Table 5. Outcomes Associated With Use of Azithromycin Compared With Amoxicillin.
| Variable | No. of episodes | OR (95% CI)a |
|---|---|---|
| Cardiac events in overall cohort | ||
| Within 5 d | 4 282 570 | 1.08 (0.98-1.20) |
| Within 10 d | 4 234 226 | 1.05 (0.97-1.15) |
| Within 30 d | 4 105 722 | 0.98 (0.92-1.04) |
| Subgroups | ||
| Age ≥65 y | 372 885 | 1.21 (0.96-1.52) |
| Concurrent use of QT-prolonging drugs | 874 935 | 1.40 (1.04-1.87) |
| Factors associated with cardiac events | ||
| Model 1b | 1 318 514 | 1.15 (0.94-1.40) |
| Model 2c | 434 233 | 1.29 (0.73-2.27) |
| Cardiovascular disease | ||
| No | 4 157 508 | 1.07 (0.96-1.19) |
| Yes | 125 062 | 2.00 (0.75-5.33) |
| Sensitivity analyses | ||
| Unique patients | 3 423 819 | 1.11 (0.98-1.26) |
| Before the FDA warning from May 2012 | 1 659 140 | 1.08 (0.90-1.30) |
| After the FDA warning from May 2012 | 2 623 430 | 1.09 (0.96-1.25) |
| Cardiac events within 5 dd | 4 282 261 | 1.11 (0.98-1.23) |
Abbreviations: FDA, US Food and Drug Administration; OR, odds ratio.
a
Indicates odds of a cardiac event compared with use of amoxicillin (reference category).
b
Included age, sex, history of syncope, cardiac dysrhythmias, nonspecific chest pain, and concurrent use of QT-prolonging drug.
c
Included age, sex, antiarrhythmic agents, antiemetics, antidepressants, loop diuretics, and angiotensin-converting enzyme inhibitors.
d
Revised outcome definition based on inpatient diagnoses only.