Table 1.
Baseline characteristics of individuals under study who experienced at least one serious bleeding event
| Object drug | |||
|---|---|---|---|
| Clopidogrel | Pravastatin | ||
| Number of persons | 23,194 | 3,824 | |
| Person-days of observation time, median per individual (IQR) | 97.0 (36.0-285.0) | 130.0 (49.0-364.0) | |
| Person-days of observation time, total | 5,630,601 | 1,069,942 | |
| Person-days exposed to a precipitant drug | 1,034,742 | 152,035 | |
| Person-days unexposed to a precipitant drug | 4,595,859 | 917,907 | |
| Outcome occurrences during observation time, total | 19,530 | 3,487 | |
| Outcome occurrences during person-days exposed to a precipitant drug, total | 3,546 | 558 | |
| Outcome occurrences during person-days unexposed to a precipitant drug, total | 15,984 | 2,929 | |
| Demographic characteristics | |||
| Age in years at start of observation time, median (IQR) | 75.5 (66.5-83.0) | 72.1 (62.0-80.1) | |
| Female sex, n (%) | 14,068 (60.7%) | 2,306 (60.3%) | |
| Race | White | 11,349 (48.9%) | 1,724 (45.1%) |
| Black | 3,783 (16.3%) | 600 (15.7%) | |
| Hispanic/Latino | 3,584 (15.5%) | 612 (16.0%) | |
| Other/Unknown | 4,478 (19.3%) | 888 (23.2%) | |
| State of residence | CA | 8,540 (36.8%) | 1,932 (50.5%) |
| FL | 5,831 (25.1%) | 699 (18.3%) | |
| NY | 6,270 (27.0%) | 822 (21.5%) | |
| PA | 2,553 (11.0%) | 371 (9.7%) | |
| Nursing home resident at start of observation time, n (%) | 919 (4.0%) | 65 (1.7%) | |
| Exposure to precipitant drugs in person-days of observation time (%) | |||
| Doxepin | unexposed | 5,600,276 (99.5%) | 1,063,084 (99.4%) |
| exposed | 20,260 (0.4%) | 3,746 (0.4%) | |
| indeterminate | 10,065 (0.2%) | 3,112 (0.3%) | |
| Estazolam | unexposed | 5,626,789 (99.9%) | 1,069,367 (99.9%) |
| exposed | 2,723 (0.0%) | 445 (0.0%) | |
| indeterminate | 1,089 (0.0%) | 130 (0.0%) | |
| Eszopiclone | unexposed | 5,606,359 (99.6%) | 1,067,628 (99.8%) |
| exposed | 14,672 (0.3%) | 1,438 (0.1%) | |
| indeterminate | 9,570 (0.2%) | 876 (0.1%) | |
| Flurazepam | unexposed | 5,609,149 (99.6%) | 1,062,585 (99.3%) |
| exposed | 13,807 (0.2%) | 4,882 (0.5%) | |
| indeterminate | 7,645 (0.1%) | 2,475 (0.2%) | |
| Lorazepam | unexposed | 5,374,099 (95.4%) | 1,038,147 (97.0%) |
| exposed | 132,347 (2.4%) | 19,010 (1.8%) | |
| indeterminate | 124,155 (2.2%) | 12,785 (1.2%) | |
| Ramelteon | unexposed | 5,623,881 (99.9%) | 1,069,481 (100.0%) |
| exposed | 2,918 (0.1%) | 30 (0.0%) | |
| indeterminate | 3,802 (0.1%) | 431 (0.0%) | |
| Temazepam | unexposed | 5,364,517 (95.3%) | 1,040,865 (97.3%) |
| exposed | 183,339 (3.3%) | 20,438 (1.9%) | |
| indeterminate | 82,745 (1.5%) | 8,639 (0.8%) | |
| Trazodone | unexposed | 5,430,109 (96.4%) | 1,033,750 (96.6%) |
| exposed | 133,066 (2.4%) | 24,336 (2.3%) | |
| indeterminate | 67,426 (1.2%) | 11,856 (1.1%) | |
| Triazolam | unexposed | 5,611,512 (99.7%) | 1,066,288 (99.7%) |
| exposed | 12,309 (0.2%) | 2,346 (0.2%) | |
| indeterminate | 6,780 (0.1%) | 1,308 (0.1%) | |
| Zaleplon | unexposed | 5,617,535 (99.8%) | 1,066,530 (99.7%) |
| exposed | 7,608 (0.1%) | 2,165 (0.2%) | |
| indeterminate | 5,458 (0.1%) | 1,247 (0.1%) | |
| Zolpidem | unexposed | 5,083,515 (90.3%) | 989,939 (92.5%) |
| exposed | 397,849 (7.1%) | 58,934 (5.5%) | |
| indeterminate | 149,237 (2.7%) | 21,069 (2.0%) | |
CA: California; FL: Florida; IQR: interquartile range; NY: New York; PA: Pennsylvania