Table 1.
Characteristics of persons experiencing serious hypoglycemia by antidiabetes object drug
| Object drug | |||||
|---|---|---|---|---|---|
| glimepiride | glipizide | glyburide | metformin (control object) |
||
| Number of persons, total | 495 | 1,123 | 1,049 | 800 | |
| warfarin-triggered groupa | 161 | 345 | 315 | 232 | |
| antidiabetes-triggered groupb | 143 | 287 | 288 | 219 | |
| combination-triggered groupc | 39 | 121 | 120 | 79 | |
| Person-days of observation time, total | 263,305 | 625,872 | 606,369 | 554,690 | |
| Time exposed to warfarin | 95,321 | 209,497 | 197,031 | 176,094 | |
| Time unexposed to warfarin | 167,984 | 416,375 | 409,338 | 378,596 | |
| Person-days of observation time by concomitancy-triggering drug | |||||
| warfarin-triggered group | 47,150 | 106,638 | 94,581 | 82,118 | |
| antidiabetes-triggered group | 37,847 | 75,876 | 82,848 | 78,704 | |
| combination-triggered group | 10,324 | 26,983 | 19,602 | 15,272 | |
| Person-days of observation time, median per individual (Q1; Q3) | 298 (83; 748) | 324 (93; 813) | 309 (93; 816) | 421 (91; 1,023) | |
| warfarin-triggered group | 476 (181; 994) | 573 (225; 1,117) | 531 (206; 1,137) | 749 (350; 1,462) | |
| antidiabetes-triggered group | 223 (70; 581) | 286 (124; 713) | 326 (129; 765) | 533 (194; 1,131) | |
| combination-triggered group | 139 (48; 727) | 222 (78; 616) | 204 (85; 628) | 342 (117; 664) | |
| Number of outcome occurrence during observation time | 654 | 1,554 | 1,405 | 1,197 | |
| Exposed time | 255 | 531 | 482 | 435 | |
| Unexposed time | 399 | 1,023 | 923 | 762 | |
| Number of outcome occurrence during observation time by concomitancy-triggering drug | |||||
| warfarin-triggered group | 121 | 235 | 177 | 177 | |
| antidiabetes-triggered group | 104 | 203 | 209 | 190 | |
| combination-triggered group | 30 | 93 | 96 | 68 | |
| Demographic characteristics | Category | % of persons (unless otherwise noted) | |||
| Age in years at start of observation time | Median (Q1; Q3) | 74.7 (66.3; 82.9) | 71.1 (60.5; 79.2) | 73.4 (64.4; 80.4) | 65.1 (52.1; 74.2) |
| Sex | Female | 65.5 | 65.3 | 63.5 | 64.9 |
| Race/ethnicity | White | 57.8 | 40.2 | 43.6 | 46.1 |
| Black | 14.7 | 25.7 | 21.7 | 20.6 | |
| Hispanic/Latino | 12.9 | 17.4 | 17.3 | 18.4 | |
| Other/unknown | 14.5 | 16.7 | 17.3 | 14.9 | |
| State of residence | CA | 39.0 | 45.6 | 52.6 | 47.0 |
| FL | 8.9 | 9.6 | 6.5 | 7.3 | |
| NY | 18.6 | 22.4 | 20.3 | 23.9 | |
| OH | 21.4 | 10.6 | 12.7 | 12.6 | |
| PA | 12.1 | 11.8 | 7.9 | 9.3 | |
| Calendar year at start of observation time | 1999 | d | 4.6 | 6.8 | 2.5 |
| 2000 | 6.9 | 9.3 | 13.6 | 5.9 | |
| 2001 | 4.6 | 9.4 | 10.7 | 7.3 | |
| 2002 | 6.9 | 10.6 | 10.3 | 6.4 | |
| 2003 | 10.5 | 8.1 | 10.9 | 8.6 | |
