Table 1.
Distribution of demographic, cardiovascular, and gastrointestinal covariates after trimming between exposure cohorts
| Covariate | UK (CPRD, THIN, ISD) | SNR | GePaRD | |||
|---|---|---|---|---|---|---|
| Prucalopride N = 2521 |
PEG N = 12,603 |
Prucalopride N = 3194 |
PEG N = 16,769 |
Prucalopride N = 5326 |
PEG N = 25,388 |
|
| Sex, female | 95.2 | 95.5 | 90.6 | 91.4 | 88.5 | 88.1 |
| Age, 18–54 years | 71.5 | 72.8 | 45.7 | 46.8 | 34.9 | 32.9 |
| At least one cardiovascular risk factora | 60.5 | 59.1 | 55.5 | 51.8 | 76.7 | 79.7 |
| History of hospitalization for CVD | 5.4 | 4.3 | 6.5 | 6.4 | 11.6 | 14.6 |
| Any revascularization procedures | 1.5 | 1.3 | 3.2 | 3.4 | 6.4 | 8.1 |
| Aspirin and other antiplatelets | 14.6 | 12.1 | 19.9 | 19.7 | 11.5 | 13.8 |
| Statins | 17.3 | 15.7 | 23.9 | 22.7 | 21.3 | 22.6 |
| Antihypertensives | 42.1 | 36.1 | 49.6 | 46.5 | 56.1 | 61.9 |
| Antidiabetics | 7.0 | 6.0 | 9.6 | 9.8 | 9.9 | 12.6 |
| Anticoagulants | 3.2 | 2.8 | 16.4 | 15.5 | 20.3 | 28.0 |
| Hyperlipidemia diagnosis | 8.8 | 7.7 | 7.1 | 6.8 | 43.8 | 44.3 |
| Hypertension diagnosis | 13.7 | 13.7 | 21.0 | 21.8 | 54.7 | 60.2 |
| Obesityb | 17.4 | 21.2 | 0.8 | 0.6 | NA | NA |
| Obesity treatments | 6.6 | 5.5 | 1.2 | 1.3 | 0.0 | 0.1 |
| Diabetes diagnosis | 6.7 | 5.4 | 8.2 | 8.7 | 17.9 | 21.8 |
| Chronic renal disease diagnosis | 3.6 | 3.3 | 1.1 | 1.3 | 10.9 | 14.9 |
| Cancer | 5.9 | 6.6 | 9.1 | 10.5 | 27.3 | 40.9 |
| Smoking (CPRD/THIN only)c | ||||||
| Never smoker | 49.1 | 48.2 | NA | NA | NA | NA |
| Former smoker | 31.0 | 29.5 | NA | NA | NA | NA |
| Current smoker | 19.2 | 21.2 | NA | NA | NA | NA |
| Unknown | 0.7 | 1.1 | NA | NA | NA | NA |
| COPD diagnosis | 3.6 | 3.3 | 3.7 | 4.3 | 35.2 | 36.6 |
| Asthma without COPD diagnosis | 17.9 | 13.8 | 8.1 | 6.4 | 5.5 | 4.9 |
| Recent hospitalizationd | 6.4 | 7.6 | 2.7 | 2.5 | 5.9 | 15.9 |
| Number of outpatient medical visits with constipation diagnoses (CPRD/THIN/SNR/GePaRD only) ≥ 1e | 76.9 | 40.4 | 34.0 | 7.4 | 48.1 | 13.9 |
| Number of medical visits with IBS diagnoses (CPRD/THIN/SNR/GePaRD only) ≥ 1e | 34.5 | 17.8 | 11.8 | 2.3 | 19.9 | 5.1 |
| Number of unique other gastrointestinal-related outpatient diagnoses (CPRD/THIN/SNR/GePaRD only), 1–12f | 44.3 | 31.1 | 46.9 | 32.6 | 83.0 | 69.0 |
| Constipation inpatient diagnosis (CPRD/ISD/SNR/GePaRD only) | 38.2 | 5.5 | 7.6 | 1.9 | 19.5 | 12.8 |
| IBS inpatient diagnosis (CPRD/ISD/SNR/GePaRD only) | 5.5 | 1.7 | 1.8 | 0.4 | 2.1 | 0.5 |
| Other gastrointestinal-related inpatient diagnosis (CPRD/ISD/SNR/GePaRD only) | 39.0 | 20.4 | 24.3 | 14.6 | 39.8 | 37.6 |
| Prescription or dispensing for opioid medicationsg | 36.5 | 36.2 | 25.3 | 31.3 | 20.8 | 44.0 |
| Chronic opioid useh | 33.8 | 30.2 | 21.9 | 23.3 | 18.1 | 36.7 |
| Economic deprivation category (UK only) | ||||||
| Q1 (least deprived) | 22.1 | 19.3 | NA | NA | NA | NA |
| Q2 | 19.0 | 18.4 | NA | NA | NA | NA |
| Q3 | 20.1 | 20.5 | NA | NA | NA | NA |
| Q4 | 19.0 | 20.9 | NA | NA | NA | NA |
| Q5 (most deprived) | 18.8 | 19.7 | NA | NA | NA | NA |
| Unknown | 1.1 | 1.1 | NA | NA | NA | NA |
| Economic deprivation category (SNR only) | ||||||
| Q1 (least deprived) | NA | NA | 24.9 | 21.8 | NA | NA |
| Q2 | NA | NA | 24.6 | 24.7 | NA | NA |
| Q3 | NA | NA | 25.3 | 24.5 | NA | NA |
| Q4 (most deprived) | NA | NA | 25.3 | 29.0 | NA | NA |
Data are presented as %
BMI body mass index, COPD chronic obstructive pulmonary disease, CPRD Clinical Practice Research Datalink, CVD cardiovascular disease, GePaRD German Pharmacoepidemiological Research Database, IBS irritable bowel syndrome, ISD Information Services Division, MACE major adverse cardiovascular events, NA not applicable, PEG polyethylene glycol 3350, SNR Swedish National Registers, THIN The Health Improvement Network
aHistory of CVD (including all MACE component endpoints), hypertension, smoking, hyperlipidemia, diabetes, aged > 55 years, or BMI > 30 kg/m2
bNot available for ISD; for CPRD and THIN defined as whether or not BMI > 30 kg/m2 documented within the prior 3 years of cohort entry and for SNR based on recorded diagnosis of obesity prior to cohort entry date
cIdentified using the information reported closest in time to the cohort entry date within the prior 10 years
dAny hospitalization, regardless of diagnosis, in the 14 days immediately preceding cohort entry
eDiagnoses occurring any time before taking the index study medication
fTotal number of unique other gastrointestinal diagnoses occurring any time before the index study medication. Other gastrointestinal diagnoses considered were esophageal conditions, gastroduodenal conditions, appendicitis, hernias, intestinal conditions, peritonitis, liver conditions, biliary conditions, pancreatic conditions, gastrointestinal hemorrhage, malabsorption, and inflammatory bowel disease
gOccurring in the 6 months before cohort entry
hChronic opioid use was defined as more than one unique prescription or dispensing (i.e. occurring on separate days) for an opioid during the 12 months before the index date