Table 1.
Characteristics of linaclotide users in the United Kingdom, Spain, and Sweden.
| United Kingdom | Spain | Sweden | |
|---|---|---|---|
| Total patients (N, %) | 1319 (100) | 1981 (100) | 5081 (100) |
| Age in years at index date | |||
| Mean (SD) | 46.7 (16.7) | 56.6 (16.6) | 50.6 (17.9) |
| ⩾65 years old (n, %) | 233 (17.7) | 719 (36.3) | 1195 (23.5) |
| 18–65 years old (n, %) | 1074 (81.4) | 1259 (63.6) | 3835 (75.5) |
| <18 years old (n, %) | 12 (0.9) | <5 (NA) a | 51 (1.0) |
| Gender (n, %) | |||
| Female | 1138 (86.3) | 1697 (85.7) | 4119 (81.1) |
| Year of index date (n, %) | |||
| 2013 | 126 (9.6) | 0 (0) | 332 (6.5) |
| 2014 | 386 (29.3) | 135 (6.8) | 1461 (28.8) |
| 2015 | 331 (25.1) | 706 (35.6) | 1293 (25.4) |
| 2016 | 280 (21.2) | 512 (25.8) | 1104 (21.7) |
| 2017 | 196 (14.9) | 628 (31.7) | 891 (17.5) |
| Follow-up time in years (n, %) | |||
| Mean, SD | 1.8 (1.2) | 1.1 (1) | 2.3 (1.2) |
| Median, IQR | 1.7 (2) | 1.0 (2) | 2.4 (2) |
| IBS diagnosis (n, %) | |||
| IBS-C | 535 (40.6) | 732 (37.0) | 1476 (29.0) |
| IBS-D | 52 (3.9) | <5 (NA) a | 19 (0.4) |
| IBS-M | 50 (3.8) | 11 (0.6) | 31 (0.6) |
| IBS-U | 141 (10.7) | 449 (22.7) | 66 (1.3) |
| Unknown diagnosis | 541 (41.0) | 787 (39.7) | 3489 (68.7) |
| Subgroups not sufficiently documented in the clinical program | |||
| Elderly (⩾65 years old) | 233 (17.7) | 719 (36.3) | 1195 (23.5) |
| Pregnant women b | <5 a (NA) | <5 a (NA) | 15 (0.3) |
| Males | 181 (13.7) | 284 (14.3) | 962 (18.9) |
| Hepatic or renal impairment | 126 (9.6) | 377 (19.0) | 172 (3.4) |
| Renal impairment | 87 (6.6) | 253 (12.8) | 68 (1.3) |
| Hepatic impairment | 45 (3.4) | 209 (10.6) | 109 (2.1) |
| Cardiovascular disease | 253 (19.2) | 820 (41.4) | 1051 (20.7) |
| Hypertension | 333 (25.2) | 570 (28.8) | 1349 (26.5) |
| Diabetes | 145 (11.0) | 231 (11.7) | 204 (4.0) |
| Potential misuse and off-label use | |||
| Mechanical bowel obstruction (MBO) or inflammatory bowel disease (IBD) | 46 (3.5) | 91 (4.6) | 290 (5.7) |
| MBO | <5 (NA) a | 48 (2.4) | 58 (1.1) |
| IBD | >41 (NA) | 44 (2.2) | 234 (4.6) |
| Potential off-label use | 225 (17.1) | 589 (29.7) | 84 (1.7) |
| Obesity | 160 (12.1) | 448 (22.6) | 21 (0.4) |
| Identified from BMI value ⩾ 30 kg/m2 | 158 (12.0) | 330 (16.7) | NA |
| Identified from clinical record | 11 (0.8) | 414 (20.9) | 21 (0.4) |
| Eating disorder | 8 (0.6) | 50 (2.5) | 63 (1.2) |
| Anorexia nervosa | 7 (0.5) | 22 (1.1) | 19 (0.4) |
| Bulimia | 0 (0) | 14 (0.7) | <5 (NA) a |
| BMI < 20 kg/m2 | 63 (4.8) | 135 (6.8) | NA |
| Other comorbidities (n, %) | |||
| Psychiatric disorders | 115 (8.7) | 1263 (63.8) | 718 (14.1) |
| Depression | 98 (7.4) | 481 (24.3) | 277 (5.5) |
| Anxiety | 72 (5.5) | 774 (39.1) | 320 (6.3) |
| Coeliac disease | 22 (1.7) | 32 (1.6) | 100 (2.0) |
| Food intolerance | 7 (0.5) | 45 (2.3) | 66 (1.3) |
| Colon cancer | 5 (0.4) | 32 (1.6) | 7 (0.1) |
| Comedications (n, %) | |||
| Laxatives | 949 (71.9) | 145 (7.3) | 3654 (71.9) |
| Antibiotics | 808 (61.3) | 88 (4.4) | 2073 (40.8) |
| Proton pump inhibitors | 680 (51.6) | 804 (40.6) | 2136 (42.0) |
| Antispasmodics | 621 (47.1) | 75 (3.8) | 6 (0.1) |
| Opioids | 577 (43.7) | 273 (13.8) | 1469 (28.9) |
| Antidepressants | 530 (40.2) | 742 (37.5) | 2007 (39.5) |
| Nonsteroidal anti-inflammatory drugs | 422 (32.0) | 50 (2.5) | 625 (12.3) |
| Other analgesics | 282 (21.4) | 563 (28.4) | 1900 (37.4) |
| Prokinetic drugs c | 208 (15.8) | 161 (8.1) | 448 (8.8) |
| Histamine type 2-receptor blockers | 110 (8.3) | 35 (1.8) | 154 (3.0) |
| Calcium and aluminum-containing antacids | 91 (6.9) | <5 (NA) a | 26 (0.5) |
| Magnesium-containing antacids | 0 (0) | 6 (0.3) | 0 (0) |
BMI, body mass index; IBS, irritable bowel syndrome; IBS-C, IBS predominantly with constipation; IBS-D, IBS predominantly with diarrhea; IBS-M, IBS with mixed bowel habits; IBS-U, IBS unsubtyped; IQR, interquartile range; NA, not applicable; SD, standard deviation.
a
Cells with counts less than 5 are blinded as per policy on data privacy at CPRD and at SIDIAP.
b
These are identified as pregnant at any time during the duration of linaclotide treatment.
c
Prokinetic drugs include the following: metoclopramide, cisapride, domperidone, bromopride, alizapride, clebopride, itopride, cinitapride, and physostigmine.