Primary Care COPD Patients Compared with Large Pharmaceutically-Sponsored COPD Studies:An UNLOCK Validation Study

Background: Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care.Objective: We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials.Methods: Baseline data of seven primary care databases (n = 3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria.Results: Overall, patients included in the LPCS were younger (mean difference (MD)-2.4; p = 0.03), predominantly male (MD 12.4; p = 0.1) with worse lung function (FEV1% MD -16.4; p &lt;0.01) and worse quality of life scores (SGRQ MD 15.8; p = 0.01). There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with &gt;= 1 and &gt;= 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had &gt;= 1 exacerbations per year and 12% had &gt;= 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT).Conclusion: Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.</p

Improving antibacterial prescribing safety in the management of COPD exacerbations:systematic review of observational and clinical studies on potential drug interactions associated with frequently prescribed antibacterials among COPD patients

BACKGROUND: Guidelines advise the use of antibacterials (ABs) in the management of COPD exacerbations. COPD patients often have multiple comorbidities, such as diabetes mellitus and cardiac diseases, leading to polypharmacy. Consequently, drug-drug interactions (DDIs) may frequently occur, and may cause serious adverse events and treatment failure. OBJECTIVES: (i) To review DDIs related to frequently prescribed ABs among COPD patients from observational and clinical studies. (ii) To improve AB prescribing safety in clinical practice by structuring DDIs according to comorbidities of COPD. METHODS: We conducted a systematic review by searching PubMed and Embase up to 8 February 2018 for clinical trials, cohort and case-control studies reporting DDIs of ABs used for COPD. Study design, subjects, sample size, pharmacological mechanism of DDI and effect of interaction were extracted. We evaluated levels of DDIs and quality of evidence according to established criteria and structured the data by possible comorbidities. RESULTS: In all, 318 articles were eligible for review, describing a wide range of drugs used for comorbidities and their potential DDIs with ABs. DDIs between ABs and co-administered drugs could be subdivided into: (i) co-administered drugs altering the pharmacokinetics of ABs; and (ii) ABs interfering with the pharmacokinetics of co-administered drugs. The DDIs could lead to therapeutic failures or toxicities. CONCLUSIONS: DDIs related to ABs with clinical significance may involve a wide range of indicated drugs to treat comorbidities in COPD. The evidence presented can support (computer-supported) decision-making by health practitioners when prescribing ABs during COPD exacerbations in the case of co-medication

The use of health status questionnaires in the management of chronic obstructive pulmonary disease patients in clinical practice

Current guidelines recommend chronic obstructive pulmonary disease (COPD) management based on symptoms or health status assessment and lung function parameters. However, COPD is a complex and heterogeneous disease that needs an individualized approach for proper disease management. A structured consultation including health status assessment tools, such as the Clinical COPD Questionnaire and the COPD Assessment Test should improve the quality of the consultation, providing more information than symptoms alone. Both questionnaires are designed to provide the clinician information enabling a more personalized disease approach and subsequent management. Although both Clinical COPD Questionnaire and COPD Assessment Test have good discriminate properties, their use as prognostic markers of severity and their ability to modify disease management has not yet been fully established. New studies are needed to further determine their value on several disease outcomes

Asthma/COPD service in general practice. Study into feasibility and effectiveness

