Table 5.
Selected cohort characteristics of pregnancies with and without exposure to duloxetine during first trimester. Values are numbers (percentages) unless stated otherwise
| Characteristic | Unadjusted | Accounting for propensity score strata | |||||
|---|---|---|---|---|---|---|---|
| Duloxetine (n=2532) | Unexposed (n=1 284 827) | Standardized difference* | Duloxetine (n=2223) | Unexposed (n=392 928) | Standardized difference* | ||
| Mean (SD) age, years | 27.74 (5.53) | 24.93 (5.36) | 0.51 | 27.81 (5.55) | 27.76 (5.56) | 0.01 | |
| Race/ethnicity: | |||||||
| White | 2003 (79.1) | 518 455 (40.4) | 0.86 | 1761 (79.2) | 315 827 (80.4) | −0.03 | |
| Black or African-American | 219 (8.6) | 400 432 (31.2) | −0.59 | 193 (8.7) | 30 859 (7.9) | 0.03 | |
| Hispanic or Latino | 70 (2.8) | 181 970 (14.2) | −0.42 | 61 (2.7) | 9549 (2.4) | 0.02 | |
| Asian or other Pacific Islander | 32 (1.3) | 56 128 (4.4) | −0.19 | 30 (1.3) | 5155 (1.3) | 0.00 | |
| Native American | 33 (1.3) | 21 136 (1.6) | −0.03 | 29 (1.3) | 5056 (1.3) | 0.00 | |
| Other | 117 (4.6) | 75 858 (5.9) | −0.06 | 101 (4.5) | 18 013 (4.6) | 0.00 | |
| Unknown | 58 (2.3) | 30 848 (2.4) | −0.01 | 48 (2.2) | 8469 (2.2) | 0.00 | |
| Chronic comorbid conditions: | |||||||
| Hypertension | 191 (7.5) | 34 556 (2.7) | 0.22 | 173 (7.8) | 30 313 (7.7) | 0.00 | |
| Diabetes | 152 (6.0) | 30 063 (2.3) | 0.18 | 135 (6.1) | 23 922 (6.1) | 0.00 | |
| Renal disease | 23 (0.9) | 4695 (0.4) | 0.07 | 22 (1.0) | 3970 (1.0) | 0.00 | |
| Obesity/overweight | 152 (6.0) | 33 501 (2.6) | 0.17 | 142 (6.4) | 24 906 (6.3) | 0.00 | |
| Indications for duloxetine: | |||||||
| Depression | 1235 (48.8) | 77 678 (6.0) | 1.09 | 1234 (55.5) | 223 353 (56.8) | −0.03 | |
| Anxiety | 778 (30.7) | 52 167 (4.1) | 0.75 | 777 (35) | 138 909 (35.4) | −0.01 | |
| Neuropathic pain | 267 (10.5) | 20 024 (1.6) | 0.38 | 267 (12.0) | 46 252 (11.8) | 0.01 | |
| Fibromyalgia | 264 (10.4) | 11 829 (0.9) | 0.42 | 263 (11.8) | 42 201 (10.7) | 0.03 | |
| Non-neuropathic pain | 1234 (48.7) | 198 581 (15.5) | 0.76 | 1233 (55.45) | 213 645 (54.4) | 0.02 | |
| Other psychiatric conditions: | |||||||
| Sleep disorder | 144 (5.7) | 10 560 (0.8) | 0.28 | 136 (6.1) | 23 672 (6.0) | 0.00 | |
| Bipolar disorder | 330 (13.0) | 17 340 (1.3) | 0.46 | 294 (13.2) | 50 799 (12.9) | 0.01 | |
| Psychosis | 20 (0.8) | 2570 (0.2) | 0.08 | 19 (0.9) | 3359 (0.9) | 0.00 | |
| Schizophrenia | 25 (1.0) | 2096 (0.2) | 0.11 | 23 (1.0) | 4041 (1.0) | 0.00 | |
| Personality disorder | 56 (2.2) | 2613 (0.2) | 0.18 | 55 (2.8) | 9490 (2.4) | 0.00 | |
| Adjustment disorder | 29 (1.1) | 4620 (0.4) | 0.09 | 25 (1.1) | 4382 (1.1) | 0.00 | |
| Tobacco use | 279 (11.0) | 52 341 (4.1) | 0.27 | 266 (12.0) | 47 559 (12.1) | 0.00 | |
| Alcohol misuse or dependence | 31 (1.2) | 4744 (0.4) | 0.10 | 28 (1.3) | 5054 (1.3) | 0.00 | |
| Drug misuse or dependence | 84 (3.3) | 11 587 (0.9) | 0.17 | 80 (3.6) | 14 339 (3.6) | 0.00 | |
| Other drug exposures: | |||||||
| Benzodiazepines | 979 (38.7) | 46 726 (3.6) | 0.95 | 911 (41.0) | 160 239 (40.8) | 0.00 | |
| Other hypnotics | 608 (24.0) | 48 070 (3.7) | 0.61 | 563 (25.3) | 97 232 (24.7) | 0.01 | |
