Table 2.
Adverse Events in Placebo-Controlled Trials of Roflumilast In Patients With Chronic Obstructive Pulmonary Disease*
| Roflumilast 500 mcg Once Daily | Placebo | |
|---|---|---|
| Rabe et al. (2005)15 | n = 555 | n = 280 |
| Diarrhea | 9% | 2% |
| Nasopharyngitis | 8% | 7% |
| Nausea | 5% | 1% |
| Upper respiratory tract infection | 4% | 5% |
| Calverley et al. (2007)29 | n = 760 | N = 753 |
| Diarrhea | 9% | 3% |
| Nasopharyngitis | 7% | 7% |
| Headache | 6% | 2% |
| Influenza | 5% | 5% |
| Nausea | 5% | 1% |
| Fabbri et al. (2009)30 | ||
| Trial M2-127 | n = 466 | n = 467 |
| Weight loss | 9% | 1% |
| Diarrhea | 8% | 3% |
| Nasopharyngitis | 7% | 7% |
| Nausea | 5% | < 1% |
| Trial M2-128 | ||
| Diarrhea | 9% | < 1% |
| Nasopharyngitis | 6% | 5% |
| Weight loss | 6% | < 1% |
| Caverley et al. (2009)31 | ||
| Trial M2-124 | n = 769 | n = 755 |
| Weight loss | 12% | 3% |
| Diarrhea | 8% | 3% |
| Nasopharyngitis | 7% | 7% |
| Acute bronchitis | 5% | 5% |
| Nausea | 5% | 2% |
| Trial M2-125 | n = 778 | n = 790 |
| Diarrhea | 9% | 3% |
| Weight loss | 8% | 3% |
| Nasopharyngitis | 5% | 6% |
| Upper respiratory tract infection | 4% | 5% |