Real life COPD patients compared to large COPD study populations An UNLOCK external validity study A.L. Kruis, LUMC, Leiden, the Netherlands B. Stallberg,

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Real life COPD patients compared to large COPD study populations An UNLOCK external validity study A.L. Kruis, LUMC, Leiden, the Netherlands B. Stallberg, Uppsala University, Uppsala, Sweden R. Jones, University of Plymouth, UK I. Tsiligianni, UMCG, Groningen, Agia Barbara Health Care Center, Heraklion, Crete T. van der Molen, UMCG, Groningen, the Netherlands J.W.H. Kocks, UMCG, Groningen, the Netherlands N.H. Chavannes, LUMC, Leiden, the Netherlands

Background COPD Guidelines have not been widely adopted in daily practice Recommendations are based on large RCTs, including selected COPD populations Can the results of such RCTs be extrapolated to our larger, real life, primary care population of COPD patients?

Objective To investigate the external validity of six large COPD studies ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD To examine the proportion of primary care patients eligible for these studies based on inclusion criteria

Methods Seven primary care databases (NL, Sweden, UK, Greece): 3508 COPD patients Comparison of baseline characteristics Age, gender, smoking status, pack years, BMI, lung function, exacerbations, dyspnea, quality of life (CCQ, SGRQ) Assessment of % of primary care patients eligible for inclusion

Results - 1 CharacteristicUnlockIsoldeTristanTorchUpliftEclipsePoet- COPD Patients (N) Age, yr Male (%) Current smokers Pack years BMI Unlock: older, more female, more current smokers with less pack years

Results – 2 CharacteristicUnlockIsoldeTristanTorchUpliftEclipsePoet- COPD FEV1 % FER GOLD I GOLD II GOLD III GOLD IV Unlock: higher FEV1 and FER, different distribution in GOLD stages

Results - 3 CharacteristicUnlockIsoldeTristanTorchUpliftEclipse SGRQ CCQ1.5 (1.0) MRC MRC >2 (%) Unlock: better QoL, similar MRC, different distribution of MRC stages

Results – exacerbation rate UNLOCKISOLDETORCHUPLIFTECLIPSEGOLD GUIDELINE GOLD I0.55 GOLD II GOLD III GOLD IV Unlock: lower exacerbation rates per GOLD stage

Results – frequent exacerbators UNLOCK 2013 ECLIPSE 2010 Patients (N) ≥ 2 exacerbations p/yr GOLD I (%)12- GOLD II (%)2122 GOLD III (%)3233 GOLD IV (%)2847 Unlock: lower percentage of frequent exacerbators

Results - % eligible patients Inclusion criteriaISOLDE 2000 TRISTAN 2003 TORCH 2007 UPLIFT 2008 ECLIPSE 2010 POET-COPD 2011 Age FER ≤ FEV Reversibility Current/exsmoker Pack years ≥ Exacerbation ≥ Total % of patients in primary care

Conclusion Large COPD studies included highly selected COPD populations Predominantly men with: – Worse lung function – More pack years – More exacerbations Primary care: frequent exacerbators in GOLD I (13%) and GOLD II (19%)!