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Table 2 Analysis of exacerbations (moderate to severe)

From: Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD

 

Roflumilast

Placebo

Effect size

Characteristic

n

Rate

n

Rate

Rate ratio (SE)

Change (%)

p value

   M2-111

567

0.595

606

0.692

0.860 (0.085)

-14.0

0.129

   M2-112

760

0.455

753

0.537

0.848 (0.081)

-15.2

0.085

Pooled results

       

Overall

1327

0.523

1359

0.610

0.857 (0.059)

-14.3

0.026

Sex

       

   Female

369

0.612

385

0.648

0.943 (0.117)

-5.7

0.637

   Male

958

0.495

974

0.609

0.813 (0.071)

-18.7

0.018

Smoking status

       

   Current smoker

529

0.529

530

0.643

0.823 (0.094)

-17.7

0.086

   Former smoker

798

0.568

829

0.663

0.857 (0.078)

-14.3

0.092

Concomitant treatment

      

   ICS

809

0.720

813

0.886

0.812 (0.068)

-18.8

0.014

   No ICS

518

0.424

546

0.460

0.923 (0.124)

-7.7

0.550

Concomitant treatment

     

   Short-acting anticholinergics

786

0.706

818

0.864

0.817 (0.066)

-18.3

0.012

   No short-acting anticholinergics

541

0.368

541

0.370

0.995 (0.147)

-0.5

0.974

COPD severity

       

   Very severe COPD

329

0.738

345

0.885

0.833 (0.101)

-16.7

0.132

   Severe COPD

864

0.526

909

0.609

0.864 (0.080)

-13.6

0.113

COPD history

       

Emphysema

352

0.579

413

0.586

0.989 (0.120)

-1.1

0.925

Chronic bronchitis ± emphysema

817

0.486

847

0.659

0.738 (0.068)

-26.2

0.001

Chronic bronchitis ± emphysema with concomitant ICS

492

0.608

493

0.871

0.698 (0.077)

-30.2

0.001

Chronic bronchitis ± emphysema: no ICS

325

0.391

354

0.462

0.845 (0.140)

-15.5

0.310

Cough score at Week 0

      

   ≥ 1 (average/day)

896

0.560

939

0.708

0.791 (0.067)

-20.9

0.006

   < 1 (average/day)

395

0.523

385

0.508

1.030 (0.142)

3.0

0.830

Sputum score at Week 0

      

   ≥ 1 (average/day)

829

0.576

862

0.700

0.822 (0.074)

-17.8

0.030

   < 1 (average/day)

458

0.512

460

0.549

0.933 (0.113)

-6.7

0.565

Study completion status

       

   Completers

894

0.453

1011

0.573

0.790 (0.064)

-21

0.004

   Non-completers

433

1.126

348

1.155

0.975 (0.113)

-2.5

0.826

  1. Rates (per patient/year), Rate ratio and two-sided p-values (significance level 5%) are based on a Poisson regression model with the following factors and covariates: treatment, age, sex, smoking status, baseline post-bronchodilator FEV1 (% predicted), study, concomitant treatment with ICS and country pool (only for the overall population).
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Respiratory Research

ISSN: 1465-993X

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