disease: a cross-sectional study in primary healthcare in Greenland. Int J Circumpolar Health 2013., 72doi:10.3402/ijch.v72i0.20108
- [9]Chavez PC, Shokar NK: Diagnosis and management of chronic obstructive pulmonary disease (COPD) in a primary care clinic. COPD 2009, 6:446-451.
- [10]Arne M, Lisspers K, Ställberg B, Boman G, Hedenström H, Janson C, Emtner M: How often is diagnosis of COPD confirmed with spirometry? Respir Med 2010, 104:550-556.
- [11]Koefoed MM, de Pont Christensen R, Søndergaard J, Jarbøl DE: Lack of spirometry use in Danish patients initiating medication targeting obstructive lung disease. Respir Med 2012, 106:1743-1748.
- [12]Borg G: Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med 1970, 2:92-98.
- [13]Van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF: Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes 2003, 1:13. BioMed Central Full Text
- [14]GOLD: Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2006. http://www.goldcopd.org/Guidelines/guidelines-global-strategy-for-diagnosis-management-2006.html webcite. (Accessed April 2014)
- [15]GOLD: Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2010. http://www.goldcopd.org/Guidelines/guideline-2010-gold-report.html webcite. (Accessed April 2014)
- [16]Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A, Anderson J, Maden C: TRial of Inhaled STeroids ANd long-acting beta2 agonists study group: Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003, 361:449-456.
- [17]Mahler DA, Wire P, Horstman D, Chang C-N, Yates J, Fischer T, Shah T: Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2002, 166:1084-1091.
- [18]Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T: The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest 2003, 124:834-843.
- [19]Gershon AS, Victor JC, Guan J, Aaron SD, To T: Pulmonary function testing in the diagnosis of asthma: a population study. Chest 2012, 141:1190-1196.
- [20]Buffels J, Degryse J, Liistro G: Diagnostic certainty, co-morbidity and medication in a primary care population with presumed airway obstruction: the DIDASCO2 study. Prim Care Respir J 2009, 18:34-40.
- [21]Rodriguez-Roisin R: Toward a consensus definition for COPD exacerbations. Chest 2000, 117(5 Suppl 2):398S-401S.
- [22]Burge S, Wedzicha JA: COPD exacerbations: definitions and classifications. Eur Respir J Suppl 2003, 41:46s-53s.
- [23]Pauwels R, Calverley P, Buist AS, Rennard S, Fukuchi Y, Stahl E, Löfdahl CG: COPD exacerbations: the importance of a standard definition. Respir Med 2004, 98:99-107.
- [24]Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA: Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998, 157(5 Pt 1):1418-1422.
- [25]Langsetmo L, Platt RW, Ernst P, Bourbeau J: Underreporting exacerbation of chronic obstructive pulmonary disease in a longitudinal cohort. Am J Respir Crit Care Med 2008, 177:396-401.
- [26]Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK: Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000, 320:1297-1303.
- [27]Corrado A, Rossi A: How far is real life from COPD therapy guidelines? An Italian observational study. Respir Med 2012, 106:989-997.
- [28]DREES (French Ministry of Health Directorate for Research, Evaluation and Statistics): [Physicians: Estimations on January 1, 2008. Statistical Series, No. 127, October 2008] in French. 2013. http://www.drees.sante.gouv.fr/IMG/pdf/seriestat127.pdf webcite. (Accessed September 2013)