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%)!