Risk of pneumonia with budesonide-containing treatments in COPD: an individual patient-level pooled analysis of interventional studies

References

• Global Initiative for Chronic Obstructive Lung Disease (GOLD)Global Strategy for Diagnosis, Management, and Prevention of COPD2016 Available from: http://goldcopd.org/global-strategy-diagnosis-management-prevention-copd-2016/Accessed April 2, 2016
   Google Scholar
• CalverleyPPauwelsRVestboJCombined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trialLancet2003361935644945612583942
   PubMed Web of Science ®Google Scholar
• CalverleyPMAndersonJACelliBSalmeterol and fluticasone propionate and survival in chronic obstructive pulmonary diseaseN Engl J Med2007356877578917314337
   PubMed Web of Science ®Google Scholar
• SinghSLokeYKRisk of pneumonia associated with long-term use of inhaled corticosteroids in chronic obstructive pulmonary disease: a critical review and updateCurr Opin Pulm Med201016211812219926996
   PubMed Web of Science ®Google Scholar
• YangIAClarkeMSSimEHFongKMInhaled corticosteroids for stable chronic obstructive pulmonary diseaseCochrane Database Syst Rev20127CD002991
   PubMed Web of Science ®Google Scholar
• SuissaSPatenaudeVLapiFErnstPInhaled corticosteroids in COPD and the risk of serious pneumoniaThorax201368111029103624130228
   PubMed Web of Science ®Google Scholar
• SuissaSCoulombeJErnstPDiscontinuation of inhaled corticosteroids in COPD and the risk reduction of pneumoniaChest201514851177118326110239
   PubMed Web of Science ®Google Scholar
• KewKMSeniukovichAInhaled steroids and risk of pneumonia for chronic obstructive pulmonary diseaseCochrane Database Syst Rev20143CD010115
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyInhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease2015 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Inhaled_corticosteroids_for_chronic_obstructive_pulmonary_disease/human_referral_prac_000050.jsp&mid=WC0b01ac05805c516fAccessed July 2, 2016
   Google Scholar
• ICH Harmonised Tripartite GuidelineClinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A1994 updated 2005. Available from: http://www.gmp-compliance.org/guidemgr/files/E2A_GUIDELINE.PDFAccessed April 2, 2016
   Google Scholar
• SmithCTWilliamsonPRMarsonAGInvestigating heterogeneity in an individual patient data meta-analysis of time to event outcomesStat Med20052491307131915685717
   PubMed Web of Science ®Google Scholar
• HigginsJPThompsonSGQuantifying heterogeneity in a meta-analysisStat Med200221111539155812111919
   PubMed Web of Science ®Google Scholar
• SinDDTashkinDZhangXBudesonide and the risk of pneumonia: a meta-analysis of individual patient dataLancet2009374969171271919716963
   PubMed Web of Science ®Google Scholar
• BourbeauJRouleauMYBoucherSRandomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary diseaseThorax19985364774829713447
   PubMed Web of Science ®Google Scholar
• CalverleyPMBoonsawatWCsekeZZhongNPetersonSOlssonHMaintenance therapy with budesonide and formoterol in chronic obstructive pulmonary diseaseEur Respir J200322691291914680078
   PubMed Web of Science ®Google Scholar
• FukuchiYSamoroRFassakhovRBudesonide/formoterol via Turbuhaler(R) versus formoterol via Turbuhaler(R) in patients with moderate to severe chronic obstructive pulmonary disease: phase III multinational study resultsRespirology201318586687323551359
   PubMed Web of Science ®Google Scholar
• PauwelsRALöfdahlCGLaitinenLALong-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary DiseaseN Engl J Med1999340251948195310379018
   PubMed Web of Science ®Google Scholar
• RennardSITashkinDPMcElhattanJEfficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trialDrugs200969554956519368417
   PubMed Web of Science ®Google Scholar
• SharafkhanehASouthardJGGoldmanMUryniakTMartinUJEffect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized studyRespir Med2012106225726822033040
   PubMed Web of Science ®Google Scholar
• SzafranskiWCukierARamirezAEfficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary diseaseEur Respir J2003211748112570112
   PubMed Web of Science ®Google Scholar
• TashkinDPRennardSIMartinPEfficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trialDrugs200868141975200018778120
   PubMed Web of Science ®Google Scholar
• VestboJSørensenTLangePBrixATorrePViskumKLong-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trialLancet199935391671819182310359405
   PubMed Web of Science ®Google Scholar
• WelteTMiravitllesMHernandezPEfficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary diseaseAm J Respir Crit Care Med2009180874175019644045
