TABLE 1.
Baseline Characteristics, Insulin Episode and Use, and Outcomes of LAI and NPH Insulin Users with T1DM
| LAIa | LAI + RAI | NPHa | NPH + RAI | |
|---|---|---|---|---|
| Insulin episodes | ||||
| Unique patients with at least 1 episode | N = 4,591 | |||
| Total number of episodesa | N = 12,828 | |||
| Insulin episodes, n | 4,870 | 6,933 | 391 | 634 |
| Episodes per user, mean (SD) | 1.58 (1.1) | 1.81 (1.4) | 1.55 (1.1) | 1.87 (1.5) |
| Months per episode, mean (SD) | 1.32 (2.2) | 5.04 (5.0) | 1.44 (2.5) | 4.80 (5.0) |
| Months of follow-up, mean (SD) | 2.04 (3.2) | 9.12 (9.5) | 2.16 (3.60) | 9.00 (9.7) |
| Dispensing per user, mean (SD) | 2.06 (2.0) | 4.25 (4.8) | 2.21 (2.4) | 4.56 (5.3) |
| Dispensing per episode, mean (SD) | 1.30 (1.1) | 2.35 (2.8) | 1.42 (1.7) | 2.44 (3.3) |
| Days supply per user, mean (SD) | 40.7 (67.6) | 143.4 (178.0) | 48.2 (86.4) | 151.2 (191.1) |
| Days supply per episode, mean (SD) | 25.7 (47.5) | 79.2 (111.6) | 31.1 (63.8) | 80.8 (116.6) |
| Patient characteristics by insulin episode | ||||
| Females, n (%) | 1,786 (36.7) | 2,465 (35.6) | 152 (38.9) | 187 (29.5) |
| Age groups, n (%) | ||||
| 18-49 years | 4,198 (86.2) | 5,947 (85.8) | 287 (73.4) | 476 (75.1) |
| 50-64 years | 641 (13.2) | 949 (13.7) | 94 (24.0) | 149 (23.5) |
| 65-79 years | 29 (0.6) | 36 (0.5) | NC | NC |
| All LAI | All NPH | |||
| Clinical characteristics by insulin episode | ||||
| Combined CCI, mean (SD) | 0.1 (0.5) | 0 (0.6) | ||
| Hyperlipidemia, n (%) | 685 (14.0) | 74 (15.7) | ||
| Hypertension, n (%) | 459 (9.4) | 73 (15.5) | ||
| Metformin, n (%) | 137 (2.8) | 15 (3.2) | ||
| Peripheral neuropathy, n (%) | 68 (1.4) | 10 (2.1) | ||
| Retinopathy, n (%) | 195 (4.0) | 19 (4.0) | ||
| Hypoglycemia | MACE | |||
| Outcomes by insulin episode for all exposure cohorts | ||||
| Users with events, n | 13 | 15 | ||
| Episodes with events, n | 21 | 23 | ||
| Episodes per user with events, mean (SD) | 2.08 (1.7) | 2.00 (1.8) | ||
| Users with events per 10,000 years at risk, n | 35 | 40 | ||
| Episodes with events per 10,000 years at risk, n | 56.3 | 61.7 | ||
aDoes not include episodes in LAI + sulfonylurea (26 users, 34 events) or NPH + sulfonylurea (< 10 users, events not calculated).
CCI = Charlson Comorbidity Index; LAI = long-acting insulin; MACE = major adverse cardiac events; NPH = neutral protamine Hagedorn insulin; NC = not calculated; RAI = rapid-acting insulin; SD = standard deviation; T1DM = type 1 diabetes mellitus.