Table 3.
Nonfatal and Fatal Serious Adverse Events.*
| Event | Metoprolol (N = 268) | Placebo (N = 264) | P Value† |
|---|---|---|---|
| Nonfatal adverse events — no. of events per person-yr‡ | |||
| All events | 0.650 | 0.430 | 0.07 |
| Cardiovascular event | |||
| Myocardial infarction | 0.009 | 0.004 | 0.51 |
| Heart failure | 0.008 | 0.014 | 0.57 |
| Stroke | 0.004 | 0.008 | 0.65 |
| Arrhythmias | 0.012 | 0.008 | 0.71 |
| Hypotension | 0 | 0.004 | 0.31 |
| Other cardiovascular event | 0.004 | 0.004 | 0.99 |
| Respiratory event | |||
| COPD exacerbation§ | 0.430 | 0.190 | 0.02 |
| Pneumonia | 0.084 | 0.057 | 0.34 |
| Other respiratory event | 0.020 | 0.004 | 0.16 |
| Fatal events — no. of patients (%)¶ | |||
| All events | 11 (4.1) | 5 (1.9) | 0.14 |
| COPD | 7 (2.6) | 1 (0.4) | — |
| Sudden cardiac death | 0 | 1 (0.4) | — |
| Lung cancer | 1 (0.4) | 0 | — |
| Sepsis | 1 (0.4) | 1 (0.4) | — |
| Unknown | 1 (0.4) | 2 (0.8) | — |
| Other | 1 (0.4) | 0 | — |
Listed are adverse events that were reported as serious by the investigator.
For nonfatal adverse events, P values were calculated by Student’s t-test. For fatal adverse events, the P value for the overall between-group comparison was calculated by the log-rank test; P=0.17 by Fisher’s exact test for the overall comparison among the causes of death.
Nonfatal events are reported as rates per person-year because the patients could have had more than one event. A complete list of nonfatal serious adverse events is provided in Table S2.
COPD exacerbations that are listed here may not meet the protocol-defined criteria for the primary end point.
After the treatment period, three additional deaths occurred in the metoprolol group (two from COPD and one from pneumonia) and four in the placebo group (one from COPD, one from lung cancer, and two from unknown causes).