1. 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

2. 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?

3. 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

4. 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

5. Results - 1 CharacteristicUnlockIsoldeTristanTorchUpliftEclipsePoet- COPD Patients (N)350875114656112599221647376 Age, yr66646365 63 Male (%)6175 76756574 Current smokers43365243293648 Pack years44 424749 39 BMI2625 2627 Unlock: older, more female, more current smokers with less pack years

6. Results – 2 CharacteristicUnlockIsoldeTristanTorchUpliftEclipsePoet- COPD FEV1 %6350454448 49 FER5943-49444553 GOLD I200-0000 GOLD II5052-35464448 GOLD III27 48 -49444243 GOLD IV3-158129 Unlock: higher FEV1 and FER, different distribution in GOLD stages

7. Results - 3 CharacteristicUnlockIsoldeTristanTorchUpliftEclipse SGRQ335047494650 CCQ1.5 (1.0) MRC2.32.7 MRC >2 (%)355052 Unlock: better QoL, similar MRC, different distribution of MRC stages

8. Results – exacerbation rate UNLOCKISOLDETORCHUPLIFTECLIPSEGOLD GUIDELINE GOLD I0.55 GOLD II0.810.920.90.700.850.7-0.9 GOLD III1.25 1.75 1.00.971.341.1-1.3 GOLD IV1.131.31.152.001.2-2.0 Unlock: lower exacerbation rates per GOLD stage

9. Results – frequent exacerbators UNLOCK 2013 ECLIPSE 2010 Patients (N)27562138 ≥ 2 exacerbations p/yr GOLD I (%)12- GOLD II (%)2122 GOLD III (%)3233 GOLD IV (%)2847 Unlock: lower percentage of frequent exacerbators

10. Results - % eligible patients Inclusion criteriaISOLDE 2000 TRISTAN 2003 TORCH 2007 UPLIFT 2008 ECLIPSE 2010 POET-COPD 2011 Age 77-9010077100 FER ≤ 70 93 FEV1 835839597759 Reversibility 78 --- Current/exsmoker 82- - Pack years ≥ 10 -93 Exacerbation ≥ 1 -44--- Total % of patients in primary care 39172042 23

11. 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%)!