Table 3.
Acute pancreatitis incidence rates (IR) and incident rate ratios (IRR; crude and adjusted)
| Characteristic | MMX mesalazine | All comparators | IRR (95 % CI)a |
|---|---|---|---|
| Crude rates | |||
| Events, n | 20 | 46 | |
| Person-time, years | 2,338.2 | 4,576.1 | |
| IR (95 % CI)b | 8.55 (5.54–13.21) | 10.05 (7.54–13.41) | 0.85 (0.48–1.47) |
| Age categories, years IR (95 % CI)b | |||
| 18–29 | 20.03 (10.15–39.53) | 29.70 (18.78–46.94) | 0.67 (0.25–1.63) |
| 30–39 | 10.68 (4.56–25.00) | 10.27 (5.20–20.27) | 1.04 (0.27–3.60) |
| 40–49 | 5.52 (1.88–16.22) | 4.32 (1.68–11.11) | 1.28 (0.19–7.55) |
| ≥50 | 4.32 (1.68–11.10) | 7.06 (4.35–11.47) | 0.61 (0.15–1.89) |
| Gender, IR (95 % CI)b | |||
| Female | 10.91 (6.37–18.66) | 8.94 (5.84–13.66) | 1.22 (0.56–2.55) |
| Male | 6.11 (2.96–12.61) | 11.23 (7.61–16.58) | 0.54 (0.20–1.29) |
| Adjusted rates | |||
| Events, n | 20 | 21 | |
| Person-time, years | 2,220.07 | 1,958.90 | |
| Propensity-matched IR (95 % CI)b | 9.01 (5.81–13.96) | 10.72 (6.99–16.44) | 0.84 (0.46–1.55) |
| Adjusted 1 IR (95 % CI)c | 4.40 (1.94–9.98) | 5.62 (2.57–12.31) | 0.78 (0.42–1.46) |
| Adjusted 2 IR (95 % CI)d | 2.37 (0.91–6.15) | 3.10 (1.24–7.75) | 0.76 (0.41–1.43) |
| Age categories, years | |||
| 18–29 | |||
| Propensity-matched IR (95 % CI)b | 21.43 (10.72–42.86) | 26.77 (13.93–51.45) | 0.80 (0.31–2.08) |
| Adjusted 1 IR (95 % CI)c | 25.17 (10.50–60.33) | 32.76 (15.15–70.83) | 0.77 (0.29–2.01) |
| Adjusted 2 IR (95 % CI)d | 22.77 (8.52–60.86) | 30.66 (12.89–72.96) | 0.74 (0.28–1.95) |
| 30–39 | |||
| Propensity-matched IR (95 % CI)b | 11.10 (4.62–26.67) | 12.16 (5.06–29.22) | 0.91 (0.26–3.15) |
| Adjusted 1 IR (95 % CI)c | 9.06 (1.78–46.10) | 10.89 (3.01–39.38) | 0.83 (0.21–3.23) |
| Adjusted 2 IR (95 % CI)d | 3.61 (0.42–30.63) | 4.35 (0.78–24.29) | 0.83 (0.20–3.44) |
| 40–49 | |||
| Propensity-matched IR (95 % CI)b | 5.80 (1.87–17.99) | 4.80 (1.20–19.17) | 1.21 (0.20–7.24) |
| Adjusted 1 IR (95 % CI)c | 2.13 (0.26–17.66) | 1.89 (0.20–17.76) | 1.13 (0.18–6.99) |
| Adjusted 2 IR (95 % CI)d | 1.42 (0.13–15.19) | 1.25 (0.10–15.80) | 1.13 (0.18–7.00) |
| ≥50 | |||
| Propensity-matched IR (95 % CI)b | 4.55 (1.71–12.12) | 6.29 (2.62–15.12) | 0.72 (0.19–2.69) |
| Adjusted 1 IR (95 % CI)c | 3.56 (0.39–32.19) | 4.60 (0.99–21.25) | 0.77 (0.16–3.80) |
| Adjusted 2 IR (95 % CI)d | 1.80 (0.17–19.15) | 2.26 (0.37–13.86) | 0.80 (0.16–3.97) |
| Gender | |||
| Female | |||
| Propensity-matched IR (95 % CI)b | 11.52 (6.69–19.83) | 6.95 (3.32–14.59) | 1.66 (0.66–4.15) |
| Adjusted 1 IR (95 % CI)c | 7.72 (3.05–19.55) | 4.94 (1.81–13.51) | 1.56 (0.61–4.00) |
| Adjusted 2 IR (95 % CI)d | 3.58 (1.12–11.46) | 2.35 (0.70–7.83) | 1.52 (0.59–3.92) |
| Male | |||
| Propensity-matched IR (95 % CI)b | 6.41 (3.06–13.46) | 14.70 (8.71–24.82) | 0.44 (0.18–1.08) |
| Adjusted 1 IR (95 % CI)c | 2.00 (0.54–7.45) | 4.70 (1.43–15.38) | 0.43 (0.17–1.07) |
| Adjusted 2 IR (95 % CI)d | 1.05 (0.22–5.10) | 2.52 (0.58–10.98) | 0.42 (0.17–1.04) |
CI confidence interval
aMMX mesalazine relative to all comparators
bPer 1000 person-years
cAdjustment 1, adjusted for age category, gender, and daily dose
dAdjustment 2, adjusted for age category, gender, daily dose, steroids, enalapril, viral herpes, furosemide, sulfasalazine, and post-surgery procedures