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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 NetherlandsB. Stallberg, Uppsala University, Uppsala, SwedenR. Jones, University of Plymouth, UKI. Tsiligianni, UMCG, Groningen, Agia Barbara Health Care Center, Heraklion, CreteT. van der Molen, UMCG, Groningen, the NetherlandsJ.W.H. Kocks, UMCG, Groningen, the NetherlandsN.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 - 1Characteristic Unlock Isolde Tristan Torch Uplift Eclipse Poet-
COPDPatients (N) 3508 751 1465 6112 5992 2164 7376
Age, yr 66 64 63 65 65 63 63
Male (%) 61 75 75 76 75 65 74
Current smokers 43 36 52 43 29 36 48
Pack years 44 44 42 47 49 49 39
BMI 26 25 25 26 27
Unlock: older, more female, more current smokers with less pack years
Results – 2 Characteristic Unlock Isolde Tristan Torch Uplift Eclipse Poet-
COPDFEV1 % 63 50 45 44 48 48 49
FER 59 43 - 49 44 45 53
GOLD I 20 0 - 0 0 0 0
GOLD II 50 52 - 35 46 44 48
GOLD III 2748
- 49 44 42 43
GOLD IV 3 - 15 8 12 9
Unlock: higher FEV1 and FER, different distribution in GOLD stages
Results - 3
Characteristic Unlock Isolde Tristan Torch Uplift Eclipse
SGRQ 33 50 47 49 46 50
CCQ 1.5 (1.0)
MRC 2.3 2.7
MRC >2 (%) 35 50 52
Unlock: better QoL, similar MRC, different distribution of MRC stages
Results – exacerbation rate
UNLOCK ISOLDE TORCH UPLIFT ECLIPSE GOLD GUIDELINE
GOLD I 0.55
GOLD II 0.81 0.92 0.9 0.70 0.85 0.7-0.9
GOLD III 1.251.75
1.0 0.97 1.34 1.1-1.3
GOLD IV 1.13 1.3 1.15 2.00 1.2-2.0
Unlock: lower exacerbation rates per GOLD stage
Results – frequent exacerbatorsUNLOCK 2013
ECLIPSE2010
Patients (N) 2756 2138
≥ 2 exacerbations p/yr
GOLD I (%) 12 -
GOLD II (%) 21 22
GOLD III (%) 32 33
GOLD IV (%) 28 47
Unlock: lower percentage of frequent exacerbators
Results - % eligible patientsInclusion criteria ISOLDE
2000TRISTAN 2003
TORCH 2007
UPLIFT 2008
ECLIPSE 2010
POET-COPD 2011
Age 77 - 90 100 77 100FER ≤ 70 93 93 93 93 93 93FEV1 83 58 39 59 77 59Reversibility 78 78 78 - - -Current/exsmoker 82 - 82 82 82 -Pack years ≥ 10 - 93 93 93 93 93Exacerbation ≥ 1 - 44 - - - 44
Total % of patients in primary care 39 17 20 42 42 23
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%)!