Table 2. Association between lansoprazole and incident TB disease, compared with omeprazole or pantoprazole.
Outcome Exposure Group |
Pyrs at Risk (x100,000) |
TB Cases (n) | Rate of TB Per 100,000 pyrs |
Crude HR (95% CI): | Adjusted* HR (95% CI): |
---|---|---|---|---|---|
Primary Analysis: TB date = CPRD date − 12 months | |||||
All PPI exposure included | |||||
Omep/pantop exposed | 12.6 | 193 | 15.3 (13.3–17.7) | Referent | Referent |
Lansop exposed | 8.6 | 86 | 10.0 (8.1–12.4) | 0.65 (0.51–0.84) | 0.68 (0.52–0.89) |
Censored at 1st break | |||||
Omep/pantop exposed | 5.6 | 76 | 13.6 (10.9–17.0) | Referent | Referent |
Lansop exposed | 3.7 | 32 | 8.6 (6.1–12.2) | 0.63 (0.42–0.95) | 0.59 (0.36–0.97) |
Post-treatment periods only | |||||
Post omep/pantop | 22.7 | 251 | 11.0 (9.8–12.5) | Referent | Referent |
Post lansop | 15.0 | 143 | 9.6 (8.1–11.3) | 0.87 (0.70–1.06) | 0.94 (0.73–1.21) |
Sensitivity Analyses | |||||
TB date = CPRD recorded date—All PPI exposure included | |||||
Omep/pantop | 15.7 | 322 | 20.5 (18.4–22.9) | Referent | Referent |
Lansop | 10.4 | 157 | 15.1 (12.9–17.7) | 0.74 (0.61–0.89) | 0.75 (0.62–0.92) |
TB date = CPRD date − 24 months—All PPI exposure included | |||||
Omep/pantop | 10.0 | 139 | 13.9 (11.7–16.4) | Referent | Referent |
Lansop | 7.1 | 72 | 10.2 (8.9–11.0) | 0.73 (0.55–0.98) | 0.77 (0.57–1.04) |
TB date = CPRD date − 5 years)—All PPI exposure included | |||||
Omep/pantop | 4.6 | 67 | 14.4 (11.3–18.3) | Referent | Referent |
Lansop | 3.8 | 34 | 9.0 (6.4–12.6) | 0.63 (0.41–0.95) | 0.72 (0.47–1.09) |
TB Sensitivity Analysis: definition (earliest of HES and CPRD record − 12 months; note reduced population size due to linkage eligibility)—All PPI exposure included | |||||
Omep/pantop | 7.1 | 101 | 14.2 (11.7–17.3) | Referent | Referent |
Lansop | 5.1 | 61 | 12.0 (9.3–15.4) | 0.84 (0.61–1.15) | 0.86 (0.61–1.19) |
TB date = CPRD recorded date − 12 months in white patients only—All PPI exposure included | |||||
Omep/pantop | 7.8 | 100 | 12.8 (10.6–15.6) | Referent | Referent |
Lansop | 5.3 | 50 | 9.4 (7.2–12.5) | 0.73 (0.52–1.03) | 0.72 (0.51–1.02) |
Excluding people with <28 days total supply of PPI—All PPI exposure included | |||||
Omep/pantop | 12.3 | 190 | 15.3 (13.3–17.7) | Referent | Referent |
Lansop | 8.4 | 84 | 10.0 (8.1–12.4) | 0.65 (0.50–0.84) | 0.67 (0.51–0.88) |
Excluding people with prior isoniazid exposure—All PPI exposure included | |||||
Omep/pantop | 12.6 | 193 | 15.3 (13.3–17.7) | Referent | Referent |
Lansop | 8.6 | 85 | 10.0 (8.0–12.3) | 0.65 (0.50–0.83) | 0.67 (0.52–0.88) |
*Adjusted for age (continuous), sex, calendar year (categorised as 1989–1993, 1994–2012 in single years, 2013–2015), annual practice lansoprazole prescribing proportion (quartile), asthma, blood cancer, COPD, depression, diabetes, poorly controlled diabetes, drug abuse, HIV, IBD, RA, prior use of antimalarials, practice index of multiple deprivation quintile, inhaled corticosteroids, oral corticosteroids, and travel vaccines
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; CPRD, Clinical Practice Research Datalink; HES, Hospital Episode Statistics; HR, hazard ratio; IBD, inflammatory bowel disease; PPI, proton pump inhibitor; pyrs: person-years; TB, tuberculosis