TABLE 1.
Patient Demographics and Clinical Characteristics Assessed at the Index Date or During the Baseline Period
| Index treatment | All patients(N = 14,700) | ||||
|---|---|---|---|---|---|
| Prucalopride(n = 675) | Lubiprostone(n = 1,591) | Linaclotide(n = 11,105) | Plecanatide(n = 1,329) | ||
| Index date characteristics | |||||
| Age, years, mean (SD) | 47.02 (14.41) | 50.89 (17.15) | 48.04 (14.74) | 47.73 (13.56) | 48.27 (14.93) |
| Sex, n (%) | |||||
| Female | 586 (86.8) | 1,276 (80.2) | 9,035 (81.4) | 1,139 (85.7) | 12,036 (81.9) |
| Male | 89 (13.2) | 315 (19.8) | 2,070 (18.6) | 190 (14.3) | 2,664 (18.1) |
| US region, n (%) | |||||
| South | 322 (47.7) | 882 (55.4) | 6,747 (60.8) | 854 (64.3) | 8,805 (59.9) |
| Northeast | 194 (28.7) | 327 (20.6) | 1,967 (17.7) | 245 (18.4) | 2,733 (18.6) |
| North central | 85 (12.6) | 275 (17.3) | 1,601 (14.4) | 149 (11.2) | 2,110 (14.4) |
| West | 72 (10.7) | 104 (6.5) | 781 (7.0) | 79 (5.9) | 1,036 (7.0) |
| Unknown | 2 (0.3) | 3 (0.2) | 9 (0.1) | 2 (0.2) | 16 (0.1) |
| Insurance plan type, n (%) | |||||
| Basic/major medical, comprehensive, or EPO | 18 (2.7) | 76 (4.8) | 441 (4.0) | 57 (4.3) | 592 (4.0) |
| HMO | 49 (7.3) | 166 (10.4) | 1,145 (10.3) | 137 (10.3) | 1,497 (10.2) |
| POS | 67 (9.9) | 94 (5.9) | 813 (7.3) | 121 (9.1) | 1,095 (7.4) |
| PPO | 401 (59.4) | 930 (58.5) | 6,348 (57.2) | 726 (54.6) | 8,405 (57.2) |
| PPO with capitation | 0 (0.0) | 31 (1.9) | 101 (0.9) | 14 (1.1) | 146 (1.0) |
| CDHP | 87 (12.9) | 160 (10.1) | 1,389 (12.5) | 155 (11.7) | 1,791 (12.2) |
| HDHP | 48 (7.1) | 111 (7.0) | 711 (6.4) | 112 (8.4) | 982 (6.7) |
| Unknown | 5 (0.7) | 23 (1.4) | 157 (1.4) | 7 (0.5) | 192 (1.3) |
| Any constipation-related treatment before the index date,a n (%) | |||||
| Yes | 208 (30.8) | 225 (14.1) | 314 (2.8) | 276 (20.8) | 1,023 (7.0) |
| Baseline characteristicsb | |||||
| CCI score, mean (SD) | 0.61 (1.16) | 0.70 (1.45) | 0.52 (1.13) | 0.51 (1.04) | 0.54 (1.16) |
| Selected comorbidities, n (%) | |||||
| Anxiety | 176 (26.1) | 344 (21.6) | 2,336 (21.0) | 289 (21.7) | 3,145 (21.4) |
| Chronic pulmonary disease | 90 (13.3) | 180 (11.3) | 1,171 (10.5) | 148 (11.1) | 1,589 (10.8) |
| Depression | 156 (23.1) | 289 (18.2) | 1,736 (15.6) | 217 (16.3) | 2,398 (16.3) |
| Diabetes | 90 (13.3) | 205 (12.9) | 1,554 (14.0) | 155 (11.7) | 2,004 (13.6) |
| Fatigue | 125 (18.5) | 245 (15.4) | 1,548 (13.9) | 221 (16.6) | 2,139 (14.6) |
| Gastroesophageal reflux disease | 217 (32.1) | 419 (26.3) | 2,519 (22.7) | 339 (25.5) | 3,494 (23.8) |
| Hyperlipidemia | 154 (22.8) | 468 (29.4) | 3,105 (28.0) | 354 (26.6) | 4,081 (27.8) |
| Hypertension | 165 (24.4) | 522 (32.8) | 3,377 (30.4) | 346 (26.0) | 4,410 (30.0) |
| Hypothyroidism | 137 (20.3) | 259 (16.3) | 1,606 (14.5) | 202 (15.2) | 2,204 (15.0) |
| Migraine | 82 (12.1) | 133 (8.4) | 909 (8.2) | 133 (10.0) | 1,257 (8.6) |
| Overweight/obesity | 83 (12.3) | 253 (15.9) | 1,691 (15.2) | 193 (14.5) | 2,220 (15.1) |
| Congestive heart failure | 16 (2.4) | 58 (3.6) | 240 (2.2) | 22 (1.7) | 336 (2.3) |
| Constipation-related HCRU,c n (%) | |||||
| Inpatient visits | 15 (2.2) | 36 (2.3) | 130 (1.2) | 12 (0.9) | 193 (1.3) |
| ED visits | 38 (5.6) | 113 (7.1) | 674 (6.1) | 67 (5.0) | 892 (6.1) |
| Outpatient visits | 531 (78.7) | 1,029 (64.7) | 6,676 (60.1) | 979 (73.7) | 9,215 (62.7) |
| Outpatient office/clinic or urgent care visits | 523 (77.5) | 1,010 (63.5) | 6,564 (59.1) | 964 (72.5) | 9,061 (61.6) |
| Outpatient hospital/surgical center visits | 20 (3.0) | 38 (2.4) | 238 (2.1) | 45 (3.4) | 341 (2.3) |
Index dates were defined as the date of the first prescription fill for prucalopride, lubiprostone, linaclotide, or plecanatide on or after April 2, 2019.
aIncludes use of lubiprostone, linaclotide, or plecanatide.
b Baseline characteristics were evaluated during the baseline period, which was defined as the 6 months before the index date.
cConstipation-related HCRU was defined as HCRU for which a diagnosis code for constipation can be found in 1 of the first 3 positions for the corresponding claim (constipation-related diagnosis codes are reported in Supplementary Table 2 (333.2KB, pdf) ).
CCI = Charlson Comorbidity Index; CDHP = consumer-directed health plan; ED = emergency department; EPO = exclusive provider organization; HCRU = health care resource utilization; HDHP = high deductible health plan; HMO = health maintenance organization; POS = point of service plan; PPO = preferred provider organization.