Table 2.
Proportions, rates, and hazard ratios for ADAPT participants classified by treatment assignment and contrasting intervals of observation.
| Treatment assignment: | Naproxen | Celecoxib | Placebo | |
|---|---|---|---|---|
| Primary intention-to-treat analysis: | ||||
| 1 | No. of participants (person-years) | 655 (2,220) | 668 (2,234) | 985 (3,336) |
| 2 | AD cases (rate) | 18 (0.008) | 24 (0.011) | 30 (0.009) |
| 3 | AD rate ratio vs. placebo (CI) | 0.90 (0.47–1.67) | 1.2 (0.67–2.1) | -- |
| 4 | Deaths (rate) | 24 (0.011) | 31 (0.014) | 38 (0.012) |
| 5 | Death rate ratio vs. placebo (CI) | 0.94 (0.54–1.62) | 1.23 (0.74–2.03) | -- |
| 6 | AD or death (rate) | 50 (0.023) | 60 (0.027) | 77 (0.023) |
| 7 | AD or death ratio vs. placebo (CI) | 0.89 (0.59–1.34) | 1.1 (0.78–1.67) | -- |
| Secondary analyses: | ||||
| 8 | A. Participants (person-years) after exclusion of prevalent AD | 652 (2,220) | 667 (2,234) | 981 (3,336) |
| 9 | AD cases (rate)* | 15 (0.007) | 23 (0.010) | 26 (0.008) |
| 10 | AD rate ratio vs. placebo (CI) | 0.87 (0.43–1.70) | 1.2 (0.72–2.41) | -- |
| 11 | Improvement in proportional hazards models by interaction with time before or after 2.5 yrs. following randomization | P = 0.013 | P = 0.074 | -- |
| 12 | AD cases early (person-years) HR-early (CI) | 9 (1,241) 2.67 (0.88–8.07) | 10 (1,289) 3.01 (1.02–8.94) | 5 (1,876) -- |
| 13 | AD cases late (person-years) HR-late (CI) | 6 (979) 0.43 (0.17–1.08) | 13 (945) 0.93 (0.46–1.87) | 21 (1,460) -- |
| 14 | B. Participants (person-years) with CIND at enrollment | 15 (32) | 16 (47) | 23 (66) |
| 15 | AD cases (rate) | 4 (0.12) | 7 (0.15) | 4 (0.06) |
| 16 | HR (CI) | 3.2 (0.72–13.8) | 4.0 (1.00–15.6) | -- |
| 17 | C. Participants (person-years) with no cognitive diagnosis at enrollment | 637 (2,163) | 651 (2,169) | 958 (3,217) |
| 18 | AD cases (rate)* | 11 (0.005) | 16 (0.007) | 22 (0.007) |
| 19 | AD rate ratio vs. placebo (CI) | 0.74 (0.33–1.60) | 1.1 (0.53–2.15) | -- |
| 20 | Improvement in model by term for interaction with time before or after 2.5 yrs. following randomization | P = 0.016 | P = 0.037 | -- |
| 21 | AD cases early (person-years) HR-early (CI) | 7 (1,212) 2.50 (0.72–8.7) | 8 (1,252) 3.11 (0.92–11) | 4 (1,828) -- |
| 22 | AD cases late (person-years) HR-late (CI) | 4 (952) 0.33 (0.11–0.98) | 8 (917) 0.64 (0.28–1.5) | 18 (1,390) -- |
Raw data are shown in conventional font; estimated or derived results in italics. HR = hazard ratio; CI = 95% confidence interval; “early” and “later” identify times before and after 2.5 years following randomization; CIND = cognitive impairment, no dementia.
*
Proportional hazards assumption violation; we did not calculate HRs for these analyses.