| |
Combination [12-15] |
4S trail [1] |
| Low dose (10-20 mg A or S) |
High dose (80 mg A or S) |
∆ (95 CI) |
placebo |
S |
∆ (95 CI) |
| Patients |
15,488 |
15,465 |
|
2,223 |
2,221 |
|
| Deaths |
1,626 (10.5) |
1,614 (10.4) |
0.0 (-0.7 to 0.7) |
256 (11.5) |
182 (8.2) |
3.3 (1.5 to 5.1)** |
| Cardiac deaths |
744 (4.8) |
723 (4.7) |
0.1 (-0.4 to 0.6) |
189 (8.5) |
111 (5.0) |
3.5 (2.0 to 5.0)** |
| MIs |
1,092 (7.1) |
907 (5.9) |
1.2 (0.7 to 1.7)** |
502 (22.6)a |
353 (15.9) |
6.7 (4.3 to 9.1)** |
| Strokes |
6.8 (3.9) |
525 (3.4) |
0.5 (0.1 to 0.9)* |
66 (3.0) |
43 (1.9) |
1.1 (0.2 to 2.0)* |
| In the combination, the high-dose arm (80 mg) is compared with the low-dose arm; in the 4S trial, the drug treatment arm is compared to placebo. In parentheses beside the number of patients is the percent of total patients in that category. ∆ is the percentage difference in the low-dose versus high-dose arms (combination) or S arm versus placebo (4S trial); the 95 confidence intervals for ∆ (95 CI) are shown in parentheses. * p < 0.05 by proportions test; ** p < 0.001 by proportions test with Z > 3. |
a In the 4S trial, major coronary was defined as definite or probable or silent MI, resuscitated cardiac arrest or intervention-associated MI. This accounts, in part, for why there are more MIs in the 4S trial than in the TNT, IDEAL and SEARCH trials which used less inclusive definitions. In the 4S trial, if only definite MIs are counted, the numbers are 270 (12.1) on placebo and 164 (7.4) on S with a differential of 4.7 (p < 0.001). |
|