DoelHet beschrijven van de effectiviteit en het functioneren van een astma/COPD-dienst (AC-dienst).OpzetObservationeel onderzoek.MethodeIn Noord-Nederland kunnen huisartsen patiënten met luchtwegklachten voor onderzoek verwijzen naar de AC-dienst, die in 2007 werd opgericht door lokale longartsen, huisartsen en het huisartsenlaboratorium Certe. De patiënt vult voor het onderzoek thuis 3 vragenlijsten in, de Clinical COPD Questionnaire(CCQ), de Asthma Control Questionnaire(ACQ) en een anamnesevragenlijst. In het laboratorium wordt de longfunctie bepaald en lichamelijk onderzoek uitgevoerd. Alle gegevens worden via internet naar een longarts gestuurd, die de huisarts via diens informatiesysteem adviseert over diagnose en behandeling. Zo nodig kan de longarts een vervolgconsult aanbieden. Voor deze publicatie beschikten wij over de gegevens van 14.748 aangemelde patiënten en 3721 vervolgconsulten.ResultatenDe longartsen diagnosticeerden 6201 patiënten (42%) met astma, 2728 (19%) met COPD en 1039 (7%) met de dubbeldiagnose ‘astma/COPD’. De longarts adviseerde voor 940 patiënten (6%) een medicatieverandering en een vervolgconsult na 3 maanden. In deze groep daalde het aantal instabiele COPD patiënten (CCQ ≥ 1) van 134 (67%) naar 99 (50%). Het aantal patiënten met instabiel astma (ACQ ≥ 1,5) daalde van 245 (43%) naar 137 (24%). Bij 1642 (11%) patiënten adviseerde de longarts geen medicatieverandering en verzocht de huisarts om een vervolgconsult na 12 maanden. Deze patiënten waren in het algemeen stabiel, met lichte verbeteringen in rookstatus, exacerbaties en inhalatietechniek.ConclusieOngeveer 60% van de patiënten in de regio is in de periode 2007-2014 ten minste eenmaal door de AC-dienst beoordeeld. De adviezen aan de huisartsen over diagnose en behandeling resulteerden in betere patiëntgerelateerde uitkomsten, zowel bij astma- als bij COPD-patiënten.OBJECTIVE: A study of the effectiveness and functioning of an asthma/COPD service (AC service).DESIGN: Observational study.METHOD: General practitioners (GPs) in the northern part of the Netherlands can refer patients with airway symptoms to the AC service, which was set up in 2007 by local pulmonologists, GPs and the primary care laboratory CERTE. Before the assessment, patients fill in three questionnaires at home: the Clinical COPD Questionnaire (CCQ), the Asthma Control Questionnaire (ACQ) and a medical history list. The laboratory assesses lung function and a physical examination is carried out. All data is sent via the Internet to a pulmonologist, who advises the GP on diagnosis and treatment via an information system. The pulmonologist can offer a follow-up service if required. For this publication we had access to data from 14,748 registered patients and 3721 follow-up consultations.RESULTS: The pulmonologist diagnosed 6201 (42%) patients with asthma, 2728 (19%) with COPD and 1039 (7%) with 'asthma/COPD overlap syndrome'. The pulmonologist advised that 940 patients (6%) should have a change in medication and reassessment after 3 months. In this group, the number of unstable COPD patients (CCQ ≥ 1) dropped from 134 (67%) to 99 (50%). The number of patients with unstable asthma (ACQ ≥ 1.5) dropped from 245 (3%) to 137 (24%). For 1642 (11%) patients the pulmonologist advised no change in medication and the GP referred the patient for reassessment after 12 months. These patients were generally stable, with a slight improvement in smoking status, exacerbations and inhalation technique.CONCLUSION: Approximately 60% of all patients with asthma or COPD in this region were assessed by the AC service at least once in the period 2007-2014. Advice on diagnosis and treatment given to the GP resulted in better patient-related outcomes in both asthma and COPD patients.</p

Een astma/COPD-dienst voor de huisartsenpraktijk

Doel Het beschrijven van de effectiviteit en het functioneren van een astma/COPD-dienst (AC-dienst). Opzet Observationeel onderzoek. Methode In Noord-Nederland kunnen huisartsen patiënten met luchtwegklachten voor onderzoek verwijzen naar de AC-dienst, die in 2007 werd opgericht door lokale longartsen, huisartsen en het huisartsenlaboratorium Certe. De patiënt vult voor het onderzoek thuis 3 vragenlijsten in, de Clinical COPD Questionnaire(CCQ), de Asthma Control Questionnaire(ACQ) en een anamnesevragenlijst. In het laboratorium wordt de longfunctie bepaald en lichamelijk onderzoek uitgevoerd. Alle gegevens worden via internet naar een longarts gestuurd, die de huisarts via diens informatiesysteem adviseert over diagnose en behandeling. Zo nodig kan de longarts een vervolgconsult aanbieden. Voor deze publicatie beschikten wij over de gegevens van 14.748 aangemelde patiënten en 3721 vervolgconsulten. Resultaten De longartsen diagnosticeerden 6201 patiënten (42%) met astma, 2728 (19%) met COPD en 1039 (7%) met de dubbeldiagnose ‘astma/COPD’. De longarts adviseerde voor 940 patiënten (6%) een medicatieverandering en een vervolgconsult na 3 maanden. In deze groep daalde het aantal instabiele COPD patiënten (CCQ ≥ 1) van 134 (67%) naar 99 (50%). Het aantal patiënten met instabiel astma (ACQ ≥ 1,5) daalde van 245 (43%) naar 137 (24%). Bij 1642 (11%) patiënten adviseerde de longarts geen medicatieverandering en verzocht de huisarts om een vervolgconsult na 12 maanden. Deze patiënten waren in het algemeen stabiel, met lichte verbeteringen in rookstatus, exacerbaties en inhalatietechniek. Conclusie Ongeveer 60% van de patiënten in de regio is in de periode 2007-2014 ten minste eenmaal door de AC-dienst beoordeeld. De adviezen aan de huisartsen over diagnose en behandeling resulteerden in betere patiëntgerelateerde uitkomsten, zowel bij astma- als bij COPD-patiënten

Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD

BACKGROUND: Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). METHODS: Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. RESULTS: In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). CONCLUSIONS: This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety