Table 2.
Patient outcomes in the roflumilast treatment trials
| Rabe 200562500 μg | Calverley 200763 | Calverley 200965 |
Fabbri 200968 |
||
|---|---|---|---|---|---|
| Salmeterol | Tiotropium | ||||
| Pre-FEV1 (mL) | 88 | 36 | 48 | 49 | 80 |
| Post-FEV1 (mL) | 97 | 39 | 55 | 60 | 81 |
| SGRQ | –1.7 | +0.3 | |||
| Dropouts (%) | 22/11 | 29/22 | 33/31 | 23/18 | 17/10 |
| Exacerbation rate | 0.28/0.30 | 0.86/0.92 | 1.14/1.37 | 18/11 | 11/16 |
| Weight loss (kg) | N/A | N/A | 2.2 | 2.2 | 2.1 |
| Diarrhea (%) | 9/2 | 9/3 | 8/3 | 8/3 | 9/1 |
| Nausea (%) | 5/1 | 5/1 | 4/2 | 5/1 | 3/1 |
| Headache (%) | N/A | 6/2 | 3/1 | 3/1 | 2/0 |
Notes: Pre-FEV1 refers to mean change in prebronchodilator FEV1 at the end of the trial. Post-FEV1 refers to the mean change in postbronchodilator FEV1 at the end of the trial. SGRQ refers to change in mean St George Respiratory Question Score at the end of the treatment period. A reduction in score represents an improvement. Dropouts represent the percentage of patients that did not complete the treatment period. For each study, the first percentage represents the percentage of subjects in the roflumilast treatment arm that did not complete the study and the second percentage represents dropouts in the placebo arm. In each study, a greater percentage dropped out of the roflumilast treatment arms. The exacerbation rate refers to the number of moderate and severe exacerbations, exacerbation rate per patient, or the percentage of patients experiencing exacerbations during the study. In each case, the first number represents the roflumilast arm and the second the placebo arm of the studies. The next row contains the average difference in weight loss between the placebo arm and the treatment arms. In the three studies reporting weight loss, patients receiving roflumilast lost an average of slightly more than 2 kg more than the placebo-treated patients (N/A, data are not available). The last three rows represent the percentages of patients reporting diarrhea, nausea, and headache. In each case, the first percentage represents the percentage of patients reporting the side effect in the roflumilast arm and the second represents the percentage reporting the side effect in the placebo arm.