   PubMed Web of Science ®Google Scholar
• ShakerSBDirksenAUlrikCSThe effect of inhaled corticosteroids on the development of emphysema in smokers assessed by annual computed tomographyCOPD20096210411119378223
   PubMedGoogle Scholar
• SinDTashkinDRadnerFAn update on the risk of pneumonia related to budesonide use in COPD: Pooled analysisAm J Respir Crit Care Med2012185A2945
   Google Scholar
• LaptsevaIMLaptsevaEABorshchevskyVVGurevichGKalechitsOInhaled budesonide in the management of chronic obstructive pulmonary diseaseEur Respir J200220Suppl 38244s
   Google Scholar
• MiriciABektasYOzbakisGErmanZEffect of inhaled corticosteroids on respiratory function tests and airway inflammation in stable chronic obstructive pulmonary diseaseClin Drug Investig20012112835842
   Web of Science ®Google Scholar
• OzolDAysanTSolakZAMogulkocNVeralASebikFThe effect of inhaled corticosteroids on bronchoalveolar lavage cells and IL-8 levels in stable COPD patientsRespir Med200599121494150015946834
   PubMed Web of Science ®Google Scholar
• RenkemaTESchoutenJPKoëterGHPostmaDSEffects of long-term treatment with corticosteroids in COPDChest19961095115611628625660
   PubMed Web of Science ®Google Scholar
• SenderovitzTVestboJFrandsenJSteroid reversibility test followed by inhaled budesonide or placebo in outpatients with stable chronic obstructive pulmonary disease. The Danish Society of Respiratory MedicineRespir Med1999931071571810581660
   PubMed Web of Science ®Google Scholar
• YildizFBasyigitIYildirimEBoyaciHIlgazliADoes addition of inhaled steroid to combined bronchodilator therapy affect health status in patients with COPD?Respirology20049335235515363007
   PubMed Web of Science ®Google Scholar
• CalverleyPMKunaPMonsóEBeclomethasone/formoterol in the management of COPD: a randomised controlled trialRespir Med2010104121858186820965712
   PubMed Web of Science ®Google Scholar
• European Federation of Pharmaceutical Industries and Associations (efpia) and Pharmaceutical Research and Manufacturers of America (PhRMA)2013Principles for Responsible Clinical Trial Data Sharing Available from: http://www.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdfAccessed April 2, 2016
   Google Scholar
• PauwelsRASearsMRCampbellMFormoterol as relief medication in asthma: a worldwide safety and effectiveness trialEur Respir J200322578779414621086
   PubMed Web of Science ®Google Scholar
• ShefferALSilvermanMWoolcockAJDíazPVLindbergBLindmarkBLong-term safety of once-daily budesonide in patients with early-onset mild persistent asthma: results of the Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) studyAnn Allergy Asthma Immunol2005941485415702816
   PubMed Web of Science ®Google Scholar
• HalpinDMGrayJEdwardsSJMoraisJSinghDBudesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trialsInt J Clin Pract201165776477421676119
   PubMed Web of Science ®Google Scholar
• RobertsMMapelDPetersenHBlanchetteCRamachandranSComparative effectiveness of budesonide/formoterol and fluticasone/salmeterol for COPD managementJ Med Econ201114676977621942463
   PubMedGoogle Scholar
• Miller-LarssonAJanssonPRunströmABrattsandRProlonged airway activity and improved selectivity of budesonide possibly due to esterificationAm J Respir Crit Care Med20001624 Pt 11455146111029361
   PubMed Web of Science ®Google Scholar
• CrimCCalverleyPMAndersonJAPneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study resultsEur Respir J200934364164719443528
   PubMed Web of Science ®Google Scholar
• JansonCLarssonKLisspersKHPneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting beta2 agonist: observational matched cohort study (PATHOS)BMJ2013346f330623719639
   PubMed Web of Science ®Google Scholar
• JenRRennardSISinDDEffects of inhaled corticosteroids on airway inflammation in chronic obstructive pulmonary disease: a systematic review and meta-analysisInt J Chron Obstruct Pulmon Dis2012758759523055709
   PubMed Web of Science ®Google Scholar
• EkALarssonKSiljerudSPalmbergLFluticasone and budesonide inhibit cytokine release in human lung epithelial cells and alveolar macrophagesAllergy199954769169910442524
   PubMed Web of Science ®Google Scholar
• LatorreMNovelliFVagagginiBDifferences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICSPulmo Pharmacol Ther2015304450
   PubMed Web of Science ®Google Scholar
• EMAPRAC Reviews Known Risk of Pneumonia with Inhaled Corticosteroids for Chronic Obstructive Pulmonary Disease2016 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Inhaled_corticosteroids_Article_31/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500203472.pdfAccessed April, 2016
   Google Scholar