Table II.
Incidence rates and adjusted hazard ratios of safety outcomes in flavocoxid and NSAID users
| Outcome | Match | Exposure | Events, n | Person year | IR per 1000 PY (95% CI) | Adjusted* HR (95% CI) | IRD per 1000 PY (95% CI) | ||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Empty Cell | Fixed or Variable ratio | Ratio | Caliper width | ||||||
|
| |||||||||
| Hypersensitivity pneumonitis | Fixed | 2 | 0.05 | Flavocoxid | 1 | 945.8 | 1.1 (0.0–5.9) | NA | 1.1 (−1.0, 3.1) |
| NSAID | 0 | 1677.5 | 0.0 (0.0–2.2) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 1 | 881.4 | 1.1 (0.0–6.3) | 3.88 (0.24–63.51) | 1.0 (−1.2, 3.2) | |
| NSAID | 1 | 6105.1 | 0.2 (0.0–0.9) | ||||||
| Any hospitalized liver injury | Fixed | 2 | 0.05 | Flavocoxid | 3 | 944.8 | 3.2 (0.7–9.3) | 1.16 (0.23–6.01) | 0.8 (−3.5, 5.1) |
| NSAID | 4 | 1674.5 | 2.4 (0.7–6.1) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 3 | 880.4 | 3.4 (0.7–10.0) | 2.40 (0.63–9.11) | 2.1 (−1.9, 6.0) | |
| NSAID | 8 | 6101.9 | 1.3 (0.6–2.6) | ||||||
| Hospitalized drug induced liver injury | Fixed | 2 | 0.05 | Flavocoxid | 1 | 946.0 | 1.1 (0.1–5.9) | 0.53 (0.05–6.33) | −0.7 (−3.6, 2.2) |
| NSAID | 3 | 1675.4 | 1.8 (0.4–5.2) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 1 | 881.6 | 1.1 (0.0–6.3) | 1.05 (0.13–8.73) | 0.2 (−2.2, 2.5) | |
| NSAID | 6 | 6102.8 | 1.0 (0.4–2.1) | ||||||
| Hospitalized GI bleeding (sensitive) | Fixed | 2 | 0.05 | Flavocoxid | 5 | 945.3 | 5.3 (1.7–12.3) | 0.49 (0.18–1.34) | −4.8 (−11.6, 1.8) |
| NSAID | 17 | 1673.3 | 10.2 (5.9–16.3) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 3 | 881.4 | 3.4 (0.7–9.9) | 0.55 (0.18–1.68) | −4.6† (−9.0, −0.2) | |
| NSAID | 49 | 6095.7 | 8.0 (5.9–10.6) | ||||||
| Hospitalized GI bleeding (specific) | Fixed | 2 | 0.05 | Flavocoxid | 1 | 946.1 | 1.1 (0.0–5.9) | 0.30 (0.03–2.93) | −1.9 (−5.3, 1.4) |
| NSAID | 5 | 1676.1 | 3.0 (1.0–7.0) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 1 | 881.7 | 1.1 (0.0–6.3) | 0.36 (0.05–2.70) | −1.7 (−4.2, 0.9) | |
| NSAID | 17 | 6102.3 | 2.8 (1.6–4.5) | ||||||
| Myocardial infarction | Fixed | 2 | 0.05 | Flavocoxid | 2 | 945.7 | 2.1 (0.3–7.6) | 0.91 (0.15–5.63) | −0.3 (−4.0, 3.5) |
| NSAID | 4 | 1677.0 | 2.4 (0.6–6.1) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 1 | 881.4 | 1.1 (0.0–6.3) | 0.30 (0.03–2.92) | −3.5† (−6.2, −0.7) | |
| NSAID | 28 | 6099.6 | 4.6 (3.1–6.6) | ||||||
| Acute kidney injury | Fixed | 2 | 0.05 | Flavocoxid | 13 | 943.8 | 13.8 (7.3–23.6) | 1.43 (0.70–2.93) | 3.0 (−6.0, 12.0) |
| NSAID | 18 | 1674.6 | 10.7 (6.4–17.0) | ||||||
| Variable | 10 | 0.01 | Flavocoxid | 10 | 880.7 | 11.4 (5.4–20.9) | 1.49 (0.70–3.20) | 3.0 (−4.4, 10.4) | |
| NSAID | 51 | 6095.9 | 8.4 (6.2–11.0) | ||||||
CI = Confidence interval, GI = Gastrointestinal, HR = Hazard Ratio; IRD=Incidence rate difference; NA = Not able to estimate given 0 cases in referent group; NSAIDs = Non-steroidal anti-inflammatory drugs, PS = propensity score; PY = person years; NA = not assessable (zero events in referent exposure group).
*
Reference = NSAID, adjusted for covariates with SMD>0.1 after propensity score match.
†
denotes an incidence rate difference with a 95% confidence interval that does not include 0.