Table 2.
Characteristics of incident PPI-users
| Age groups (years) | 0–19 | 20–34 | 35–49 | 50–64 | 65–79 | 80 + | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N (%) |
21,210 (3.7) |
85,243 (14.9) |
120,557 (21.1) |
166,944 (29.2) |
121,737 (21.3) |
56,233 (9.8) |
571,924 (100.0) |
||||||
| Women (%) | 57.6 | 56.1 | 56.8 | 56.1 | 58.3 | 64.2 | 57.6 | ||||||
|
German-DDD: median (25th percentile, 75th percentile) |
30 (28, 74) |
60 (30, 120) |
60 (30, 180) |
100 (58, 210) |
130 (60, 336) |
200 (90, 508) |
100 (56, 208) |
||||||
|
WHO-DDD: median (25th percentile, 75th percentile) |
30 (14, 55) |
30 (15, 60) |
45 (28, 100) |
60 (30, 120) |
86 (30, 200) |
100 (50, 280) |
60 (30, 120) |
||||||
| Long-term users (German-DDD > 180) (%) | 8.7 | 16.0 | 25.6 | 34.3 | 46.3 | 57.3 | 33.6 | ||||||
| Long-term users (WHO-DDD > 180) (%) | 4.1 | 6.3 | 12.0 | 18.3 | 27.4 | 37.6 | 18.5 | ||||||
| PPI on-label indications (previous, same, or one quarter after first PPI prescription) | |||||||||||||
| Gastroesophageal reflux disease (GERD) (K21) (%) | 10.9 | 16.8 | 21.3 | 23.9 | 24.7 | 18.5 | 21.5 | ||||||
|
Heartburn (R12) (%) |
2.9 | 4.8 | 4.1 | 3.5 | 2.7 | 1.6 | 3.4 | ||||||
|
Peptic ulcer (K25-K28) (%) |
0.7 | 1.5 | 1.9 | 2.4 | 3.1 | 3.6 | 2.4 | ||||||
|
Helicobacter pylori (B98) (%) |
1.4 | 2.2 | 2.8 | 2.6 | 2.1 | 1.0 | 2.3 | ||||||
|
Esophagitis (K20) (%) |
0.6 | 0.6 | 0.7 | 0.7 | 0.7 | 0.5 | 0.6 | ||||||
|
Zollinger-Ellison syndrome (E16.4) (%) |
0.00 | 0.01 | 0.01 | 0.02 | 0.01 | 0.01 | 0.01 | ||||||
| Co-medications (up to 90 days before or at same day as first PPI prescription) | |||||||||||||
|
NSAID‡ (M01A, M01B, N02A, N02B, C10BX) (%) |
35.3 | 39.8 | 48.1 | 51.1 | 48.9 | 55.8 | 48.2 | ||||||
|
Antithrombotic drugs (B01A) (%) |
5.4 | 5.0 | 5.7 | 11.0 | 23.7 | 37.1 | 14.0 | ||||||
|
Corticosteroids (H02) (%) |
3.7 | 5.4 | 7.6 | 8.5 | 9.7 | 9.6 | 8.0 | ||||||
|
SSRI§ (N06AB) (%) |
1.0 | 2.1 | 3.3 | 3.9 | 3.6 | 5.1 | 3.5 | ||||||
| PPIs possibly used to prevent medication-related ulceration (on-label indication)† (%) | 6.6 | 7.6 | 10.1 | 14.4 | 57.9 | 69.2 | 26.8 | ||||||
| Proportion without on-label PPI-indication (including†) at first intake (%) | 78.8 | 70.7 | 64.9 | 59.7 | 25.0 | 21.3 | 52.0 | ||||||
| Proportion without PPI on-label (including†) or off-label indication at first intake (%) | 42.9 | 41.7 | 43.8 | 42.9 | 16.6 | 15.4 | 34.6 | ||||||
| Off-label indications (previous, same, or one quarter after first PPI prescription) in users without documentation of an on-label indication | |||||||||||||
| Age groups (years) | 0–19 | 20–34 | 35–49 | 50–64 | 65–79 | 80 + | Total | ||||||
| N (%) |
16,702 (5.6) |
60,258 (20.3) |
78,279 (26.3) |
99,706 (33.5) |
30,397 (10.2) |
11,979 (4.0) |
297,321 (100.0) |
||||||
|
Gastritis/duodenitis (K29) (%) |
34.5 | 30.4 | 23.6 | 20.1 | 23.0 | 18.0 | 24.1 | ||||||
| Upper stomach pain/dyspepsia, not specified (R10.1) (%) | 13.0 | 12.3 | 9.4 | 6.8 | 6.9 | 4.5 | 8.8 | ||||||
|
Hernia diaphragmatica (K44) (%) |
0.4 | 1.0 | 1.6 | 2.4 | 4.6 | 3.7 | 2.1 | ||||||
| Other diseases of stomach/duodenum (K31) (%) | 2.1 | 2.2 | 2.0 | 1.8 | 2.3 | 1.7 | 2.0 | ||||||
|
Dyspepsia (K30) (%) |
1.8 | 2.0 | 1.5 | 1.3 | 1.4 | 1.3 | 1.5 | ||||||
| Other diseases of the digestive system incl. bleeding, (K92) (%) | 1.5 | 1.4 | 1.1 | 1.3 | 2.0 | 2.8 | 1.4 | ||||||
|
Other diseases of esophagus (K22, K23) (%) |
0.2 | 0.3 | 0.4 | 0.8 | 1.8 | 1.5 | 0.7 | ||||||
|
Crohn’s disease (K50) (%) |
0.7 | 1.1 | 0.8 | 0.6 | 0.5 | 0.2 | 0.7 | ||||||
| Cancer of esophagus/stomach (C15, C16) (%) | 0.0 | 0.0 | 0.1 | 0.3 | 0.8 | 1.1 | 0.2 | ||||||
need for gastro-protection modified according to Fischbach, 2019:
-age > = 65 years: monotherapy with NSAID OR ASA (as anti-thrombotic agent, ATC = B01AC06) OR DOAC OR VKA OR combination of at least two other types of antithrombotic medication
-age < 65 years: prescription of NSAID together with anti-thrombotic medication or corticosteroid or SSRI or diagnosis of ulcer; prescription of ASA OR DOAC OR VKA together with corticosteroid or SSRI or diagnosis of ulcer; prescription of a combination of different classes of anti-thrombotic medications (i.e. Heparin and DOAC) or dual platelet inhibition (ASA with clopidogrel, prasugrel or ticagrelor)
NSAID non-steroidal anti-inflammatory drug, SSRI selective serotonin reuptake inhibitor, ASA acetylsalicylic acid, DOAC direct oral anticoagulant, VKA vitamin K-antagonist