| Barbiturates | 124 (4.9) | 14 042 (1.1) | 0.22 | 111 (5.0) | 19 572 (5.0) | 0.00 | |
| Anxiolytics | 129 (5.1) | 5852 (0.5) | 0.29 | 118 (5.3) | 20 392 (5.2) | 0.01 | |
| Anticonvulsants | 642 (25.4) | 29 354 (2.3) | 0.71 | 590 (26.5) | 99 450 (25.3) | 0.03 | |
| Antipsychotics | 505 (19.9) | 18 630 (1.4) | 0.63 | 463 (20.8) | 77 907 (19.8) | 0.02 | |
| SSRIs | 705 (27.8) | 88 971 (6.9) | 0.57 | 645 (29.0) | 121 358 (30.9) | −0.04 | |
| SNRIs | 103 (4.1) | 10 809 (0.8) | 0.21 | 92 (4.1) | 17 233 (4.4) | −0.01 | |
| Other antidepressants | 720 (28.4) | 40 109 (3.1) | 0.74 | 667 (30.0) | 116 681 (29.7) | 0.01 | |
| Stimulants | 198 (7.8) | 10 738 (0.8) | 0.35 | 172 (7.7) | 29 167 (7.4) | 0.01 | |
| Anti-diabetes drugs | 100 (3.9) | 13 468 (1.0) | 0.19 | 86 (3.9) | 15 036 (3.8) | 0.00 | |
| Insulin | 80 (3.2) | 12 212 (1.0) | 0.16 | 69 (3.1) | 12 322 (3.1) | 0.00 | |
| Antihypertensives | 373 (14.7) | 41 000 (3.2) | 0.41 | 329 (14.8) | 56 095 (14.3) | 0.01 | |
| Opioid analgesics | 1554 (61.4) | 310 792 (24.2) | 0.81 | 1425 (64.1) | 252 815 (64.3) | 0.00 | |
| Triptans | 178 (7.0) | 15 504 (1.2) | 0.30 | 165 (7.4) | 28 900 (7.4) | 0.00 | |
| NSAIDs | 958 (37.8) | 221 631 (17.2) | 0.47 | 894 (40.2) | 157 677 (40.1) | 0.00 | |
| Multfetal gestation | 87 (3.4) | 47 282 (3.7) | −0.01 | 77 (3.5) | 13 572 (3.5) | 0.00 | |
| Potentially teratogenic drug exposures: | |||||||
| Danazol | 0 (0) | 21 (0) | −0.01 | 0 (0) | 0 (0) | ||
| Synthetic progestins | 88 (3.5) | 25 715 (2.0) | 0.09 | 80 (3.6) | 14 054 (3.6) | 0.00 | |
| Methimazole | <11 (0.1) | 678 (0.1) | 0.02 | <11 (0.13) | 570 (0.1) | 0.00 | |
| Propylthiouracil | <11 (0.2) | 1466 (0.1) | 0.01 | <11 (0.18) | 742 (0.2) | 0.00 | |
| Corticosteroids | 453 (17.9) | 92 250 (7.2) | 0.33 | 402 (18.08) | 70 912 (18.0) | 0.00 | |
| Fluconazole | 133 (5.3) | 28 109 (2.2) | 0.16 | 115 (5.17) | 19 664 (5.0) | 0.01 | |
| Mean (SD) healthcare utilization: | |||||||
| Comorbidity index | 1.58 (1.85) | 0.92 (1.40) | 0.40 | 1.62 (1.88) | 1.61 (1.85) | 0.01 | |
| Morphine equivalents | 19 774 (489 396) | 754 (67 877) | 0.05 | 21 635 (521 363) | 18 278 (373 453) | 0.01 | |
| No of diagnoses | 5.95 (4.65) | 2.80 (3.33) | 0.78 | 6.33 (4.70) | 6.43 (4.77) | −0.02 | |
| No of ED visits | 0.72 (1.30) | 0.35 (0.89) | 0.33 | 0.77 (1.32) | 0.81 (1.66) | −0.03 | |
| No of generics dispensed | 5.63 (4.19) | 1.81 (2.48) | 1.11 | 5.88 (4.25) | 5.93 (4.31) | −0.01 | |
| No of hospital admissions | 0.05 (0.27) | 0.04 (0.23) | 0.05 | 0.06 (0.28) | 0.06 (0.28) | 0.01 | |
| No of outpatient visits | 5.58 (6.43) | 2.11 (3.43) | 0.67 | 5.96 (6.62) | 5.94 (6.38) | 0.00 | |
| No of psychiatric hospital admissions | 0.04 (0.22) | 0.01 (0.09) | 0.17 | 0.04 (0.23) | 0.04 (0.23) | 0.01 | |
| No of psychiatrist visits | 2.28 (4.94) | 0.33 (2.14) | 0.51 | 2.48 (5.09) | 2.46 (5.05) | 0.00 | |
ED=emergency department; NSAID=non-steroidal anti-inflammatory drug; SNRI=selective serotonin-norepinephrine reuptake inhibitor; SSRI=selective serotonin reuptake inhibitor.
*
See supplementary materials (sTables 4-7) for how this was estimated.