| 2004 | 11.1 | 7.1 | 9.2 | 10.0 | |
| 2005 | 10.5 | 10.0 | 8.9 | 10.9 | |
| 2006 | 12.7 | 13.0 | 10.8 | 11.4 | |
| 2007 | 9.3 | 7.8 | 6.3 | 9.8 | |
| 2008 | 8.5 | 6.9 | 4.8 | 10.1 | |
| 2009 | 8.5 | 6.6 | 3.2 | 7.8 | |
| 2010 | 5.7 | 4.0 | 3.3 | 7.0 | |
| 2011 | d | 2.5 | 1.4 | 2.5 | |
| Dually-enrolled for Medicare anytime during baseline period | Yes | 87.1 | 81.2 | 83.3 | 76.4 |
| Exposure to Precipitant Drug | Category | % of person-days | |||
| Warfarin | Yes | 36.2 | 33.5 | 32.5 | 31.7 |
| Pre-specified time-varying covariates |
Category | % of person-days (unless otherwise noted) | |||
| Acute infection in prior 15 days | Yes | 10.8 | 11.1 | 10.8 | 9.8 |
| ACE inhibitors in prior 31 days | Yes | 28.4 | 30.7 | 30.7 | 33.8 |
| Angiotensin II receptor antagonists in prior 31 days | Yes | 18.5 | 14.3 | 13.4 | 14.7 |
| Atypical antipsychotics in prior 31 days | Yes | 5.6 | 7.8 | 5.2 | 12.5 |
| Average daily dose, in milligrams | Median (Q1; Q3) | 2.0 (1.0; 4.0) | 5.0 (5.0; 10.0) | 5.0 (2.5; 5.0) | 1,000 (1,000; 1,000) |
| Beta-blockers in prior 31 days | Yes | 37.7 | 38.8 | 33.2 | 34.6 |
| Calcineurin inhibitors in prior 31 days | Yes | 0.2 | 0.4 | 0.2 | 0.1 |
| Corticosteroids in prior 31 days | Yes | 6.2 | 6.3 | 4.9 | 5.5 |
| CYP2C9 inhibitors in prior 31 days | Yes | 6.0 | 2.8 | 2.5 | 3.5 |
| CYP3A4 inhibitors in prior 31 days | Yes | 19.4 | 15.8 | 13.7 | 21.6 |
| MAO inhibitors in prior 31 days | Yes | 0.0 | 0.4 | 0.4 | 0.0 |
| Other drugs that can cause hypoglycemia in prior 31 days | Yes | 2.8 | 5.3 | 3.8 | 3.2 |
| Protease inhibitors in prior 31 days | Yes | 0.6 | 0.2 | 0.2 | 0.1 |
| Quinolones in prior 15 days | Yes | 3.6 | 2.9 | 2.8 | 2.8 |
| Retinoids in prior 31 days | Yes | 0.0 | 0.0 | 0.0 | 0.2 |
| Salicylates in prior 31 days | Yes | 7.9 | 10.5 | 9.5 | 9.2 |
| Thiazide diuretics in prior 31 days | Yes | 14.7 | 12.7 | 13.4 | 16.6 |
ACE: angiotensin converting enzyme. MAO: monoamine oxidase. CYP: cytochrome P450 enzyme.
Warfarin-triggered group: observation time (person-days) in which the concomitant use of object and precipitant drugs was initiated by warfarin during the ongoing antidiabetic treatment.
Antidiabetes-triggered group: observation time (person-days) in which the concomitant use of object and precipitant drugs was initiated by an antidiabetic drug during the ongoing warfarin treatment.
Combination-triggered group: observation time (person-days) in which the concomitant use of object and precipitant drugs was initiated by warfarin and an antidiabetic drug on the same day, i.e., prescriptions of warfarin and an antidiabetic drug were dispensed on the same day.
Small numbers of observation are suppressed by the cell suppression policy of the Centers for Medicare and Medicaid Services (data source).